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Biotechnology Jobs & Careers Search

Find your next job in Biotechnology. Search Biotechnology jobs from thousands of job and career search sites. A search engine for jobs with a different approach to job and career searches. In one simple search, job seekers get free access to millions of employment opportunities from thousands of websites. Find your next job in Biotechnology today.

FDA Clears the First Rapid Test to Detect Bacteria in Pooled Platelets
Fenwal, Inc. announced that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD(R) test as a quality control test to detect bacterial contamination in whole blood-derived, pooled ...

New Consortium Paves the way for Improved Treatment of Hypertension and Associated Vascular Complications
Top Institute Pharma has formed a consortium with Actelion Pharmaceuticals Ltd, Erasmus Medical Centre and Maastricht University to define new modalities for the treatment of hypertension and ...

US Government Awards Contract to Bavarian Nordic for the Development of Freeze-Dried IMVAMUNE Smallpox Vaccine
Bavarian Nordic A/S announced that BARDA (Biomedical Advanced Research and Development Authority) has awarded a new contract to Bavarian Nordic for the development of a freeze-dried version of its ...

Andalusian scientists study plant compounds to unmask latent HIV virus
Researchers from the University of Cadiz and the University of Cordoba study different plant substances to "awaken” the latent HIV-1 virus, immune to the current therapy, and to obtain more effective ...

Cancers' sweet tooth may be weakness
The pedal-to-the-metal signals driving the growth of several types of cancer cells lead to a common switch governing the use of glucose, researchers at Winship Cancer Institute of Emory University ...

Genzyme Announces Results of Phase 2/3 Trial of Advanced Phosphate Binder
Genzyme Corporation reported results of a phase 2/3 study of its advanced phosphate binder (APB). The trial met its primary endpoint, which was to show that the APB lowered phosphate levels ...

Frost & Sullivan: The North American and Western European Biopesticides Markets Will Grow Strong Thanks to Chemical-free Crops
The biopesticides market in Western Europe and North America is growing strongly. The increasing demand for chemical-free crops, paralleled by the expansion of land for organic farming, has led to ...

ThromboGenics and BioInvent Win "Licensing Deal of the Year” at the Scrip Awards 2009
ThromboGenics NV and BioInvent International announce that they won "Licensing Deal of the Year” at the Scrip Awards 2009. The award recognises the major partnership deal that ThromboGenics and ...

Ablynx achieves third milestone in drug discovery and development collaboration
Ablynx announced that it will receive an undisclosed milestone payment from Novartis. The payment has been triggered by successful delivery to Novartis of Nanobody® candidates which met specific ...

BioAlliance Pharma ranked as France's fastest growing company in the 2009 Deloitte Technology Fast 50
BioAlliance Pharma SA announced that it has won first prize in Deloitte's Technology Fast 50 2009TM ranking of France's fastest-growth technology companies. The ranking is drawn up according to ...

Cellectis European patent EP 1 485 475 upheld at European Patent Office
Cellectis S.A. has announced that the European Patent Office has upheld European Patent EP 1 485 475 owned by Cellectis and relating to the invention of engineering methods for meganucleases. This ...

US Food and Drug Administration grants priority review for Actelion's miglustat in Niemann-Pick type C disease
Actelion Ltd announced that a supplemental new drug application (sNDA) for an extension of indication for Zavesca® (miglustat) for the treatment of progressive neurological manifestations in adult ...

Joint efforts to control diseases transmitted from animals to humans
Around 200 scientists from Germany, Austria and Switzerland came together at the Federal Institute for Risk Assessment (BfR) in Berlin to discuss the current situation in the field of zoonoses, ...

BioXell Supports Planned Acquisition by Cosmo Pharmaceuticals
BioXell S.p.A. announced that it has entered into a transaction agreementwith Cosmo Pharmaceuticals S.p.A., under which the parties have agreed on the terms and conditions according to which Cosmo ...

Novartis: US interim data show lower doses of antigen may suffice to generate a protective immune response against A(H1N1)
Novartis announced new interim data from ongoing clinical trials demonstrating that a single 7.5µg dose of the company's influenza A(H1N1) 2009 unadjuvanted vaccine, half of the currently-approved US ...

Innate Pharma initiates collaboration with Celgene to evaluate the clinical potential of REVLIMID combined with IPH 2101
Innate Pharma announced that Celgene Corporationhas agreed to collaborate with Innate Pharma to evaluate the potential clinical synergy of the combination treatment regimen of lenalidomide ...

The Linde Group and Algenol Biofuels agree to cooperate in CO2 and O2 management for biofuel production from algae
The Linde Group and the US company Algenol Biofuels LLC have agreed to collaborate in a joint development project in order to identify the optimum management of carbon dioxide (CO2) and oxygen (O2) ...

AFFiRiS AG: Alzheimer's Vaccine Candidate AD02 moves into Clinical Phase II Testing
AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical ...

Evotec Wins German Government Research Grant
Evotec announced that it has been granted up to €2.5 m in research funds from the BMBF, within the Neu2 consortium, to advance research and development activities on the target Serine Racemase for ...

Finding a protective mechanism for retinal cells could save sight
Determining what triggers the death of retinal cells, called photoreceptors, could hold the key to stopping blinding disorders caused by a wide range of eye diseases, Yale School of Medicine ...

Bionity.COM News
The latest news about trends and developments in the biotech, pharma and life science industries

 

Big Pharma Seeks to Insulate Itself from Impact of Patent Cliff

New Information Technology Fails To Accelerate FDA Drug Approvals, Reports

Xigen S.A., Swiss Developer of Therapeutic Peptides, Raises $20 Million in Series B Funding

FDA Panel Rejects Protein Sciences Corporation's Cell Culture Flu Vaccine, Wants More Safety Data

ImmunoGen, Inc. Licenses Anti-Cancer Technology to Amgen ; to Get Up to $34 Million in Milestone Payments

Causative Gene Of Rare Disorder Discovered By Sequencing Only Protein-Coding Regions Of Genome, University of Washington Study

Movetis Seeking up to 112.4 Million Euros in IPO

FDA Approves Intravenous Formulation Of Pfizer Inc.'s Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

New 'Skin' From Stem Cells, INSERM Study

Genes Do Not Modify Lung Function With Asthma Drug Salmeterol, Study in

Schizophrenia Gene's Role May Be Broader, More Potent, Than Thought, University of California, San Francisco (UCSF) Study

Covidien Says FDA Extends Review of Opiod Pain Drug

Experimental Drug Studied As Possible Treatment For Spinal Injuries, Purdue University Study

Roche's Actemra Successful in Arthritis Study; Meets Primary Endpoint in Phase III Study

Sweet! Sugared Polymer a New Weapon Against Allergies and Asthma, Johns Hopkins University Study

Carvedilol Shown To Have Unique Characteristics Among Beta Blockers, University of Illinois Study

FDA Advisory Committee Finds Data Support the Claim That Pfizer Inc.'s SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations

EU Panel Blocks Merck KGaA's Erbitux in Lung Cancer

Ranbaxy Laboratories Recalls Skin Infection Drug, Sotret in the U.S.
Business-Standard.com -- Indias leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be out of specification.

Antigenics Inc. (New York) Cancer Vaccine Gets Negative EU Panel Vote

Merck & Co., Inc. Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)

Dendreon Corporation Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010
SEATTLE, Nov 20, 2009 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which...

Cell Therapeutics, Inc. Wins Federal Appeal to Pursue $22.8 Million Claim Against

Procter & Gamble Repurchasing Shares, Quiet on Potential Deals

Pfizer Inc. Executive: In Talks To Expand Licensing Pact With Aurobindo Pharma

GlaxoSmithKline, Merck & Co., Inc. Developing Drugs for Kala Azar, Disease Transmitted by Sandflies

IMPAX Laboratories, Inc. Drives Stronger Performance with Business Analytics

ARMONK, N.Y., Nov. 20 /PRNewswire-FirstCall/ -- IBM announced today that Impax Laboratories, Inc. , a technology-based specialty pharmaceutical company, is using IBM business analytics technology to gain stronger insights into their business and better predict risks and market opportunities.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090416/IBMLOGO )

In such a highly...

BioPharm Executive: Where'd the Jobs Go?
The Pharmaceutical Research and Manufacturers of America (PhRMA) took great exception to a recent story published in the New York Times. It suggested that drug manufacturers have raised prices this year to cushion themselves against future cuts that would come with health care reform.

Not so, says

ImmuPharma plc CEO Slams Stock Plunge After Drug Trial

The Danger Of Marketing Prescription Drugs Online

Rising Prices of Drugs Lead to Call for Inquiry

PPD, Inc. to Acquire BioDuro, LLC

Genzyme Corporation's Pompe Drug Rejected--New Production Woes

Gene Protects Brain-Eaters From Mad Cow-Type Disease, University College London Study

FDA Advisory Committee Finds Data Support the Safety and Effectiveness of Pfizer Inc.'s Prevnar 13 Vaccine for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children

Genzyme Corporation's Worst Biotech CEO of '09

Genzyme Corporation Ends Development of Kidney Treatment, Renvela's Successor

Drug Offers Hope For Down???s Syndrome, Stanford University School of Medicine Study

Spanish Study Led By Shows Alcohol May Cut Heart Risk; But Experts Critical

Pivotal Study For Sciele Pharma, Inc.'s PSD502 -- The First Potential Treatment For Premature Ejaculation

U.S. FDA Panel Rejects FDA and Genentech (South SF)'s Xolair Asthma Drug for Children

FDA to Review Actelion Ltd.'s Zavesca for Additional Use

Common Pain Relief Medication May Encourage Cancer Growth, University of Chicago Study

VIVUS, Inc. Says Erectile Dysfunction Trial Meets Goals

Procter & Gamble Recalls Some Vicks Spray After Bacteria Found

Pfizer Inc. Says May Enter Japan Generic Drug Market

Genentech (South SF) and Biogen Idec, Inc. (Massachusetts) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

AstraZeneca PLC Judge to Urge Return of Seroquel Cases to Courts

Cancers' Sweet Tooth May Be Weakness, Emory University Researchers Say

Biogen Idec, Inc. (Massachusetts)'s Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn't Look So Deadly Anymore

AstraZeneca PLC Asks for U.S. Approval of Brilinta

FDA Warns Heartburn Drugs Interfere with Sanofi-Aventis (France), Bristol-Myers Squibb Company's Plavix

Drug Maker Perrigo Company to Hire 60 Workers at Headquarters, Production Facility in Allegan, Michigan

Ex-Biotech CEO, Entrepreneur Form VC Firm UnionBridge Management LLC To Create Drug Companies

Heart Disease A Killer In Psychotic Individuals, Study

Pneumococcal Conjugate Vaccines Effective at Preventing Child Deaths, Study Suggests

Asterand plc Announces Agreement to Acquire BioSeek, Inc. For Up to $14 Million

US FDA Wants Panel to Probe Pfizer Inc. Vaccine Efficacy

UCB Group Plans Job Cuts

NicOx SA in Fund Raising to Speed Naproxcinod Launch; Plans to Raise $149 Million

Starpharma Holdings Ltd Announces $15.6 Million Capital Raising

QIAGEN N.V. Is Poised for More Purchases After $2 Billion Spree

Biotech Cosmo Pharmaceuticals S.p.A. Aims to Buy Rival BioXell S.p.A. for $41 Million

Niacin Adds No Benefit for Statin Patients, Johns Hopkins University School of Medicine Study

Jennerex Inks Deal with Lee's Pharmaceutical Holdings in China

Not Just Swine Flu - New Cold Virus May Lurk, Too, Doctors Discover

Detonating Tumor-Killer Drug in Cancers on Command, Baystate Medical Center Study Confirms Efficacy of University of Massachusetts - Amherst Researcher's System

Folic Acid, B12 Supplements May Increase Cancer Risk, Study

US FDA Staff Question Pfizer Inc. Lung Drug Data

Vaccines On Horizon For AIDS, Alzheimer's, Herpes

Many In U.S. Still Lack Cholesterol Tests, Drugs, But Levels Of "Bad" Cholesterol On The Decline Overall, Centers for Disease Control and Prevention (CDC) Study

deCODE genetics, Inc. Files Voluntary Chapter 11 Petition to Facilitate Sale of Assets

Steel, Rubber Found in Some Genzyme Corporation Drugs

Drug Therapy More Cost-Effective Than Angioplasty for Diabetic Patients with Heart Disease, Stanford University School of Medicine Study

Genetic Variation Linked to Individual Empathy, Stress Levels, Oregon State University Study

New Combination Therapy Could Deliver Powerful Punch to Breast Cancer, Medical College of Georgia Study

University of Pennsylvania Study Finds that Antioxidant Found in Vegetables Has Implications for Treating Cystic Fibrosis
Nutrition Horizon -- 17 Nov 2009 --- Scientists at the University of Pennsylvania School of Medicine discovered that a dietary antioxidant found in such vegetables as broccoli and cauliflower protects cells from damage caused by chemicals generated during the body's inflammatory response to infection and injury. The finding has implications for such inflammation-based disorders as cystic fibrosis ...

In Amazon, A Frustrated Search For Cancer Cures By Paulista University Researchers
SAO SEBASTIAO DE CUIEIRAS, Brazil (Reuters) - The task of harvesting the secrets of Brazil's vast Amazon rain forest that could help in the battle against cancer largely falls to Osmar Barbosa Ferreira and a big pair of clippers.

Isis Pharmaceuticals, Inc. Cholesterol Drug Meets All Goals of Key Trial

Emergent BioSolutions to Create Up to 125 Jobs in New Baltimore Facility

Ondine Biopharma Corporation to Buy Privately Held Photodynamic Therapy Company

QRxPharma Pty Ltd. Announces A $21.6 Million Fully Underwritten Capital Raising

PolyMedix Inc. Completes $20.7 Million Equity Financing

Genentech (South SF) Puts Words In The Mouths Of Politicians

Aspirin Without Bristol-Myers Squibb Company And Sanofi-Aventis K.K.'s Plavix As Good After Heart Bypass, Study

Trubion Pharmaceuticals Inc. CEO Retires

SEATTLE, Nov. 16 /PRNewswire-FirstCall/ -- Trubion Pharmaceuticals, Inc. announced today that Peter Thompson, M.D., FACP, President, Chief Executive Officer, Chairman of the Board of Directors and co-founder of Trubion, has retired from the company to pursue other interests. Steven Gillis, Ph.D., former Lead Director of Trubion's Board of Directors, has been appointed Executive Chairman...

Roche Holding AG , Genentech (South SF) Apply for Avastin Advanced Breast Cancer Use

Mutant Genes 'Key To Long Life', Albert Einstein College of Medicine Study

Human Genome Sciences, Inc.'s Anthrax Drug Denied Approval

NeurogesX, Inc. Receives FDA Approval of Qutenza(TM) (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)

Poniard Pharmaceuticals, Inc. Cancer Drug Misses Study Goal; Shares Plunge

Largest Gene Study of Childhood Inflammatory Bowel Disease Identifies Five New Genes, Children's Hospital of Philadelphia Study

Gene Linked to Breast Cancer Might Boost Heart Health,
Nov. 15 (Bloomberg) -- A gene linked to breast cancer in 1 in 10 Jewish women may raise the risk of heart ailments, says a study in mice using gene therapy to improve cardiac function.

Toxins In Plastic 'Feminise Boys', University of Rochester Study

Fate Therapeutics Closes $30 Million Series B Financing

FDA Approves Xanodyne Pharmaceuticals, Inc.'s Lysteda to Treat Heavy Menstrual Bleeding

Bristol-Myers Squibb Company to Spin Off Mead Johnson Nutrition Company Stock

Niacin Bests Ezetimibe as Add-On Therapy, Johns Hopkins University School of Medicine Researchers Say

Rivaroxaban Drops Pro-Coagulation Factor in HF Patients, Johnson & Johnson Researchers Say
MedPage Today -- ORLANDO -- Biomarkers of hypercoagulability -- ominous signs in patients with heart failure -- appear to be reduced by treatment with the oral, direct Factor Xa inhibitor rivaroxaban, a researcher said here.

Vaccine Against Chlamydia Not Far Away, University of Gothenburg Study

Patients Suffering STEMI Fare Better with Ticagrelor Therapy, University of Paris Study
MedPage Today -- ORLANDO -- The investigational platelet aggregation inhibitor ticagrelor appeared to produce better outcomes in patients with high-risk, acute coronary syndromes than clopidogrel (Plavix), investigators reported here in a finding that mirrored results of an earlier, larger study.

Nabi Biopharmaceuticals , GlaxoSmithKline Sign Nicotine Addiction Vaccine Deal; Will Get $40 Million Upfront and is Eligible for More Than $500 Million

Popular Anti-Platelet Therapy Reduces Risk of Cardiovascular Events in Men and Women, Journal of the American College of Cardiology Study

US FDA Warns Shire Pharmaceuticals , Eisai Company, Ltd. on Promotions

Cannasat Therapeutics Inc. Announces New Chief Executive Officer: M.B.A., C.Dir.

Spherix Says Diabetes Drug Shows Promise; Shares Jump

Boehringer Ingelheim Corporation Drug Shown to Kindle Female Sex Drive

Genta Incorporated Reduced Workforce by Approximately 30%; Announces Third Quarter 2009 Financial Results

Roche , Novartis Corporation Asthma Drug Effect Modest - FDA Staff

Cerus Corporation Stock Trading Halted; FDA Blood Products Advisory Committee to Review and Discuss Proposed Phase III Clinical Trial Design for the INTERCEPT Blood System

Antivirals Key To Preventing Severe H1N1 Disease, World Health Organization Says
GENEVA, Nov 12 (Reuters) - Antiviral medicines can prevent H1N1 flu deaths and should be given quickly to pregnant women, very young children and people with underlying medical problems who fall ill, the World Health Organisation said on Thursday.

Talecris Biotherapeutics to Add 250 Jobs in $270M Clayton Expansion

BioInvent Signs Licensing Agreement with Daiichi Sankyo Co Ltd. for the Discovery and Development of Therapeutic Antibodies

Cephalon, Inc., Barr Pharmaceuticals, Inc. Settle Patent Infringement Suit

FDA Begins to Shape Rules for Online Drug, Device Ads

Alnylam Pharmaceuticals Provides Update on RNAi Pipeline, Platform, and Technology at Its R&D Day

Eli Lilly and Company Snags AstraZeneca PLC Executive as New R&D Head

Too Much Mineral Supplement Selenium Can Raise Cholesterol, University of Warwick Study

Low Birth Weight And Diabetes Have A Common Genetic Background, Helmholtz Zentrum Munchen Study

University of Illinois Researchers Have Immune Cells Running In Circles

Paradoxical Protein Might Prevent Cancer, Karolinska Institute Study

Coffee Break: Compound Brewing New Research In Colon, Breast Cancer, Study
Texas Agrilife -- COLLEGE STATION A compound in coffee has been found to be estrogenic in studies by Texas AgriLife Research scientists.

NicOx SA Announces NCX 6560 Meets Primary and Secondary Objectives in First-in- Man Study

Boehringer Ingelheim Corporation's Desire Drug May Prove Sex Really Is All in Her Head

FDA Head To Speed Drug Reviews; Clean Up Problems With Medical Device Reviews, Visit China

BioSpace.com Featured News and Stories

 

Xigen S.A., Swiss Developer of Therapeutic Peptides, Raises $20 Million in Series B Funding

FDA Panel Rejects Protein Sciences Corporation's Cell Culture Flu Vaccine, Wants More Safety Data

ImmunoGen, Inc. Licenses Anti-Cancer Technology to Amgen ; to Get Up to $34 Million in Milestone Payments

Movetis Seeking up to 112.4 Million Euros in IPO

FDA Approves Intravenous Formulation Of Pfizer Inc.'s Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Covidien Says FDA Extends Review of Opiod Pain Drug

Roche's Actemra Successful in Arthritis Study; Meets Primary Endpoint in Phase III Study

FDA Advisory Committee Finds Data Support the Claim That Pfizer Inc.'s SPIRIVA(R) HandiHaler(R) Reduces COPD Exacerbations

EU Panel Blocks Merck KGaA's Erbitux in Lung Cancer

Ranbaxy Laboratories Recalls Skin Infection Drug, Sotret in the U.S.
Business-Standard.com -- Indias leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be out of specification.

Antigenics Inc. (New York) Cancer Vaccine Gets Negative EU Panel Vote

Merck & Co., Inc. Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)

Dendreon Corporation Receives FDA Acknowledgement of Complete Response, PDUFA Date Assigned as May 1, 2010
SEATTLE, Nov 20, 2009 /PRNewswire-FirstCall via COMTEX/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE(R) (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which...

Cell Therapeutics, Inc. Wins Federal Appeal to Pursue $22.8 Million Claim Against

Procter & Gamble Repurchasing Shares, Quiet on Potential Deals

Pfizer Inc. Executive: In Talks To Expand Licensing Pact With Aurobindo Pharma

GlaxoSmithKline, Merck & Co., Inc. Developing Drugs for Kala Azar, Disease Transmitted by Sandflies

Sucampo Pharma Europe Receives Marketing Authorization for Amitiza(R) in Switzerland for Treatment of Chronic Idiopathic Constipation

FDA Extends NDA Review for Neuromed Pharmaceuticals's Exalgo(TM) Extended-Release Tablets
CAMBRIDGE, Mass. & VANCOUVER, British Columbia--(BUSINESS WIRE)--CombinatoRx, Incorporated (NASDAQ: CRXX) and Neuromed Pharmaceuticals Inc., a privately-held biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued Neuromed a letter extending its review of the New Drug Application (NDA) for the product candidate Exalgo (hydromorphone HCl) extended-release...

Recordati S.p.A: European Medicines Evaluation Agency Adopts A Positive Opinion For Silodosin (Brands Urorec(R) And Silodyx(R))

Pfizer Inc. Receives FDA Approval For Geodon(R) (Ziprasidone HCI) Capsules For The Adjunctive Maintenance Treatment Of Bipolar Disorder In Adults

Genta Incorporated's Genasense(R) Given as High-Dose IV Infusion with Chemotherapy Shows Promising Activity in Advanced Melanoma

Pozen, Inc. Announces Start of Enrollment For PA32540 Phase 3 Program
CHAPEL HILL, N.C.--(BUSINESS WIRE)--POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.

Circassia Limited Announces Successful Results From Phase II Clinical Study of ToleroMune(R) Cat Allergy Therapy Study Identifies Optimal Treatment Approach for Late-Stage Development

OXFORD, England, November 20 /PRNewswire/ -- Circassia Ltd, a specialty biopharmaceutical company focused on allergy, today announced positive results from a recently completed phase II clinical study of its ToleroMune(R) cat allergy therapy, which successfully identified the optimal dosing regimens to progress into late-stage development. The clinical trial, which was the first of its kind...

Stem Cell Therapeutics Announces Positive Review by Data Safety and Monitoring Board for the Phase IIb Stroke Trial

Moberg Derma Reports Positive Phase II Results For K201 Against Atopic Eczema

Ligand Pharmaceuticals Inc. Presents New Preclinical Data on its Lead SARM Molecule LGD-4033 at the Annual Meeting
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal...

Inovio Biomedical Corporation Universal Flu Vaccines Demonstrate Broadly Protective Immune Responses Against Multiple Seasonal & Pandemic Influenza Viruses in Pre-Clinical Studies
SAN DIEGO--(BUSINESS WIRE)--Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets. In addition, ferrets immunized with Inovio...

IMPAX Laboratories, Inc. Drives Stronger Performance with Business Analytics

ARMONK, N.Y., Nov. 20 /PRNewswire-FirstCall/ -- IBM announced today that Impax Laboratories, Inc. , a technology-based specialty pharmaceutical company, is using IBM business analytics technology to gain stronger insights into their business and better predict risks and market opportunities.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090416/IBMLOGO )

In such a highly...

Karolinska Development AB and Start Landmark Co-Investment Fund for Life Science Innovation

STOCKHOLM, November 20 /PRNewswire/ -- Karolinska Development AB today announced that the European Investment Fund (EIF) has entered into a co-investment agreement with the company. The co-investment fund will be managed by Karolinska Development and used to invest in the company's portfolio of early-stage pharmaceutical and medical technology companies. EIF has agreed to invest 26.7 M Euros...

Arcadia Biosciences, Inc. and Vilmorin Announce Strategic Alliance to Develop and Market Nitrogen Use Efficient Wheat
DAVIS, Calif. & PARIS--(BUSINESS WIRE)--Arcadia Biosciences, Inc., an agricultural technology company focused on developing technologies and products that benefit the environment and human health, and Vilmorin, the worlds fourth-largest seed company and the global leader in wheat genetics and seed, today announced that they have reached an agreement for the development and commercialization of Nitrogen...

KineMed, Inc. Receives an Investigator-Initiated Study Grant From Daiichi Sankyo Co Ltd. to Further Explore Mechanism(s) of Action Associated with Welchol(R) (colesevelam HCl) in Type 2 Diabetes Mellitus
EMERYVILLE, Calif.--(BUSINESS WIRE)--KineMed, Inc., a translational and personalized medicine development company, announced today that the company has received an investigator initiated study grant from Daiichi Sankyo, Inc. to conduct a clinical study designed to better understand and characterize the beneficial effects of Welchol (colesevelam HCl) in patients with Type 2 Diabetes Mellitus (T2DM...

Warner Chilcott Prices Secondary Equity Offering

ARDEE, Ireland, Nov. 19 /PRNewswire/ -- Warner Chilcott plc today announced the pricing of its previously announced secondary offering of 20,000,000 of its ordinary shares at a price to the public of $22.25 per share. The selling shareholders include funds affiliated with Bain Capital Partners, DLJ Merchant Banking, J.P. Morgan Partners (advised by CCMP Capital) and Thomas H. Lee Partners...

KINAXO Biotechnologies Completes Financing Round to Enhance Biomarker Development
Martinsried, Germany, November 20, 2009 / b3c newswire / - KINAXO Biotechnologies GmbH announces the completion of a financing round, gaining two new investors in the company, Leifina and Conmit Invest. At the same time KINAXO reports that Jrgen Schumacher has been elected as a new member of the companys advisory board.

KINAXO shareholders Axel Ullrich, Hellmut Kirchner, Manfred Ferber...

Cambridge-based Ligon Discovery Raises $1M in Seed Funding

CAMBRIDGE, Mass., Nov. 19 /PRNewswire/ -- Ligon Discovery, Inc., which uses proprietary small molecule microarray technology to find drugs against high-value targets, today announced that it has raised $1M in seed financing led by incTANK Ventures. The company will use the capital to complete its initial discovery campaign that will screen over 100 high-value disease protein targets. With...

Newron Pharmaceuticals Raises CHF7.9m (7.75m USD) In A Private Placement To International Institutional Investors
Milan, Italy 20 November 2009 Newron Pharmaceuticals S.p.A. (Newron), a research and development company focused on novel CNS and pain therapies, announced that it has raised gross proceeds of CHF7.9m through a private placement to institutional investors. The private placement was conducted without preferential subscription rights to institutional investors and was managed by Jefferies International...

Sensient Technologies Corporation Announces Private Placement Debt Transaction
MILWAUKEE--(BUSINESS WIRE)--Sensient Technologies Corporation (NYSE: SXT) announced today that it has entered into an agreement with a group of financial institutions for the issuance of $110 million in fixed-rate, senior notes. The dollar-denominated debt will have a six-year average life with a final maturity in May 2017. Proceeds from the offering will be used to repay outstanding debt.

Biocryst Pharmaceuticals Announces Pricing of Public Offering of Common Stock

BIRMINGHAM, Ala., Nov. 19 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. today announced the pricing of a public offering of 5,000,000 shares of its common stock at $9.75 per share, resulting in gross proceeds of $48.75 million. All of the shares are being offered by BioCryst pursuant to an effective shelf registration statement previously filed with the Securities and Exchange...

Spherix Announces Results of Annual Shareholders Meeting

BETHESDA, Md., Nov. 19 /PRNewswire-FirstCall/ -- Spherix Incorporated , an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the results of Tuesday's Annual Meeting of Shareholders.

At the meeting, shareholders of Spherix Incorporated elected...

Annual and Special Shareholders meeting of ZoomMed/Pharmaceutical Contracts Signed for $1,482,500 During Q1-Q2

MONTREAL, QUEBEC--(Marketwire - November 20, 2009) - ZoomMed Inc. (TSX VENTURE: ZMD), creator of the ZRx Prescriber, the e-Pic communication network and the ZRx Pharma communication network announced during its shareholders meeting held today 10:00 am, the signing new contracts with pharmaceutical companies...

China Cord Blood Completes Secondary Offering on NYSE
ChinaBio Today -- China Cord Blood Corporation listed its ordinary shares on the New York Stock Exchange and, at the same time, completed a secondary offering. The company placed 3.3 million shares at a price of $6.05 for gross proceeds of $20 million. China allows one cord blood collection license for each major area, and China Cord Blood owns the licenses for Beijing and Guangdong. More details...

Omnicare, Inc. Declares Quarterly Cash Dividend
COVINGTON, Ky.--(BUSINESS WIRE)--The Board of Directors of Omnicare, Inc. (NYSE:OCR), a leading provider of pharmaceutical care for the elderly, declared today a quarterly cash dividend of 2.25 cents ($0.0225) per share on its common stock. The dividend is payable December 21, 2009 to stockholders of record on December 7, 2009.

Lannett Company, Inc. Reauthorizes Stock Repurchase Program
PHILADELPHIA--(BUSINESS WIRE)--Lannett Company, Inc. (NYSE AMEX: LCI) today announced that its Board of Directors has approved a reauthorization of the stock repurchase program. Under the program, the company is authorized to repurchase up to $5 million of Lannetts outstanding common stock from time to time in open market and privately negotiated transactions.

GLG Life Tech Corporation Commences Trading on NASDAQ

VANCOUVER, BRITISH COLUMBIA--(Marketwire - November 20, 2009) - GLG Life Tech Corporation (TSX: GLG)(NASDAQ: GLGL) ("GLG" or the "Company"), the vertically integrated leader in the agricultural and industrial development of high quality stevia...

XOMA (US) LLC Receives Determination Letter
BERKELEY, Calif., Nov. 19, 2009 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced that it received a letter from the staff of The NASDAQ Stock Market LLC on November 13, 2009 indicating that the NASDAQ staff has concluded that XOMA's previously-announced common share financing completed on September 30, 2009 did not comply with...

EKR Therapeutics, Inc. Named Private Company of the Year By New Jersey Technology Council
BEDMINSTER, N.J.--(BUSINESS WIRE)--EKR Therapeutics, Inc., a specialty pharmaceutical company focused on commercializing acute-care hospital products, today announced that it has been named Private Company of the Year by the New Jersey Technology Council (NJTC), a more than 1,200 member non-for-profit organization supporting growth in New Jersey's various technology sectors including health sciences...

WaferGen Biosystems to Introduce New Service for Gene-Expression Profiling Using the SmartChip(TM) Real-Time PCR System

FREMONT, Calif., Nov. 19 /PRNewswire-FirstCall/ -- WaferGen Biosystems, Inc. , a leading developer of state-of-the-art genetic analysis systems, today announced a new, innovative service for gene-expression profiling of thousands of genes using the SmartChip(TM) Real-Time PCR System. By taking advantage of the SmartChip Real-Time PCR system, WaferGen will offer universities, pharmaceutical...

Company Profile for Amneal Pharmaceuticals
(BUSINESS WIRE)--Amneal Pharmaceuticals LLC, headquartered in Hauppauge, NY is a U.S.-based firm that develops, manufactures and distributes generic pharmaceuticals regulated and approved by the U.S. FDA. Known as Generics New Generation, the company utilizes its newly expanded R&D and manufacturing capabilities to conceive breakthrough developments with lasting impact for a robust product pipeline...

GlaxoSmithKline to Manufacture Flu Treatment Relenza in China
ChinaBio Today -- GlaxoSmithKline will begin manufacturing its treatment for flu, Relenza, in China to supply Chinas domestic market. GSK received approval of the drug in September from the SFDA. Relenza, like Tamiflu from Roche, aims at reducing both the severity and the duration of flu symptoms, though some resistance to the drugs seems to be evident. More details...

Company Profile for PreventionGenetics LLC
(BUSINESS WIRE)--PreventionGenetics, a market leading biotechnology company located in Marshfield, WI, provides DNA testing for clinical and research and DNA Banking for all individuals. PreventionGenetics offers clinical DNA testing for more than 300 different disorders, making it one of the most comprehensive genetics testing laboratories in the world.

Formatech, Inc. Release: The New Face of Formatech.com
ANDOVER, Mass.--(BUSINESS WIRE)--Formatech, Inc is pleased to announce the launch of their new website. The redesigned site features detailed information about the variety of services Formatech offers, including: product development, lyophilization development, their signature Stability Fingerprinting program and cGMP manufacturing capabilities to support clinical trials, to name a few. The site also...

SaBTO Recommends Use of ProMetic Life Sciences Inc.'s P-Capt(R) Prion Reduction Filter to Protect Children From vCJD Blood Transmission

MONTREAL, QUEBEC, CANADA and LILLE, FRANCE--(Marketwire - November 20, 2009) - ProMetic Life Sciences Inc. (TSX: PLI) ("ProMetic") and MacoPharma SA ("MacoPharma") announce that the Advisory Committee on the Safety of Blood, Tissues and Organs ("SaBTO"), an independent Committee that advises the UK Department...

Cellectis BioResearch Launches Cgps(R) CHO-S CEMAX(R) - An Efficient Protein Production Kit
Paris, November 4, 2009 - Cellectis bioresearch, a specialist in genomecustomization and a subsidiary of Cellectis S.A. (Alternext: ALCLS), today launchedcGPS CHO-S CEMAX, a kit which enables targeted integration into suspensioncell cultures. By reducing the amount of time required to obtain clones and byimproving production stability, this kit represents an advancement in the production...

Devgen NV Business Update
Zwijnaarde, Belgium - November 20, 2009 - Devgen nv (Euronext Brussels; DEVG) issues today a business and financial update for the third quarter 2009.

Operational highlights Q3 2009

Regulatory approval and market launch of Devgen's nematicide in Turkey

Devgen received regulatory approval for its nematicide product Devguard in Turkey for use in four of the most important...

Omeros Corporation Reports Third Quarter 2009 Financial Results and Development Highlights

SEATTLE, Nov. 19 /PRNewswire-FirstCall/ -- Omeros Corporation today announced unaudited financial results for the third quarter ended September 30, 2009. For the three months ended September 30, 2009, Omeros reported a net loss of $3.9 million, or $1.34 per share, as compared to a net loss of $7.4 million, or $2.54 per share, for the same period in 2008. For the nine months ended September 30...

RaySearch Laboratories Interim report January 1 ??? September 30, 2009
STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News: RaySearch Laboratories (STO:RAYB):

SeraCare, Inc. Reports Fourth Quarter and Fiscal Year 2009 Results
MILFORD, Mass.--(BUSINESS WIRE)--SeraCare Life Sciences, Inc. (NASDAQ: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today reported operational and financial results for its fourth quarter and fiscal year ended September 30, 2009.

Frontage Laboratories Expands Management Team
EXTON, Pa.--(BUSINESS WIRE)--Frontage, a leading high quality provider of drug development services and preclinical, bioanalytical, analytical, and formulation services to the global biopharmaceutical industry, announces the hire of two key leadership positions and an expansion to the business development team.

PharMerica Names to Its Board of Directors
LOUISVILLE, Ky.--(BUSINESS WIRE)--PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced that it has appointed Geoffrey G. Meyers to the Companys Board of Directors.

Labopharm to Present at Dundee Emerging Growth Summit

LAVAL, QC, Nov. 20 /PRNewswire-FirstCall/ - Labopharm Inc. today announced that James R. Howard-Tripp, President & Chief Executive Officer of the Company, will present at the Dundee Emerging Growth Summit at the Design Exchange in Toronto, on Thursday, November 26, 2009 at 2:30 p.m. ET.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance...

Alexza Pharmaceuticals, Inc. to Present at the 21st Annual Piper Jaffray Health Care Conference

MOUNTAIN VIEW, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Alexza Pharmaceuticals, Inc. announced today that its corporate presentation will be webcast live during the 21st Annual Piper Jaffray Health Care Conference on Wednesday, December 2, 2009 at 9:00 a.m. Eastern Time. The presentation will be webcast from The New York Palace Hotel in New York and will be presented by Thomas B. King...

ImmuPharma plc CEO Slams Stock Plunge After Drug Trial

Julie Brill Nominated to FTC: A Message to Drug Manufacturers?
The IN VIVO Blog -- -The Obama administration may have sent a subtle message to drug manufacturers Monday, when it nominated Julie Brill to be one of two new commissioners at the Federal Trade Commission. The message? Make sure your marketing practices dont collide with consumers best interests.

PPD, Inc. to Acquire BioDuro, LLC

Genzyme Corporation's Pompe Drug Rejected--New Production Woes

FDA Advisory Committee Finds Data Support the Safety and Effectiveness of Pfizer Inc.'s Prevnar 13 Vaccine for the Prevention of Invasive Pneumococcal Disease in Infants and Young Children

Genzyme Corporation Ends Development of Kidney Treatment, Renvela's Successor

Paloma Pharmaceuticals, Inc. Presents at the International Conference Molecular Targets and Cancer Therapeutics

U.S. FDA Panel Rejects FDA and Genentech (South SF)'s Xolair Asthma Drug for Children

FDA to Review Actelion Ltd.'s Zavesca for Additional Use

VIVUS, Inc. Says Erectile Dysfunction Trial Meets Goals

Procter & Gamble Recalls Some Vicks Spray After Bacteria Found

Pfizer Inc. Says May Enter Japan Generic Drug Market

Genentech (South SF) and Biogen Idec, Inc. (Massachusetts) Receive a Complete Response from the FDA for Rituxan for Chronic Lymphocytic Leukemia

AstraZeneca PLC Judge to Urge Return of Seroquel Cases to Courts

Medivir AB: Epiphany Biosciences, Inc. Announces Positive Results from Its Phase 2b Trial in Shingles
STOCKHOLM--(BUSINESS WIRE)--Regulatory News: Medivir (STO:MVIRB): Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The studys primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash. The...

Epiphany Biosciences, Inc. Announces Positive Results from Its Phase 2b Trial in Shingles

SAN FRANCISCO, Nov. 18 /PRNewswire/ -- Epiphany Biosciences announced results from its Phase 2b dose-ranging study of EPB-348 (valomaciclovir) in patients with shingles (herpes zoster) infection. The study's primary endpoint was non-inferiority of once-daily valomaciclovir compared to thrice-daily valacyclovir in terms of time to complete crusting of the shingles rash. The double-blinded...

Biogen Idec, Inc. (Massachusetts)'s Tysabri, the MS Drug Haunted by Deadly Side Effect, Doesn't Look So Deadly Anymore

Initial Phase 2 Results for Myriad Pharmaceuticals, Inc.' Azixa(TM) (MPC-6827) in Metastatic Melanoma
SALT LAKE CITY, Nov. 18, 2009 (GLOBE NEWSWIRE) -- Myriad Pharmaceuticals, Inc. (Nasdaq:MYRX) today announced the presentation of initial clinical data from an ongoing Phase 2a study of Azixa(TM) (MPC-6827), a microtubule destabilizing agent in stage 4 melanoma patients. Azixa is in two additional phase 2 studies in recurrent glioblastoma multiforme (GBM). Myriad Pharmaceuticals further announces that...

AstraZeneca PLC Asks for U.S. Approval of Brilinta

Astellas Pharma Inc. and XenoPort, Inc. Announce Submission of a New Drug Application in Japan Requesting PMDA Approval of ASP8825/XP13512 for Restless Legs Syndrome
TOKYO & SANTA CLARA, Calif.--(BUSINESS WIRE)--Astellas Pharma Inc. and XenoPort, Inc. (NASDAQ:XNPT) today announced that a new drug application (NDA) has been filed with the Pharmaceuticals and Medical Device Agency (PMDA) in Japan for ASP8825 (gabapentin enacarbil), also known as XP13512, as a potential treatment for restless legs syndrome (RLS). The data supporting safety and efficacy in the NDA...

Delcath Systems, Inc. Reports Substantial Progress Recent Follow-On Public Offering Provides Resources to Execute Plan Active Negotiations with Potential International Partners Continuing Phase III Study Enrollment Completed Executive Management Team Completed

NEW YORK, Nov. 19 /PRNewswire-FirstCall/ -- Delcath Systems, Inc. , a medical technology company developing the Delcath Percutaneous Hepatic Perfusion (PHP(TM)) System, a minimally invasive drug delivery platform for the regional treatment of cancer metastatic to the liver, today reported on the Company's recent progress.

"Since we last communicated with our shareholders in late July...

Altair Therapeutics Announces Commencement of a Multi-Center Phase IIa Clinical Trial of Inhaled AIR645 to Treat Asthma
SAN DIEGO--(BUSINESS WIRE)--Altair Therapeutics, Inc., a privately-held, biopharmaceutical company developing novel therapeutics for respiratory diseases, today announced the commencement of its IL-4 receptor alpha inhibitor bronchoprovocation trial. Study AIR645-CS2 is a phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and efficacy of inhaled...

Aegera Therapeutics Initiates a Randomized Phase 2B Study with AEG35156 for the Treatment of Acute Myeloid Leukemia (AML)

MONTREAL, Nov. 19 /PRNewswire/ - Aegera Therapeutics Inc. announced today the dosing of the first patient in a randomized Phase 2B study of AEG35156, a targeted antisense therapeutic in mid-stage development for multiple oncology indications.

The study, entitled "An Open-Label Randomized Phase 2 Study of the X-Linked Inhibitor of Apoptosis (XIAP) Antisense AEG35156 Given in Combination with...

Pluristem Therapeutics Presents Three Month Follow-Up Data from First Patient to Receive Placental Derived PLX-PAD at Two Meetings in Germany and France

Geron Corporation Presents Interim Clinical Data on Its Telomerase Inhibitor Drug at
MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq:GERN) today announced the presentation of interim data from its ongoing trial of imetelstat (GRN163L), a telomerase inhibitor drug, in patients with refractory, advanced solid cancers at the 2009 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

AVI BioPharma, Inc. Presents Update on AVI-4658 at International Conference

Dynavax Technologies Corporation Completes Enrollment of First Cohort of Patients in Phase 1b Clinical Trial for Hepatitis B Therapy

AFFiRiS GmbH: Interim Analysis of Clinical Phase I Data Triggered Decision to Move Alzheimer's Vaccine Candidate AD02 into Clinical Phase II Testing

VIENNA, Austria, November 19 /PRNewswire/ -- AFFiRiS AG will focus its Alzheimer's vaccine program on one product candidate at an unexpectedly early stage of development: the vaccine candidate AD02 is planned to enter into Phase II clinical trial early in 2010. This decision by the company immediately follows the completion of two Phase I trials with the candidates AD01 and AD02. The company...

Thallion Pharmaceuticals Inc. Presents Poster on the Apoptotic Properties of TLN-4601 at the Conference

Afexa Life Sciences Inc. Release: COLD-FX(R) Maker Broadens Its Scientific Direction: Launches Pilot Trial of New Formulation LIP-01 Geared to Lowering Cholesterol and Lipids

EDMONTON, ALBERTA--(Marketwire - November 19, 2009) - Afexa Life Sciences Inc. ("Afexa" or the "Company") (TSX: FXA) maker of COLD-FX today announced the launch of a pilot clinical trial of a new formulation, LIP-01 that has shown promise in reducing blood lipids - including cholesterol. Cholesterol can...

Advanced Cell Technology Files IND With FDA For First Human Clinical Trial Using Embryonic Stem Cells to Treat Eye Disease
WORCESTER, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB:ACTC) announced today that it filed an Investigational New Drug (IND) Application with the US Food and Drug Administration (FDA) to initiate a Phase I/II multicenter study using embryonic stem cell derived retinal cells to treat patients with Stargardts Macular Dystrophy (SMD). Among the most common causes of untreatable blindness...

Inovio Biomedical Corporation Universal DNA Vaccine for Chikungunya Virus Demonstrates Protective Antibody Responses in Monkey Model

Cytokinetics, Inc. Announces Non-Clinical Data Relating to GSK-923295 Presented at the 2009 International Conference

Basilea Pharmaceutica Presents New Research Data On Oncology Drug Candidate BAL27862 At International Cancer Conference

BASEL, SWITZERLAND--(Marketwire - November 19, 2009) - Basilea Pharmaceutica Ltd.(SWISS: BSLN) presents new research data on its innovative antitumordrug candidate BAL27862 at the international conference on MolecularTargets and Cancer Therapeutics in Boston (MA). BAL27862 is a novel,intravenous and orally bioavailable small molecule. It disrupts themicrotubule...

Ligand Pharmaceuticals Inc. Earns $2 Million in Milestone Payments from Merck & Co., Inc.
SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced today that it has received $2 million in milestone payments from N. V. Organon, a subsidiary of Merck & Co., Inc., stemming from its research collaboration that is due to expire at the end of December.

International Stem Cell Corporation Announces Collaboration with The Scripps Research Institute's Center for Regenerative Medicine to Study Parthenogenetic Stem Cells
OCEANSIDE, Calif.--(BUSINESS WIRE)--International Stem Cell Corporation (OTCBB: ISCO), www.internationalstemcell.com announced today that it is collaborating with renowned stem cell researcher Jeanne F. Loring, Ph.D., and the Scripps Research Institute (La Jolla, CA) to study parthenogenetic stem cells and potentially therapeutic cells that can be derived from them.

Acurian, Inc. Announces Licensing Agreement with i3 (Ann Arbor, Michigan) for Clinical Research Site Selection Services
HORSHAM, Pa.--(BUSINESS WIRE)--Acurian, Inc., a leading, full-service provider of patient recruitment and retention solutions, announced today that it entered into an agreement with pharmaceutical services company i3 to offer improved site identification and selection to its customers. Through the agreement, Acurian will provide site selection support to trial sponsors via i3s services that offer...

Caliper Life Sciences Partners with to Offer Customized Chemistry and Biology Programs for Drug Discovery Research

HOPKINTON, Mass., Nov. 19 /PRNewswire-FirstCall/ -- Caliper Life Sciences, Inc. , a leading provider of tools and services for drug discovery and life sciences research, today announced a strategic partnership between the company's contract research organization, Caliper Discovery Alliances & Services (CDAS), and Prestwick Chemical (Strasbourg, France) to provide customized outsourced medicinal...

Unilife Medical Solutions Appoints Unifill(TM) Automated Assembly Line Supplier

LEWISBERRY, PA--(Marketwire - November 19, 2009) - Unilife Medical Solutions Limited ("Unilife"or "the Company") (ASX: UNI)(PINKSHEETS: UNIFF) today announced theappointment of Mikron Group ("Mikron") as its contracted supply partner forthe development and supply of automated assembly systems to support...

Reflect Scientific, Inc. Enters Cooperative Agreement With

OREM, UT--(Marketwire - November 19, 2009) - Reflect Scientific, Inc. (OTCBB: RSCF), a providerof diverse products and services for the biotechnology, pharmaceutical,medical, industrial and transportation industries, announced the Companyhas entered into a collaborative arrangement with Resonon for incorporation...

Cellix Ltd. Is Successful Grant Recipient Of FP7 Marie Curie Industry Academia Partnership And Pathways (IAPP) Grant In The Area Of Melanoma Research Co-Ordinated By University College Dublin
The European Commission recently awarded an FP7 Marie Curie Industry Academia Partnership and Pathways (IAPP) grant, termed Target-Melanoma, totalling 1,736,483 to Prof. William Gallaghers group at University College Dublin. The grant, which will run from 2009-2013, will be distributed between the consortium members comprising academic institutions and industrial organisations including the UCD Conway...

Nutra Pharma Corp. Introduces Chronic Pain Reliever, Nyloxin OTC, for International Distribution
PLANTATION, Fla.--(BUSINESS WIRE)--Nutra Pharma Corp. (OTCBB: NPHC), a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), has announced today the introduction of Nyloxin OTC for the treatment of chronic pain. Nyloxin OTC will be marketed and sold internationally alongside the Companys prescription pain reliever, Nyloxin Rx.

VisEn Medical, Inc. Launches New OsteoSense(R) 800 and VivoTag(R) 800 Fluorescence Molecular Imaging Agents Expands VisEn's Fluorescence Molecular Imaging Agent Portfolio to Enable Enhanced Multiplexed Readouts of Key Biomarkers in Research and Drug Development

BEDFORD, Mass., Nov. 19 /PRNewswire/ -- VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced today the commercial launch of its new OsteoSense(R) 800 imaging agent for targeting areas of bone turnover and microcalcification in vivo. The new 800 nm OsteoSense agent complements VisEn's OsteoSense 680 and 750 products, and is expected to further...

Helix BioMedix, Inc. Secures Additional Intellectual Property
BOTHELL, Wash.--(BUSINESS WIRE)--Helix BioMedix, Inc. (OTCBB: HXBM), a developer of bioactive peptides, today announced the United States Patent and Trademark Office has allowed multiple claims in one of the companys recent patent applications. US patent application 12/005653, Short Bioactive Peptides for Cellular and Immunological Modulation, covers a number of peptides including Heptapeptide...

Precision BioSciences Announces that CELLECTIS SA Loses Patent Protection for Single-Chain Meganucleases in Europe
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Yesterday, the European Patent Office (EPO) revoked previously granted claims of Cellectis European Patent No. EP 1485475 during an oral hearing in an opposition proceeding initiated by Precision BioSciences. As a result of the opposition, Cellectis previously granted claims to single-chain meganucleases, including those derived from I-CreI, were revoked...

Cancer Prevention and Research Institute of Texas's First Round of Requests for Prevention Funding Exceeds Total Budget Amount
AUSTIN, Texas--(BUSINESS WIRE)--CPRIT receives requests totaling over $28 million in response to its initial prevention funding opportunities.

Affymax, Inc. Prices Public Offering of Common Stock
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq:AFFY) today announced that it has priced an underwritten public offering of 4,109,589 shares of its common stock at a price of $18.25 per share. Net proceeds, after estimated underwriting discounts and commissions and estimated expenses, will be approximately $69.6 million. Affymax has granted the underwriters a thirty-day option to purchase...

ImmunoCellular Therapeutics, Ltd Issues Letter to Shareholders
LOS ANGELES--(BUSINESS WIRE)--ImmunoCellular Therapeutics, Ltd. (OTCBB: IMUC) (IMUC), a biotechnology company that is focused on the development of novel immune-based cancer therapies, issued the following Letter to Shareholders today:

GTC Biotherapeutics Receives Extension to Regain Compliance with NASDAQ Listing Standards
FRAMINGHAM, Mass.--(BUSINESS WIRE)--GTC Biotherapeutics, Inc. ("GTC", NASDAQ: GTCB) has received from a NASDAQ Hearings Panel an extension to March 16, 2010 to regain compliance with the market value of listed securities requirement for continued listing on The NASDAQ Capital Market, as specified by NASDAQ Listing Rule 5550(b)(2). The Companys common stock will continue to be listed on The NASDAQ...

Affymax, Inc. Announces Proposed Public Offering of Common Stock
PALO ALTO, Calif.--(BUSINESS WIRE)--Affymax, Inc. (Nasdaq: AFFY), today announced that it intends to offer, subject to market and other conditions, shares of its common stock in an underwritten public offering. Affymax expects to grant the underwriters a thirty-day option to purchase additional shares of common stock to cover overallotments, if any.

Bioanalytical Systems, Inc. Announces Compliance With NASDAQ Capital Markets Requirements

WEST LAFAYETTE, IN--(Marketwire - November 19, 2009) - Bioanalytical Systems, Inc. (NASDAQ: BASI) announced today that its application to transfer from the NASDAQStock Market to the NASDAQ Capital Market has been accepted. The transferwill occur on November 20, 2009.

The Company had previously been...

NeoStem, Inc. Outlines to Shareholders Near-term and Long-term Business Strategies Following Acquisition of Chinese Pharmaceutical Company

NEW YORK, Nov. 19 /PRNewswire-FirstCall/ -- NeoStem, Inc. , announced today that it has sent the following letter to its shareholders, discussing the Company's acquisition, on October 30, 2009, of China Biopharmaceuticals Holdings, Inc. (CHBP), an integrated bio-pharmaceutical company based in the People's Republic of China. The merger gives NeoStem a controlling 51% interest in Suzhou Eyre...

AmerisourceBergen Completes Public Offering of $400 Million 4.875% Senior Notes Due 2019
CHESTERBROOK, Pa.--(BUSINESS WIRE)--AmerisourceBergen Corporation (NYSE: ABC) today announced it had completed its public offering of $400 million principal amount of 4.875% Senior Notes due November 15, 2019. AmerisourceBergen intends to use approximately $221.9 million of the net proceeds from this offering to repay substantially all the amounts outstanding under its multi-currency revolving credit...

Germany-Based Caprotec Bioanalytics Opens US Subsidiary in Burlington, Massachusetts; Appoints President
BURLINGTON, Mass. and BERLIN, Nov. 19 /PRNewswire/ -- caprotec bioanalytics GmbH announced today the opening of its US-based subsidiary based in Burlington, MA. caprotec Inc. will be responsible for North American sales, marketing and support of caprotec's proprietary Capture Compound Mass Spectrometry (CCMS) technology and its related products.

caprotec is partnering with Genovative Solutions...

ExL Pharma's Leading European Digital Marketing and Public Relations Conferences to Be Hosted at Bayer Schering Pharma Corporate Headquarters, March 29-30th, 2010

NEW YORK, NY--(Marketwire - November 18, 2009) - Bayer Schering Pharma and ExL Pharma todayannounced that the 2nd Annual Digital Pharma Europe and 2nd Annual EuropeanPublic Relations and Communications Summit will be hosted at the BayerSchering Pharma World Headquarters in Berlin, Germany on March 29-30, 2010.

These events which feature

OSI Pharmaceuticals, Inc. to Webcast its R&D Analyst Day on Thursday, December 3rd
MELVILLE, N.Y.--(BUSINESS WIRE)--OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it will host a live webcast of its R&D Analyst Day on Thursday, December 3, 2009 at 12:30 p.m. Eastern Time. The webcast will be hosted by Colin Goddard, Ph.D., Chief Executive Officer, and members of OSIs management team. The Company will discuss the status of its oncology and diabetes/obesity research...

Global Biopharma Wolfe Laboratories Inc. Helps Veterans Return to College and Rejoin the Workforce
WATERTOWN, Mass.--(BUSINESS WIRE)--In honor of Veterans Day, Wolfe Laboratories, Inc. (WLI), a biopharmaceutical development services company, hosted a site visit for veterans involved in the Veterans Upward Bound (VUB) program to introduce career options in the life sciences industry and help to translate their military experience into a career in biopharma.

Quark Pharmaceuticals Inc. Reports Progress of siRNA Clinical Programs

FREMONT, Calif., Nov. 19 /PRNewswire/ -- Quark Pharmaceuticals, Inc., the leader in siRNA therapeutics in clinicals, announced today that four of its siRNA R&D platform based programs have met clinical development milestones; patient enrollment was completed in three clinical studies and a new IND opened for ocular neuroprotection drug candidate QPI 1007:

...

Isis Pharmaceuticals, Inc. Announces Its R&D Webcast Presentation

CARLSBAD, Calif., Nov. 19 /PRNewswire-FirstCall/ -- Isis Pharmaceuticals, Inc. announces the following webcast:

When: Thursday, December 3, 2009, at 8:30 a.m. PT / 11:30 a.m. ET

How: Live on the Internet. Simply log on to our Web site listed above.

If you are unable to participate during the live event, a replay...

Cobalis Corp., Maker of Revolutionary Allergy Relief Product PreHistin(R) "The World's FIRST Prehistamine" Confirms Filing of Five Count Lawsuit Against in US Bankruptcy Court
IRVINE, Calif.--(BUSINESS WIRE)--Cobalis Corporation (Pink Sheets: CLSC) confirms filing Five Count Adversarial Complaint on November 9, 2009 against secured creditor Yorkville Advisors/YA Global Investments, L P (YAGI) f/k/a Cornell Capital Partners, L P in US Bankruptcy Court, Santa Ana, CA.

MONITORING FORCE GmbH Requests Acknowledgment of Flibanserin as Orphan Drug

OmniComm Systems, Inc. Continues Its Rapid Expansion by Opening a New Office in Monmouth Junction, NJ

FORT LAUDERDALE, FL--(Marketwire - November 19, 2009) -

Highlighted Links

 

OmniComm Website
OmniComm Systems, Inc. (OTCBB:

454 Life Sciences Unveils New Bench Top Sequencer, Significant Improvements to the Genome Sequencer FLX System Including 1,000 bp Reads for 2010
BRANFORD, Conn.--(BUSINESS WIRE)--454 Life Sciences, a Roche Company (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY), announced today at the Association of Molecular Pathology Annual Meeting in Kissimmee, Florida a series of revolutionary developments which significantly expand the companys high-throughput sequencing portfolio. Addressing the growing demand for next-generation sequencing data in everyday...

AcroMetrix Announces the Launch of the OptiQual(R) HPV Genotype Panel
BENICIA, Calif.--(BUSINESS WIRE)--AcroMetrix, a leading manufacturer of quality control material for clinical diagnostic and blood testing laboratories, announced today the launch of its OptiQual HPV Genotype Panel. Designed to help clinical laboratories comply with CLIA guidelines for qualitative molecular assays that detect Human Papillomavirus (HPV), this addition to AcroMetrixs line of women...

BioSpace.com Featured News

 

Expiration Trade Behind Osiris Activity
optionMONSTER submits:

By Chris McKhann

As we close in on expiration at the end of today's session, traders are rolling out positions that they don't want to be without going into Monday. That's what we are seeing today in Osiris Therapeutics (OSIR), where traders are rolling put positions out a month.


Complete Story »

BioMed News Bytes: AstraZeneca, Delcath, Unilife
Mike Havrilla submits:

On 11/19/09, AstraZeneca (NYSE: AZN) announced the submission of a New Drug Application (NDA) to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is BRILINTA, pending approval from the FDA. This submission is based on the results of a comprehensive program, including data from PLATO (A Study of Platelet Inhibition and Patient Outcomes), the Phase 3 head-to-head trial comparing ticagrelor plus aspirin with clopidogrel (Plavix) plus aspirin. Ticagrelor is the first reversibly binding oral P2Y12 adenosine diphosphate (ADP) receptor antagonist. The mode of action involves inhibiting the action of platelets in the blood to prevent platelets from sticking together, thereby reducing recurrent thrombotic (blood clot) events.

On 5/11/09, AZN announced top line results from the phase III trial, PLATO (A Study of Platelet Inhibition and Patient Outcomes), which demonstrate that BRILINTA (ticagrelor), the investigational oral antiplatelet treatment for acute coronary syndromes (ACS), has achieved a statistically significant primary efficacy endpoint versus Plavix (clopidogrel), in the prevention of cardiovascular (CV) events in patients with ACS. The primary efficacy measure was time to first occurrence of any event from the composite of myocardial infarction, stroke, and CV death. In PLATO, the overall safety profile for BRILINTA was in line with the safety data observed in the Phase 2 studies.


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A Possible New Indication for Progenix's Relistor Could Revive Its Fortunes
David Greene submits:

On Wednesday (Nov. 18), Progenic's Pharmaceutical (PGNX), received some good news in the form of a Reuters story stating that the widely-used painkiller drug, morphine, may actually accelerate cancer growth in patients. Researchers in the US have results from two studies that show that morphine could be on the wrong side of the fight against cancer. But PGNX's drug, Relistor, has shown promise in reversing some of the tumor-generating effects in mice and, significantly, in lung cancer cells.

The article also quoted Patrick SIngleton of the University of Chicago Medical Center, who remarked on the findings of two studies at a Oncology meeting recently, as saying, "This drug might actually inhibit the progression of lung cancer."


Complete Story »

Santarus' Zegrid Facing Back-to-Back FDA Approval Dates
R. Saito submits:

Santarus’ (SNTS) main drug, Zegerid, is coming up on back-to-back FDA approval dates in early December. Zegerid is a proprietary immediate-release formulation that combines the proton pump inhibitor omeprazole with the antacid sodium bicarbonate indicated for upper gastrointestinal diseases and disorders, including gastrointestinal reflux disease (GERD). It is the first and only immediate release proton pump inhibitor on the market.

The first of these FDA approval dates is December 4th, for a 505(b)(2) application of a tablet form of Zegerid to be marketed by Santarus by prescription. The tablet formulation would add to Santarus’ current capsule and powder form of the drug. The 505(b)(2) pathway is an abbreviated application used for approval of a different format of currently approved drugs, and historically these applications have a high rate of approval with the FDA.


Complete Story »

Competition in Blood - Thinners: Win - Win for Everyone Involved
derek loweDerek Lowe submits:

The InVivo Blog has a good article on a controversy in the blood-thinning market. Plavix (clopidogrel) has a very strong share of that, of course, but since Effient (prasugrel) was finally approved, Lilly (LLY) and Dai-Ichii are looking to take as much of that market as they can. And one opening might be that not everyone responds similarly to Plavix.

In some cases, that's because there are some drug-drug interactions, a problem the FDA has recently addressed. The proton pump inhibitors, especially, are metabolized through the CYP2C19 pathway. That's a problem, since that enzyme is needed to convert clopidogrel into its active form (Plavix, as it comes out of the pill, is a prodrug - its thiophene ring needs to get torn open). This sort of thing has been seen many times before - it's one of the many headaches that you can endure in drug development as you profile the metabolizing pathways for your drug candidate and compare them to the other compounds your patient population might be taking. There are some combinations that just will not work (several involving CYP3A4, which is often the first one you test for), and it looks like we can add Plavix/2C19 to the list.


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Echo Therapeutics: Positive Developments for a Needle-Free Diabetes Monitoring System
Mike Havrilla submits:

Echo Therapeutics (ECTE.OB) is a diabetes management company developing the needle-free Symphony Transdermal Continuous Glucose Monitoring (tCGM) System as a non-invasive, wireless, transdermal solution for monitoring blood sugar levels and the needle-free Prelude SkinPrep System for transdermal drug delivery applications.

On 11/19/09, the Company announced positive results in a pilot clinical study which included Prelude skin preparation and the placement of 10 Symphony tCGM biosensors on subjects with Type 1 or Type 2 Diabetes. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer to establish the gold standard / reference in this study, resulting in 97% accuracy for the Symphony tCGM System that was derived from approximately 900 glucose measurements with no adverse events related to the Prelude skin prep / permeation process.


Complete Story »

Oral-lyn vs. Afresa: How Generex Will Beat Mannkind
R.J Steffens submits:

As biotech companies and large pharma embark on paths to usher in more effective diabetes drugs to market, one of the more significant concerns regarding diabetes related drug development is safety. The FDA has increasingly issued new alerts from previously approved drugs such as GlaxoSmithKline's (GSK) Avandia, Eli Lilly's (LLY) Byetta and Bristol-Myers Squibb's (BMS) Onglyza while deciding whether the safety risks of new drugs such as Novo Nordisk's (NVO) Victoza and Mannkind's (MNKD) Afresa have benefits to outweigh the safety risks. In thinking of Afresa, most insulin drugs have mainly been regarded as safe by US drug regulators, however Pfizer and inhalable insulin attracted an inordinate amount of scrutiny and requirements of pulmonary testing and Phase IV monitoring. Also in June, the FDA said it is reviewing data on the safety of Sanofi-Aventis's (SNY) popular Lantus insulin over highly publicized and inconsistent cancer findings.

There has only been one new diabetes related drug that has risen above the questions of whether the risk of taking the drug has outweighed the positive effect of its intended claims. That new drug is Generex's (GNBT) buccal insulin Oral-lyn. The most obvious example of the proven safety profile of Generex's buccal insulin came this past September when the company announced the FDA granted approval for the Treatment IND usage of Oral-lyn buccal insulin under the FDA's Treatment Investigational New Drug program. Drugs that are granted approval by the FDA for the Treatment IND program must demonstrate the prospect of efficacy through clinical testing without the concern for safety issues that call any benefit into question. Generex's Oral-lyn is the only developmental drug intended to treat diabetes that has ever been approved in this special access program. This is a noteworthy achievement for Generex's regulatory team, led by Mr. George Markus, which also illustrates their ability in successfully communicating with the world's most stringent regulatory body.


Complete Story »

Cheating Death: Possible Winners and Losers in Life Extension Strategies
Cam Hui submits:

I was at dinner with some friends and the conversation turned to the topic of undiscovered investment opportunities. One of my nominations for undiscovered investment theme was life extension technology. In October 2009, the respected medical journal Lancet published a study indicating that given the trend of progress in life extension strategies, people born in the year 2000 in today’s major industrialized countries will likely live to 100.

What does that mean for investors? Who are the winners and losers under such a scenario?


Complete Story »

Biotech Stocks for a Possible Year-End Rally
R. Scott Raynovich submits:

Biotech stocks are in a recovery mode and poised for a Q4 rally extending to early January, according to Raynoreport.com's chief biotech contributor Raygent Associates.

Raygent notes that the year-end rally has been a trend in the past few years (’05,’06 and ’07 trends), though it was certainly disrupted by the recent financial crisis of ‘08/09. The IBB tracking ETF looks to be basing at levels of 75-79, so a rally would take this popular ETF beyond 80, seeking the September highs of 85.


Complete Story »

BioMed News Bytes: GeoVax, Cerus, Discovery Labs, NeurogesX
Mike Havrilla submits:

On 11/17/09, GeoVax (GOVX.OB) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for the Company’s therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package.

Following the FDA response to the Pre-IND meeting questions, GeoVax will prepare and submit to the FDA an IND application for the therapeutic trial. A new IND with the FDA is required since this will be the first time the GeoVax vaccine will be used for a therapeutic application. The IND process is expected to take a number of months to complete and based on the Company's current progress, commencement of the trial is targeted for early 2010.


Complete Story »

Lumizyme Rejected Again: Downgrading Genzyme Recommendation from Buy to Hold

This is a follow up to my earlier post regarding the news that promising Pompe disease drug, Lumizyme, received a Complete Response Letter from the FDA. I defer the reader to that post for full details and analysis regarding my views on the Lumizyme Complete Response Letter and the recent manufacturing setback at the Allston plant. However, below the reader will find my views on how this news has impacted my valuation of the company.

Negative impact to valuation:


Complete Story »

BioMed News Bytes: Cytori, Poniard, Alkermes, Spherix, CRXX, HGSI
Mike Havrilla submits:

On 11/16/09, Cytori Therapeutics (NASDAQ: CYTX) completed enrollment in a 70-patient, international breast cancer reconstruction study, RESTORE 2. The study is evaluating the use of cell-enriched fat grafting to restore functional and cosmetic deformities in women who have undergone partial mastectomy for early breast cancer. Interim data on the first 32 patients who have reached the six-month follow-up will be presented as a poster at the San Antonio Breast Cancer Symposium on 12/12/0 at 7am (CT) by Mrs. Eva Weiler-Mithoff, MD, lead investigator at the Glasgow Royal Infirmary.

Cytori expects to present six-month data for 15-30 patients while final, 12-month data on all patients is expected in early 2011. The ClinicalTrials.gov identifier is NCT00616135 for the RESTORE-2 study, which is a European study designed to evaluate the transplantation of ADRC-enhanced autologous (patient-derived) fat tissue into and around breast deformities. Data from this post-marketing study will also be used to support market adoption and insurance reimbursement for the procedure.


Complete Story »

Cholesterol Drug Trials: A Victory for Abbott Means a Loss for Merck
derek loweDerek Lowe submits:

Over the weekend, the results in a small cardiovascular trial came out that compared Merck's (MRK) Zetia (ezetimibe/simvastatin) against Abbott's (ABT) Niaspan (time-release niacin). Niacin's an under-appreciated therapy in the field - it has tolerability problems, mainly irritating and uncomfortable hot flushing, but it really does seem to help normalize lipid numbers. (And that's why Merck itself, among others, have taken cracks at the market).

This latest trial was a small one, but people have been starved for data on Zetia ever since it took a surprising hit (in the ENHANCE trial) suggesting that it might not be very efficacious. There's an ongoing larger trial that should answer this question once and for all, but those numbers won't be showing up for another two years. For now, anything that can help clarify what's going on is of great interest to Merck, its investors, and to cardiologists and their patients.


Complete Story »

Santarus, Depomed Poised to Gain from Anticipated Sales of Glumetza
R. Saito submits:

Early last year, the FDA approved a new drug in the fight against adult-onset, type II diabetes, Glumetza. Glumetza is a new form of Metformin, a generic drug with many problems in uptake and gastric side-effects. Glumetza is a long-acting, timed release, once daily version of the drug that now finally can take full advantage of the effects of Metformin to normalize blood sugar in patients with type II diabetes while minimizing the side-effects associated with Metformin. The drug works by reducing the amount of sugar produced in the liver, and the amount of sugar absorbed in the body. It also helps the body respond better to its own insulin, thereby reducing instances of damaging high levels of blood sugar. Think of Glumetza as a once-a-day wonder drug for the approximately 19 million people in the US suffering from adult-onset, or type II diabetes.

Since the FDA approved the drug early last year, it has slowly started to penetrate the marketplace. The small company behind the drug is Depomed (DEPO) of Menlo Park, CA. Late summer last year, Depomed inked a deal with a larger company, Santarus (SNTS) of San Diego, CA, to market and sell the drug in the US using its well established sales and marketing network. In the deal, Santarus paid Depomed an up-front payment, while Santarus in turn will receive 75-80% of the gross margin from sales of Glumetza. Both companies were winners in this deal, as Depomed received much needed cash in the credit crunch and cash strong Santarus will have huge earnings potential as sales of Glumetza take off.


Complete Story »

Playing the Options Game in RIM; Cel Sci Not Yet Trading to Its Potential
VFC submits:

In "Readers Respond" I do my best to answer readers' questions, but keep in mind that my responses to these questions are my opinions and personal speculation that I have based on my own research and due diligence.

Also, I will try to respond to a number of requests that I've received via email or comments to the board asking for 'VFC's Take' on stocks that readers have found. While I'll do my best to address as many as I can, please take a few things into consideration while reading:


Complete Story »

ISIS' Short-Term Trends Demonstrate When Technical Analysis Is Important
The Curious Investor submits:

This is a follow up to my post, “ISIS Pharmaceuticals breaches long term support.” As many of you may know, posts from this blog are often (though not always) syndicated on SeekingAlpha.com. In the case of my previous post on ISIS, I caught significant flack from the Seeking Alpha community. Among other things, I was accused of not understanding how to invest in biotech and generally missing the point on ISIS’ anti-sense technology. (For those interested, I actually posted on ISIS’ business and fundamental value in a previous post.)

Well, I figure it’s time to post a follow up to my previous post. To recap, here is the chart I posted on October 5, 2009. This is a three-year weekly chart which I typically use to determine the intermediate/long term market trend driving the stock.


Complete Story »

Don't Like Celsius Holdings? Try Cel-Sci Instead
VFC submits:

A comment from Scott regarding Celsius Holdings (CSUH.OB):

You tell a nice warm story about Carl being the big dog and you waiting under the table at dinner time, but the numbers and profitablity win in the end. And you're brushing off the basic financial landscape.


Complete Story »

Developments for Parkinson's Disease Ignite Investor Enthusiasm
Michael Becker submits:

In our August 2009 article titled “Treating Parkinson’s Disease: Investment Opportunities and Challenges,” we reviewed some of the historical challenges associated with developing treatments for Parkinson’s disease [PD] and cited reasons for optimism going forward in addition to highlighting several promising companies making progress. Since that time, many of the companies we featured have reported clinical progress, presented promising new data, and produced significant returns for investors – with several stocks reaching 52-week highs. In view of renewed investor enthusiasm for companies working in the area of PD, the purpose of this article is to provide an update on previously mentioned companies and introduce some new players that are making headlines in the PD space.

Improvements on Existing Therapies


Complete Story »

Sanofi-Aventis to Establish Venture Capital Fund, Looking for 'Right Brain Activity'
The Burrill Report submits:

By Marie Daghlian

Chris Viehbacher, CEO of Sanofi-Aventis (SNY), said his company will establish a venture capital fund, joining an ever-growing queue of pharma venture capital funds seeking to gain better access biotech innovation. Viehbacher confirmed the French drugmaker’s plans in comments made at an event at Sanofi’s R&D campus in Cambridge, Massachusetts, the online publication Xconomy reported. The company also announced a significant expansion and extension of its collaboration with Regeneron Pharmaceuticals (REGN). The deal comes a month after Sanofi-Aventis struck a partnership deal with Merrimack Pharmaceuticals focused on the biotech's experimental antibody drug for cancer, and continues Sanofi's strategy of looking outside the company for what Viehbacher calls "right brain activity" that leads to creativity and innovation.


Complete Story »

Big Pharma Willing to Pay for Biotech Innovation
The Burrill Report submits:

By Marie Daghlian

If the past week is any indication, big pharma is showing that it is willing to pay for biotech innovation. On the receiving end this week, Alder Biopharmaceuticals stands to reap more than $1 billion from collaboration with Bristol Myers Squibb (BMY) for the development and commercialization of ALD518, a novel biologic that has completed phase 2a development for the treatment of rheumatoid arthritis. Bothell, Washington-based Alder is granting Bristol-Myers Squibb worldwide exclusive rights to develop and commercialize ALD518 for all potential indications except cancer, for which Alder will retain rights and grant Bristol-Myers Squibb an option to co-develop and commercialize outside the United States. In return, Bristol-Myers Squibb will pay Alder an upfront cash payment of $85 million, potential development-based and regulatory-based milestone payments of up to $764 million across a range of indications, and potential sales-based milestones that may exceed $200 million and royalties on net sales. Alder also has an option to require Bristol-Myers Squibb to make an equity investment of up to $20 million in Alder during an initial public offering.


Complete Story »

Biotech Sector and Stocks Analysis from Seeking Alpha
'Biotech' Tag RSS Syndication from SeekingAlpha.com

 

Veridiam Wins Workplace Excellence Crystal Award in Mid-Size Company Category
SAN DIEGO, Nov. 20 /PRNewswire/ -- Veridiam (www.veridiam.com) won the prestigious Crystal Award in the mid-size company category at the 2009 Workplace Excellence Awards. The awards are sponsored by the San Diego Society for Human Resources Management and recognize innovative and exceptional human resources practices.

Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent
NATICK, Mass. and LONDON, Nov. 20 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval to market its WallFlex® Fully Covered Esophageal Stent for the treatment of malignant esophageal strictures (obstructions) caused by tumors in patients with resectable or non-resectable esophageal cancer.

Novavax Prices Public Offering of Common Stock
ROCKVILLE, Md., Nov. 20 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it has priced an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $3.30 per share. The approximately $21 million of net proceeds, after deducting the underwriting discounts and commissions, will be used for preclinical studies and clinical trials of our VLP-based vaccines, internal research and development programs, working capital, capital expenditures and other general corporate purposes. The offering is expected to close on or about November 25, 2009, subject to the satisfaction of customary closing conditions.

Dendreon Receives FDA Acknowledgement of Complete Response
SEATTLE, Nov. 20 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. Dendreon is seeking licensure for PROVENGE for men with metastatic castrate-resistant prostate cancer (CRPC).

Merck Receives CHMP Positive Opinion for New Fertility Treatment, ELONVA(R)
WHITEHOUSE STATION, N.J., Nov. 20 /PRNewswire-FirstCall/ -- Merck & Co., Inc. today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has recommended approval of ELONVA® (corifollitropin alfa injection) as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program. If approved by the European Commission, Merck would receive marketing authorization for ELONVA with unified labeling valid in all European Union Member States.

Novavax Announces Public Offering of Common Stock
ROCKVILLE, Md., Nov. 20 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) today announced that it intends to offer shares of its common stock in an underwritten public offering. Piper Jaffray & Co. and Lazard Capital Markets LLC are acting as joint book running managers.

Soligenix Forms Consortium to Develop Thermostable Technology to Advance RiVax(TM) and Other Rapidly Acting Vaccines
PRINCETON, N.J., Nov. 20 /PRNewswire-FirstCall/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines. Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to support this work.

BD Completes Acquisition of HandyLab, Inc.
FRANKLIN LAKES, N.J., Nov. 20 /PRNewswire-FirstCall/ -- BD (Becton, Dickinson and Company) (NYSE: BDX) today announced the completion of its acquisition of HandyLab, Inc., an Ann Arbor, Michigan-based company that develops and manufactures molecular diagnostic assays and automation platforms.

Cell Therapeutics Wins Federal Appeal to Pursue $22.8 Million Claim Against The Lash Group
SEATTLE, Nov. 20 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that the Ninth Circuit Court of Appeals reversed a U.S. District Court order and ruled that CTI should be allowed to pursue all of its claims against The Lash Group, sending the case back to the District Court for trial. CTI filed a complaint against The Lash Group, CTI's former third-party reimbursement consultant for CTI's product TRISENOX, in 2007 seeking $22.8 million in damages for expenses already incurred related to the investigation, defense and a settlement of claims by the U.S. government concerning Medicare reimbursement for TRISENOX and other business losses.

Karolinska Development and EIF Start Landmark Co-Investment Fund for Life Science Innovation
STOCKHOLM, November 20 /PRNewswire/ -- Karolinska Development AB today announced that the European Investment Fund (EIF) has entered into a co-investment agreement with the company. The co-investment fund will be managed by Karolinska Development and used to invest in the company's portfolio of early-stage pharmaceutical and medical technology companies. EIF has agreed to invest 26.7 M Euros in the co-investment fund. The agreement represents EIF's largest single investment in the Nordic region to date.

Spherix Announces the Closing of $6.3 Million Registered Direct Offering
BETHESDA, Md., Nov. 19 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, announced today it closed the previously reported $6.3 million registered direct placement to institutional investors of 2,760,870 shares of its common stock and warrants to purchase up to 1,104,348 additional shares of its common stock. Each unit, consisting of one share of common stock and a warrant to purchase 0.40 of a share of common stock, was sold for a purchase price of $2.30 per unit. The warrants have an exercise price of $3.25 per share and are exercisable at any time after the closing of the transaction and before the 5th anniversary of such initial issuance date. Net proceeds, after deducting placement agent fees and other offering expenses, will be approximately $6 million.

American BioSciences Rebuts Misleading Statements Made by Hungarian Competitor
BLAUVELT, N.Y., Nov. 19 /PRNewswire/ -- Dr. Mate Hidvegi, inventor of Avemar fermented wheat germ extract, responds to a press release issued on November 17 by Biropharma Kft, discrediting the Hungarian company for making false and self-serving statements about its U.S. competitor American BioSciences.

Omeros Corporation Reports Third Quarter 2009 Financial Results and Development Highlights
SEATTLE, Nov. 19 /PRNewswire-FirstCall/ -- Omeros Corporation (Nasdaq: OMER) today announced unaudited financial results for the third quarter ended September 30, 2009. For the three months ended September 30, 2009, Omeros reported a net loss of $3.9 million, or $1.34 per share, as compared to a net loss of $7.4 million, or $2.54 per share, for the same period in 2008. For the nine months ended September 30, 2009, the Company reported a net loss of $15.5 million, or $5.29 per share, as compared to a net loss of $17.4 million, or $6.07 per share, for the same period in 2008.

DONG Energy and Inbicon Inaugurate One of the World's Largest Demo Plants for 2nd Generation Biofuel
COPENHAGEN, Nov. 19 /PRNewswire/ -- Danish Prince Joachim inaugurated the DONG Energy and Inbicon cellulosic ethanol plant in Kalundborg, Denmark, on Wednesday, November 18. The facility is one of the world's first and largest 2nd generation ethanol demonstration biorefineries. Genencor's Accellerase enzymes are used in the plant's innovative process for converting straw to fuel. Genencor, a Division of Danisco, was the first to market with commercial enzymes for converting cellulosic materials, such as agricultural and forestry wastes and bioenergy crops, into biofuel. The DONG/Inbicon technology will provide ethanol for E85 fuel (85% ethanol), which will fill the tanks of VIP cars for the UNFCCC Global Climate Summit in Copenhagen, from December 7 to 18.

ScinoPharm Announces SafeBridge Potent Compound Safety Certification
TAINAN, Taiwan, Nov. 19 /PRNewswire-Asia/ -- ScinoPharm, a leading global supplier of active pharmaceutical ingredients (APIs), announced that its Tainan facility has received the Potent Compound Safety Certification from SafeBridge(R) Consultants, Inc. The Certification confirms ScinoPharm's competency and proficiency in the safe handling of potent active pharmaceutical ingredients (APIs), and applies to specific laboratories and production areas used for the manufacturing and handling of potent compounds.

The Deal Names Abbott Top Dealmaker for Second Consecutive Year
ABBOTT PARK, Ill., Nov. 19 /PRNewswire-FirstCall/ -- The Deal magazine has named Abbott (NYSE: ABT) as one of its Most Admired Corporate Dealmakers for the second consecutive year. The Deal honored Abbott as its Most Admired Dealmaker in pharma/biotech for the most effective strategic use of acquisitions and divestitures since January 2006.

Spherix Announces Results of Annual Shareholders Meeting
BETHESDA, Md., Nov. 19 /PRNewswire-FirstCall/ -- Spherix Incorporated (Nasdaq: SPEX), an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced the results of Tuesday's Annual Meeting of Shareholders.

NeoStem Outlines to Shareholders Near-term and Long-term Business Strategies Following Acquisition of Chinese Pharmaceutical Company
NEW YORK, Nov. 19 /PRNewswire-FirstCall/ -- NeoStem, Inc. (NYSE Amex: NBS), announced today that it has sent the following letter to its shareholders, discussing the Company's acquisition, on October 30, 2009, of China Biopharmaceuticals Holdings, Inc. (CHBP), an integrated bio-pharmaceutical company based in the People's Republic of China. The merger gives NeoStem a controlling 51% interest in Suzhou Eyre Pharmaceutical Co. Ltd., CHBP's primary operating subsidiary and a prominent and profitable China pharmaceutical company. The letter outlines NeoStem's near-term and long-term business strategies following this acquisition.

Video: Personalized Medicine Drives Multiple Markets, Finds Frost & Sullivan
MOUNTAIN VIEW, Calif., Nov. 18 /PRNewswire/ -- With the launch of several companion diagnostics over the past year, we have officially entered the personalized medicine era. These diagnostics and follow-on therapeutics utilize molecular analysis technologies to diagnose and manage a patient's disease or predisposition towards a disease. The ultimate goal is to prescribe a therapeutic plan tailored to an individual's genetics and environmental profile. While revenues from companion diagnostics are just starting to trickle in, the push towards personalized medicine is driving several markets along the pipeline of drug discovery. From "bench to bedside," this healthcare trend continues to spur basic research technologies, biomarker discovery, pharmacogenomics services, and of course, companion diagnostics and therapeutics.

Aware Inc. Introduces AccuRad ImageShare(TM) Platform at RSNA 2009
BEDFORD, Mass., Nov. 19 /PRNewswire-FirstCall/ -- Aware, Inc. (Nasdaq: AWRE), a global provider of imaging and biometrics software, today announced it will showcase its new AccuRad ImageShare Platform, a standards-based cross-enterprise image sharing platform for health information exchange (HIE), at the RSNA 2009 Scientific Assembly and Annual Meeting. Aware will also participate in the Integrating the Healthcare Enterprise (IHE®) Image Sharing Demonstration at RSNA, demonstrating use of AccuRad ImageShare Platform to retrieve and display medical imagery from other standards-based systems. RSNA is sponsored by the Radiological Society of North America and takes place in Chicago during the week of November 29.

Biotechnology
Press Releases from PR Newswire about Biotechnology

 

ImmunoGen bags second $35M deal with Amgen

ImmunoGen today announced its second licensing deal with Amgen in three months. The biotech giant gains rights to ImmunoGen's maytansinoid Targeted Antibody Payload (TAP) technology, which uses antibodies to deliver a cancer cell-killing agent, to develop anticancer therapeutics to an undisclosed target. In September Amgen licensed the TAP technology for another undisclosed cancer target. Similar to the September deal, today's pact gives ImmunoGen $1 million up front and milestone payments potentially totaling $34 million plus royalties on the sales of any resulting products.

"Amgen undertook extensive diligence prior to taking the first license that enabled them to move ahead quickly with this second license," said ImmunoGen CEO Daniel Junius in a statement. "The commitment Amgen is showing to the development of significant new anticancer compounds using our TAP technology is impressive--both in the pace that they took this second license and in their thoroughness around product timelines."

- here's Immunogen's release
- see the brief from Mass High Tech

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ImmunoGen, Amgen forge $35M pact on cancer tech
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Roche touts Actemra results for sJIA

Roche announced positive results from a late-stage trial of Actemra for systemic onset Juvenile Idiopathic Arthritis (sJIA), a disease that causes intermittent fever, rash, and arthritis symptoms. The drug--a potential blockbuster--met its primary endpoint by significantly improving disease signs and symptoms. Patients treated with the Actemra experienced a significant reduction in the signs and symptoms of the disease after 12 weeks of treatment compared with those in the placebo arm. Additionally, the drug was generally well tolerated.

Actemra is one of the Swiss drugmaker's greatest pipeline hopes, and has been approved by Japanese and European regulators. Despite winning backing from an expert panel, Roche was dealt a serious setback last year when the FDA declined to approve the drug for the treatment of rheumatoid arthritis, delaying it for at least 18 months. The company said full data and safety follow-up from this trial will be used to support future regulatory filings for a label in a sJIA indication. If approved, Actemra would be the first drug available to treat sJIA.

- check out Roche's release
- read the report from Reuters

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FDA extends review for pain drug

The FDA wants more time to review the NDA for Exalgo, a pain drug to be sold by Mallinckrodt, and has extended the Prescription Drug User Fee Act date three months to Feb. 22, 2010. The FDA's decision comes after more information was submitted to the NDA.

Neuromed Pharmaceuticals, which sold the rights to the drug to Mallinckrodt in June, will work with Mallinckrodt to obtain FDA approval for Exalgo (hydromorphone HCl), according to the CombinatoRx statement. Neuromed merged with CombinatoRx in July.

Representatives from Mallinckrodt and Neuromed appeared before joint meeting of the FDA's Anesthetics and Life Support and Drug Safety and Risk Management Advisory Committees in September to solicit feedback with regard to the proposed Risk Evaluation and Mitigation Strategy program for Exalgo.

The benefit of Exalgo is that sufferers won't have to take the drug as often as other treatments already on the market. But FDA staff reviewers have expressed concern about the drug's potential for abuse, noting that it can easily be crushed. At the September meeting, the committees expressed approval for the companies' proposed REMS, called the Exalgo Alliance, which combines education, controlled access and ongoing surveillance.

- read the CombinatoRx release

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Caterpillar shot fails to win vote on safety

In a 6 to 5 vote, the FDA's Vaccines and Related Biological Products Advisory Committee has determined that Connecticut-based Protein Sciences hasn't proven that its innovative flu vaccine FluBlok--which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells--is safe. The shot was being watched because it can be produced more quickly than traditional chicken-egg-based vaccines.

Members of the panels said that Protein Sciences' clinical trials weren't large enough to support mass production. However, 9 of the 11 panelists said the shot was as effective as licensed vaccines in adults ages 18 to 49, according to a Bloomberg report. The committee recommended several additional post-licensure FluBlok studies that would provide more safety and efficacy data in certain patient populations, including the elderly, pregnant women, children and people with compromised immune systems, according to a Hartford Courant article.

FluBlok did have its champions on the panel, according to AFP. "This would have been a breakthrough for the United States and it would certainly have been helpful to have this available this fall," said panelist Theodore Eickhoff of the University of Colorado.

As a result of the vote, Protein Sciences says it will consider making FluBlok abroad. "Other countries--Australia, for example, and Europe--have already said they feel that our vaccine meets the criteria (for safety), but we have always focused on the US," Protein Sciences Chief Operating Officer Manon Cox told AFP.

- read the AFP coverage
- check out the Hartford Courant report
- read the Bloomberg story

Related Articles:
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Movetis plots European IPO

Belgian drugmaker Movetis said today that it will seek up to €112.4 ($167 million) in an upcoming IPO. The gastroenterology company--which was founded in 2006 as a spin-off Johnson & Johnson units Janssen and Ortho-McNeil--recently won European approval of its chronic constipation treatment Resolor. It's also marketed in Iceland, Liechtenstein, Norway and Switzerland. J&J holds rights to the drug in the rest of the world. Movetis plans to use the IPO money to launch Resolor in Germany and Britain next year, and hopes to expand the drug's indication to men and children (current EU approval applies only to women).

Industry watchers are hopeful that Movetis' IPO could be the beginning of the end of the IPO drought in Europe. But Movetis is unlike other drug developers in that it has a more mature pipeline, making it a better IPO candidate. The proceeds will also fund development of M0002 for ascites and M0003 for heartburn and regurgitation.

- here's the Reuters report

Related Article:
Movetis: Top VC deals of 2007

MD governor applauds expansion of Emergent BioSolutions

Maryland Governor Martin O'Malley recently discussed the expansion of Emergent BioSolutions, a Maryland-based biopharmaceutical company, which will open a 60,000 square foot bioprocessing center in Each Baltimore to expand and increase production capacity on the groundbreaking vaccines that they produce.  The expansion is expected to result in up to 125 jobs over the next five years. Release

Xarelto approval hopes revived?

Bayer HealthCare and Johnson & Johnson have good news to present about their blood-thinner Xarelto--a potential blockbuster that the FDA declined to approve months ago. Results from a long-term clinical trial showed taking Xarelto led to an 82 percent lower risk that a venous blood clot would form again compared with placebo, according to a Reuters article.

The Phase III EINSTEIN-extension study followed roughly 1,200 patients who had suffered a thrombosis and undergone six or 12 months of anticoagulant therapy, Bayer says in a statement. Patients in the study received either once-daily Xarelto or a placebo for another six to 12 months. Bayer said more "promising" detailed results from the study will be presented at an American Society of Hematology conference Dec. 8.

The FDA issued a complete response letter for Xarelto in May that asked for more data on the therapy. The companies did not detail exactly what additional information the FDA requested. Xarelto is approved to treat venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery in more than 80 countries, including Australia, Canada, China and Mexico.

- read the Reuters coverage
- check out the Bayer release

Related Articles:
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ACT begins stem cell blindness trial

In the next few weeks, Advanced Cell Technologies will file IND with the FDA for retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. If the FDA signs off on ACT's trial, it will be only the second stem cell study to be approved in the U.S. ACT's program will use stem cells to regenerate a certain type of retina cell necessary for vision; it's Phase I/II trial in human would enroll 12 subjects to test the therapy. In animal trials, the company was able to cure blindness in rats.

"We are very pleased with the long-term safety and efficacy data," says Dr. Robert Lanza, ACT's Chief Scientific Officer, in a statement. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."

Geron made news earlier this year when it filed for the first-ever human stem cell trial. That study is currently on hold while the FDA evalutates safety data in animal models.

- see ACT's release
- read the Reuters report

Related Articles:
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Start-up get funding for microarray work

IncTank Ventures has put up $1 million in funding to back Cambridge, MA-based start-up Ligon Discovery. Ligon is hoping that its technology platform, Small-Molecule Microarrays (SMMs), will bring the power of microarrays to target screening. The technology was developed at Havard University and the Broad Institute, and allows for massively-parallel screening against protein targets of any function. Mass High Tech notes that the company was founded by Broad Institute and Havard members Patrick Kleyn, Angela Koehler and Benjamin Ebert, among others.

- here's the Mass High Tech brief

Caterpillar-based flu shot could be on horizon

The FDA's Vaccines and Related Biological Products Advisory Committee today will determine whether Protein Sciences' flu vaccine FluBlok, which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells, warrants approval.

FluBlok can be produced in a third of the time it takes larger drugmakers, including Sanofi-Aventis, GlaxoSmithKline and Novartis, to make their chicken egg-based shots, according to a Bloomberg article. If approved, FluBlok would represent the first cell-culture derived influenza vaccine licensed in the U.S., according to FDA briefing documents posted ahead of the committee meeting.

FDA documents also revealed that the vaccine was as safe and effective as other shots. The agency made this assessment based on data from four studies of 3,231 adults.

Protein Sciences has grown to 63 employees from 40 in the last three months, and if the vaccine is approved, it may be the smallest company to receive an FDA drug approval, Daniel Adams, Protein Science's CEO, tells Bloomberg. The company may have shots ready for next flu season, he adds.

- read the Bloomberg story 
- check out the FDA briefing documents

Related Articles:
Hamburg offers chicken/egg solution
Protein Sciences wins $150M contract for gene-based vax program

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