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...

Expiration Trade Behind Osiris Activity
optionMONSTER submits:

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.

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."

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.

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

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.

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.

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?

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.

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.

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.

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.

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

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.

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:

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.)

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.

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

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.

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

By Marie Daghlian

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.