Big Win for J&J with Elan Deal
David Van Knapp submits:

Johnson & Johnson (JNJ) has made a significant improvement to its business. Under a deal announced Thursday, J&J will take a major stake in biotech company Elan (ELN), thereby gaining access to Elan's Alzheimer's disease treatments, in particular leading drug bapineuzumab.

In the transaction, J&J will take a 50.1% ownership in Elan's Alzheimer's program, plus an 18.4% ownership in the remaining part of Elan. In return, Elan gets a $1 billion equity investment and a $500 million commitment to fund further development and marketing of promising Alzheimer's treatments. The major focus will be on further development of and launch activities for bapineuzumab, which is in Phase 3 clinical trials.

Why I'm Closing Illumina for Now
Trader Mark submits:

I only have about a 0.4% stake in Illumina (ILMN), so I am going to take about a 8% loss on this last batch (stock is down about 10%) on the earnings warning. The stock had just been flopping around listlessly, so it was not a major position for us, thankfully.

A large gap has been created which is going to take time to work through and time is money. It's not exactly a "value buyers" dream down here either as it is still rich.... valuations like this are based on continued excellence in execution and ILMN's armor has been penetrated from that angle. The stock is down a lot less than in after hours Wednesday (when it was down -20%) unlike Myriad Genetics (MYGN) which was obliterated and down far worse than in the after hours the night before - so there is (relative) promise there.

Elan Shares Spike on JNJ Investment News
optionMONSTER submits:

By Chris.McKhann

Rumors turned to reality this morning, as Elan (ELN) shares jump in the pre-market on news that Johnson and Johnson (JNJ) will invest $1 billion in the biotechnology company.

Is IBB the Best Biotech ETF?
Don Dion submits:

Healthcare has dominated the headlines in recent weeks, as President Obama presents his new proposals and the industry recovers from a position where it was perhaps oversold. Where, in this mix, are ETFs the most helpful? iShares Nasdaq Biotech (IBB) helps investors navigate the popular, but hit-or-miss, biotech subsector. Healthcare has gained short-term momentum in recent weeks, and IBB is up 9.23% for the one-month period ending June 26. IBB offers investors exposure to a broad range of biotech funds with a concentration in large-cap names, a strategy that will save investors some of the pain that comes from failed start-ups. With the healthcare industry just regaining its footing, and government pressure being applied more acutely to other subsectors of healthcare, IBB offers solid long-term exposure to the biotech sector.

FDA Calendar Updates: Repros, Discovery, Acorda, Human Genome Sciences
Mike Havrilla submits:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally created this calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter ((CRL)) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

How Far Myriad Has Fallen: Is Information Leaking out?
Trader Mark submits:

How far Myriad Genetics (MYGN) has fallen! This had been one of the star stocks of the last 12 months as it seemed to do no wrong. In fact during 2 of the worst swoons in market history (Sep-Oct 08, and Jan-Feb 09) the stock held its ground and/or advanced! But the past few months have not treated it kindly. Tuesday night after the bell, Myriad came out with a "slight" revenue warning - $86M for fiscal fourth quarter (analysts had estimated $91.6M as consensus); so a 6% shortfall. This miss takes them to a $326M year versus prior guidance of $330M, and versus analysts' $336M.

For that, the stock was down 17%+ in after hours Tuesday. It seems overdone but a few issues here: (1) this is the second "miss" by management in a short period of time (2) the stock has been expensive even with the dramatic drop since late winter and (3) we really have to start questioning if someone on the inside is leaking information out.

Vanda Pharmaceuticals Comes Back from the Dead
Derek Lowe submits:

I wrote last summer about Vanda Pharmaceuticals (VNDA) and their difficulty getting a new antipsychotic Fanapt (iloperidone) through the FDA. At the time, they'd received one of those wonderful requests for more information from the agency, of the kind that spread cheer whenever they appear. I couldn't see how the company could clear this up without (probably) having to spend a lot of money that it didn't have, and I was very pessimistic about their survival.

Illumina Cuts Forecast on Stimulus Spend Delays
Eric Savitz (Barron's) submits:

Genzyme: The Next Big Biotech Machine

Rarely do I even acknowledge biotech equities due to the inherent risk and uncertainty in the industry. But as of late, one biotech firm has garnered my attention, due to extremely high margin of safety at their current market value. I have also watched this company grow over the last 4 years, and their successful execution of what has been an increasingly dynamic strategic vision.

Oculus CEO: Inaccurate Reports Becoming a Safety Issue

Responding to investor concerns that TheStreet.Com has continued targeting thriving small-cap biomedical companies with inaccurate articles, BioMedReports has been repeatedly contacted by officials of publicly traded companies-- among them, Hoji Alimi who serves as CEO of Petaluma, California based Oculus Innovative Sciences (NASDAQ:OCLS).

Mr. Alimi’s breakthrough Microcyn® Technology- a water based, biocompatible solution used increasingly around the world to help prevent and treat infections in chronic and acute wounds- has been gaining attention both on Wall Street and in the national media due to its rapid kill anti-microbial and healing properties.

The Emisphere Story Just Got Bigger
Joseph Ramelli submits:

There has been a huge positive development in the Emisphere story that hasn’t really filtered out yet. A friend stumbled upon a patent application filed by Novartis (NVS) entitled “Use of Calcitonin for the Treatment of Rheumatoid Arthritis.” The patent application can be viewed here.

2. A method according to claim 1 for inhibiting inflammation of the joints associated with rheumatoid arthritis in a patient in need thereof comprising administering orally to said patient a therapeutically effective amount of a calcitonin in free or salt form and a delivery agent for calcitonin.

Can Spectrum Pharmaceuticals Benefit from FDA Action on Zevalin?
Michael Becker submits:

According to the American Cancer Society [ACS], non-Hodgkin lymphoma [also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma] is a cancer that starts in cells of the lymph system, which is part of the body’s immune system. NHL is the fifth most common cancer in both men and women in the United States [not counting skin cancers]. In 2009, the ACS estimates that there will be nearly 66,000 new cases of NHL in the United States and that about 20,000 people will die from the disease. In general, the overall 5-year relative survival rate for people with NHL is 65%, and 10-year relative survival is 54%.

Cell Genesys: BioSante Sees Something Other than Cash
EP Vantage submits:

Cell Genesys (CEGE) has been rescued from what looked like a certain slow death by BioSante Pharmaceuticals (BPA), which has agreed to buy the developer of one of last year’s failed cancer vaccine projects for $38m in an all-stock transaction (Cell Genesys' prostate cancer vaccine heads for the dustbin, October 16, 2008).

The press release announcing the deal highlighted a 12% premium to Cell Genesys’ share price, but considering the stock has been trading at a fraction of its value prior to the initial failure of its GVAX Immunotherapies, this measure is largely irrelevant. A clearer picture can be gained by looking at the premium over cash; with $36m in the bank as of last week, BioSante has actually paid very little for a company which was valued at $275m this time last year.

FDA Calendar Updates: AspenBio, CytRx, Cephalon, Pozen, Sanofi, AMAG
Mike Havrilla submits:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally launched the calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter ((CRL)) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Becton Dickinson: Riding the Biotech Boom
David Fessler submits:

Analysts are starting to pile into the biotech bandwagon now. And for good reason: the AMEX Biotech Index is actually lower today than it was nine years ago. Translated into investor-speak, the opportunities in biotech today are fantastic. I’m not a biotech guy, but my fellow analyst Marc Lichtenfeld is, and he writes about them regularly.

Geron Pushes Higher on GE Healthcare Alliance
Jamie Moye submits:

Geron Corp. (GERN) yesterday traded strongly higher after announcing a collaboration with GE Healthcare to develop and commercialize evaluation technologies from human embryonic stem cells (hESCs). The multi-year collaboration is designed to assist in the discovery of new drugs, their ongoing development and toxicity screening.

The news had shares of Geron soaring up to 22 percent on heavy volume in morning trading, as the collaboration brings another level of legitimacy to Geron’s stem cell program, which has long been clouded by the controversial nature of hESCs.

5 More Stock Briefs
VFC submits:

Antigentics (AGEN): Shares of Antigentics spiked to over two dollars during mid day trading on Tuesday, in part due to a rumor circulating around the Internet of a possible early approval for Oncophage. Specifics of the rumor are unclear, but since Oncophage is not currently under FDA review, the speculation is probably regarding the European application for approval.

There is undoubtedly little truth to this rumor, in VFC's opinion, and the spike is most likely the result of mere manipulation more than anything else. Any news, or legitimate speculation, regarding additional approvals for Oncophage would cause a spike in the AGEN share price of more than 10%.

FDA Calendar Updates: AMAG Pharma, Takeda
Mike Havrilla submits:

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter ((CRL)) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

17 Reasons Why Bayer Might Acquire Spectrum Pharmaceuticals

Spectrum Pharmaceuticals (Nasdaq: SPPI) has two upcoming dates with regulators in the coming months.

• July 2: Zevalin
• October 8: Fusilev

Lilly's Free Compound Screening Will Draw Many Takers
Derek Lowe submits:

Bay Area Youth to Represent ALS Patients at Giants' and Angels' Baseball Games on July 4th

Johnson & Johnson Completes Initial Tender Offer for Cougar Biotechnology

BioCis Pharma Reports Positive Phase IIa Clinical Results in Atopic Dermatitis

ThromboGenics and BioInvent Start Recruitment of Second 100 Patient Cohort in Phase II DVT Prophylaxis Study With TB-402

ACT Announces Partnership With Gilead Sciences Inc.

Remuda Ranch Programs for Eating and Anxiety Disorders Reports Need for Increasing Awareness of Eating Disorders in Males

avVaa World Health Care Products, Inc. Announces Engagement of Koeppel Direct for their DRTV-Direct Response Television Media Buying Campaign

Lixte Biotechnology Holdings' Lead Compound, LB-1.2, Enhances the Effectiveness of Standard Cancer Chemotherapy in Animal Models

Peregrine Pharmaceuticals to Report Fiscal Year 2009 Financial Results

Oncolytics Biotech(R) Inc. Completes Patient Enrolment in U.K. Combination REOLYSIN(R) and Paclitaxel/Carboplatin Head and Neck Cancer Trial

WuXi PharmaTech Receives Award from BASF

deCODE-led Megastudy Finds New Genetic Clues to Causes of Schizophrenia

Cellular Dynamics International and Roche Expand Existing Cardiotoxicity Screening Agreement

Video: Axel Ullrich Named Winner of 2009 Dr. Paul Janssen Award for Biomedical Research

Biocept, Inc. Announces Two New Director Appointments

Thomson Reuters Publishes Three Pharma Matters Reports Covering the First Quarter of 2009

New Leadership Team at International Trachoma Initiative to Build Stronger Partnerships to Eliminate Blinding Trachoma

New Review on PROSTVAC(TM) Published by Key Investigators From NCI

Encorium Group Updates Expected Timeframe with Respect to the Sale of its U.S. Business

Study Showed VYVANSE(R) (lisdexamfetamine dimesylate) CII Provided Significant Efficacy at 14 Hours After Administration in Adults with ADHD in an Adult Simulated Workplace Environment

A fierce response from readers

When we ran the 2009 Fierce 15 report at the beginning of this week, we expected a big response. But even the optimists among the editorial crew here were surprised by the hard numbers. Monday provided the biggest single daily haul of page views in FierceBiotech's history. And Tuesday offered another bumper crop of readers. It all helped us make June the single biggest month ever for Web traffic.

Eisai creates jobs, readies Aricept NDA

Japan's Eisai has completed construction of a European Knowledge Centre in the UK, which could bring up to 250 jobs to the region. It's part of a £100 million effort to launch a strategic base giving Eisai it's first manufacturing facilities in Europe.

King, Acura get FDA response letter

The FDA has issued a Complete Response Letter to King Pharmaceuticals and Acura Pharmaceuticals regarding their NDA for the pain drug Acurox. The agency has questions about the potential abuse deterrent benefits of Acurox, which the two companies say they can address without having to conduct additional clinical trials. Report

J&J to invest $1B in Elan, scoops up drug program

After months of rumors regarding potential deals, Ireland's Elan Pharmaceuticals announced this morning that Johnson & Johnson will invest a billion dollars into the company while taking control of Elan's rights in a key Alzheimer's drug program.

Sanofi-Aventis wins big with Multaq approval

After a long, dry spell, Sanofi-Aventis' pipeline has finally produced a winner. The FDA has approved its blockbuster heart therapy Multaq.

Sepracor depression drug flunks a mid-stage test

Sepracor ran into an unexpected setback on a mid-stage therapeutic for depression. Researchers say that the drug--SEP-225289--failed to deliver positive data in a trial that dosed 514 patients over eight weeks.

Discovery Labs shares pummeled on new Surfaxin roadblock

Discovery Laboratories lost more than half of its stock value yesterday afternoon, plunging to 52 cents a share after investors got news of a new roadblock at the FDA for its respiratory drug Surfaxin.

Discovery Labs: Surfaxin approval unlikely

Following an end of review meeting with the FDA, Discovery Labs said yesterday that it is unlikely that its lung drug Surfaxin will gain the agency's approval anytime soon. The company was dealt a blow in April when the FDA rejected it's application for the drug, saying that certain aspects of a Surfaxin biological activity test (a quality control stability and release test) had to be resolved before the Surfaxin can win approval. The drug is intended to treat premature infants with Respiratory Distress Syndrome.

FDA wants more info on Novartis' Menveo vax

The FDA has asked Novartis for more information on its meningitis vaccine Menveo, which is likely to push back any approval date to late this year or early in 2010. And the manufacturer was quick to note that the agency is focused on questions regarding production, not safety or efficacy. That means no new clinical trials are needed to satisfy the agency's request.

Are biotech CEO's worth what they're paid?

With a number of UK biotechs struggling to find cash to stay afloat, investors are raising some sharp questions about the pay packages that executives in the industry earn. A recent survey by Nature Biotechnology concluded that the average CEO in the UK earned close to half a million dollars in annual compensation, modest compared to many U.S. salaries.

Search Powered By Google

   

Job & Career Search

                    job title, keywords, company, location

ADVERTISEMENT

Advertisement

Investing Jobs

Finance Jobs

Advertisement

MARKET INDICATORS

 

Stock Markets Overview
Volume Leaders
Percent Advances
Percent Declines
Daily 52 Week Highs
Daily 52 Week Lows
Market Indices
S&P 500
NASDAQ 100
Exchange Traded Funds - ETF Watch
FOREX FX Exchange Rates
Futures Prices by Exchange
Futures Prices by Type
US Morning Call Commentary

Stock Market News, Indicators, Market and Industry Articles Source. Find out what is happening in the Stock Markets. Visit iHaveNet.com for the latest Stock Market News by Sector and Industry. Your Single Source to Stock Market, Economic, Business and Industry News Articles.

ADVERTISEMENT

Job & Career Search

                    job title, keywords, company, location