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FDA Calendar Updates: Amgen, Bayer, Biogen, Noveko, Peplin, Transdel
BIIB
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+5.01%
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151 days
<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 246 entries as of 7/8/09. 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 <font> BioMedReports.com </font> , 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...
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FDA Decision Calendar: Pain Drug Delays Likely
BIIB
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-12.22%
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148 days
(closed on 07/08/09)
FDA Decision Calendar: Pain Drug Delays Likely By Mike Havrilla on 2/9/09 ETF Innovators The tables at my website link below include an updated calendar of 86 expected FDA new product decisions and 89 pending clinical trial result estimates + pending FDA re-submissions or new submissions for regulatory approval. Click here for a link to my previous calendars. New FDA Decision Calendar Entries: <> 1.) Biogen Idec (BIIB) and Genentech (DNA) have a PDUFA...
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Biogen Reports Another PML Case in Tysabri Patient
BIIB
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+29.15%
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102 days
(closed on 02/10/09)
<> 
After the market close, Biogen (BIIB) filed an 8-K with the SEC reporting a new case of the potentially fatal brain disease known as PML or progressive multifocal leukoencephalopathy in a patient receiving their multiple sclerosis [MS] drug Tysabri, adding to the two new cases which were reported previously in July. Biogen is currently trading down by about 15% after hours while marketing partner Elan (ELN) is down by about 25% as of 5:15 PM. The news adds more uncertainty to Tysabri, which was removed from th...
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Biogen Reports Another PML Case in Tysabri Patient
BIIB
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+0.00%
in
3 hours
(closed on 10/30/08)
<>
After the market close, Biogen (BIIB) filed an 8-K with the SEC reporting a new case of the potentially fatal brain disease known as PML or progressive multifocal leukoencephalopathy in a patient receiving their multiple sclerosis [MS] drug Tysabri, adding to the two new cases which were reported previously in July. Biogen is currently trading down by about 15% after hours while marketing partner Elan (ELN) is down by about 25% as of 5:15 PM. The news adds more uncertainty to Tysabri, which was removed from th...
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Biotech Blues: Four Stocks on Sale with Hope
BIIB
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-3.42%
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4 days
(closed on 10/29/08)
<> The following group of biotech companies have market caps of at least $300M with a one year stock price change that is below the iShares Nasdaq Biotech ETF (IBB) loss of 21.8% (Source: Google Finance, 10/25/08) with potential upside catalysts over the next year.
Alnylam Pharma (ALNY): $872M, -31.6%
Biogen Idec (BIIB): $12B, -48.4%
BioMarin Pharma (BMRN): $1.7B, -33%
Momenta Pharma (MNTA): $348M, -23.4%
Momenta and Novartis (NVS) expect to launch a generic version (M-Enoxaparin) of the injectable...
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From the Blogosphere
Orphan Status for BioMarin Drug – Analyst Blog
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Recently, BioMarin Pharmaceutical Inc. (BMRN) announced that the U.S. Food and Drug Administration (FDA) granted orphan drug status to its candidate 3,4-diaminopyridine amifampridine phosphate (3,4-DAP), for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS).
As a reminder, BioMarin acquired the privately held Huxley Pharmaceuticals Inc. last month which possessed rights to a proprietary form of 3, 4-diaminopyridine amifampridine phosphate for LEMS treatment.
In October 2009, the Committee for Medicinal Products for Human Use of the European Medicines Evaluations Agency gave a posi...
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Biogen’s Rituxan Label Expansion Delayed – Analyst Blog
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Biogen Idec (BIIB) and Genentech, Inc., a wholly-owned member of the Roche Group (RHHBY.PK), announced that they have received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for Rituxan. The companies were seeking approval for the use of Rituxan (rituximab) plus fludarabine and cyclophosphamide (FC) in patients with previously untreated and treated chronic lymphocytic leukemia (CLL).
Although the companies did not provide any details regarding the letter, they said that the agency has not asked them to submit any new data. Genentech and Biogen intend to w...
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H&Q Healthcare Investors Closed-End Fund Decently Valued
H&Q Healthcare Investors (HQH) appears to a be a decent value now within the closed-end fund universe. It is broadly diversified, and primarily invests in biotechnology, medical devices, pharmaceuticals and medical delivery. It also invests a limited portion of the portfolio in smaller, emerging companies and some restricted securities. In their last SEC filing (as of June 30), the top five holdings were: Teva (TEVA), Gilead (GILD), Celgene (CELG), Amgen (AMGN) and Biogen (BIIB). <>On August 4, the fund discontinued their managed distribution policy. HQH had been paying out 2% of NAV in capit...
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Wider Loss for Alnylam – Analyst Blog
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Alnylam Pharmaceuticals Inc. (ALNY) reported a third-quarter loss of 22 cents per share, below the Zacks Consensus Estimate of 24 cents but wider than the year-ago loss of 7 cents. The higher loss in the quarter is attributable to higher stock based compensation and legal expenses. <>Revenues for the quarter came in at $24.2 million as against $25.7 million in the year-ago quarter, down 5.8%. Research and development costs increased 5% to $23.2 million primarily because of increased costs for clinical and pre-clinical programs coupled with increased R&D headcount to support Alnylam’s allianc< />< />< />< />< />< /><><><><>< />< />< /><>< /><>< /><>< /><>< /><><>< /><>< /><>< />< />...
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Big Pharma & Biotech – Industry Outlook
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The pharmaceutical industry has witnessed major changes in 2009. Performance has been affected by factors like sluggish prescription trends, intensifying generic competition and limited phase III catalysts. The next five years are expected to reflect a significant imbalance between new product introductions and patent losses.
According to IMS Health (RX), this is the main reason why global pharmaceutical market growth will be restricted to the mid-single digits through 2013. Over the next five years, products that currently generate about $137 billion in sales are expected to face generic co...
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