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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
NVS
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+21.31%
in
124 days
<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. 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 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 clinica...
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Updated FDA, Clinical Trial Calendars: AZN, MYGN, NVS, PSDV
NVS
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+17.87%
in
104 days
(closed on 07/21/09)
<> The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA deadline dates. The entries are updated on a daily basis as new information becomes available with a total of 113 entries through 4/8/09. The FDA Calendar includes the following information: company name, ticker, decision ...
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A Resurgence in Cell Therapeutics
NVS
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-3.12%
in
6 days
(closed on 04/08/09)
Since I profiled Cell Therapeutics (CTIC) two months ago as a cancer biotech that was down, but not out; the stock price has more than quadrupled from 8 cents to 36 cents during intraday trading today. CTIC continues to reduce operating expenses and sold its remaining stake in a joint venture to market cancer drug Zevalin to Spectrum Pharma (SPPI) for $16.5M last month (in addition to receiving $15M last December from SPPI for the initial 50% stake). <> CTIC reduced operating expenses in 2008 by 33% and prov...
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Updated Clinical Trial and FDA Decision Calendars
NVS
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+4.88%
in
18 days
(closed on 04/02/09)
<> <> Below is a summary of updates to the www.BioMedReports.com database of 242 entries included in the FDA and Clinical Trial Calendars. The two web links below are for the FDA calendar home page and a recent article highlighting 14 extreme trades of companies with market caps below $200M with pending FDA decisions.
http://biomedreports <wbr> </wbr> .com/fda-calendar.ht <wbr> </wbr> ml
http://biomedreports <wbr> </wbr> .com/articles/most-p <wbr> </wbr> opular/627-trading-f <wbr> </wbr> da-decisions-14-extr <wbr> </wbr> eme-trades.html
The FDA Calenda...
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Momenta Pharma's Three-Part Strategy
NVS
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+3.59%
in
9 days
(closed on 03/15/09)
Momenta Pharma (MNTA) is pursuing a three-part business model which includes complex generic equivalents in partnership with the Sandoz division of Novartis (NVS), proprietary compounds, and follow-on- biologics (FOB). <> Momenta is partnered with Sandoz to develop a generic equivalent (M-Enoxaparin) of the multi-billion dollar injectable blood thinner Lovenox ($3.9B in worldwide sales for 2008). While MNTA + NVS were not the first to file for a generic version of Lovenox, the 180-day exclusivity period awarded to the first-to-file company is set to expire on 4/1/09 for Amphasta...
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From the Blogosphere
Anti-Smoking Vaccine from Glaxo – Analyst Blog
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GlaxoSmithKline (GSK) and Nabi Biopharmaceuticals (NABI) signed a licensing agreement for a nicotine conjugate vaccine (NicVAX) as well as for the development of a second generation nicotine vaccine. NicVAX is an investigational vaccine for the treatment of nicotine addiction and the prevention of smoking relapse. Earlier in October, the vaccine received a $10 million grant from the National Institute on Drug Abuse. <>As per the agreement, Nabi will get an upfront payment of $40 million and is eligible to receive more than $500 million (together with upfront payment) as option fees and milesto...
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Zacks Analyst Blog Highlights: GlaxoSmithKline plc, Sanofi-Aventis, Novartis, Baxter International and AstraZeneca – Press Releases
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For Immediate Release Chicago, IL – November 16, 2009 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: GlaxoSmithKline plc (GSK), Sanofi-Aventis (SNY), Novartis (NVS), Baxter International (BAX) and AstraZeneca (AZN). Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=5513 Here are highlights from Friday’s Analyst Blog: <><>Glaxo...
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Glaxo H1N1 Vaccine Approved – Analyst Blog
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GlaxoSmithKline plc (GSK) recently received approval from the U.S. Food and Drug Administration (FDA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. The FDA approved the supplemental biologics license application (sBLA), which was filed as a strain change supplement to Glaxo’s FluLaval seasonal flu vaccine. This means that Glaxo can now market its swine flu vaccine for use in adults to prevent influenza.
The company has already received an order for 7.6 million doses of its swine flu vaccine from the United States Department of Health and Human Services. This order is ...
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Gilead Awaits Committee Outcome – Analyst Blog
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Gilead Sciences, Inc (GILD) is awaiting the outcome of the Anti-Infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) scheduled on December 10, 2009. The committee will review Gilead ’s aztreonam for inhalation solution, an investigational product for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF). Earlier, in September 2008, the drug was denied approval by the FDA, which then asked Gilead to resubmit the application with more data.
In September 2009, the drug received conditional...
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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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