Gilead's Strong Fundamentals Should ContinueBusiness continues to look strong for Gilead Sciences (GILD). The company's tenofovir-based HIV products (Viread, Truvada and Atripla) are number one and widening their lead. The clinical data continues to support the switching of patients from older generation molecules such as abacavir and lamivudine to Gilead's franchise. Also driving impressive trends are revised HIV treatment guidelines from the U.S. Department of Health and Human Services recommending only Truvada (and Atripla) as the backbone of choice in naïve patients.These new guidelines, put into place in November 2008, downgraded Epzicom to an alternative medication based on cardiovascular risk and high rates of virologic failure. Finally, the new FDA chief, Margaret Hamburg, a former New York City Health Commissioner, has significant experience in combating infectious disease, such as HIV/AIDS, and we believe that this type of focused leadership only further adds to the ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  

Genzyme [GENZ: 58.37, -0.29 (-0.49%)]: On 5/21/09, GENZ announced that it has submitted the final documentation to address all items in the FDA’s complete response letter from 3/2/09 (CRL) for Lumizyme (alglucosidase alfa), which is produced at the 2,000 L bioreactor

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Highlights include Gilead Sciences (GILD), AstraZeneca (AZN), Sanofi-Aventis (SNY) and Genzyme (GENZ).Last week, President Obama nominated Margaret "Peggy" Hamburg, a former New York City Health Commissioner, to lead the U.S. Food and Drug Administration (FDA). Hamburg's appointment must be confirmed by Congress. The president also named Baltimore Health Commissioner Joshua Sharfstein as FDA deputy commissioner.Hamburg earned her M.D. from Harvard Medical School and completed her training at the New York Hospital/Cornell University Medical Center. She did research in neuroscience at Rockefeller University in New York from 1985 to 1986, and in neuropharmacology at the National Institute of Mental Health in Bethesda, Maryland.From 1986 to 1988, she served in the U.S. Office of Disease Prevention and Health Promotion, and from 1989 to 1990 she was assistant director of the National Institute of Allergy and Infectious Diseases at NIH, where her ...