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NYTimes.com

The F.D.A.’s decision appeared to lower the bar slightly for approval of certain cancer drugs.

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NYTimes.com

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Feb 21 2008, 11:42 AM EST
Genmab Steps Up Production Capacity through $240M Purchase of PDL BioPharma's Site
Deal covers a 1,000 L and a 10,000 L bioreactor plus a leased development lab.Full Story

Feb 20 2008, 12:40 PM EST
Possible $195M Encysive Buyout by Pfizer Will Save Firm from NASDAQ Delisting
Purchase price is $2.35 per share.Full Story

Feb 20 2008, 12:37 PM EST
Precancerous Stem Cells Can Form Tumor Blood Vessels
PLoS ONE paper also showed that these cells create new vessels and larger tumor masses more efficiently than normal cells.Full Story

Feb 20 2008, 12:41 PM EST
Celgene Signs On to Advance Acceleron's Bone Loss Programs for $50M Upfront
Deal for Phase I drug and three discovery-stage compounds could ultimately be worth over $1.8 billion.Full Story

Feb 19 2008, 11:54 AM EST
Scientists Discover Gene Fusion Linked to HIV Resistance in Monkeys
PNAS study shows that TRIM5 and cyclophilin combine to protect against retroviruses.Full Story

Feb 19 2008, 11:52 AM EST
Merck Serono to Use Biolex' Technology for Antibody Optimization
Firm hopes to better the therapeutic profile of its antibody candidate.Full Story

Feb 19 2008, 11:56 AM EST
Celera Taps Geisinger Health Systems' Biorepository to Advance Liver Disease Test
Diagnostic assay will be developed to assess risk of NASH.Full Story

Feb 19 2008, 11:52 AM EST
Memory Pharmaceuticals and Roche to Add Biomarker Trials to Schizophrenia Development Program
P50 sensory gating and mismatch negativity will be evaluated as potential efficacy markers for nicotinic alpha-7 agonists in this disorder.Full Story

Feb 15 2008, 11:26 AM EST
Investors Commit $49.3M to Cadence Pharmaceuticals
Final gross proceeds may go down to $43 million depending on certain NASDAQ rules.Full Story

Feb 15 2008, 11:23 AM EST
Invitrogen Invests in Q Therapeutics to Advance Knowledge of Technologies Required in Cell Therapy R&D
Company hopes that transaction will allow the firm to expand its portfolio in this area.Full Story

GenEngNews.com

Draft Guidance May Be Too Soon, Too Simple

Rockville, MD (Feb. 15)—The US Food and Drug Administration issued a draft guidance for industry titled “Good Reprint Practices” regarding the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

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Pharmaceutical Technology