FDAnews Drug Daily Bulletin

The NIH has announced a new supplemental ethics regulation that essentially bans its employees from collaborating with pharmaceutical and biotechnology companies.

The FDA is eager for industry to implement the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (SDTM) so reviewers can gain experience with the standard, but industry has been slow to respond, FDA officials said at a recent public meeting at agency headquarters in Rockville, Md.

Discovery Laboratories has suffered a setback in its development of respiratory drug Surfaxin when the contract manufacturer hired to produce the product was issued a Form 483 by the FDA.

Pfizer has signed a deal to license a set of compounds from German-based drugmaker Schering AG that could be developed into products to prevent heart attacks and strokes.

Hubei Tongji Benda Ebei Pharmaceutical Co., a subsidiary of Amersin Life Sciences, has entered into a sales contract with Zhangjiang Pharmacy Co. to supply 1.5 million doses of Ribavirin in injection form.

Pfizer and Microsoft have filed parallel lawsuits against website operators and spam advertisers that they say sell illegal cheap versions of Pfizer's erectile dysfunction drug Viagra.

Onondaga County is suing 70 leading national pharmaceutical companies, claiming they defrauded taxpayers of millions of dollars by overcharging Medicaid through inflated drug prices.

Pfizer and ActivX Biosciences, a wholly owned subsidiary of Tokyo-based Kyorin Pharmaceutical, have entered into a strategic collaborative agreement encompassing multiple projects ranging from discovery to developmental stage programs across multiple research sites of Pfizer's Global Research and Development organization.

Proxima Therapeutics, a privately held Atlanta company that develops cancer treatments, has agreed to be acquired by Cytyc for $160 million

The Pittsburgh-area subsidiary of British drugmaker GlaxoSmithKline has filed a lawsuit against Nicodrops to stop the California company from making what it says are false claims about Nicodrops' anti-smoking product.

Peninsula Pharmaceuticals has delayed the pricing of its initial public offering and entered into discussions with a pharmaceutical company regarding the potential acquisition of Peninsula.

New Jersey-based pharmaceutical giant Merck has announced it will close its San Diego research unit offering the remaining 110 employees jobs elsewhere.