FDAnews Drug Daily Bulletin

The Biotechnology Industry Organization (BIO) has not relaxed its position regarding an abbreviated approval process for generic biologics, despite comments in a recent docket submission to the FDA that appear to indicate some softening on the topic, according to a representative of the trade group.

Pfizer's highly anticipated nerve pain medication Lyrica received FDA approval Dec. 31, 2004, but the victory was somewhat bittersweet for the firm, as the agency decided to classify the drug as a controlled substance, which could negatively affect its sales.

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has issued an untitled letter to Schering informing the company of misleading information it published recently in a professional detail aid promoting the use of Foradil Aerolizer 12 mcg.

A key objective of the FDA's Office of Drug Safety (ODS) in fiscal 2003 was to develop a more cohesive working relationship with the review division staff in the Office of New Drugs (OND), according to ODS, which has come under attack recently for allegedly being too close to OND.

Bristol-Myers Squibb has hired Somerset, N.J.-based Ventiv Health to help sell its antibiotics Cefzil and Tequin.

Allied Capital finished its buyout of Insight Pharmaceuticals on Dec. 31, 2004, following an investment of roughly $155 million in the maker of nonprescription medications.

Manhattan Pharmaceuticals has signed a letter of intent to merge with Tarpan Therapeutics, a privately held, New York-based pharmaceutical company developing dermatological therapeutics, in an all stock transaction.

Oxford BioMedica, a gene therapy company, has entered into an agreement to license its LentiVector technology to Biogen Idec for use in research activities.

Biotech company Sangamo BioSciences is collaborating with drugmaker Pfizer to produce enhanced proteins. Financial terms of the agreement were not disclosed.

Infinity Pharmaceuticals has entered into a collaborative agreement with Novartis to jointly design a collection of novel small molecules to be synthesized by Infinity using its innovative chemical technology platform.

Pacific Biometrics and BestNet Communications have announced the execution of a Letter of Intent between the two companies.

Biopure has obtained commitments from institutional and individual investors to purchase approximately $11.3 million of its common stock for anticipated net proceeds to Biopure of approximately $10.4 million.