FDAnews Drug Daily Bulletin

The cost of the Medicare prescription drug benefit is expected to more than double over a 10-year period to almost $1 trillion dollars, according to a congressional aide, who laid much of the blame for the increase squarely at the feet of drug manufacturers.

The number of domestic field inspections conducted by the FDA's Office of Regulatory Affairs (ORA) will decline across the board in fiscal 2006, with the biggest drop coming in good manufacturing practice (GMP) inspections, according to figures contained in the agency's proposed budget request.

Radio-frequency identification (RFID) use in the pharmaceutical industry is growing under state and federal mandates to secure the supply chain and prevent counterfeiting, but technology limitations and security weaknesses may slow full implementation, according to an ABI Research study, "The RFID Life Sciences Market," which looks at the driving forces behind adoption and RFID's benefits.

The FDA has named John Gardner director of the Division of Compliance Risk Management and Surveillance (DCRMS), which operates within the Center for Drug Evaluation and Research's Office of Compliance.

Elscint Ltd. announced that Teva Pharmaceutical Industries Ltd. has exercised its option to enter into a joint venture with Gamida-Cell Ltd., in which Elscint (through a wholly owned subsidiary) holds 29.2 percent on a fully diluted basis, in order to develop and commercialize StemEx for the treatment of Leukemia and Lymphoma.

Solvay Pharmaceuticals has signed an agreement with the Norwegian authorities whereby Solvay Pharmaceuticals will supply influenza vaccines to Norway in the case of a pandemic.

Entelos Inc., a Foster City-based biosimulation technology company, announced that it will extend its partnership with international pharmaceutical company Organon International to co-develop and commercialize biologic and small molecule rheumatoid arthritis therapies.

Ivax Corp. agreed to buy Phoenix Scientific, a generic veterinary drugmaker. An agreement calls for Ivax to pay a combination of $196.85 million in cash and $75 million common stock for all of Phoenix.

Cornerstone BioPharma Inc. has struck a deal to transfer its Humibid family of products to Adams Laboratories Inc. Humibid is an anti-congestion drug.

Akorn, Inc. announced that it has entered into the agreement to license a patent titled, "M-EDTA Pharmaceutical Preparations of Uses Thereof" (the "Invention") and related technology rights invented by Issam I.

Otsuka Pharmaceutical has announced that it has concluded a collaborative research and licensing agreement with Galenea, a Massachusetts-based bioventure company, as of Jan. 8.

BioCryst Pharmaceuticals, Inc. announced that it has priced a registered direct offering for the sale of 4,350,000 shares of its common stock at a price of $5.50 per share to institutional investors.