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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.
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.