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The Senate sponsors of a medical malpractice reform bill have removed an earlier
provision that would have shielded drugmakers from punitive damages if they
followed all necessary FDA guidelines when seeking approval of their products.
A new study of several clinical research trials involving Cox-2 inhibitors suggests
the drugs increase blood pressure more than conventional nonsteroidal anti-inflammatory
drugs (NSAIDs).
The FDA has published a new draft guidance that provides
recommendations on how the public, including industry representatives, may participate
in open public hearing sessions conducted as part of advisory committee meetings.
The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC)
has issued Johnson & Johnson subsidiary Centocor an untitled letter for
a visual aid that it says misrepresents the effectiveness of rheumatoid arthritis
(RA) drug Remicade.
Codexis, a privately held biosciences company, has acquired Germany's Julich
Fine Chemicals GmbH (JFC), a leading supplier of specialty enzymes (biocatalysts)
for organic synthesis and chiral building blocks to pharmaceutical and chemical
companies worldwide.
Nippon Shinyaku has mutually agreed with Janssen Pharmaceutical and Grunenthal
GmbH to collaborate in the development of Tramadol HCl, an oral analgesic developed
by Grunenthal, in Japan.
Argonaut Technologies has entered into a definitive agreement under which Argonaut
Technologies will sell stock and certain assets of its consumables and flash
chromatography business to Biotage AB of Uppsala, Sweden.
Pharmaceuticals and diagnostics firm Mayne Group Ltd. said that its pharmaceuticals
arm, Mayne Pharma, would collaborate with international generic and specialty
pharmaceutical company Pliva to develop and make two biogeneric products used
by cancer patients.
The Brisbane-based Biotechnology company, Agenix Ltd., has sold its Milton Pharmaceuticals
subsidiary, freeing management and financial resources to build Agenix's molecular
imaging pipeline.