FDAnews Drug Daily Bulletin
Feb. 23, 2005 | Vol. 2 No. 38
Ivax has signed a settlement agreement with rival Alpharma that will enable it to launch a generic version of Pfizer's Neurontin before Alpharma's 180 days of marketing exclusivity expires.
Ferring Pharmaceuticals is appealing a recent court ruling that cut short its patent protection on antidiuretic treatment DDAVP -- a move that could delay the launch of a generic version of DDAVP by Barr Laboratories.
Two drugmakers have sent "Dear Healthcare Professional" letters to physicians alerting them about the potential for medication mix-ups and adverse drug interactions involving their products.
The FDA's Electronic Submissions Gateway has moved a step closer to reality as the agency selected the vendors that will build the system, a central collection portal for electronic submissions from FDA-regulated industries and other government agencies.
PTC Therapeutics, (PTC), a biopharmaceutical company focused on the discovery, development and commercialization of small-molecule drugs targeting post-transcriptional control mechanisms, has announced that the company has been awarded $1.7 million from Cystic Fibrosis Foundation Therapeutics, (CFFT), the drug discovery and development affiliate of the Cystic Fibrosis Foundation.
Medisyn Technologies, a company that has fashioned a rapid drug-design and development process, has raised $1.5 million in bridge financing as it seeks to accelerate its own development.
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.
GlaxoSmithKline Pharmaceuticals said on Tuesday it will manufacture vaccines in Nasik at a plant that will start operations in early 2006.
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.
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.
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.
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.
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