FDAnews Drug Daily Bulletin
Feb. 21, 2005 | Vol. 2 No. 36
A bipartisan coalition including some of the nation's most powerful and influential senators has introduced a bill that would allow U.S. consumers to import "safe prescription drugs" from other countries.
One of the FDA's major goals for 2005 and 2006 is to speed marketing approval times for generic drugs, but the agency will have to accomplish that task without much of an increase in funding for its generic drug program.
Illinois has become the latest state to sue multiple drugmakers for inflating drug prices by overstating the average wholesale prices (AWP) of their products under Medicaid and Medicare programs.
The U.S. District Court for the Southern District of New York has granted summary judgment to Barr Laboratories in its challenge to patents on desmopressin acetate tablets. The decision effectively ends a 30-month stay on the FDA's approval of Barr's product, the company said.
Spectrum Pharmaceuticals announced that it has acquired an exclusive worldwide license to develop and commercialize endothelinB agonists for the treatment of cancer, including treatment of solid tumors, from Chicago Labs Inc., a privately held company.
Neosil, a privately held specialty dermatology company, announced that it completed in-licensing of several hair growth products from OsteoScreen Inc., a private company focused on drug discovery for bone diseases.
Kucera Pharmaceutical Co., whose cash crunch last year forced it to close its research and administrative offices in Winston-Salem, has won a $100,000 federal grant to pursue medical research of respiratory diseases.
OctoPlus, the drug delivery and development company and Biolex Inc., a protein therapeutics company, announced today that they have entered into collaboration for co-development of a controlled release formulation of recombinant human alfa interferon.
Yamanouchi Pharmaceutical has announced that is has agreed with Daiichi Suntory Pharma to terminate a marketing agreement between the two companies regarding the penem-type antibiotic Farom (faropenem sodium) on March 31, 2005.
Halozyme Therapeutics, a development stage biopharmaceutical company developing and commercializing recombinant human enzymes, announced it has signed a commercial manufacturing supply agreement with Avid Bioservices, a wholly owned subsidiary of Peregrine Pharmaceuticals.
Discovery Laboratories Inc. said Friday it has obtained commitments for buying about $26.5 million of its common stock in a registered direct offering.
has announced that it has stroke a basic agreement with the major shareholders of Ichijiku Pharmaceutical for a corporate merger scheduled in March.
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