FDAnews Drug Daily Bulletin
Jan. 14, 2005
| Vol.
2 No.
10
Republican lawmakers are on the verge of renewing their push for medical liability legislation, which will likely contain a provision that critics contend would bar punitive damages against drugmakers that market dangerous products. Statin developers have received positive news on the research front in the form of two clinical studies that indicate statin drugs help reduce the body's level of c-reactive protein (CRP), which has been associated with increased risks of coronary disease. The governor of Illinois has asked the Canadian prime minister to consider adopting stronger rules for internet and mail-order pharmacies rather than banning prescription drug exports altogether. Merck's anti-emetic Emend will qualify for coverage as a Medicare Part B drug under a proposed coverage decision recently issued by the Centers for Medicare & Medicaid Services (CMS). Abgenix will receive a milestone payment from Chiron triggered by Chiron's filing of an investigational new drug (IND) application with the FDA for the novel oncology compound CHIR-12.12, a fully human antagonist antibody targeting CD40. Bolder BioTechnology has been awarded a grant for more than $300,000 from NIH InNexus Biotechnology has entered into a co-development arrangement for its TransMab Antibody Technology with Epitomics of Burlingame, Calif. ViroPharma has received a $6 million payment for its existing inventory of Pleconaril bulk drug substance from Schering-Plough Corp. Schering-Plough assumed responsibility for all future development and commercialization of an intranasal formulation of Pleconaril under an agreement signed last year. Chelsea Therapeutics, which took on a new name and a new headquarters last July, has raised $14.5 million in a private placement. Chelsea was known as Aspen Therapeutics before it moved. Alpharma and Synthon Pharmaceuticals have announced that Alpharma's sales force will co-promote Synthon's Pexeva. Dragon Pharmaceutical has announced that at the annual meeting of shareholders held Jan. 11, the shareholders approved the acquisition by Dragon of Oriental Wave by accepting all the proposals in over 99 percent of the shares represented and voting. Corixa, a developer of immunotherapeutics, has signed a license agreement with Genentech in which Corixa will grant Genentech exclusive worldwide rights to a novel target for the possible development of humanized antibody-based therapeutics. ISTA Pharmaceuticals has announced plans to offer 4,500,000 shares of its common stock in an underwritten public offering pursuant to its existing and effective shelf registration statement. |
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