FDAnews Drug Daily Bulletin
April 12, 2005 | Vol. 2 No. 72
Ortho-McNeil Neurologics has updated prescribing information on its Alzheimer's drug Reminyl to disclose recent deaths among patients participating in two clinical trials of the drug, according to an FDA MedWatch report.
In a major win for Toronto-based biotechnology company Biovail, a U.S. district court has granted the company's request for summary judgment in two related class-action lawsuits involving the company's hypertension and angina medication, Tiazac.
Sentrx has completed an FDA electronic submissions pilot and has begun sending individual case safety reports from a leading pharmaceutical company to the agency through the Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway, the technology company said.
A bill recently introduced in the House would significantly curtail the times that drugmakers could promote erectile dysfunction (ED) products over the airwaves -- a proposal that may indicate a growing discontent with the pharmaceutical industry's use of direct-to-consumer (DTC) advertising.
Dendrite International, a leading provider of sales, marketing and clinical solutions for the life science and pharmaceutical industries, announced that it signed a comprehensive, five-year software and services agreement with the sanofi-aventis Group in the U.S., the third largest pharmaceutical company in the world and the largest in Europe.
The law firm of Kenneth B. Moll & Associates filed the first worldwide class action lawsuit against Pfizer, on behalf of all persons who died or were injured by the pain medication, Bextra.
After recently completing a fundraising round, Potentia Pharmaceuticals Inc. now has the cash to fuel the startup biotechnology company's growth.
Innovate Oncology, a company founded by Bioaccelerate Holdings, announced that it has entered into an exclusive agreement with Prostagenics, acquiring the rights to develop and commercialize Capridine-Beta for the treatment of prostate cancer.
Reliant Pharmaceuticals, Inc. announced that the term of the promotion agreement with Novartis for Lescol (fluvastatin sodium) and Lescol XL (fluvastatin sodium extended-release tablets) will be extended.
CellCentric, a Cambridge company exploiting a critical area of genetic research, has won £250,000 funding that has triggered a commercial collaboration with Babraham Institute.
Diversa Corporation announced that it has signed an agreement with Cargill Health and Food Technologies to discover and develop novel enzymes for the cost-effective production of a proprietary product.
Private biopharmaceutical firm, VasoGenix Pharmaceuticals, has signed a worldwide agreement with QLT USA Inc. to develop a potentially major new treatment for congestive heart failure.
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