Nitromed’s BiDil Combination Therapy for Congestive Heart Failure
November 8, 2004 by admin · Leave a Comment
On November 8, 2004 Nitromed reported that the data from its Phase 3 A-HeFT trial would be published in the New England Journal of Medicine and presented at the American Heart Association’s Late Breaking Scientific Sessions. This randomized, placebo-controlled, double blind clinical trial enlisted 1050 African American patients with New York Heart Association class III [...]
Sanofi-Synthelabo’s Eloxatin for Postsurgical Treatment of Stage III Colon Cancer
November 5, 2004 by admin · Leave a Comment
On November 5, 2004 Sanofi-Synthelabo’s Eloxatin™ (oxaliplatin for injection) received US FDA approval for use in combination with conventional chemotherapy (5-flurouracil and leukovorin) for the postsurgical treatment of stage III colon cancer patients. According to the company, this is the first new chemotherapy approval for the adjuvant treatment of colon cancer in over a decade. [...]
MedImmune’s CAIV-T Influenza Vaccine
November 1, 2004 by admin · Leave a Comment
On November 1, 2004 MedImmune announced that enrollment in its Phase 3 CAIV-T influenza vaccine trial had been completed. This pivotal trial is designed to compare the company’s nasally administered cold-adapted vaccine to the standard injectable vaccine in 8,492 children between 6 and 59 months of age. CAIV-T is refrigerator stable and is regarded by [...]
Eli Lilly and Sankyo’s CS-747 / Prasugrel for Acute Coronary Syndrome
October 25, 2004 by admin · Leave a Comment
On October 25, 2004 Eli Lilly and Company and Sankyo Company announced that a Phase 3 clinical trial comparing the antiplatelet agents prasugrel and Plavix™ is scheduled to begin later this year. The study, known as TRITON-TIMI 38, will include a reported 13,000 patients who are suffering acute coronary syndromes (heart attacks or unstable angina) [...]
Wyeth’s Enbrel for treatment of Psoriasis
July 30, 2004 by admin · Leave a Comment
On July 30, 2004 Wyeth reported that a European Commission panel had recommended that regulators approve Enbrel as a treatment for psoriasis after other treatments were found inadequate or inappropriate. The Committee for Medicinal Products for Human Use will report its findings to the European Commission for endorsement before Enbrel can receive marketing approval. Wyeth [...]
Elan/Biogen Idec’s Antegren (Natalizumab) for Treatment of Multiple Sclerosis
July 26, 2004 by admin · Leave a Comment
On July 26, 2004 Elan Corp.’s application for approval of its multiple sclerosis (MS) drug Antegren was accepted for review by the FDA. Elan has developed Antegren with U.S. partner Biogen Idec. The company has stated that this therapy represents a new approach in the treatment of MS and is expected to eventually generate annual [...]
Neurochem’s Alzhemed for treatment of Alzheimer’s
July 18, 2004 by admin · Leave a Comment
On July 18, 2004, Neurochem Inc. released interim data pertaining to a Phase II open-label extension study of the effects of Alzhemed on cognitive function and global measure of performance in patients with mild-to-moderate Alzheimer’s Disease. According to Neurochem, the study showed that approximately 70% of the mild AD patients had stabilized or improved cognitive [...]
Nymox Pharmaceutical NX-1207 for BPH
July 14, 2004 by admin · Leave a Comment
On July 14, 2004 Nymox Pharmaceutical Corporation reported FDA approval for the NX-1207 clinical trial protocol for benign prostatic hyperplasia (BPH). In January 2004 the company had reported Phase I results which indicated that safety and tolerability data were sufficient for the company to move NX-1207 into Phase II testing. The recent FDA ruling has [...]
Xenova Group’s TA-NIC for the Treatment of Nicotine Addiction
July 14, 2004 by admin · Leave a Comment
On July 14, 2004 Xenova Group plc released results of a second clinical trial with TA-NIC, a therapeutic vaccine under development for the treatment of nicotine addiction. The company reported that this randomized, placebo controlled, double-blinded study involved a total of 60 smokers and was designed to prove safety and tolerability data while measuring anti-nicotine [...]
Vytorin for the Treatment of Hyperlipidemia
May 14, 2004 by admin · Leave a Comment
Vytorin is a combination therapy comprised of two drugs already separately approved for the treatment of hyperlipidemia. Zocor (simvistatin) and Zetia (ezetimibe) are combined in this oral medication currently awaiting an FDA decision on approval. Results released by Merck and Schering-Plough in March 2004 from Phase III clinical trials demonstrated that patients taking Zocor and [...]