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Abraxis announced that it has received Health Canada approval for Abraxane for the treatment of metastatic breast cancer, including previously untreated metastatic disease.
Eli Lilly and Amylin Pharmaceuticals announced results from a study indicating that Byetta (exenatide) improves blood sugar levels as effectively as biphasic insulin aspart 30/70 (NovoMix 30) for people with Type 2 diabetes failing to achieve acceptable blood sugar control on both metformin and a sulfonylurea, two common oral diabetes medications.
Cytokinetics has announced positive results from a first-in-humans, Phase I trial evaluating CK-1827452, a cardiac myosin activator, administered intravenously.
Evotec has reported that during the one-month safety and tolerability study of EVT 301, several cases of asymptomatic elevated liver function tests in the elderly group have been observed, though no cases were observed within the young volunteer group.
Genzyme announced two-year interim results from a Phase II trial comparing Campath (alemtuzumab) with Rebif (interferon beta-1a) for the treatment of multiple sclerosis (MS).
Results recently published in the New England Journal of Medicine showed significant benefits for patients suffering from relapsing multiple sclerosis (MS) who were treated with Novartis' FTY720 (fingolimod), according to the company.
Critical Therapeutics announced the results of its Phase II clinical trial designed to assess the safety and preliminary efficacy of CTI-01, an anti-inflammatory compound, in patients at risk of serious complications, including organ damage, while undergoing major cardiac surgery involving the use of a cardiopulmonary bypass machine.
Preliminary data presented by Merck at the European Association for the Study of Diabetes annual meeting in Copenhagen, Denmark, demonstrated a significant mean placebo-subtracted reduction in A1C of 2.1 percent from a mean baseline A1C of 8.8 percent with Januvia (sitagliptin phosphate) 50 mg twice daily and metformin 1,000 mg twice daily in patients off therapy at randomization.
Join FDAnews Thursday, Sept. 21, for "Reduce cGMP Inspections: Lower Your Site Risk Potential (SRP) Score." In this 90-minute interactive audioconference, Justin O. Neway, Ph.D., vice president and chief science officer, Aegis Analytical Corp., gives advice on how to reduce SRP scores. On Sept. 26, join FDAnews for "Crisis Management in Life Sciences: Lessons Learned." In this 90-minute audioconference with Q&A session, internationally known consultant, author and former FDA Associate Commissioner Wayne Pines hands you strategies to develop and implement a systematic and effective crisis management plan so your company can handle the same problems with relative ease that could cripple or destroy less prepared companies.