TOP 100 MEDICAL SITES
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| Unraveling Crohn's Genetic Trail Researchers are focusing on genetic mutations linked to irritable-bowel conditions like Crohn's disease and ulcerative colitis. The hope: to develop a cure, rather than just treat the symptoms. online.wsj.com |
FDA Panel Recommends Novartis MS Drug The Burrill Report submits: By Michael Fitzhugh A Food and Drug Administration panel has unanimously backed the safety and effectiveness of Novartis' (NVS) multiple sclerosis treatment fingolimod. The panel voted 25-0 in support of fingolimod's “substantial evidence of effectiveness” in treating patients with relapsing remitting multiple sclerosis. That makes it likely the drug will be the first oral MS treatment to gain FDA approval, beating Merck (MRK), Sanofi (SNY) and Teva (TEVA) - all of which are developing their own oral MS drugs - to the punch.Complete Story » seekingalpha.com |
Kamada: Wise Strategy or Overly Ambitious? EP Vantage submits:Following US approval for Kamada’s (KAMAF.PK) Glassia, a novel liquid formulation of alpha-1 antitrypsin [AAT], the Israeli drug developer is preparing to enter a landscape already dominated by Talecris (TLCR) Biotherapeutics’ Prolastin-C. The incumbent generated sales of $319m last year and controls approximately three-quarters of the market for products treating AAT deficiency, a hereditary condition implicated in lung diseases such as emphysema and chronic obstructive pulmonary disease [COPD]. Coincidently, Glassia’s approval came in the same week as a report published by the research consortium the Cochrane Library, which claimed that AAT-replacement therapies are clinically questionable, overly-expensive and should be withdrawn from the market; a controversial conclusion that prompted a swift backlash from patient advocacy groups in the US. Kamada itself has also dismissed the report’s findings and is confident it can expand the market with its formulation and win new patients, all the while working on an inhaled version of the therapy which it anticipates will be the real game-changer for this market.Complete Story » seekingalpha.com |
Good News for Alimera’s Pipeline Zacks.com submits: Recently, Alimera Sciences’ (ALIM) pipeline received a boost when the US Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA") for its lead candidate, Iluvien. Furthermore, the agency has decided to review the application on a priority basis. The company is looking to gain approval for Iluvien for the treatment of diabetic macular edema (DME).The company filed the NDA with the FDA in late June 2010. The US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months. Based on that criterion, a response from the FDA should be out in the fourth quarter of 2010.Complete Story » seekingalpha.com |
WellPoint Unit to Reimburse Policyholders A WellPoint subsidiary in Colorado agreed to repay policyholders in that state $20 million after an examination by the state insurance commissioner concluded that several premium increases were unjustified. online.wsj.com |