| Spherix Announces First Quarter 2010 Financial Results (PR Newswire) Spherix Incorporated , an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today reported results for the three months ended March 31, 2010. us.rd.yahoo.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 |
LabCorp Announces $250 Million Stock Repurchase Program (Business Wire) BURLINGTON, N.C.----Laboratory Corporation of America® Holdings today announced that its Board of Directors has authorized a new stock repurchase program under which LabCorp may purchase up to an additional aggregate of $250 million of its Common Stock from time-to-time. us.rd.yahoo.com |
Immunogen: What Really Happened With T-DM1’s Filing? Ohad Hammer submits:Last week, Roche (RHHBY.PK) announced that the FDA was unwilling to accept T-DM1’s accelerated approval filing for breast cancer, sending Immunogen’s (IMGN) shares tumbling almost 40%. The filing was based on impressive results from a single arm phase II trial in 3rd line HER2 breast cancer. Typically, gaining regulatory approval requires a large, randomized phase III study but in cases of highly unmet need where patients are bereft of effective treatment options, the FDA may consider approval in a limited patient population.Surprisingly, it turns out that the FDA was unwilling to even consider approval for T-DM1 based on the phase II. T-DM1’s data set is one of the most impressive ever generated in late stage breast cancer, which is why the market (myself included) was confident T-DM1 would win FDA approval. The reason for the FDA’s response as appears in the official press release was that “all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population”. In other words, T-DM1 did not qualify for accelerated approval based on the phase II results. This got people scratching their heads as no further details were provided by the FDA, Roche or Immunogen.Complete Story » seekingalpha.com |
The Law Office of Robbins Umeda LLP Announces an Investigation of the Acquisition of Clarient, Inc. by GE Healthcare [Business Wire] - Robbins Umeda LLP has commenced an investigation into possible breaches of fiduciary duty and other violations of state law by members of the Board of Directors of Clarient, Inc. in connection with their efforts to sell Clarient to GE Healthcare, a unit of General Electric Company . us.rd.yahoo.com |