| FDA, Clinical Trial News: Discovery Labs, Hospira, Javelin Pharma Mike Havrilla submits:Yesterday, Discovery Labs (NASDAQ:DSCO) announced that the re-validation has been completed for the Biological Activity Test (BAT) for quality control and stability for SURFAXIN (lucinactant). DSCO has submitted a protocol to the FDA, outlining its plans for preclinical studies and expects feedback from the Agency in June. The company affirmed its prior guidance for a NDA resubmission to the FDA during 1Q11. Hospira (NYSE:HSP) announced this morning that it is extending its $2.20 per share ($145 million) cash tender offer for Javelin Pharma (AMEX:JAV) until 2-June, referencing unsatisfied conditions. JAV disagreed with the statement by HSP and believes the latter is using a DYLOJECT supply chain issue in the UK as the basis for extending the tender offer.Complete Story » seekingalpha.com |
Draft Health Rules Set Hurdles Draft regulations being developed by the Obama administration say more than half of employer health care plans may lose their grandfathered status, which excepts the plans from some rules. online.wsj.com |
Penwest: Change Is Coming ValueHuntr submits:Penwest Pharmaceuticals Co. (PPCO) on Tuesday announced that its Board of Directors has approved certain changes to the Company’s corporate governance practices that are designed to make the Board more responsive to shareholder input and accountable for its performance. The Company also announced that Kevin C. Tang has been selected as Chairman of the Board.Some of you may remember Kevin Tang from his almost succesful bid to liquidate Vanda Pharmaceutical (VNDA) last year as it traded below its net cash value. Mr. Tang ended up withdrawing his request for dissolution after the FDA approved its drug Fanapt, which caused shares of Vanda to skyrocket 900% in a single day. To this day, that remains one of our best investments, and we are glad Mr. Tang is back.Complete Story » seekingalpha.com |
Concussions Rise in Student Athletes Concussions among child athletes rose sharply in recent years, a new study found, prompting a pediatricians' group to recommend schools and sports groups adopt stricter safety controls for young people. online.wsj.com |
Summary Box: GE to buy diagnostics firm Clarient [AP] - THE DEAL: General Electric Co. said its healthcare unit will buy diagnostics company Clarient Inc. to speed its expansion into cancer diagnostic and therapy selection tools. us.rd.yahoo.com |