| 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 |
J&J Bought Defective Motrin A Johnson & Johnson contractor last year told employees to act like customers when removing a defective painkiller from retail stores. The medicine was formally recalled several months later at the urging of the FDA. online.wsj.com |
AVANIR Pharmaceuticals F3Q10 (Qtr End 06/30/10) Earnings Call Transcript AVANIR Pharmaceuticals (AVNR)F3Q10 (Qtr End 06/30/10) Earnings CallComplete Story » seekingalpha.com |
Firms, Unions to Draw Health Funds Almost 2,000 employers and unions will be allowed to submit their retirees' medical bills for reimbursement by a $5 billion government fund, the Obama administration will disclose Tuesday, suggesting the fund will be spread widely but thinly. 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 |