| 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 |
Avastin's Breast Cancer Indication Falters, FDA Panel Says An FDA advisory panel called on the agency to revoke its approval of Roche's Avastin as a breast-cancer treatment after studies failed to show benefit. online.wsj.com |
Seattle Genetics: The Busy Season Is Set to Begin Jason Chew submits: This autumn is turning out to be a busy season for Seattle Genetics (SGEN). The company is expecting results from up to three clinical trials between September and October- each of which, if successful, may form the basis for the filing of an NDA.Two trials are nearing completion for flagship compound SGN-35, or brentuximab vedotin. SGN-35 is an antibody-drug-congugate (ADC) targeted to CD30. The CD30 antigen is a marker for Hodgkin’s Lymphoma (HL), Anaplastic Large Cell Lymphoma (ALCL), as well as other T-cell lymphomas. The two pivotal trials are in refractory Hodgkin’s Lymphoma and ALCL.Complete Story » seekingalpha.com |
HistoRx Recognized as a 2010 Company to Watch by the Connecticut Technology Council [PR Newswire] - HistoRx was recognized as a 2010 Company to Watch by the Connecticut Technology Council at the Innovation Pipeline Awards ceremony last week in New Haven, Connecticut. Â HistoRx was recognized for significant milestones achieved in 2010: us.rd.yahoo.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 |