Nearly three years after Theravance Inc. and Astellas Pharma US Inc. filed their application for telavancin, a once-daily injectable antibiotic to treat adults with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), the FDA finally granted approval of the long-embattled drug. (BioWorld World)

Shares of Dynavax Technologies Corp. soared 45.7 percent Thursday after the FDA lifted a clinical hold on the company's investigational hepatitis B vaccine Heplisav, an immunostimulatory sequence targeting Toll-like receptor 9 (TLR9) combined with hepatitis B surface antigen, finally giving the biotech some good news after 18 months of tribulations. (BioWorld Today)

The rumors earlier this week about an acquisition of Sepracor Inc. by Dainippon Sumitomo Pharma Co. (DSP) Ltd., which drove shares of the Marlborough, Mass.-based firm up 26 percent Wednesday, proved true early Thursday, with the Japanese drugmaker bidding $23 per share, or about $2.6 billion, for Sepracor. (BioWorld Today)

SILVER SPRING, Md. - FDA advisers Wednesday said the response rate and duration of response from Allos Therapeutics Inc.'s single-arm study were reasonably likely to predict the clinical benefit of Folotyn (pralatrexate) in treating patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). (BioWorld Today)