The FDA granted approval late Friday for Tarceva (erlotinib) as a maintenance therapy for non-small-cell lung cancer patients, a decision that defied a negative 12-to-1 panel vote last year but is likely to offer only a modest boost to sales of the drug from OSI Pharmaceuticals Inc. and Genentech Inc./Roche AG. (BioWorld Today)
Small biotech CureDM LLC's approach to treating diabetes by stimulating the body's production of insulin-producing islet cells might be months away from the clinic, but it's already sparked the interest of big pharma, landing the firm a potential $335 million deal with Sanofi-Aventis. (BioWorld Today)
Ardea Biosciences Inc. is shoring up its cash position on the heels of promising Phase IIb results for gout compound RDEA594, even as the buzz around the drug increases ahead of much-anticipated data from a combination study expected later this quarter. (BioWorld Today)
AMAG Pharmaceuticals Inc. is picking up $60 million up front in a potential $280 million deal with Takeda Pharmaceutical Co. Ltd. for iron replacement therapy Feraheme (ferumoxytol), some much-needed good news for the small biotech still dealing with fallout from the drug's safety data reported earlier this year. (BioWorld Today)
Though much-anticipated Phase III mipomersen data aren't expected until later this year, Isis Pharmaceuticals Inc. gave investors a nice surprise with news of a potential $1.5 billion RNA drug discovery alliance with GlaxoSmithKline plc. (BioWorld Today)
