Seaside Therapeutics fails to achieve main goal in major trial in autism

Ryan McBride Seaside Therapeutics missed the main target of a midstage trial of its lead drug STX209 in patients with autism spectrum disorder (ASD), yet benefits of treatment observed ...

Even if Actavis buy fails, Valeant looks ready for bigger deals

Tracy Staton Valeant ($ VRX) CEO J. Michael Pearson hasn't made a secret of his ambitions. He wants to be within spitting distance of Big Pharma. Numbers-wise, that means he's ...

Atlas Venture targets early-stage biotech bets with new $265M fund

Ryan McBride After a period of revamping a venture strategy gone wrong, Atlas Venture has come out today with news about an oversubscribed 9th fund of $ 265 million. It's a rare ...

FDA breaks with expert advisers in rejecting Titan addiction med

Tracy Staton In the end, a vote by an outside panel of FDA experts favoring approval of Titan Pharmaceuticals' Probuphine didn't influence the outcome at all. Agency staffers ...

Merck spotlights new deals, R&D review as demands to rebuild pipeline grow

John Carroll Merck CEO Kenneth Frazier Merck ($ MRK) managed to disappoint just about everyone this morning, cutting its full-year earnings expectations as generics eat up ...

VCs provide $40M to finance Celator’s pivotal PhIII AML study

John Carroll Princeton, NJ-based Celator Pharmaceuticals has raised close to $ 40 million, enough to get its lead cancer drug–a reformulation of standard drugs infused in nano-sized ...

FDA steamrolls over panel vote, spurns Titan’s addiction drug Probuphine

John Carroll In the end, a vote by an outside panel of FDA experts favoring approval of Titan Pharmaceuticals' Probuphine didn't influence the outcome at all. Agency staffers ...

FDA rules on Plan B, but not on judge’s order

Eric Palmer In a move that appears to be testing the waters, the FDA on Thursday approved Plan B One-Step emergency contraception for sale to girls and women ages 15 and older without ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS