FDA delays decision on Heron’s twice-rejected nausea drug

Damian Garde Heron Therapeutics, pushing to finally win approval for a long-delayed treatment for chemotherapy-induced nausea, will have to wait another month or so as the FDA has put ...

NIH urged to ‘break taboo’ against using its power to bypass drug patents

Emily Wasserman The National Institutes of Health (NIH) has said that it would take "extraordinary" circumstances for the agency to address rising drug prices, even as skyrocketing ...

FDA slaps down BioMarin’s Duchenne’s drug as rival nears a moment of truth

John Carroll After outlining its objections to BioMarin's application for its experimental Duchenne muscular dystrophy drug drisapersen in an internal review and hearing clear objections ...

What public outcry? New year brings dozens of double-digit drug price hikes

Tracy Staton All eyes may be on rising drug costs, but that doesn't mean pharma companies are backing away from price hikes. In recent days, analysts have spotlighted hundreds of ...

Roche and AbbVie line up for quick approval for cancer drug venetoclax

Damian Garde Partners Roche and AbbVie are speeding toward FDA approval with a cancer treatment tabbed as a potential blockbuster, picking up a priority review for a blood cancer therapy. FierceBiotech ...

Drug price increases saw ‘high water mark’ year in 2015: Analysts

Emily Wasserman Price hikes have landed pharma in hot water lately, with lawmakers, the public and presidential hopefuls lashing out at companies over skyrocketing costs. But things ...

UPDATED: Congressional reps urge the NIH to ‘march in’ on rising drug prices

Emily Wasserman Up in arms about rising drug prices, a cadre of lawmakers have called for Congressional action. But the lawmaking process won't happen quickly enough for some of ...

Adamas soars as its Parkinson’s drug comes through in Phase III

Damian Garde Adamas Pharmaceuticals' lead drug met its main goals of reducing side effects related to Parkinson's disease treatment in a late-stage trial, the company said, ...

Brace yourselves: The drug pricing brouhaha isn’t dying down

Tracy Staton Drug prices were already a sore subject, but the pain grew this fall, when the now-former CEO of Turing Pharmaceuticals Martin Shkreli unapologetically jacked up the price ...

UPDATED: Alexion grabs an FDA OK–the 41st of ’15–for rare-disease drug Kanuma

John Carroll Seven months after Alexion bagged the rare-disease drug Kanuma in its $ 8.4 billion buyout of Synageva, the FDA has come through with a marketing approval. The agency ...

Mylan latest caught up in DOJ probe of generic drug prices

Eric Palmer Mylan said today that it got a special delivery from the Justice Department Thursday, making it the most recent of a string of drugmakers to get a subpoena from federal ...

Startup raises $15M to turn an old diabetes drug into a potent cancer killer

Damian Garde A group of scientists at UCLA have cooked up some compounds that could harness the cancer-fighting properties of metformin while avoiding the biological hurdles that have ...
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