UPDATED: Novo to spend $1.2B, hire 700 for its first major drug plant in U.S.

Eric Palmer With a game-changing oral diabetes treatment moving through clinical trials, Novo Nordisk will spend about $ 2 billion on its first API plant in the U.S., ...

Syndax banks an $80M crossover round for PhIII cancer drug

John Carroll Two months after signing up AstraZeneca R&D leader Briggs Morrison as its new CEO, Waltham, MA-based Syndax has raised $ 80 million from a syndicate that includes ...

FDA clears a controversial female libido drug despite ‘modest’ effects and dangerous risks

Damian Garde The FDA cleared Sprout Pharmaceuticals' much-scrutinized flibanserin, a first-of-its-kind pill designed to boost women's sexual desire, but not without sticking ...

Esperion surges after FDA offers a shot at quick approval for LDL-lowering drug

John Carroll Shares of Esperion Therapeutics shot up more than 10% after the market closed on Monday–after the biotech tipped off investors that the FDA is not going to require ...

KemPharm spikes as its anti-abuse pain drug rolls toward the FDA

Damian Garde KemPharm, at work on an abuse-deterrent formulation of hydrocodone, said its lead drug performed well in a study designed to determine how easily the pill can be ground ...

Roche dumps its cancer drug R&D pact with Wilex

John Carroll Roche is bowing out of a two-year-old collaboration with a subsidiary of a struggling Wilex. FierceBiotech News

FibroGen’s anemia drug, not yet approved, is a hit among cheating cyclists

Damian Garde FibroGen's in-development treatment for anemia is still in the midst of Phase III development, but thanks to a legal loophole, the pill has made its way into the world ...

Novartis wins an early approval for a new skin cancer drug

Damian Garde Novartis won accelerated approval for a promising oncology drug, gearing up to launch a new treatment for an advanced form of the most common type of skin cancer. FierceBiotech ...

Cancer docs try to rally public behind plan to fight drug prices

Eric Palmer Cancer doctors at the famed Mayo Clinic have been up in arms about escalating prices of cancer drugs. Now they have recruited a bunch of colleagues and are trying to rile ...

‘Cures’ bill, designed to speed drug approvals, could be too much of a good thing, dissenters say

Damian Garde The FDA has made strides in shortening review times and accelerating the path for breakthrough treatments, but a new bill designed to break down even more regulatory barriers ...

Apogenix inks cancer drug development deal for China

John Carroll Germany's Apogenix, which is backed by SAP co-founder Dietmar Hopp, has struck an exclusive licensing agreement with CANbridge Life Sciences to develop and commercialize ...

Maryland Rep joins chorus of Amphastar critics, urging OD drug price deal

Tracy Staton Amphastar is in hot water with U.S. officials again. After New York and other states put the squeeze on the company to drop the price of its overdose drug, naloxone, Rep. ...
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