Bluebird bio builds its case for gene therapy as first sickle cell patient responds

John Carroll FierceBiotech News

NIH slams the brakes on drug production after contamination scare

Damian Garde The National Institutes of Health has halted production at a plant that makes drugs for clinical trials after discovering some alarming manufacturing mishaps, a move that ...

Clovis boasts promising ovarian cancer responses for AstraZeneca rival rucaparib

John Carroll Over the weekend, Clovis Oncology took another big step toward its near-term goal of launching commercial operations, with plans to take pharma giant AstraZeneca head-on ...

Adding Opdivo to Yervoy ups melanoma treatment efficacy–but it ups rate of serious side effects, too

Carly Helfand The data on Bristol-Myers Squibb's hot new immunotherapy Opdivo kept rolling out Sunday at ASCO, showing that combining the drug with fellow Bristol cancer-fighter ...

UPDATED: Bristol-Myers dominates–and disappoints–at ASCO immuno-oncology debut

John Carroll Bristol-Myers Squibb and rival Merck started off the big annual scientific meeting of ASCO with a bang, rolling out a slate of new studies spotlighting ...

Valeant, Actavis on verge of FDA nods in IBS for Xifaxan, eluxadoline

Tracy Staton Get ready for a showdown in the irritable bowel syndrome market. FiercePharma News

J&J touts a blockbuster-rich pipeline with 10 filings on the horizon

Damian Garde Johnson & Johnson says it's on track to submit more than 10 new drugs for FDA approval over the next four years, and the company believes each of those contenders ...

Baxter pads biopharma unit with pre-spinoff oncology buy

Carly Helfand As Baxter gears up to spin off its biopharma unit into new company Baxalta, it wants to make sure the new pharma has enough revenue to rely on. And to do that, it's ...

GSK weighing scrapping investor payout to boost dividend instead

Eric Palmer Analysts are suggesting that GlaxoSmithKline is thinking hard about scrapping a plan to reward investors by paying them about £4 billion and instead use money from ...

Eyeing big niche in obesity, Novo rolls out Saxenda at $1,000 per month

Tracy Staton Novo Nordisk says its new drug Saxenda has a niche in the U.S. obesity market. Now, the Danish drugmaker has the chance to prove it. Saxenda is rolling out ...

Argos gets a $40M China deal for AGS-003

John Carroll China's Lummy HK and the China BioPharma Capital I Fund have agreed to acquire $ 10 million worth of Durham, NC-based Argos Therapeutics stock in exchange for rights ...

Safety scare with AstraZeneca’s diabetes drug could shake up the DPP-4 field

Damian Garde The FDA raised some alarming concerns tied to AstraZeneca's Onglyza ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors, sounding a worrying ...
Page 5 of 98« First...34567...102030...Last »
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS