Chinese advisers push for tougher generics quality standards

Carly Helfand China's political advisers are encouraging domestic generic drug development–but at the same time, they're also pushing for tougher quality standards. On ...

Allergan CEO Saunders could cash out Pfizer deal with $187M, Bloomberg figures

Eric Palmer Even if Brent Saunders does not get the CEO role at Pfizer as a condition of Allergan agreeing to a buyout, which is reportedly being demanded, he will still get ...

Valeant cuts ties with shadowy pharmacy Philidor

Carly Helfand Valeant is severing all ties with specialty pharmacy Philidor–which a short seller recently claimed it used to inflate its top line–after reports that Philidor ...

FDA rejects AstraZeneca’s diabetes combo and demands more data

Damian Garde The FDA wants to see more clinical trial data on AstraZeneca's new combination diabetes treatment, the company said, likely delaying a potential launch by more than ...

FDA puts off its decision on Newron’s Parkinson’s drug

Damian Garde Italian biotech Newron Pharmaceuticals will have to wait another three months for a final FDA decision on its investigational Parkinson's treatment. FierceBiotech News

Fierce’s coverage of the Martin Shkreli saga

Alok Saboo Martin Shkreli's controversial Turing Pharmaceuticals made global headlines this week after the startup chose to jack up the price of a decades-old drug to boost revenue, ...

Perrigo CEO has slammed Mylan for months–but he owns its shares

Carly Helfand Perrigo CEO Joseph Papa has cautioned investors against taking up an offer from hostile suitor Mylan. But Papa is already a Mylan shareholder himself. FiercePharma News

Volatile valuations make biotech a haven for short sellers

Damian Garde The years-long glut of biotech IPOs has flooded the public markets with high-risk life sciences companies, and shorts have taken a particular interest in those newly public ...

India’s Cipla gets U.S. beachhead with $550M deal for 2 generics operations

Eric Palmer India's Cipla has lagged behind its compatriots in challenging U.S. drugmakers on their own turf, currently getting less than 10% of its revenues from the lucrative ...

GSK inks exclusive vaccines deal with new GlycoVaxyn affiliate

Amirah Al Idrus When GlaxoSmithKline bought out GlycoVaxyn for $ 190 million earlier this year, it gained a set of early-stage vaccines and commissioned GlycoVaxyn's team ...

Shire and Sangamo break up their gene-editing partnership

Damian Garde Shire and Sangamo Biosciences are going their separate ways after three-plus years of collaboration in gene editing, with each company hanging on to the programs best aligned ...

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 ...
Page 3 of 11812345...102030...Last »
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS