After partnering with Big Pharmas, Incyte bags its own PD-1 drug in $795M deal

John Carroll After signing up for combo studies with all the leaders in the checkpoint inhibitor race, Incyte has found a checkpoint program for itself. FierceBiotech News

Stem cell researcher cleared of misconduct after U-turn

Nick Paul Taylor A stem cell researcher who was accused by colleagues of making up data has been cleared of scientific misconduct. The decision is a boost for Dr. Paolo Macchiarini, ...

Allergan recalls eye drugs after patients complain of particles, blurred vision

Carly Helfand Since Allergan and Actavis joined hands to become a new-look Allergan, the company has already had to recall a from the Actavis side. Now, it's recalling one from ...

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 ...

Avalanche hits the brakes on its gene therapy program after a Phase II misstep

Damian Garde Avalanche Biotechnologies, months removed from a costly Phase II dud, is calling off plans for further study of its lead gene therapy candidate, heading back to the lab ...

UPDATED: GSK site closed after Legionella bacteria detected in cooling tower

Eric Palmer After detecting the bacteria for Legionnaires' disease in its cooling tower, GlaxoSmithKline has temporarily closed a manufacturing plant in North Carolina and sent ...

Generics maker Alvogen eyes faster growth after CVC-led buyout

Tracy Staton A group of investment funds has teamed up to buy generics maker Alvogen. A consortium led by CVC Capital Partners snapped up a majority stake in the NJ-based company, in ...

Are CV studies worth it for diabetes meds? After Merck and Sanofi’s recent successes, some say no

Carly Helfand Some industry watchers are wondering whether those large, expensive trials–which aren't long enough to establish long-term outcomes–were worth it. FiercePharma ...

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 ...

ProPublica: Safety questions over GSK’s Advair linger after years on the asthma throne

Carly Helfand U.S. regulators gave GlaxoSmithKline's Advair the green light a decade and a half ago, paving the way for a long reign that saw the med grow to more than $ 8 billion ...

Flexus founders regroup after $1.25B Bristol-Myers deal

Damian Garde Flexus Biosciences turned heads around the industry when Bristol-Myers Squibb signed a $ 1.25 billion deal to buy the fledgling biotech in February, but the company's ...

Pfizer shutters vaccine sales business in China after Prevenar setback

Carly Helfand As it beefs up its vaccines business, Pfizer's looking to bolster revenue from the top-selling Prevenar family of shots. But on that front, it's come up against ...
© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS