The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for…
An Ohio federal judge denied a new trial to plaintiffs in a lawsuit against Abbott Laboratories who claimed their son was born with birth defects because the company failed to…
The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act. Source: Drug Industry Daily
The Supreme Court appeared divided Monday on the constitutionality of the PTO’s patent re-examination process of inter partes review — in a debate with wide implications for drugmakers on whether…
The move is in part related to Brexit, the UK's exit from the European Union. Source: BioSpace
Diabetes is huge problem for Americans. Source: BioSpace
Kenneth Pittman, writing for Seeking Alpha, takes a look at why Shire is thinking of unloading its neuroscience division and suggesting an alternative. Source: BioSpace
News of the layoffs comes hard on the heels of the company's credit rating having been cut to junk status by Fitch Rating. Source: BioSpace
Since taking over at Teva earlier this fall, Kare Schultz has been swiftly moving to shore up the finances and pay down the massive debts of the beleaguered pharmaceutical company.…
Biogen will receive an exclusive, worldwide license to commercialize ALKS 8700 and will pay Alkermes a mid-teens royalty on worldwide net sales of ALKS 8700. Source: BioSpace