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The FDA released a draft guidance explaining the circumstances when packages and cases are exempted from certain requirements of the 2013 Drug Supply Chain Security Act.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 Hatch-Waxman Act did not strike a good balance between generic access and brand-name innovation, according to public comments to the FDA from both PhRMA and the Association for Accessible…
The UK’s competition watchdog agency claimed the drugmaker Concordia overcharged the NHS by millions for its hypothyroid medication liothyronine, also known as Cytomel, following price increases of almost 6,000 percent…
Makers of biopharmaceuticals will need to become more modular and agile to adjust for trends in personalized medicine and oncology, according to the Tufts Center for the Study of Drug…
A federal judge blocked Aegerion’s proposed $36 million deal to settle claims of illegal marketing tactics for its cholesterol drug Juxtapid, ordering the case to trial. Source: Drug Industry Daily
The European Medicines Agency launched the new version of its EudraVigilance adverse event database Nov. 22, providing more tools for analysis. Source: Drug Industry Daily
The FDA cited a compounding pharmacy in Indiana for producing unapproved drugs and for violations of sanitary standards. Source: Drug Industry Daily