International Pharmaceutical Regulatory Monitor

A Superior Court jury in Hartford, Connecticut found Boehringer Ingelheim not liable for the severe internal bleeding a Pensacola, Florida, man suffered after using the company’s blood thinner Pradaxa. Source: International Pharmaceutical Regulatory Monitor

Drugmakers argued against broad orphan exclusivity for Eagle Pharmaceuticals’ Bendeka (bendamustine) in public comments to the FDA. Source: International Pharmaceutical Regulatory Monitor

The U.S. Court of Appeals for the Federal Circuit upheld a 2017 ruling by the Patent Trials and Appeals Board rejecting Forward Pharma’s challenge to Biogen’s Tecfidera patent. Source: International Pharmaceutical Regulatory Monitor

President Trump signed two bills into law barring pharmacy benefit managers and insurers from placing gag clauses in their contracts with pharmacies that prohibit them from alerting consumers to less expensive drug options. Source: International Pharmaceutical Regulatory Monitor

PhRMA released new guidelines on price transparency in advertising in an effort to preempt tough mandatory regulations that would require ads to include featured drugs list prices. Source: International Pharmaceutical Regulatory Monitor

The FDA released new guidance on how researchers can comply with both agency regulations and pending Common Rule revisions that protect human subjects in clinical trials. Source: International Pharmaceutical Regulatory Monitor

The FDA scrapped a proposed rule that would have required drug sponsors to report possibly fabricated data in the clinical trials. Source: International Pharmaceutical Regulatory Monitor

The EMA’s Committee for Medicinal Products for Human Use recommended six medicines for approval at its October meeting. Source: International Pharmaceutical Regulatory Monitor

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is seeking industry feedback on a potential no-deal Brexit scenario in which the agency would function as a medicine and medical device regulator on its own. Source: International Pharmaceutical Regulatory Monitor

The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Source: International Pharmaceutical Regulatory Monitor