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:…
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…
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…
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…
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…
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…
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…