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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. Read More
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. Read More
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. Read More
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. Read More
China’s State Medical Insurance Administration approved 17 cancer drugs for inclusion in the country’s national health insurance system with deeply discounted prices. Read More
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. Read More
The European Medicines Agency entered the third phase of its plan to keep industry gears moving while the agency prepares for the UK’s exit from the EU, and said it will temporarily reduce or suspend more activities to save resources. Read More
The European Medicines Agency wants to develop a common data model (CDM) to help speed Europe’s drug development and it’s looking for a hybrid because no current system can answer all the questions posed by the product life cycle. Read More
The FDA issued draft guidance that outlines what the agency considers an ideal and robust verification system that’s also in line with legislative requirements. Read More