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A group of seven district attorneys general in Tennessee cannot sue opioid makers Purdue, Teva and Mallinckrodt under a state law that allows civil suits against drug dealers, a circuit court judge ruled. 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
A Hartford Superior Court jury found Boehringer Ingelheim not liable for the severe internal bleeding a Pensacola, Florida, man suffered after using the company’s blood thinner Pradaxa. Read More
President Trump signed two bills into law Wednesday 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
An FDA advisory committee voted in favor of licensing Celltrion’s drug candidate as a biosimilar for Roche’s blockbuster cancer-fighting Rituxan (rituximab). 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 FDA added immediate-release opioids to its risk evaluation and mitigation strategy (REMS) for opioid analgesics, saying the move will encourage “rational prescribing.” Read More
FDA guidance on submitting field alert reports contradicts federal regulations on the time frame for when reports must be submitted, Perrigo and GlaxoSmithKline said in public comments. Read More
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. Read More
Failure to submit trial data to ClinicalTrials.gov on time could cost drugmakers up to $10,000 per violation, the FDA said in new draft guidance. Read More
FDA Commissioner Scott Gottlieb announced a four-pronged agency initiative to take on antimicrobial resistance, in part by creating incentives for drugs that treat it. Read More