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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
An FDA advisory panel narrowly voted Thursday not to recommend approval of Trevena’s NDA for oliceridine, an opioid treatment for moderate-to-severe acute pain in adults. Read More
“We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients,” Gottlieb said. Read More
Congress is considering legislation that would narrow the eligibility requirements for hospitals. The Protecting Safety-Net 340B Hospitals Act, sponsored by Rep. Joe Barton (R-Texas), would raise the minimum Medicare reimbursement a hospital must receive to make the cut. Read More
But the New Jersey court disagreed, ruling that consolidating the suits in the Garden State — which has stronger protections for drugmakers who use FDA-approved labeling — was proper because that’s where the drugmaker was headquartered at the time. Read More
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