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The UK healthcare cost watchdog gave the final green light for national coverage of GlaxoSmithKline’s skin cancer drug Tafinlar, a decision that was made in record time, according to the drug’s evaluators. Read More
Pfizer is the latest company to win approval of opioid abuse-deterrent labeling, after the FDA cautiously okayed new statements about Embeda late Friday. Read More
The UK’s healthcare cost agency affirmed its June recommendation to cover Novartis’ cancer drug Glivec as an adjuvant treatment for patients at high risk of post-surgery recurrence of gastrointestinal stromal tumors. Read More
The European Medicines Agency has approved Janssen and Pharmacyclics’ blood cancer drug Imbruvica for two indications, a move that follows similar approvals in the U.S. this summer. Read More
The FDA’s proposal that drugmakers add microbiology and pharmacogenics information to product labels should apply only to new prescription drugs and biologics, said industry experts. Read More
The FDA late Wednesday approved two breakthrough therapies for idiopathic pulmonary fibrosis: Boehringer Ingelheim’s Ofev and Intermune’s Esbriet, both of which are set to hit the market within the next two weeks, the companies said. Read More
The UK’s health cost watchdog says it is not ready to change the way it appraises medicines and other technologies, but acknowledges that further consideration is needed of how new treatments are developed, evaluated and supported for coverage. Read More
A question-and-answer document released by the European Medicines Agency in September clarifies terms of engagement and expected outcomes for applicants to the agency’s adaptive licensing pilot program. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More
The FDA approved Eisai’s Akynzeo to treat nausea and vomiting from chemotherapy, the latest success by the Japanese drugmaker to expand its portfolio of such products. Read More