The UK National Institute for Health and Care Excellence ruled that Merck’s cancer immunotherapy Keytruda is not cost-effective in metastatic urothelial carcinoma. Source: Drug Industry Daily

The generic drug industry maintained its pace for a record-setting year in FDA approvals — and passed 1,000 in ANDA submissions. Source: Drug Industry Daily

A New Jersey appeals court revived more than 2,000 liability lawsuits against Roche over its acne treatment Accutane. Source: Drug Industry Daily

The FDA cited Fusion IV Pharmaceuticals for incomplete labels and failing to properly monitor environmental conditions. Source: Drug Industry Daily

The European Medicines Agency invited stakeholders to comment on a planned guidance on nonclinical development of radiopharmaceutical products. Source: Drug Industry Daily

Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations.…

A federal judge shut down a Salt Lake City drug compounder Aug. 3 under a consent decree issued in a case brought by the FDA after inspections uncovered numerous regulatory…

The FDA finalized 48 guidances for generics manufacturers, outlining the recommended studies for demonstrating bioequivalence for dozens of active ingredients and combinations, to assist the industry with generating evidence to…

AbbVie filed a federal lawsuit in Delaware claiming Boehringer Ingelheim is illegally infringing on patents in its development of a Humira biosimilar. Source: Drug Industry Daily

An FDA advisory committee voted 10-to-1 Thursday to recommend approval of Pfizer’s Xeljanz (tofacitinib) for treatment of psoriatic arthritis. Source: Drug Industry Daily