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EC Approves Expanded Indication for Vertex’s Kalydeco Novartis’ Ultibro Breezhaler Shows Superiority Over GSK’s Seretide in COPD Valeant Recalls Cholesterol Drug Read More
The UK’s National Institute for Health and Care Excellence says it will not recommend Amgen’s Repatha as an option for people with high cholesterol and mixed dyslipidemia. Read More
A new report is predicting that spending on prescription and OTC medications will climb 30 percent in the next five years, fueled largely by improved sales and access in emerging markets. Read More
German drugmaker Merck KGaA and Pfizer have received breakthrough therapy designation for immunotherapy avelumab for second-line treatment of metastatic Merkel cell carcinoma. Read More
BMS’ Opdivo Gets Priority Review in RCC AMA Votes to Ban DTC Advertising of Prescription Drugs ANSM Suspends Manufacturing at Catalent Facility Read More
Roche subsidiary Genentech will exercise its option to commercialize Ophthotech’s wet age-related macular degeneration drug Fovista with Novartis outside the U.S. Read More
Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. Read More
During clinical development, biosimilars makers can request as many meetings with FDA reviewers as necessary but they need to be outcomes-based with a priority on narrowly defined questions that the FDA can answer. Read More
The Department of Justice, the FDA and other federal partners announced a nationwide sweep that resulted in the filing of criminal and civil cases against 89 makers of dietary supplements. Read More
The majority of the Senate Committee on Health, Education, Labor and Pensions, from both sides of the aisle, supported Robert Califf’s nomination as the next FDA commissioner Tuesday. Read More