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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
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