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With a mixed bag of results and much at stake for BioMarin’s Duchenne muscular dystrophy treatment drisapersen, FDA reviewers overwhelmingly decided the largest, most complete trial in the drug’s development weakened “promising” findings from earlier studies. Read More
Eli Lilly scored an FDA approval Tuesday for EGFR inhibitor Portrazza in combination with chemotherapy for second-line treatment in metastatic squamous non-small cell lung cancer. Read More
Two senators are pressing the Department of Health and Human Services to authorize prescription drug importation from Canada to combat price gouging in the marketplace. Read More
On Tuesday, the FDA released the Oct. 22 warning letter issued to Sandoz sites in Kalwe and Turbhe, Maharashtra, India, which Sandoz had earlier hinted at during its third quarter earnings call. With the release of the warning letter, the extent of the data integrity issues are now known. Read More
The FDA has issued a lengthy warning letter to Dr. Reddy’s Laboratories for three India facilities — two in Andhra Pradesh and one in Telangana — for several data integrity and GMP issues that the agency says “represent long-standing failures to adequately resolve significant manufacturing quality problems.” Read More
A Merck subsidiary could lose patent protection on the popular antibiotic Cubicin next year, after a federal appellate court invalidated four of the company’s five patents on the drug. 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
Generic manufacturer Heritage Pharmaceuticals has been hit with a warning letter for what the FDA calls “serious violations” of postmarket reporting requirements. Read More
The U.S. Supreme Court has refused to hear patent infringement cases brought by two drugmakers against Apotex, paving the way for the Canadian company to produce a generic version of Benicar. Read More