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Oncopeptides is appealing a formal request from the FDA to withdraw its blood cancer therapy drug Pepaxto (melphalan flufenamide) as the agency flexes its newfound regulatory authority for pulling drugs that receive an accelerated approval but fail confirmatory studies. Read More
In July, the court said that PTAB used incorrect legal framing and conducted an erroneous obviousness analysis in its opinion on separate but related Medtronic patents. Read More
The complex process of regulating combination products begins with the FDA’s determination of which center — CDRH, CBER or CDER — will take the lead role in overseeing a product’s development, but even after that determination is made, the way regulations are applied opens up another layer of complexity. Read More
A federal appeals court handed another win to Axonics in its ongoing battle with Medtronic over claims that Medtronic’s patents for a sacral-nerve stimulation device are invalid. Read More
Two draft guidances with the FDA’s recommendations for Biosimilar User Fee Act (BsUFA III) classification categories and preparation for formal meetings with agency staff were issued today. Read More
Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the postmarket setting. Read More
Texas has settled with Takeda Pharmaceuticals and Baxter International for $42 million over allegations the companies provided kickbacks to Medicaid providers to recommend prescription medications including the attention deficit hyperactivity drug (ADHD) Vyvanse (lisdexamfetamine dimesylate). Read More
The big three drug associations, representing brand pharmaceuticals, generics and biotechnology, have all expressed strong objections to the CMS proposed rule for the Medicaid Drug Rebate program “stacking” requirement that revises the definition of “best price.” Read More
Nektar Pharmaceuticals has launched a two-pronged attack on Eli Lilly: A legal filing charging that Lilly intentionally sabotaged its development of Rezpeg, an investigational biologic the companies were co-developing for systemic lupus erythematosus (SLE) and dermatologic conditions, and a public relations campaign designed to alert the public to the allegedly shady dealings. Read More
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More