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. Source: Drug Industry…
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. Source: Drug Industry…
Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the…
Two large pharmaceuticals announced acquisitions designed to bolster their portfolios in biotechnology with Novo Nordisk — maker of Wegovy — acquiring Inversago Pharma, also working on a weight loss drug;…
The latest FDA drug approvals include traditional approval of pralsetinib for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, a monoclonal antibody for infants and children at severe risk…
The FDA’s efforts to safeguard against the presence of diethylene glycol (DEG) ethylene glycol (EG) in drug products have resulted in the agency issuing 22 warning letters on the potentially…
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…
Cybersecurity patches — both proactive to address potential threats and reactive to respond to threats that have already occurred — can be expected to be part of any connected device’s…
Formycon and Fresenius Kabi’s FYB202 will be among the first Stelara (ustekinumab) biosimilars to launch, after the makers reached a legal settlement with Johnson & Johnson, whose patent on the…
Upcoming events in the coming weeks include six FDA advisory committee meetings as well as the GMP Quality Management vSummit and webinars from FDAnews, a WCG company on reliability assessment…