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Datascope/Maquet/Getinge’s Cardiosave Hybrid and Rescue Intra-aortic Balloon Pump (IABP) is seeing a recall deemed class I — the most serious type of recall as use of the device may cause serious injury or death — for the third time in the past nine months, this time for a potential electrical shutdown. Read More
Over the past week, the FDA issued final guidance on acceptable intake limits for nitrosamines and draft guidances on QTc information in human prescription drug and biological product labeling, classification categories for biosimilars, formal meetings for biosimilars and postmarketing approaches in clinical trials. 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Acknowledging that collecting diverse patient data prior to drug approval is not always feasible, the FDA has published draft guidance that gives direction on gathering underrepresented population data in the postmarket setting.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
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; and Regeneron acquiring Decibel Therapeutics, with gene therapy candidates for hearing loss. Read More
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 of respiratory syncytial virus (RSV), the first treatment for people two years of age and older with the viral skin infection molluscum contagiosum, and a treatment for an eyelid disease called Demodex blepharitis. Read More
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 lethal contaminant since March — and nine on the issue just this week. 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
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 lifecycle. But in the medical device world, these patches constitute design changes, which are strictly regulated, says Eric Henry, a senior quality systems and compliance adviser in the law firm King & Spalding. Read More
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 blockbuster drug is set to expire this fall. Read More
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 and medical device risk management tools. Read More