The FDA Thursday approved Mylan NV’s Semglee (insulin glargine), adding another player to the U.S. insulin space that has been pretty much controlled by three companies – Eli Lilly and Co., Novo Nordisk A/S and Sanofi SA.
The impact of the COVID-19 pandemic has reached into quarters that are not historically problematic for makers of diagnostics, including China’s import and export practices for test kits. According to one caller on an FDA diagnostic town hall, export officials in China have a blacklist and a whitelist for test kits, but there is some dispute as to whether kits that are eligible for distribution in the U.S. can get off the blacklist unless that kit is specifically called out via the emergency use authorization (EUA) program.
The U.S. FDA granted Gtx Medical BV a breakthrough device designation for its implantable Go-2 Targeted Epidural Spinal Stimulation (TESS) system. The device enabled patients who had sustained traumatic spinal cord injuries to regain voluntary control over previously paralyzed muscles and walk again four or more years after paralysis, according to a study previously published in Nature.
Rear Admiral John Polowczyk, vice director of logistics for the Joint Chiefs of Staff, said in a Senate hearing that the one solution to managing pandemic supplies might be to use federal taxpayer dollars to sustain inventories in private-sector warehouses.
The U.S. FDA’s effort to marry its quality systems regulations with ISO 13485 has hardly gone off without a hitch, but Melissa Torres, director of international programs at the FDA’s device center, said the agency is “very hopeful” it can publish a draft rule for that task by the end of this year.
Minneapolis-based startup Nuvaira Inc. has received breakthrough device designation from the U.S. FDA for its Dnerva lung denervation system to reduce the risk of moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in patients receiving optimal care. The bronchoscopic procedure works by disrupting pulmonary nerve input to the lung, improving symptoms and stabilizing lung function.
Hong Kong – South Korea’s Lunit Inc. is currently in the process of applying for U.S. FDA approval for Lunit Insight Mmg, its AI software that analyzes mammography images to detect breast cancer. Other markets that the company targets entering include South America, the Middle East, and Asia Pacific, Jussarang Lee, communications manager at Lunit, told BioWorld. Founded in 2013, the Seoul-based company uses artificial intelligence to develop cancer diagnostics and therapeutics.
The nationwide recall of the fourth-most prescribed drug in the U.S. is expanding, with Teva Pharmaceutical Industries Ltd. and Marksans Pharma Ltd. being the latest manufacturers to announce voluntary recalls of metformin hydrochloride extended-release tablets due to the possibility of excessive levels of N-nitrosodimethylamine (NDMA).
The U.S. FDA’s Accreditation Scheme for Conformity Assessment program (ASCA) seems to promise a much less burdensome approach to device performance testing, but several stakeholders have made the case that as written, the draft guidance for the ASCA pilot does little more than create another layer of review of device testing, thus defeating the point of making more extensive use of testing labs.
The FDA has approved Recarbrio (imipenem-cilastatin and relebactam), from Merck & Co. Inc., of Kenilworth, N.J., to treat adults with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).
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