As part of its real-world evidence (RWE) program, the U.S. FDA released a draft guidance Nov. 29 on using registries to support regulatory decision-making for drugs and biological products.
The FDA cleared Hyperfine Research Inc.’s advanced image reconstruction technology using deep learning for its portable magnetic resonance imaging device, Swoop. The bedside MRI unit’s artificial intelligence application received clearance in January and is used with deep learning to improve image quality and diagnostic value. Hyperfine and Liminal Sciences Inc., which share a founder in serial entrepreneur Jonathan Rothberg, are both combining with special purpose acquisition company Healthcor Catalio Acquisition Corp. to go public in a deal valued at $580 million. The companies reported on Nov. 29 that the Securities and Exchange Commission declared the registration statement on form S-4 for the combination to be effective and the SPAC’s shareholders will vote on the transaction on Dec. 21.
With Omicron all the COVID-19 buzz right now, the FDA’s concern that the antiviral drug molnupiravir might enhance SARS-CoV-2 evolution might take on added weight when the Antimicrobial Drugs Advisory Committee meets Nov. 30 to advise on Merck & Co. Inc.-Ridgeback Biotherapeutics Inc.’s emergency use authorization (EUA) request for what could be the first take-at-home oral drug authorized to treat COVID-19 infections.
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) fall under new classification requirements on Nov. 25, 2021, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR).
Ascentage Pharma Group International’s olverembatinib has received marketing approval from China’s NMPA for the treatment of patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CMP-AP) harboring a T315I mutation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Alphamab, Amivas, Beigene, J&J, Kintor, Kura, Merck & Co., Novavax, Pharmather, RDIF, Relief, Sedana, Takeda.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Diasorin, Lensgen, Novacyt, Qaigen.
The U.K. National Institute of Health and Care Excellence (NICE) issued two health technology assessments dated Nov. 24, including one that gives a guarded recommendation for devices used to narrow the coronary sinus as a treatment for refractory angina. Neovasc Inc., of Richmond, British Columbia, touted the news as a positive for its Reducer device, given that this is the first instance in which NICE has lent any support for a device to treat the condition.