The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
A California man agreed to settle insider trading charges related to Tokyo-based Astellas Pharma Inc.’s buyout offer of San Francisco-based Audentes Therapeutics Inc. in December 2019 for $3 billion. Mahmoud Abdelkader’s wife worked for Audentes and allegedly determined from “facts he learned from his wife, that there was a high likelihood of Audentes being acquired,” the SEC’s complaint said.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cathera, Visby Medical.
The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – provide coverage for Leqembi (lecanemab) in the early stages of Alzheimer’s disease. Under the March 13 VA decision, the Eisai Co. Ltd. drug, which was partnered with Biogen Inc. and granted accelerated approval in January, will be listed as a nonformulary therapy that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia.
China’s NMPA approved Shanghai Shengdi Pharmaceutical Co. Ltd.’s adebrelimab (SHR-1316) for first-line treatment of extensive-stage small-cell lung cancer (ES-SCLC) in combination with chemotherapy. The approval in mainland China makes adebrelimab the third domestic PD-L1 monoclonal antibody to make it to the domestic market. Shanghai Shengdi is a subsidiary of Jiangsu Hengrui Medicine Co. Ltd.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acadia, Mersana.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: PADM Medical.
The U.K. arm of Silicon Valley Bank (SVB) is to be acquired by HSBC UK Bank plc for a symbolic £1, after senior ministers and the Bank of England worked all weekend on a rescue package. The acquisition is to complete immediately, averting what the U.K. government had acknowledged would be a crisis for the biotech and tech sector.
As the aftershocks of two U.S. bank failures rattled global markets, the Biden administration rushed to calm the nerves of the world and to prevent an even bigger tremor. “The banking system is safe,” President Joe Biden said March 13, as he assured companies and individuals who had accounts with Silicon Valley Bank or Signature Bank that they would have access to all their deposits now that the federal government has taken over the failed banks – including deposits exceeding the $250,000 protected by the FDIC.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Genentech, Intercept, Molecular Templates, Pfizer, Seagen.
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