Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
In another step that blurs the distinction between biosimilars and interchangeables, the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing a rule to give Medicare Part D plans more flexibility to substitute biosimilars for the reference biologics so Medicare beneficiaries can have timelier access to the lower-cost drugs. The rule would permit the plans to treat the biosimilar substitutions as “maintenance changes” that don’t require prior Medicare approval. Such changes would enable the substitutions to apply to all enrollees – and not just those who begin the therapy after the effective date of the change.
Wading into the “muddied waters” of rounding the numbers used in a range claimed in two drug patents, the U.S. Court of Appeals for the Federal Circuit refused to set a “bright line rule.” Instead, it tossed a lower court win for Actelion Pharmaceuticals Ltd. against Mylan Pharmaceuticals Inc. and sent the case back to that court with instructions to consider the extrinsic evidence and its impact on the claim construction.
After nearly two years with an acting director, the U.S. NIH now has a confirmed leader. The Senate voted 62-36 Nov. 7 to confirm Monica Bertagnolli, a cancer surgeon and researcher, as the next director of the research agency.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Soundwave Hearing.
Multinational pharma companies like Moderna Inc. and Sanofi SA are setting up mRNA R&D centers in Australia and are banking on the country’s decades of mRNA expertise to bring new therapeutics to the clinic and to serve as regional hubs in Asia Pacific, speakers said during the Ausbiotech 2023 conference held Nov 1-3 in Brisbane, Australia.
The U.S. Centers for Medicare & Medicaid Services has followed through on an earlier threat to reduce payments for various sorts of radiology services in the physician fee schedule, including those invoked during episodes of cancer care, but Congress may yet intervene.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Smileyscope.
Briacell Therapeutics Corp. has received IND clearance from the FDA to begin clinical studies with Bria-OTS, the first generation of the company’s personalized off-the-shelf cellular immunotherapy for breast cancer.
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