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Regulatory actions for Nov. 8, 2023

Nov. 8, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Recor.
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Genetic/Congenital

Grace Science’s gene therapy for NGLY1 deficiency cleared to enter clinic in US

Nov. 8, 2023
Grace Science LLC has received FDA clearance of its IND application for GS-100, an AAV9 gene replacement therapy for the treatment of NGLY1 deficiency.
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Cancer

Abbisko’s FGFR4 inhibitor ABSK-012 receives FDA clearance for phase I trials

Nov. 8, 2023
Abbisko Therapeutics Co. Ltd. has received FDA clearance of its IND application for ABSK-012, a highly selective small-molecule inhibitor of fibroblast growth factor receptor 4 (FGFR4), for advanced solid tumors.
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Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 7, 2023
By Tamra Sami
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.
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US CMS proposes more Medicare flexibility to increase biosimilar competition

Nov. 7, 2023
By Mari Serebrov
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.
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When is 12.5 a 13? US Fed Circuit wades into the math of rounding

Nov. 7, 2023
By Mari Serebrov
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.
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Monica Bertagnolli, NIH director

Bertagnolli confirmed as next US NIH director

Nov. 7, 2023
By Mari Serebrov
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.
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Regulatory actions for Nov. 7, 2023

Nov. 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Soundwave Hearing.
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Ausbiotech 2023: Big pharma sees promise in building mRNA platform in Australia to serve APAC

Nov. 6, 2023
By Tamra Sami
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.
Read More
Empty prescription drug bottle

Drug shortages a chronic problem, not just for generics

Nov. 6, 2023
By Mari Serebrov
With drug shortages in the U.S. both a growing and chronic problem, a congressional committee is once again probing how the FDA is handling the issue.
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