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BioWorld - Sunday, October 1, 2023
Home » Topics » Regulatory

Regulatory
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Foot pain
Neurology/Psychiatric

Artelo plans IND filing for FABP5 inhibitor ART-26.12 for neuropathic pain following FDA guidance

Sep. 8, 2023
No Comments
Artelo Biosciences Inc. has completed a pre-IND meeting with the FDA regarding the manufacturing, preclinical and clinical development plan for ART-26.12.
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White paper delves into US regulatory aspects of AI in drug, device development

Sep. 7, 2023
By Mari Serebrov
No Comments
While the U.S. FDA’s preclinical and clinical trial framework is generally well-suited to adapt to the use of artificial intelligence (AI) in developing new drugs, its regulatory framework for medical devices that incorporate evolving AI leaves a lot to be desired, according to Sen. Bill Cassidy (R-La.), the ranking member of the Senate Health, Education, Labor and Pension Committee.
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With no drugs on CMS’ list, Astellas withdraws IRA challenge

Sep. 7, 2023
By Mari Serebrov
No Comments
Astellas Pharma US Inc. voluntarily withdrew its constitutional challenge Sept. 6 to the Inflation Reduction Act’s (IRA) drug price negotiations.
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China’s NMPA approves Gloria Bio’s zimberelimab as first PD-1 MAb for cervical cancer

Sep. 7, 2023
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has given the green light to Gloria Biosciences Co. Ltd.’s anti-PD-1 monoclonal antibody, zimberelimab (Yutuo, GLS-010), for treating second-line cervical cancer, making it the first immune checkpoint inhibitor approved in China for treating the disease.
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Regulatory actions for Sept. 7, 2023

Sep. 7, 2023
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Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Applied Therapeutics, Astrazeneca, Atamyo, Bridgebio, Cantargia, Genentech, Gloria, Neurophth, Realta, Tango.
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Regulatory actions for Sept. 7, 2023

Sep. 7, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alveofit, Boston Scientific, Implantica.
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Gavel and FTC logo

US FTC and DOJ garner mixed reviews of proposed merger regulation framework

Sep. 7, 2023
By Mark McCarty
No Comments
Two U.S. federal government departments recently issued a series of guidelines for their handling of mergers and acquisitions in a draft that has provoked both support and opposition from observers. Barry Nigro of the George Washington University School of Law said he is concerned that the presumption that a transaction is necessarily anticompetitive will prompt litigation over that presumption and thus bog down the process of reviewing these transactions.
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Limb exam
Neurology/Psychiatric

Pepgen’s PGN-EDODM1 cleared to enter clinic in Canada for DM1, receives US orphan drug designation

Sep. 7, 2023
No Comments
Pepgen Inc. has received a no objection letter from Health Canada for its clinical trial application (CTA) to initiate a phase I study of PGN-EDODM1 in patients with myotonic dystrophy type 1 (DM1). Initial data from the study are expected next year.
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Neurons
Neurology/Psychiatric

Healx’s HLX-1502 awarded US orphan drug designation for neurofibromatosis type 1

Sep. 7, 2023
No Comments
The FDA has awarded orphan drug designation to Healx Ltd.’s HLX-1502 for the treatment of neurofibromatosis type 1 (NF1). HLX-1502, discovered through the company’s proprietary artificial intelligence (AI) drug discovery platform, has a first-in-class mechanism and supporting data that indicate the potential for a good safety profile.
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Cancer

Tango’s USP1 inhibitor TNG-348 cleared to enter clinic for BRCA1/2 mutant and other HRD+ cancers

Sep. 7, 2023
No Comments
Tango Therapeutics Inc. has received FDA clearance of its IND application for TNG-348...
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