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Regulatory
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PTO allowing final consideration pilot program to expire

Oct. 2, 2024
By Mark McCarty
The U.S. Patent and Trademark Office opted to allow the 2.0 pilot version of the After Final Consideration Program to expire, bringing to an end a program that ran for longer than a decade.
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Cells, DNA illustration
Endocrine/metabolic

Papillon’s PPL-002 awarded US orphan drug designation for Danon disease

Oct. 2, 2024
The FDA has awarded orphan drug designation to Papillon Therapeutics Inc.’s PPL-002, an experimental gene-modified CD34+ hematopoietic stem and progenitor cell (HSPC) therapy, for the treatment of Danon disease.
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New Japan drug approvals: cancer, insomnia, Alzheimer’s and more

Oct. 1, 2024
By Marian (YoonJee) Chu
Japan’s Ministry of Health, Labour and Welfare granted new drug approvals and expanded indications for conditions like cancer, insomnia and Alzheimer’s disease (AD) Sept. 24, including Eli Lilly and Co.’s Kisunla (donanemab) for early symptomatic AD.
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Transdermal patch on arm

China approves Sino Biopharm’s patch for Alzheimer’s disease

Oct. 1, 2024
By Tamra Sami
China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rivastigmine transdermal patch to treat mild to moderate Alzheimer’s disease. Developed by Sino Biopharm, the patch is the first domestically produced rivastigmine transdermal patch approved for marketing. Rivastigmine is a cholinesterase inhibitor used for the treatment of Alzheimer’s disease.
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Chinese flag on flagpole

China’s NMPA accepts NDAs from Innovent, Lepu

Oct. 1, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted NDAs for Innovent Biologics Inc.’s IL-23p19 antibody picankibart to treat moderate to severe plaque psoriasis, and Lepu Biopharma’s antibody-drug conjugate MRG-003, to treat recurrent or metastatic nasopharyngeal cancer.
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Green approved stamp

Akeso scores two new China approvals

Oct. 1, 2024
By Tamra Sami
Akeso Pharmaceuticals Inc. scored two approvals from China’s National Medical Products Administration on Sept. 30 before the long Labor Day holiday – one for its PCSK9 inhibitor, ebronucimab, and the second to expand use of PD-1/CTLA4 bispecific antibody cadonilimab in unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, marking the second indication for cadonilimab in China.
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U.S. Capitol building

Two House members seek answers in Jeff Shuren controversy

Oct. 1, 2024
By Mark McCarty
The controversy over conflicts of interest for Jeff Shuren, formerly the director of the U.S. FDA’s device center, reached Capitol Hill and may lead to an executive branch investigation into the matter.
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Document illustration

Given no choice, J&J yields to government on 340B rebate model

Sep. 30, 2024
By Mari Serebrov
Meeting the deadline the U.S. Health Resources & Services Administration imposed in a Sept. 27 final warning letter, Johnson & Johnson (J&J) notified the agency Sept. 30 that it would not implement its proposed 340B rebate model pending resolution of the issues.
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AI-generated illustration of heart and metabolic impact

Pi-Cardia receives FDA greenlight for transcatheter leaflet splitter

Sep. 30, 2024
By Shani Alexander
The Pi-Cardia Ltd. Shortcut — the catheter-based, leaflet modification solution for treating heart valves — received U.S. FDA clearance. The device was granted breakthrough device designation from the regulatory agency and is designed to split bioprosthetic aortic valve leaflets in patients undergoing valve-in-valve transcatheter aortic valve replacement (TAVR) procedures who are at risk of coronary obstruction.
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Ribbons of digital data

FDA’s AI glossary includes ‘AI performance monitoring’

Sep. 30, 2024
By Mark McCarty
The question of how to define artificial intelligence (AI) for medical product usage was answered by the FDA, which recently offered an AI glossary.
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