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Home » Topics » Regulatory

Regulatory
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Induced pluripotent stem cells
Neurology/psychiatric

Xellsmart announces US IND clearances for iPSC-derived cell therapies for Parkinson’s disease and ALS

April 16, 2025
Xellsmart Biopharmaceutical (Suzhou) Co. Ltd. has announced IND clearances by the FDA for its XS-411 and XS-228 cell therapies, for Parkinson’s disease and amyotrophic lateral sclerosis (ALS), respectively.
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3D representation of tumor
Cancer

Hansoh Pharma’s HS-10529 cleared to enter clinic in China for advanced solid tumors

April 16, 2025
Hansoh Pharmaceutical Group Co. Ltd. has obtained clinical trial clearance from China’s National Medical Products Administration (NMPA) for HS-10529 tablets.
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Map of Europe, Medical Device Regulation (MDR) text

Elixir granted CE mark for Lithix IVL

April 15, 2025
By Annette Boyle
Receipt of EU MDR CE mark may not be a magic potion, but Elixir Medical Corp. is certainly feeling a boost from the regulatory nod for its mechanical Lithix hertz contact intravascular lithotripsy system for treatment of moderate to severely calcified coronary artery lesions. Simultaneously, the company reported the launch of Lithix and completion of first cases in Italy, France and Germany.
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Da Vinci Xi robot - Intuitive Surgical

J&J reports completion of first cases with Ottava robotic system

April 15, 2025
By Holland Johnson
Johnson & Johnson’s Medtech division reported the completion of the first cases in the clinical trial for the Ottava robotic surgical system. The cases mark the first clinical experience with the Ottava system, which has been a long time in development.
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CMS logo and website

CMMI again under pressure as CMS closes several programs

April 15, 2025
By Mark McCarty
The Center for Medicare and Medicaid Innovation was founded with the objective of reducing Medicare spending, but many of the associated programs will be stood down by the end of this year thanks in part to a 2023 report detailing a significant increase, rather than a decrease, in spending associated with CMMI programs.
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US-China trade war accelerates with biotech in the crosshairs

April 15, 2025
By Tamra Sami
The U.S. National Security Commission on Emerging Biotechnology (NSCEB) is urging Congress to reinvest in American biotechnology because “the U.S. is dangerously close to falling behind China,” according to a May 8 report. "The United States is locked in a competition with China that will define the coming century," said NSCEB Chair Senator Todd Young (R-Ind.). “Biotechnology is the next phase in that competition. It is no longer constrained to the realm of scientific achievement. It is now an imperative for national security, economic power and global influence.”
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Kelun Biotech rendering of sacituzumab tirumotecan

Kelun posts phase I/II data of China’s first TROP2 ADC for NSCLC

April 15, 2025
By Marian (YoonJee) Chu
Phase I/II trial results of sacituzumab tirumotecan (sac-TMT; Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd.) published in Nature Medicine came a month after China’s National Medical Products Administration gave clearance to Kelun-Biotech’s supplemental NDA of sac-TMT to treat advanced non-small-cell lung cancer (NSCLC).
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Capsules and tablets scattered over a world map

Biopharma tariffs becoming more than a threat

April 15, 2025
By Mari Serebrov
U.S. tariffs on biopharmaceuticals have advanced beyond administration talking points.As a precursor to tariffs, Commerce Secretary Howard Lutnick initiated an investigation under section 232 of the Trade Expansion Act to determine the effects on national security of importing prescription drugs, according to a request for public comments scheduled to be published in the April 16 Federal Register. Publication of the notice will kick off a 21-day comment period.
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Illustration of antibodies targeting cancer cell
Immuno-oncology

China’s NMPA clears Simcere Zaiming’s FGFR2b-targeting ADC to enter clinic

April 15, 2025
Simcere Zaiming Pharmaceutical Co. Ltd. has received clinical trial approval from China’s National Medical Products Administration (NMPA) for the company’s antibody-drug conjugate (ADC), SIM-0686, for FGFR2b-positive, locally advanced or metastatic solid tumors.
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Edwards Lifesciences Sapien M3

Edwards lands first CE mark for transfemoral mitral valve replacement

April 14, 2025
By Annette Boyle
Edwards Lifesciences Corp.’s Sapien M3 secured CE mark for its Sapien M3 mitral valve replacement system for transfemoral treatment of patients with mitral valve disease who are ineligible for surgery or transcatheter edge-to-edge repair. Sapien M3 is indicated for individuals with symptomatic moderate-to-severe or severe mitral valve regurgitation.
Read More
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