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Home » Topics » Regulatory

Regulatory
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ASCO roars to life in Chicago as CEOs talk innovation

May 31, 2024
By Lee Landenberger
The American Society of Clinical Oncology (ASCO) meeting opened at the McCormick Place convention center in Chicago with after-lunchtime sessions on breast cancer, melanoma, sarcoma and advancements on adjuvant cancer vaccines. As ASCO revved up, the CEOs of Merck & Co. Inc., Gilead Sciences Inc. and Eli Lilly and Co. vented their frustrations about the impact of the Inflation Reduction Act on innovation.
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Vaccine vial and syringe

Moderna’s Mresvia approved as first mRNA-based RSV vaccine

May 31, 2024
By Karen Carey
Moderna Inc. gained U.S. FDA approval on May 31, nearly three weeks past its original PDUFA date, for its respiratory syncytial virus (RSV) vaccine Mresvia (mRNA-1345), which had both breakthrough therapy and fast track designations in the U.S.
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U.S. flag on columned building

Innovasis, two execs hit with $12M fine over FCA allegations

May 31, 2024
By Mark McCarty
The U.S. Department of Justice announced May 29 that Innovasis Inc., of Salt Lake City and two of the company’s executives have agreed to pay $12 million over allegations of payment of kickbacks to surgeons.
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Stereotaxis robotic magnetic navigation (RMN) system

Stereotaxis receives CE mark certification for devices in Europe

May 31, 2024
By Shani Alexander
Stereotaxis Inc. recently received CE mark recertification for all its devices currently available in Europe under the new Medical Device Regulation (MDR) regulatory framework. The MDR has replaced the European Medical Device Directive and includes more stringent standards but meeting the new requirements comes with frustrations and costs for many companies.
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Fundus image of eye with age-related macular degeneration.
Ocular

FDA clears Avirmax’s gene therapy for wet AMD to enter clinic

May 31, 2024
Avirmax Biopharma Inc. has received IND approval from the FDA to initiate a phase I/IIa trial for its gene therapy treatment targeting wet age-related macular degeneration (AMD), including polypoidal choroidal vasculopathy (PCV).
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Cardiovascular

China’s NMPA clears IND for Gyre’s F-230 for pulmonary arterial hypertension

May 31, 2024
Gyre Therapeutics Inc. has announced IND clearance for Gyre Pharmaceuticals’ F-230 tablets by China’s National Medical Products Administration (NMPA). F-230 is a selective endothelin receptor antagonist, for the treatment of pulmonary arterial hypertension (PAH).
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3D representation of tumor
Immuno-oncology

Actym’s ACTM-838 cleared for phase I study in solid tumors

May 31, 2024
Actym Therapeutics Inc. has obtained IND clearance from the FDA to begin a phase I trial of ACTM-838. The first-in-human study will enroll patients in the U.S. and Australia with advanced solid tumors who have failed prior lines of therapy and have no clinically beneficial treatment options.
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Many NIH-funded trials missing the mark on inclusion

May 30, 2024
By Mari Serebrov
Despite U.S. NIH policy and its peer-review grant process, providing for inclusive enrollment in phase III NIH-funded clinical trials seems to be a check-the-box exercise for many researchers. In a review of a sample of phase III NIH-funded trials conducted between 2016 and 2020, the Health and Human Services Office of Inspector General found that two-thirds had the required inclusive enrollment plans, but 57% of the trial plans provided no explanation or rationale for the enrollment targets.
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Celltrion president Young ho Yoo and Kukje Pharm President and CEO Nam Tae-Hoon

Celltrion gains Korea approval of Eylea biosimilar

May 30, 2024
By Marian (YoonJee) Chu
Celltrion Inc., of Incheon, South Korea, gained MFDS clearance of Eydenzelt (CT-P42) as a biosimilar referencing Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 30. The news comes on the heels of the U.S. FDA approving the first Eylea interchangeable biosimilars on May 20.
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EU flags at European Commission building

European Council approves another extension of the IVDR

May 30, 2024
By Mark McCarty
The European Council formally approved another delay for the In Vitro Diagnostic Regulation implementation, which now gives developers of existing high-risk in vitro diagnostics until December 2027 to obtain a renewed CE mark.
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