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.
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.
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).
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).
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.
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.
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.
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.
The problem of counterfeit devices has perplexed the U.S. FDA for some time, given that the agency had previously been forced to send the illicit products back to the originator, only to see the same devices reenter the U.S.
Full-Life Technologies Ltd. has received IND clearance by the FDA, allowing it to conduct clinical trials of 225Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer.
RSS
