LONDON – After six years in development, EMA’s new clinical trials information system (CTIS) was switched Jan. 31, bringing to life a law enacted in 2014 to create a single, harmonized regulatory system across the EU. As the embodiment of the Clinical Trial Regulation, CTIS will underpin a long-awaited simplification of the process for approving trials. Rather than separate applications to different national regulators, a single application delivered via CTIS can lead to simultaneous regulatory and ethics approvals in up to 30 countries.
After showing power in its frequency of dosing and efficacy, Vabysmo (faricimab) has been approved by the FDA for treating wet, or neovascular, age-related macular degeneration and diabetic macular edema. The bispecific monoclonal antibody was developed by Roche Holding AG units, Chugai Pharmaceutical Co. Ltd. and Genentech Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Alx, Amryt, Beigene, Bioheng, Biontech, Blueprint, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Pfizer, Provention, Regeneron, Sanofi.
Insulet Corp. received FDA clearance for its Omnipod 5 closed-loop automated insulin delivery (AID) system for patients aged six and older who have type 1 diabetes on Friday, Jan. 28, making it the first tubeless “artificial pancreas” system to get the FDA greenlight. The Omnipod 5 works with Dexcom Inc.’s widely used G6 continuous glucose monitor (CGM) to self-adjust insulin dosing using its Smartadjust algorithm.
Philips Respironics Inc., of Murrayville, Pa., was compelled to engage in multiple recalls over the use of a supplier’s polyester-based polyurethane (PE-PUR) sound abatement foam, and the latest victim of this problem is the company’s Trilogy Evo ventilator.
North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
Mighty Libtayo has stumbled. Because Regeneron Pharmaceuticals Inc. and Sanofi SA couldn’t find common ground with the FDA on postmarketing studies, the two are voluntarily withdrawing the sBLA for Libtayo (cemiplimab-rwlc) as a second-line treatment for advanced cervical cancer. Discussion about the matter continues outside the U.S., the companies said.
Bristol Myers Squibb Co.’s Breyanzi (lisocabtagene maraleucel) CAR T-cell therapy has passed muster with European regulators as a therapy for relapsed or refractory large B-cell lymphoma, setting up a likely European marketing authorization in the coming weeks.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dizal, GBT, Merck & Co., Pfizer, Sellas, Trevena.
The U.S. FDA often has difficulty turning around draft guidances into final guidances in a timely manner, but that hasn’t impeded the agency’s appetite for fast turnaround of industry responses to FDA mandated postmarket surveillance studies. Nonetheless, the Medical Device Manufacturers Association (MDMA) said in comments to the docket for the May 2021 draft guidance for Section 522 postmarket surveillance studies that a requirement that such a study be fully enrolled within 24 months should be aspirational rather than compulsory.
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