With an eye on making the U.K. more attractive for clinical trial research, the Medicines and Healthcare products Regulatory Agency took a step Oct. 12 to overhaul its clinical trials regulations by reducing the approval time for the lowest-risk studies.
The European Commission (EC) has ordered Illumina Inc. to sell Grail Inc. after it closed the acquisition without approval from EU regulators. The EC said that if Illumina fails to comply with the order, the company faces fines of up to 5% of its daily aggregate revenue or up to 10% of its annual worldwide revenue.
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Annexon, Immpact, Inovio, Supernus.
Hoping to find a niche where it can be a pacesetter in biopharma development, the Canadian government is investing CA$49 million (US$36 million) in the new Conscience Open Science Drug Discovery Network. The investment will be used to accelerate drug R&D “by leveraging Canadian strengths in artificial intelligence and employing open science principles to drive efficiencies in building Canadian innovation capacity and delivering the medicines that Canadians need,” François-Philippe Champagne, minister of Innovation, Science and Industry, said in announcing the funding Oct. 5.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acousia, Alnylam, Aquestive, Canbridge, Jasper, Novartis, Okyo, Radiopharm, Tonix, Ultimovacs.
Following an unexpected FDA complete response letter (CRL), Alnylam Pharmaceuticals Inc. said it will no longer pursue an expanded indication for Onpattro (patisiran) in the U.S. The RNAi therapeutic was approved in 2018 to treat polyneuropathy of hereditary transthyretin-mediated (ATTR) amyloidosis and seemed well on its way to snagging a second U.S. indication after the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-3 in September that the drug’s benefits outweighed its risks as a treatment for cardiomyopathy of ATTR amyloidosis. The FDA disagreed with the committee, saying in the CRL that patisiran’s clinical meaningfulness had not been established in the proposed indication.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Arcutis, ARS, GC, Janssen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agomab, Biomea Fusion, Cel-Sci, Calliditas, Coherus Biosciences, Innate.
The US FDA is offering sponsors of certain drugs and biologics more agency access as part of a pilot program that will be launching in January 2024 with the mission of accelerating the development of new therapies for rare diseases.
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