Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Carsgen, Cidara, I-Mab, Inhibrx, Priothera, Sorrento, TG, Tonix.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.
The FDA’s proposal to harmonize the Quality System Regulation (QSR) with ISO 13485 has finally become more than just a hot topic among device makers, and the agency held a March 2 advisory hearing on the matter. One of the critical concerns for industry is the proposal of a one-year term of implementation upon publication of a final harmonization rule, a timeline that some argue should be doubled or tripled in order to serve as a practicable implementation timeline.
A Seattle-based startup has secured breakthrough device designation for its blood-based Alzheimer’s disease (AD) test. Altpep Corp.’s Soba-AD platform is designed to selectively detect toxic forms of amyloid-beta peptide associated with AD progression. The company said early data indicated the assay can detect AD before symptoms including cognitive impairment and neurodegeneration arise.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Dexcom, Gleamer, Intrivo, J&J Vision, Valencia Technologies.
New drug and device regulations going into effect in Canada are serving as a reminder of the extended life of the COVID-19 pandemic. After two years of interim orders regulating the importation and sale of drugs and devices for COVID-19 clinical trials and the conduct of those trials, Canada is issuing long-term regulations that will incorporate most of the provisions of the temporary orders.
Small American device manufacturers are more likely to sell their products only in the U.S., and thus the FDA proposal to more closely align the Quality System Regulation (QSR) with ISO 13485 would seem to place unwarranted demands on these companies.
The FDA has published an updated guidance for the appeals process at the Center for Devices and Radiological Health, but the issuance of that guidance did not happen in a vacuum. Mark Duval, president of Duval & Associates in Minneapolis, told BioWorld that industry is filing more appeals of premarket decisions of late, an uptick he said is an artifact of the practice of FDA reviewers more commonly asking for additional data for these applications.
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