Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
Citing the flexibilities implemented during the COVID-19 pandemic, the Bloomberg New Economy International Cancer Coalition is pushing to convert those improvements to a permanent paradigm shift in the way cancer patients are diagnosed, treated and cared for across the globe.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Clarius Mobile Health.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allovir, JW, Keymed, Teva.
The FDA’s device center issued a safety communication advising that non-invasive genetic prenatal screening tests that are used to establish whether a fetus has a genetic abnormality can yield incorrect results. The problem stems in part from the fact that the agency has not yet reviewed any such tests, which are often administered as lab-developed tests (LDTs).
The Medicare new technology add-on (NTAP) program is a vital source of reimbursement rates for novel technologies, and several NTAP applications were extended by a year in 2021 because of the COVID-19 pandemic. That extension is set to expire for several key products, including the Eluvia drug eluting stent by Boston Scientific Corp., of Marlborough, Mass., and the Spinejack system by Stryker Corp., of Kalamazoo, Mich., forcing these companies to amortize their R&D costs at a more conventional pace.
After several delays due to COVID-19, Canada is on track to implement, within a few months, its first major changes to its Patented Medicines Regulations in more than 30 years. One change coming July 1 is a new basket of comparator countries that will be used to determine whether a drug’s Canadian price is excessive.
Shares in Medincell SA dropped 29.1% Apr. 20 on news that the U.S. FDA slapped a complete response letter (CRL) on an NDA for an extended release, long-acting formulation of risperidone, which it is co-developing with Teva Pharmaceuticals Industries Ltd. as a maintenance treatment for schizophrenia.
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: The Orthopaedic Implant Company, Zeiss.
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