Don May, Advamed’s executive vice president for payment and health care policy, said on a Sept. 11 press briefing that any device that misses its first year of new technology add-on payment (NTAP) eligibility may not be able to recover that year unless CMS makes an exception for the pandemic, seemingly leaving the Boston Scientific Eluvia device with only two years of eligibility for its NTAP application.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alliancerx Walgreens Prime, Bruker, Canopy Biosciences, Clearside Medical, Collective Medical, Fio, Genetic Technologies, Intelelabs, Intersect ENT, Natera, NaviFUS, Nebraska Health Information Initiative, Noridian Healthcare Solutions, Relay Medical, Todos Medical, Veracyte, Xifin.
The volume of clinical data reported throughout the summer has continued to fall, with only 267 items collected in August, a drop of 10% from July and the lowest amount within the last five months.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Appili, Immupharma, Junshi, Seres, Sol-Gel.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amyris, Biocomo, Editas, Harbour, Hualan, Johnson & Johnson, Lavvan, Medicinova, VBL.
The rescission order directing the U.S. FDA to abandon regulation of lab-developed tests is scarcely three weeks in the past, but two senior managers at the FDA are pushing back in an editorial appearing in the New England Journal of Medicine. The FDA’s Jeff Shuren and Tim Stenzel wrote that there is “a need for a common legislative framework” to ensure clinical tests are accurate and reliable, which implicitly concedes that the statute does not authorize the agency to regulate lab-developed tests.
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