Medicare coverage of breakthrough medical devices is in its fourth iteration under the rubric of Transitional Coverage of Emerging Technologies (TCET) and two managers at the Centers for Medicare & Medicaid Services recently penned an op-ed in a leading medical journal about the TCET program, which generated at least as many questions as answers.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Astrazeneca, Biontech, Carsgen, GSK, Kira, Moderna, Novavax, Pfizer, Roche, Telix, Zhiyu.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Acumen, Astrazeneca, Daiichi, JJP, Leo, Merck & Co., Novaliq, Novavax, Sensorion, Vanda, Vaxxinity.
The U.S. FDA recently released its guidance agenda for fiscal 2023, a plan that de-emphasizes the oft-promised draft guidance for change control for artificial intelligence (AI) algorithms, which is listed as a B priority instead of an A draft guidance priority. At this year’s Medtech Conference here in Boston, the FDA’s Melissa Torres disavowed the notion that any national regulatory authority is delaying another authority’s policy on software change control, but she acknowledged that these conversations about regulatory harmonization typically predate formal policy development.
It’s been a long road, but Astrazeneca plc’s anti-CTLA4 antibody, tremelimumab, finally earned its first U.S. FDA nod, cleared for use in combination with anti-PD-L1 drug Imfinzi (durvalumab) to treat patients with unresectable hepatocellular carcinoma (HCC). The commercial impact of the dual checkpoint therapy, however, remains to be seen, as it goes up against Roche Holding AG’s combination of Avastin (bevacizumab) and Tecentriq (atezolizumab), which gained standard-of-care status in first-line HCC in 2021.
Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medalliance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Akeso, Ars, Bristol Myers Squibb, Eli Lilly, GSK, Regeneron, Silverback.
Expanding its mandate to accelerate access to essential medicines to people in low- and middle-income countries, the Medicines Patent Pool signed its first voluntary licensing agreement for a cancer treatment, Novartis AG’s Tasigna (nilotinib). A twice-daily oral drug, Tasigna is a tyrosine kinase inhibitor included on the World Health Organization’s Model List of Essential Medicines as a second-line treatment for adult and pediatric chronic myeloid leukemia.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biontech, Covis, Leo, Moderna, Novavax, Pfizer, Revance, Tvardi.
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