To take clinical trial innovation to the next level, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is opening the CDER Center for Clinical Trial Innovation. The center, known as C3TI, “will be a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct,” said Kevin Bugin, CDER’s lead for C3TI and deputy director of operations in the Office of New Drugs.
Preclinical data of rabbits having convulsions has prompted the U.S. FDA to place a clinical hold on Neumora Therapeutics Inc.’s phase I study of NMRA-266 in healthy adults. Neumora said about 30 participants had been dosed so far in the single ascending and multiple ascending dose study, with no evidence of convulsions seen.
Some gene therapies could be big winners under the changes the U.S. Centers for Medicare & Medicaid Services (CMS) is proposing to Medicare’s new technology add-on program (NTAP) for its fiscal 2025 inpatient prospective payment system.
The U.S. Department of Justice announced that Keith Berman, formerly the CEO of Los Angeles-based Decision Diagnostics Corp., has received a prison sentence of seven years for misrepresenting the company’s developmental test for the SARS-CoV-2 virus during the height of the COVID-19 pandemic.
In the inpatient draft for fiscal 2025, the U.S. Centers for Medicare & Medicaid Services has proposed an accountable care model for beneficiaries on fee-for-service care, one which is designed to provide the coordination of care ordinarily seen only in accountable care organizations.
The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
The Hatch-Waxman Act provides a safe harbor that allows importation of an FDA-regulated article that would otherwise be deemed a case of patent infringement so long as the importation is for purposes reasonably related to obtaining regulatory approval. Edwards Lifesciences Corp. sued Meril Life Sciences Pvt Ltd. for importation of heart valves in a manner that Edwards argued was infringement under Hatch-Waxman, but while the Federal Circuit ruled 2-1 against Edwards, the dissenting opinion recommended an appeal to a full 12-judge panel that could reverse this outcome.
Samsung Bioepis Co. Ltd., of Incheon, South Korea, is the latest to announce a win in the biosimilar space, gaining MFDS approval of Epyztek (SB-17) as the country’s first biosimilar to Stelara (ustekinumab, Janssen Pharmaceutical Inc.) on April 11.
By a unanimous 12-0 vote, the U.S. FDA’s Oncologic Drugs Advisory Committee concluded that new evidence support the use of minimal residual disease (MRD) as an accelerated approval endpoint in multiple myeloma (MM) clinical trials. The FDA will now consider the recommendation, which, if incorporated into future studies, could dramatically shorten some drug developer timelines and offer more options for treating the aggressive bone marrow cancer.
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