Rather than drafting a new guidance, the U.S. FDA’s Center for Drug Evaluation and Research made some clarifying revisions to update its 16-year-old final guidance, “Investigating out-of-specification (OOS) test results for pharmaceutical production.”
Medtronic plc received FDA premarket approval for its Onyx Frontier drug-eluting stent, an update to the company’s Resolute Onyx stent. The Frontier is designed for treatment of patients with coronary artery disease (CAD), a leading cause of death in the U.S. Medtronic expects the stent to receive CE mark shortly.
The U.S. FDA posted a final guidance for feasibility and early feasibility studies for non-traditional devices for type 2 diabetes, a document that is largely unchanged from the draft. This in the eyes of some stakeholders is precisely the problem as the final guidance retains a set point for rescue medication that some in industry believe is inappropriate for a study that does not seek to establish device effectiveness.
Six weeks ahead of its June 26 PDUFA date, the U.S. FDA has approved a priority NDA for Eli Lilly and Co.’s Mounjaro (tirzepatide), an injectable treatment for adults with type 2 diabetes (T2D). The once-weekly, first-in-class medicine activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptors, which leads to improved blood sugar control. The potential market is massive, as 462 million people across the planet have T2D. The numbers have been growing 1.4% annually as the population ages and grows more obese.
News that the U.S. Trade Representative (USTR) had signed off on a compromise World Trade Organization (WTO) proposal to waive IP rights for COVID-19 vaccines caught Congress by surprise earlier in early May. Now, some members, both Democrats and Republicans, are reminding USTR Katherine Tai that she has an obligation to consult with Congress on such trade issues.
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
Wysa Ltd.’s artificial intelligence-based digital therapy received FDA breakthrough device designation for adults with chronic musculoskeletal pain, depression and anxiety. The device delivers cognitive behavioral therapy (CBT) via a digital companion or conversational agent on a smartphone.
In an effort to increase global access to COVID-19 technologies, the World Health Organization’s COVID-19 Technology Access Pool and the Medicines Patent Pool finalized a licensing agreement May 12 with the U.S. NIH for research tools, early stage vaccines and diagnostics.
As the American Urological Association (AUA) annual meeting prepares to kick off on May 12, newly published prostate cancer guidelines recommend two tests to help clinicians and patients determine the best path forward for treatment—or waiting. The latest AUA guidelines incorporated Exact Sciences Corp.’s Oncotype DX Genomic Prostate Score (GPS) test for risk-stratification of localized prostate cancer, while the National Comprehensive Cancer Network (NCCN) added Cleveland Diagnostics Inc.’s Isopsa test to help identify high-grade early prostate cancer before a biopsy or after a negative biopsy result.
The FDA has greenlighted Neuronetics Inc.’s Neurostar transcranial magnetic stimulation (TMS) system as an adjunct treatment for adults with obsessive-compulsive disorder (OCD). The noninvasive treatment, which uses repetitive, focused magnetic pulses to stimulate brain cells, is already cleared and marketed in the U.S., Japan and select other countries for major depressive disorder (MDD).
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