Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioventus, Senseonics.
The U.S. hit a milestone this week in ensuring a stable domestic supply of molybdenum-99 (Mo-99), a medical isotope critical to radiopharmaceuticals that are used in more than 40,000 diagnostic procedures in the U.S. each day.
Citing recent events that highlighted the risks of investing in companies based in China or that have the majority of their operations there, the U.S. SEC’s Division of Corporation Finance is seeking more specific disclosures from those companies about the legal and operational risks of investing in their securities.
China is making some advances in approving and reimbursing drugs to treat or prevent rare diseases. More than 60 rare disease drugs have been approved for marketing in China, with more than 40 of those included in the national medical insurance system, according to figures released at a national conference on rare diseases held in Beijing Dec. 18.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
The FDA granted 510(k) clearance to Neuronetics Inc.’s MT Cap technology for the company’s transcranial magnetic stimulation system, Neurostar Advanced Therapy for Mental Health. The MT Cap speeds the process used to determine the dose and motor threshold for treatment with the Neurostar system for major depressive disorder (MDD). The company expects to begin a limited introduction of the product within weeks, with national rollout to follow in the first quarter of 2022.
Brainsgate Ltd. came up short in a recent FDA advisory hearing for the company’s Ischemic Stroke System (ISS) to treat stroke despite that the panel was unanimously satisfied with the pivotal trial’s safety numbers. One of the issues with the pivotal study was the small enrollment of study subjects in the U.S., which demonstrates once again the hazards of relying on outside-U.S. study data in applications with the FDA.
The COVID-19 pandemic shone an unsparing light on counterfeit devices, but the FDA has previously enjoyed only limited authority to deal with those products. Thanks to legislation passed in January 2021, the agency now has authority to destroy imported counterfeit devices, including those combined with counterfeit drugs. The agency has had authority to destroy counterfeit drugs for a number of years, but that authority did not extend to counterfeit devices until passage of the Safeguarding Therapeutics Act of 2020, which was signed into law in January 2021.
PERTH, Australia – The FDA has given the green light to Telix Pharmaceuticals Ltd.’s lead radiopharmaceutical imaging agent, Illuccix, for prostate cancer. Illuccix is a kit for the preparation of gallium-68 (68Ga) prostate-specific membrane antigen (PSMA) 11 for imaging prostate cancer with positron emission tomography (PET). It targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells.
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