The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lipgems International, Precision Neuroscience.
Connex Biomedical Inc. applied for patent protection for a transcardiac access port affixed and retained post-procedure on the cardiac muscle, such as the ventricular myocardium, and an access port delivery system configured to deliver the access port, secure the access port to the muscle tissue with tissue anchors, and provide a working channel through the access port to facilitate transcardiac access and device delivery.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acrotech, Bioxcel, Inhibikase, Novavax, Noxopharm, Takeda, Theratechnologies, Transcenta, Vedanta.
Bad news for Amgen Inc. could mean upside for Mirati Therapeutics Inc., though the meeting of the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) has yet to tell the tale regarding Lumakras (sotorasib), the former’s KRAS-G12C inhibitor.
After considering the evidence, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-6 Oct. 4 that the data from a single external-controlled trial and well-established preclinical animal models present sufficient evidence to demonstrate that US Worldmeds LLC’s DFMO (eflornithine) improves event-free survival in pediatric patients with high-risk neuroblastoma.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Calliditas, Fluoguide, Galderma, Maia, Novavax, Oxford, Urogen.
Neve Ilan, Israel-based Nano-X Imaging Ltd., had rocked the world of medical imaging with promises of X-ray imaging systems that provide low-cost tomosynthesis, but the U.S. Securities and Exchange Commission says the company overpromised on the low-cost claim. The SEC said the actual production cost of the Nano-X ARC systems is at least double the $12,000 per-unit figure routinely touted by the company’s former CEO, Ran Poliakine, a factual misrepresentation that helped the company raise $165 million in an initial public offering.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accuray, Entrogen, Exthera, Seastar, Zeptometrix.
Takeda Pharmaceutical Co. Ltd. said it will work with U.S. regulators on the market withdrawal of Exkivity (mobocertinib), only two years after the oral tyrosine kinase inhibitor gained the FDA’s accelerated approval for use in locally advanced or metastatic non-small-cell lung cancer patients with EGFR exon 20 insertion mutations whose disease has progressed after chemotherapy.
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