Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ceribell, Polarean.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Hipra, M8, Molecular Targeting, Satellos.
In a balancing act between supply and drug quality, the U.S. FDA tipped the scales on behalf of quality, slapping an import alert on Intas Pharmaceuticals Ltd. in June, followed by a July 28 warning letter requiring the India-based company to develop and implement a global corrective action and preventive action plan.
China’s National Medical Products Administration (NMPA) accepted Luye Pharma Group Ltd.’s NDA for rotigotine (LY-03003) extended-release microspheres and granted it priority review for treating Parkinson’s disease. The microsphere formulation delivers the dopamine agonist in a weekly injection. If approved, LY-03003 would be the first long-acting extended-release microsphere formulation for the treatment of Parkinson’s disease (PD). The drug is also being developed in parallel in the U.S. and Japan.
A huge sigh of relief from the life sciences industry greeted U.S. President Joe Biden’s executive order that’s intended to shore up domestic manufacturing of products developed with taxpayer support. “It’s like the Titanic, [but] we just missed the iceberg,” Joseph Allen, executive director of the Bayh-Dole Coalition, told BioWorld. The fear for the past few years has been that the administration would follow in the wake of the Department of Energy, which broadly expanded the current Bayh-Dole U.S. manufacturing preference.
Both China’s NMPA and the U.S. FDA recently approved the IND applications for a phase I trial of Leads Biolabs’ LBL-034 to treat relapsed or refractory multiple myeloma. The Taiwan FDA also approved Hanchorbio Inc.’s IND application to start a multiregional phase I trial for HCB-101 for advanced solid tumors, and the China Center for Drug Evaluation cleared a phase II trial for Suzhou, China-based Transcenta Holding Ltd.’s TST-002 (blosozumab) for osteoporosis and conditions of reduced bone mineral density. In addition, the NMPA approved Shanghai-based Everest Medicines Ltd.’s application for an extended, post-approval study on Nefecon (targeted-release formulation-budesonide) to treat IgA nephropathy.
The U.S. Centers for Medicare & Medicaid Services (CMS) finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
The FDA’s recent clearance of Ultrasight Inc.’s artificial intelligence (AI)-powered ultrasound guidance technology will allow for the widespread detection of heart diseases in the U.S. and ease bottlenecks in the healthcare system that currently restrict access for many people, Davidi Vortman, CEO of Ultrasight told BioWorld. Ultrasight’s software helps medical professionals without sonography experience acquire cardiac ultrasound images at the point of care in multiple settings.
Device recalls pop up with no regard to human appreciation for seasonality, and thus it was that recalls involving three major medical device makers emerged as the steamy month of July gave way to the arid, oppressive swelter of August. These recalls affected more than 7,500 units of the Trusignal pulse oximeter by GE Healthcare Technologies Inc., nearly 23,000 units of the Sigma Spectrum and Spectrum IQ infusion pumps by Baxter Healthcare Corp., and an unspecified number of units of the Carina ventilator by Drägerwerk AG, all of which adds a little more than the usual heat to the device industry’s dog days.
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