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Home » Topics » Regulatory

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Art concept for gene therapy research
Neurology/Psychiatric

Solid Biosciences gains IND clearance for SGT-003 gene therapy in Duchenne

Nov. 15, 2023
Solid Biosciences Inc. has received FDA clearance of its IND application for SGT-003, the company’s next-generation gene therapy candidate for Duchenne muscular dystrophy (DMD). The planned first-in-human phase I/II trial will enroll pediatric patients with DMD to receive SGT-003 as a one-time intravenous infusion.
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FDA icons

Is 20+ years too long for a confirmatory trial? ODAC to weigh in

Nov. 14, 2023
By Mari Serebrov
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
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Bayer pulling Aliqopa from market in latest blow to PI3K inhibitor class

Nov. 14, 2023
Bayer AG said it will voluntarily withdraw Aliqopa (copanlisib) from the U.S. market after a confirmatory trial required by the FDA failed to meet the primary endpoint of progression-free survival vs. standard immunochemotherapy in patients with relapsed follicular lymphoma. It marks the latest stumble for PI3K-targeting drugs in the non-Hodgkin’s lymphoma space.
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Red blood cells

Takeda wins second FDA approval in two days with Adzynma for rare clotting disorder

Nov. 14, 2023
By Tamra Sami
With the U.S. FDA giving the green light to Takeda Pharmaceutical Co. Ltd.’s Adzynma for treating a rare blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme, the company has won two approvals in two days after the FDA approved fruquintinib a day earlier.
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US Senate patent reform bill draws mixed reviews

Nov. 14, 2023
By Mark McCarty
The America Invents Act of 2011 was designed to provide a durable overhaul of the U.S. patent system, but the inter partes review process has drawn fire from inventors as a patent-killing machine.
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Regulatory actions for Nov. 14, 2023

Nov. 14, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biocardia, Brixton, Lunit, Mednition, Vyspine.
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2023 Artificial Intelligence Summit

Artificial intelligence concerns resist regulatory quick fixes

Nov. 14, 2023
By Mark McCarty
In the following years, 2023 may come to be seen in medical device circles as the year of artificial intelligence (AI), but that doesn’t mean that 2023 will be seen as the year of regulatory clarity for AI.
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Mednition Cerner Sepsis

Day Zero, Oxford Nanopore count down to quickest yet sepsis ID

Nov. 14, 2023
By Annette Boyle
Day Zero Diagnostics Inc. and Oxford Nanopore Technologies plc (ONT) joined forces to battle the leading cause of death in hospitals — sepsis. Combining Day Zero’s whole genome sequencing technology for pathogen identification and antimicrobial susceptibility analysis with Oxford’s nanopore-based molecular sensing technology, the companies aim to develop a diagnostic system that provides potentially life-saving identification and guidance on antimicrobial selection in mere hours.
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Ocular

Inflammasome Therapeutics’ inflammasome inhibitor cleared to enter clinic for geographic atrophy

Nov. 14, 2023
Inflammasome Therapeutics Inc. has received FDA clearance to begin a phase I/II trial of the company’s inflammasome inhibitor for the treatment of geographic atrophy, the most severe form of dry age-related macular degeneration. This is the first clinical trial of an inflammasome inhibitor to treat geographic atrophy. The company’s sustained-release implant contains the first of a new class of inflammasome inhibitor drugs, Kamuvudines, developed by the company and designed to halt the multiple processes that cause geographic atrophy.
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Olympus voluntarily recalls bronchoscopes over airway burn concern

Nov. 13, 2023
By Mark McCarty
Olympus Corp., of Center Valley, Pa., reported Nov. 9 a voluntary field corrective action for bronchoscopes prompted by complaints of endobronchial combustion during procedures that involve the use of high-frequency (HF) therapy equipment.
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