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Home » Topics » Regulatory

Regulatory
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Rare ALS drug could win adcom despite phase III stumble

March 20, 2023
By Lee Landenberger
Despite a failed phase III study, the U.S. FDA suggests in briefing documents that tofersen (BIIB-067) is effective for treating the rare, genetic disease superoxide dismutase 1 amyotrophic lateral sclerosis (ALS). The intrathecally injected therapy is being developing by Biogen Inc. and Ionis Pharmaceuticals Inc. and is at the heart of a March 22 meeting of the agency’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom).
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Regulatory actions for March 20, 2023

March 20, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ipsen, Kuria, Likang, Novartis, Pfizer, Sarepta.
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Elekta Unity software on computer screen

FDA clears major upgrade to Elekta’s MR-Linac system

March 17, 2023
By David Godkin
Elekta AB received U.S. FDA clearance for what it called a “groundbreaking upgrade” of its MR-Linac platform which can continuously calculate the movement of a tumor anywhere in the body. The company said the Elekta Unity’s comprehensive motion management platform provides clinicians with enhanced, adaptive radiation therapy workflow to track moving organs such as the prostate, liver and pancreas.
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Medtronic - Affera Mapping and Ablation System

Medtronic wins CE mark for Affera dual-use cardiac ablation system

March 17, 2023
By Meg Bryant
Medtronic plc has scored a CE mark for its Affera mapping and ablation system for atrial arrhythmias, mere months after acquiring the technology from cardiac solutions company Affera Inc. The dual-use system, which includes the Sphere-9 catheter and Affera Prism-1 mapping software, will be available in Europe beginning in the first half of 2023.
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Regulatory actions for March 17, 2023

March 17, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbisko, Clearmind, Everest, Glenmark.
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DNA in drug capsules

Oh drat, OTAT: FDA’s turnaround on adcom for DMD prospect clips Sarepta shares

March 17, 2023
By Randy Osborne
Sarepta Therapeutics Inc. CEO Doug Ingram said the U.S. FDA has promised to schedule “expeditiously” an advisory committee meeting on the BLA related to SRP-9001 (delandistrogene moxeparvovec) for Duchenne muscular dystrophy (DMD).
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Regulatory actions for March 16, 2023

March 16, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accelus.
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Paxlovid

Adcom gives thumbs up to Paxlovid, counters rebound myth

March 16, 2023
By Mari Serebrov
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
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Regulatory actions for March 16, 2023

March 16, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Argenx, Biontech, Bioprojet, Cognition, Deciphera, Edesa, Pfizer, Skye.
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Woven Omend implant

Woven Orthopedic FDA clearance for Ogmend implant ‘game changing’ for spine surgery

March 15, 2023
By Shani Alexander
Woven Orthopedic Technologies LLC, received U.S. FDA 510(k) clearance for its Ogmend implant enhancement system for use in spine surgery. Ogmend is expected to give surgeons more confidence in using surgical screws when operating in compromised fixation scenarios.
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