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Regulatory
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Regulatory actions for April 12, 2022

April 12, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Aprinoia, Curis, Glenmark, Merck & Co., Priothera, Recursion, Scpharmaceuticals, Spectrum.
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Voqx digital stethoscope

FDA clears AI-infrasound smart stethoscope from Sanolla

April 12, 2022
By Catherine Longworth
Israeli startup Sanolla Ltd. won U.S. FDA 510(k) clearance for its smart-infrasound stethoscope Voqx. The artificial intelligence (AI)-based device is the first stethoscope cleared by the U.S. FDA to detect infrasound and audible information to identify clinical conditions. The auscultation capabilities are designed to support early assessment of cardiopulmonary conditions.
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Ossio suture anchor, composition illustration

Ossio suture anchors for shoulder repair get FDA thumbs up

April 11, 2022
By David Godkin
Ossio Inc. has received FDA clearance for Ossiofiber suture anchors used to fix soft tissue to bone in the shoulder, foot and ankle. This is the most recent of clearances for the company’s intelligent bone regeneration technology which began in 2019 as a possible alternative to permanent fixation implants for the foot and ankle alone.
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U.S. FDA headquarters

Scout Bx delivery system garners FDA clearance

April 11, 2022
By Annette Boyle
Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.
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EU flag, pills, syringe

Biopharmas aim to remedy access disparities across EU

April 11, 2022
By Mari Serebrov
The biopharma industry signed on to a new pledge to increase the availability of innovative drugs across the EU and shave months from the time patients in some EU member states must wait for access to new drugs. Members of the European Federation of Pharmaceutical Industries and Associations committed to file for pricing and reimbursement in all EU countries as soon as possible and no later than two years after receiving central EU market authorization – if local systems allow it.
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Regulatory actions for April 11, 2022

April 11, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Merit Medical, Sanolla, Truvic.
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Regulatory actions for April 11, 2022

April 11, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogen, Deinove, Gilead, Glaxosmithkline, Merck, Neurosigma, Novavax, Serum Institute.
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Elderly hands holding broken brain structure

‘Aduhelm’ of ship in AD drug access, CMS wrongly captain of patient choice?

April 8, 2022
By Randy Osborne
The release by the U.S. CMS of the final national coverage determination (NCD) for Biogen Inc.’s Alzheimer disease (AD) drug, Aduhelm (aducanumab), lit speculation on the meaning for others in the space. CMS is “still being conservative,” said Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “We’re in a new era. It’s unprecedented that Medicare doesn’t pay for a drug that received approval from the FDA,” even though it was not a full but an accelerated clearance.
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Regulatory actions for April 8, 2022

April 8, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adverum, Henlius, Ilias, Minerva, Regeneron, Sanofi, Triastek.
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Regulatory actions for April 8, 2022

April 8, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Seekin.


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