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BioWorld - Wednesday, July 6, 2022
Home » Topics » Regulatory

Regulatory
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FDA unilaterally proposes to down-classify 2 device types for detection of melanoma

June 29, 2022
By Mark McCarty
No Comments
The U.S. FDA reported a proposed down-classification for two device types intended for detection of melanoma, a move that would ease the premarket path for similar devices. The agency noted that it has received only one PMA application each for optical diagnostic devices and electrical impedance spectrometers, which suggests the agency sees these device types as suffering for want of interest on the part of device makers.
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Ipsen shares move higher after US FDA refile for ultra-rare disease drug palovarotene

June 29, 2022
By Richard Staines
No Comments

Shares in Ipsen SA edged higher June 29 after the firm announced it had refiled its palovarotene NDA with the U.S. FDA for the ultra-rare disease fibrodysplasia ossificans progressiva. The regulator granted a six-month priority review for the drug, which was once written off and had its FDA filing pulled in 2021 after officials asked for further analyses and data.


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Novavax-COVID-19-vaccine-vial

Novavax vaccine shows its chops

June 29, 2022
By Mari Serebrov
No Comments
Given that Novavax Inc.’s COVID-19 vaccine will be a latecomer to the U.S. scene if it gets FDA authorization, it’s been cast in a supporting role to the lead being played by the mRNA vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE. But the data presented at the June 28 Vaccines and Related Biologic Products Advisory Committee meeting suggest the Novavax adjuvanted protein vaccine may have the chops to take on a larger role in taming the pandemic.
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Regulatory actions for June 29, 2022

June 29, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Moleculight, Seegene.
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Regulatory actions for June 29, 2022

June 29, 2022
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bavarian Nordic, Gilead, Kite, MRM, Sanofi, Schrödinger, Soligenix, Verrica.
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Stroke illustration: brain, artery, neurons

Duo of Peijia catheters approved in China for neurointerventional surgery

June 28, 2022
By Doris Yu
No Comments
Peijia Medical Ltd. has received two marketing approvals from China’s NMPA for its catheters to be used in neurointerventional surgery. They are the balloon guide catheter (BGC) Fluxcap and delivery balloon dilation catheter Fastunnel. Both were developed by Peijia’s wholly owned subsidiary Achieva Medical Ltd.
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3D illustration of heart cross section

Acutus stock jumps following expanded FDA clearance

June 28, 2022
By Catherine Longworth
No Comments
Shares in Acutus Medical Inc. (NASDAQ:AFIB) are trading 50% higher after the arrhythmia management company reported the launch of an expanded suite of its Acqcross left-heart access products. The Carlsbad, Calif.-based company received an expanded U.S. FDA clearance for its Acqcross Qx system for use with Natick, Mass.-based Boston Scientific Corp.’s Watchman left atrial appendage closure (LAAC) device.
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US FDA rejects Spero’s oral antibiotic tebipenem, demanding further trial

June 28, 2022
By Richard Staines
No Comments

Spero Therapeutics Inc.’s oral antibiotic, tebipenem Hbr, has been rejected by the U.S. FDA for adults with complicated urinary tract infection, after the regulator said a further trial is needed for approval.


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Coronavirus variants

VRBPAC leaves US FDA with plenty of decisions to make

June 28, 2022
By Mari Serebrov
No Comments
COVID-19 boosters for the fall should contain an omicron component, the FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) said June 28, voting 19-2 to make that recommendation.
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Regulatory actions for June 28, 2022

June 28, 2022
No Comments
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Seno Medical, Varian.
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