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Regulatory
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Regulatory actions for Feb. 22, 2022

Feb. 22, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Biomarin, Dizal, Novavax, Ose, Transthera, UCB, Veloxis.
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Toy bulldozer moving FDA letter blocks

FDA provides five more device classifications via de novo petition

Feb. 18, 2022
By Mark McCarty
The FDA’s device center has long been at the task of reclassifying legacy devices that promise a moderate degree of risk, but successful de novo device applications also call for a class II listing. The agency recently posted five such risk classifications, including for a device developed by Edwards Lifesciences Corp., of Irvine, Calif.
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EMA icons

EMA: Increase in NCEs approved amid overall drop for 2021 and continued COVID-19 pressure

Feb. 18, 2022
By Nuala Moran
LONDON – Two years into the pandemic and the number of new drugs approved by the EMA fell from 97 approvals in 2020 to 92 in 2021. But both years are still well up on pre-COVID-19 times in 2019 when 66 products got the nod, according to the EMA’s annual human medicines report.
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Red blood cells

Agios’ pivot from oncology leads to an FDA approval in rare disease

Feb. 18, 2022
By Lee Landenberger
The FDA’s approval of Agios Therapeutics Inc.’s Pyrukynd (mitapivat) for treating hemolytic anemia marks a turnaround from nearly a year ago. That’s when Agios sold its commercial, clinical and research-stage oncology portfolio to privately held Servier Pharmaceuticals LLC to concentrate on rare diseases.
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Regulatory actions for Feb. 18, 2022

Feb. 18, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avita Medical, Medtronic, Ra Medical Systems.
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US FDA targets remdesivir with product-specific guidance

Feb. 18, 2022
By Mari Serebrov
As part of its ongoing effort to speed drug pricing competition in the U.S. through the development of generics, the FDA is releasing another batch of draft and revised draft product-specific guidances on the design of bioequivalence studies to support abbreviated new drug applications. Among the 30 new draft guidances is one specific to remdesivir, which was approved in October 2020 as a COVID-19 treatment.
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Reichstag, German parliament building in Berlin

European Besremi legal tussle continues

Feb. 18, 2022
By Mari Serebrov
In the latest chapter in an ongoing contract dispute between AOP Orphan Pharmaceuticals GmbH and Pharmaessentia Corp., the German Federal Court of Justice this week set aside the €143 million (US$162.8 million) in damages awarded to AOP, citing procedural flaws in quantifying the product supply and damages.
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Regulatory actions for Feb. 18, 2022

Feb. 18, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, AN2, Astrazeneca, Beigene, BMS, Cstone, Epygenix, Immune-Onc, Kato, Lupin, Moderna, Poxel, Sanofi, Valbiotis, Zai Lab.
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Hand holding FDA blocks

FDA revamp of QSR picks up steam with scheduling of advisory hearing

Feb. 17, 2022
By Mark McCarty
The FDA’s device center has been eyeing an overhaul of its Quality System Regulation (QSR) for several years, and the latest development is the scheduling of a March 2 advisory committee hearing to review the proposal. The default assumption is that the agency will post the draft rule prior to the hearing, although the routine two-day window for reviewing FDA meeting materials prior to an advisory hearing might leave stakeholders with insufficient time to examine the agency’s proposal.
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Flag of India

India’s health care industries receive mixed messages from authorities

Feb. 17, 2022
By David Ho
India’s health care industry stakeholders have been left scratching their head as authorities, who have championed self-reliance and increased supplies, provided mixed signals in recent notices.
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