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Regulatory
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Kidneys

Applaud Medical wins FDA breakthrough device designation for urinary stone device

Feb. 1, 2022
By Catherine Longworth
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
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Regulatory actions for Feb. 1, 2022

Feb. 1, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genetic Analysis.
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Australia hammers out new models to improve access to health innovations, streamline tech assessments

Feb. 1, 2022
By Tamra Sami
PERTH, Australia – A new parliamentary report, The New Frontier: Delivering better health for all Australians, is recommending significant reforms to the nation’s health care system to ensure Australians have faster access to new drugs and devices. The House of Representatives Standing Committee on Health, Aged Care and Sport examined the range of new drugs and emerging medical technologies that are in development and progressing through the regulatory system in Australia and in other countries.
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Gavel and stacks of coins

Australia’s TGA to increase industry fees to retain its cost recovery model

Feb. 1, 2022
By Tamra Sami
PERTH, Australia – Australia’s Therapeutic Good Administration (TGA) plans to increase all fees and charges to industry by 2.6% for the 2022 to 2023 financial year, and it is seeking feedback on proposed options.
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Gold chain link engraved with "partnership"

Japan keen to deepen regional partnerships, says PMDA head

Feb. 1, 2022
By Kohei Kanayasu
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region.
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North China Pharma wins NMPA approval for rabies exposure drug

Feb. 1, 2022
By Doris Yu
North China Pharmaceutical Group New Drug Research & Development Co. Ltd. has received approval from China’s NMPA to market ormutivimab as post-exposure treatment for the prevention of rabies.
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Russia preparing for WHO accreditation

Feb. 1, 2022
By Mari Serebrov
Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
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Will US FDA commissioner seat be filled any time soon?

Feb. 1, 2022
By Mari Serebrov
More than a year into U.S. President Joe Biden’s four-year term, the FDA commissioner seat remains open. While Robert Califf secured a critical endorsement Jan. 31 in his quest for a second term in the post, his hope for a sequel may still be up in the air.
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Payouts continue for Shkreli drug companies

Feb. 1, 2022
By Mari Serebrov
As part of a settlement in a class action suit, Vyera Pharmaceuticals LLC and its parent company, Phoenixus AG, of Baar, Switzerland, agreed last week to pay up to $28 million to a proposed class of third-party payers that covered Daraprim (pyrimethamine).
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Recent PI3K-delta troubles don’t deter confidence in drug class, says MEI Pharma CEO

Feb. 1, 2022
By Jennifer Boggs
Last week, Incyte Corp. said it was pulling its NDA seeking accelerated approval for the PI3K-delta inhibitor parsaclisib in three non-Hodgkin lymphoma subtypes, a move that followed recent decisions by Gilead Sciences Inc. and Secura Bio Inc. to withdraw from U.S. commercialization their respective PI3K-delta inhibitors in indications for which they’d received accelerated approval. But the recent spate of headlines is hardly “a condemnation” on the entire class of drugs, said Dan Gold, CEO of MEI Pharma Inc., which is aiming for a potential accelerated approval filing of its own PI3K-delta drug, zandelisib, this year.
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