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Chinese flag, pills

China NMPA speeds up NDA reviews to encourage new drug development

March 11, 2022
By Doris Yu
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
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Regulatory actions for March 11, 2022

March 11, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Antengene, Atyr, Immutep, In3bio, Intellia, Pharmazz, Quoin, Samsung Bioepis, Selecta, Servier, TG, Tracon.
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Cloud/cybersecurity illustration

FDA says PTC Axeda software vulnerabilities affect wide range of medical devices

March 10, 2022
By Mark McCarty
The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit.
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TGA: More feedback needed on repurposing drugs

March 10, 2022
By Mari Serebrov
Given the challenges in repurposing medicines, Australia’s Therapeutics Goods Administration (TGA) opened a second consultation on the subject March 10.
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Quoin collecting EMA tips on NS path as efforts in other quarters roll on

March 10, 2022
By Randy Osborne
Quoin Pharmaceuticals Ltd.’s scientific advice briefing document is asking the EMA for ideas on how to proceed with lead asset QRX-003 for Netherton syndrome (NS).
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U.S. Capitol and $100 bills

US spending package, minus extra pandemic funds, in Senate hands

March 10, 2022
By Mari Serebrov
Disagreement over offsets for an additional $15.6 billion in COVID-19 funding forced the supplemental pandemic funds recently requested by the White House to be cut from the fiscal 2022 spending bill, so the U.S. House would have the votes to pass the $1.5 trillion omnibus spending package late March 9.
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Regulatory actions for March 10, 2022

March 10, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Neurologica.
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Regulatory actions for March 10, 2022

March 10, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Acadia, Altamira, Antengene, Bayer, Biomind, C4, Merck & Co., Orion.
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U.S. FDA headquarters

FDA, US industry eye doubling of user fees for fifth device user fee agreement

March 9, 2022
By Mark McCarty
The FDA and device makers have finally wrapped up what may be the most contentious set of negotiations in the history of the device user fee program. Despite industrial antipathy to a recurrent doubling of user fee volumes, the fifth device user fee deal will provide the FDA with as much as $1.9 billion in user fees, roughly double the fees collected under the current agreement.
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Gloved hand holding Veros COVID-19 device

Sense Biodetection sets sights on Europe after CE mark approval

March 9, 2022
By Catherine Longworth
Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.
Read More
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