Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
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.
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.
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.
Given the challenges in repurposing medicines, Australia’s Therapeutics Goods Administration (TGA) opened a second consultation on the subject March 10.
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).
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Insightec, Neurologica.
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.
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.