Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Beigene, Hoth, Immunome, Oncternal, Orion, SGC Cell Therapy, Valneva.
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.
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 drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 7 Hills, Acadia, Altamira, Antengene, Bayer, Biomind, C4, Merck & Co., Orion.
With the pandemic lingering across the world and more COVID-19 therapies becoming available and in demand, the opportunity for counterfeits is growing.
After more than 50 years of trying, the U.S. FDA is finally withdrawing approval of Potaba (potassium aminobenzoate) tablets, capsules, powder, and other forms as well as any identical, related or similar products.
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