New York-based Avenue Therapeutics Inc. took receipt from the FDA of a surprise complete response letter (CRL) – characterized by Wainwright analyst Joseph Pantginis as “bizarre” – with regard to the NDA for intravenous (I.V.) tramadol in acute pain.
HONG KONG – South Korea’s Ministry of Food and Drug Safety (MFDS) has approved an additional indication for CT-P59, Incheon-based Celltrion Inc.’s anti-COVID-19 monoclonal antibody.
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alexion, Avenue, Astrazeneca, Celltrion, Gannex, Immunomedics, Oncopeptides, Oxular.
The regulatory path for Saniona AB’s Tesomet for treating two rare eating disorders, Prader-Willi syndrome (PWS) and hypothalamic obesity, continues to be a winding one with surprises along the way. The newest twist is pre-IND feedback from the FDA that knocked the stock down 10.5% on Oct. 9.
Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Axovant, Foresee, Innovent, Italfarmaco, Saniona.
The latest global regulatory news, changes and updates affecting biopharma, including: Health Canada explains COVID-19 disclosures; TGA on changing sponsor details; FDA awards research grants for rare diseases; Se habla español.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cerecin, Eton, Neurocrine, Regeneron, Revelation, Rhythm AI, X4, Xenon, Xortx.
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