Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Chemocentryx, Emmaus, Engene, Enlivex, Galapagos, Gensight, Gilead, Nanomab, Vifor Fresenius.
PERTH, Australia – With the approval of cystic fibrosis treatment Bronchitol (mannitol), Sydney-based Pharmaxis Ltd. joins a small group of elite Australian biotech companies to take their drugs all the way to FDA approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CSL, DBV, Chiesi, Imugene, Innocare, Innovation, Janssen, Neuraly, Pharmaxis, Polarityte, Poseida, Provention, Roche, Senhwa, Taigen.
The latest global regulatory news, changes and updates affecting biopharma, including: Canada prepares for resurgence of COVID-19 shortages; Russia sets drug pricing structure.
PERTH, Australia – Clinuvel Pharmaceuticals Ltd. announced two new pharmaceutical indications for its lead product, Scenesse (afamelanotide). “The company has until now focused on one drug and has slowly gathered evidence and is now in a position to add other products to its pipeline,” Clinuvel CEO Philippe Wolgen told BioWorld.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Avrobio, Biocryst, Biogen, Cerecin, Equillium, Nexus, Novartis, Novo Nordisk, Regeneron, União Química, Trevena.
Shares of Tricida Inc. (NASDAQ:TCDA) fell 47.2% to $4.37 on Oct. 29 after the company said the FDA would require data on how veverimer, its investigational therapy for metabolic acidosis in patients with chronic kidney disease (CKD), impacts CKD progression to support an accelerated approval. The news followed a complete response letter that met the NDA in August.
If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.
The latest global regulatory news, changes and updates affecting biopharma, including: NIH lays out final policy on data sharing; NICE to review Spinraza data; Olinvyk a Schedule II; FDA issues REMS MAPP.
RSS
