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Home Drug Discovery Drug Discovery Research & Development Pre-clinical Studies Research & Development PharmaLogic launches new radiopharmaceutical facility in New York, US Research & Development Manufacturing Latus Bio secures $54m for CNS gene therapy development Research & Development Clinical Trials Clinical Trials Patient Enrollment Human Trials Patient Enrollment US FDA approves Avacta Group’s IND application for AVA6000 Clinical Trials Patient Enrollment AM-Pharma enrols first patients in Covid-19 phase III trial Clinical Trials Patient Enrollment Regulation Regulation Drug Filing Approvals Rejections Marketing Authorisation Patents Lawsuits Drug Filing FDA accepts BLA for BMS’ subcutaneous nivolumab to treat solid tumours Drug Filing Oncology USFDA accepts NextPoint Therapeutics’s IND for NPX887 Drug Filing Production & Sales Production & Sales Manufacturing Launches Recalls Marketing & Sales Manufacturing PharmaLogic launches new radiopharmaceutical facility in New York, US Research & Development Manufacturing IMA Life to build new pharma freeze-drying equipment production site Manufacturing Pharmaceuticals and Healthcare Packaging & Supply Chain Packaging & Supply Chain Packaging Cold Chain Distribution Storage Packaging Gerresheimer Packaging PCI Pharma announces bottling line expansion at Rockford site Packaging & Supply Chain Packaging Suppliers Suppliers A-Z Suppliers Products & Services Videos White Papers No data found EventsRegister Log In Clinical Trials 10 May 2024 Drug Discovery Clinical Trials Metabolic Disorders Aardvark Therapeutics secures $85m in Series C funding round By PBR Staff Writer Aardvark Therapeutics has secured $85m in an oversubscribed Series C financing round, with Decheng Capital spearheading the investment, to complete studies of ARD-101. 22 Apr 2024 Clinical Trials Approvals Merck’s PREVYMIS gets Health Canada’s approval for CMV disease prevention By PBR Staff Writer Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients. 11 Apr 2024 Research & Development Clinical Trials Oncology TORL BioTherapeutics secures $158m for oncology pipeline development By PBR Staff Writer Clinical-stage biotechnology company TORL BioTherapeutics has announced the closure of an oversubscribed $158m Series B-2 financing round. 02 Apr 2024 Approvals Human Trials Solid Biosciences’ SGT-003 receives rare pediatric disease designation By PBR Staff Writer Solid Biosciences has received the US Food and Drug Administration’s (FDA) rare pediatric disease designation for its gene therapy candidate for Duchenne muscular dystrophy (Duchenne), SGT-003. 07 Feb 2024 Clinical Trials Drug Discovery Research & Development NIH grants $9m for nicotine cessation drug development By PBR Staff Writer The US National Institutes of Health (NIH) unit National Institute on Drug Abuse (NIDA) has granted an award of $9m for researchers to advance drug, SBP-9330, to treat nicotine addiction. 05 Dec 2023 Clinical Trials China NMPA accepts Everest Medicines’ IND application for zetomipzomib By PBR Staff Writer The China National Medical Products Administration (NMPA) has accepted Everest Medicines’ investigational new drug (IND) application for its selective immunoproteasome inhibitor, zetomipzomib. 29 Sep 2023 Regulation Clinical Trials Merck gains FDA priority review for sotatercept BLA By PBR Staff Writer The US Food and Drug Administration (FDA) has accepted Merck’s (MSD) biologics license application (BLA) of sotatercept to treat pulmonary arterial hypertension [PAH (WHO Group 1)], for priority review. 05 Jul 2023 Regulation Clinical Trials Taiho’s LYTGOBI tablets receive European Commission marketing authorisation By PBR Staff Writer Taiho Pharmaceutical and its subsidiary Taiho Oncology Europe have received conditional marketing authorisation from the European Commission for LYTGOBI (futibatinib) tablets to treat adults with cholangiocarcinoma (CCA). 04 Jul 2023 Clinical Trials Regulation FDA grants IND clearance for Phase I/IIa trial of Skyline’s SKG0106 By PBR Staff Writer The US Food and Drug Administration (FDA) has granted clearance for Skyline Therapeutics’ investigational new drug (IND) application for Phase I/IIa clinical trial of gene therapy SKG0106 to treat neovascular age-related macular degeneration (nAMD). 26 May 2023 Clinical Trials VarmX raises funds to seek IND approval for VMX-C001 By PBR Staff Writer Biotechnology company VarmX has raised an additional €30m in a Series B2 financing round to obtain investigational new drug (IND) approval for its lead compound VMX-C001.Advertise with us Contact us PRIVACY POLICY TERMS AND CONDITIONS © PBR 2024. 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