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LEXEO Therapeutics Receives Rare Pediatric Disease Designation & Orphan Drug Designation
LEXEO Therapeutics recently announced the US FDA has granted Rare Pediatric Disease designation and Orphan Drug designation to LX2006 for the treatment of….
InMed Pharmaceuticals Signs Non-Binding Letter of Intent to Acquire BayMedica, a Commercial Manufacturer of Rare Cannabinoids
InMed Pharmaceuticals Inc. recently announced it has entered into a non-binding letter of intent to acquire BayMedica Inc., a private company based in Nevada and California that specializes in the manufacture and commercialization of….
eTheRNA immunotherapies & Quantoom Biosciences Announce Strategic Collaboration for the Development of a Novel RNA Production
eTheRNA immunotherapies NV and Quantoom Biosciences S.A. recently announced they are to collaborate on the development of a revolutionary RNA production system (RPS) for both research and GMP-grade material…..
Lonza Invests to Expand Mid-Scale Small Molecule Production Capacity, HPAPI Production at Nansha, China, Facility
To help pharma and biotech companies scale up production rapidly and effectively, Swiss CDMO Lonza recently announced an investment of CHF 20 million to bring flexible, mid-scale manufacturing capabilities to its API….
Crinetics Pharmaceuticals Announces Dosing of First Patient in Phase 3 PATHFNDR-1 Study
Crinetics Pharmaceuticals, Inc. recently announced the randomization of the first acromegaly patient in its Phase 3 clinical trial of paltusotine, PATHFNDR-1. This trial will be one of two planned Phase 3 studies assessing….
Roquette Boosts Customer Support With New Digital Pharma Marketplace
Roquette recently announced the opening of its new pharma online marketplace, powered by Knowde. The e-commerce platform will provide users….
Agios Submits MAA to EMA for Mitapivat for Treatment of Adults With Pyruvate Kinase Deficiency
Agios Pharmaceuticals, Inc. recently announced it has submitted a Marketing Authorization Application (MAA) for mitapivat to the European Medicines Agency (EMA) for the treatment of adults with pyruvate kinase….
Catalent to Acquire RheinCell Therapeutics, Strengthening a Path Toward Industrialization of Induced Pluripotent Stem Cell-Based Therapies
Catalent recently announced it has reached an agreement to acquire RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs)…..
Viking Therapeutics Announces Initiation of Phase 1b Clinical Trial of VK0214 in Patients With X-ALD
Viking Therapeutics, Inc. recently announced the initiation of a Phase 1b clinical trial of VK0214, a novel small molecule agonist of the thyroid hormone receptor beta (TRb), in patients with X-linked….
Fulcrum Therapeutics Announces Results from ReDUX4 Trial With Losmapimod in Facioscapulohumeral Muscular Dystrophy Demonstrating Slowed Disease Progression & Improved Function
Fulcrum Therapeutics, Inc. recently announced results from the company’s Phase 2b trial, ReDUX4, in people with facioscapulohumeral muscular dystrophy (FSHD). Results being presented with….
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Bespak & H&T Presspart Enter Collaboration Agreement to Advance Transition to Low GWP Propellants in pMDIs
Partnership will provide GMP filling capabilities and development support for clinical trial programs with low GWP propellants….
PCI Pharma Services Begins Installation of Sterile Fill-Finish & Lyophilization Line as Part of $100-M New Facility Expansion
PCI Pharma Services has begun installation of key equipment for its newest sterile fill-finish facility on the company’s Bedford, NH campus. Twin lyophilizers and a state-of-the-art large-scale isolator….
Medigene AG Expands Patent Portfolio With Patent Grant for its Targeted T Cell Receptor
Medigene AG recently announced it has been issued a patent by the European Patent Office protecting its T cell receptor (TCR) targeting NY-ESO-1….
Altamira Therapeutics Announces Filing of Provisional Patent Application for OligoPhore Nanoparticles With siRNA Targeting p65 Protein in Treatment of Cancer & Inflammation
Altamira Therapeutics Ltd. recently announced it has filed a provisional patent application with the United States Patent Office (USPTO) which covers nanoparticles comprising the….
Adare Expands Global High Potency Handling & Packaging Capabilities
Adare Pharma Solutions, a global technology-driven CDMO specializing in oral dosage forms, recently announced expansions of its high potency handling capabilities in the….