Formulation Development
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….
Veru Announces the Presentation of a Phase 1b/2 Clinical Study Update for Sabizabulin
Veru Inc. recently announced updated clinical results from the ongoing Phase 1b/2 clinical study of sabizabulin (VERU-111), an oral cytoskeleton disruptor being evaluated for the…
Onconova Therapeutics Provides Update on the Phase 1/2a Trial of Rigosertib-Nivolumab Combination in KRAS+ Non-Small Cell Lung Cancer
Onconova Therapeutics, Inc. recently announced an update on the investigator-initiated Phase 1/2a trial of oral rigosertib plus nivolumab in advanced metastatic KRAS mutated (KRAS+) non-small…
H-CYTE Announces Publication of Positive Real-World Data Relating to the Use of Innovative Treatment to Improve Overall Lung Health
H-CYTE, Inc. recently announced the publication of its clinical observational study titled, Longitudinal Assessment of FEV1 Change Following Autologous Cellular Therapy. The study, published in…
Denali Therapeutics Announces Initiation of Phase 2 Study by Partner Sanofi
Denali Therapeutics Inc. recently announced its partner Sanofi has commenced dosing in a Phase 2 study of DNL758 (SAR443122), a peripherally-restricted small molecule inhibitor of…
Catalyst Biosciences Receives FDA Fast Track Designation for Subcutaneous MarzAA for the Treatment of Episodic Bleeding in Factor VII Deficiency
Catalyst Biosciences, Inc. recently announced the US FDA has granted Fast Track Designation for Marzeptacog alfa (activated), MarzAA, the company’s subcutaneously (SQ) administered next-generation engineered…
Idorsia Ltd Announces the Initiation of Phase 3 Registration Study of Antithrombotic Treatment for Use at the Onset of AMI Symptoms
Idorsia Ltd recently announced the initiation of the Phase 3 registration study “SOS-AMI” to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12…
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….
Prothena Announces Bristol Myers Squibb Opt-In of Anti-Tau PRX005 as the First Program From Global Neuroscience Research & Development Collaboration
Prothena Corporation plc recently announced Bristol Myers Squibb exercised its option under the global neuroscience research and development collaboration to enter into an exclusive US license for….
Hyloris Successfully Renegotiates License Agreements for Lead Products With the Alter Pharma Group
Hyloris Pharmaceuticals SA recently announced that it has successfully renegotiated and unwound its earlier license agreements with the Alter Pharma Group. Hyloris will pay the…
VectivBio Receives FDA Orphan Drug Designation for Apraglutide for Acute Graft-Versus-Host Disease
VectivBio Holding AG recently announced the FDA has granted orphan drug designation to apraglutide, a next-generation, long-acting GLP-2 analog being developed for rare gastrointestinal (GI)…
Kura Oncology Doses First Patient in Phase 1b Expansion Cohorts With Menin Inhibitor KO-539
Kura Oncology, Inc. recently announced the first patient has been dosed in the Phase 1b portion of KOMET-001, a Phase 1/2 clinical trial of the…
Corbus Pharmaceuticals Announces Topline Results from DETERMINE Phase 3 Study of Lenabasum for Treatment of Dermatomyositis
Corbus Pharmaceuticals Holdings, Inc. recently announced topline results from the Phase 3 DETERMINE study of lenabasum in adults with the rare, heterogeneous, autoimmune disease dermatomyositis.…
CHMP Recommends Approval of RINVOQ (upadacitinib) for the Treatment of Atopic Dermatitis
AbbVie recently announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of RINVOQ…
Aravive Announces Positive Initial Results from Phase 1b Portion of the Phase1b/2 Study of AVB-500 in Combination With Cabozantinib in Clear Cell Renal Carcinoma
Aravive Inc. recently announced positive initial results from the Phase 1b portion of its Phase 1b/2 study in patients dosed with 15 mg/kg of AVB-500…
Genezen Breaks Ground on cGMP Lentiviral Vector Production Facility
Genezen Laboratories, Inc., a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) focused on early-phase process development, vector production, and analytical testing services,…
