Formulation Development
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,…
uniQure to Acquire Corlieve Therapeutics & Advance its Gene Therapy Program to Treat Temporal Lobe Epilepsy (TLE)
uniQure N.V. recently announced it has entered into a definitive agreement to acquire Corlieve Therapeutics and its lead program, which will be known as….
vTv Therapeutics & Cantex Pharmaceuticals Announce Strategic Licensing Agreement for Development & Commercialization of Cancer Treatment
vTv Therapeutics Inc. and Cantex Pharmaceuticals, Inc. recently announced they have entered into a licensing agreement under which Cantex has obtained exclusive worldwide rights to….
Vectura Signs Preclinical Development Agreement With Incannex
Vectura Group plc recently announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide preclinical development services for….
Syneos Health Accelerates Decentralized Clinical Trial Delivery, Unveils New Collaboration With Site Sponsors
Syneos Health recently expanded its Decentralized Clinical Trial capabilities to include a dedicated Decentralized Clinical Trials Site Advocacy Group, continuing the momentum for….
Processa Pharmaceuticals Enters Licensing & Development Agreement With Ocuphire Pharma
Processa Pharmaceuticals, Inc. recently announced it has entered into a licensing agreement with Ocuphire Pharma, Inc. to license in RX-3117. RX-3117 is an oral, anticancer…
Onconova Therapeutics Announces Preclinical Data Demonstrating the Synergistic Anti-Cancer Activity of Rigosertib Combined With Immune Checkpoint Blockade
Onconova Therapeutics, Inc. recently announced the publication of a preclinical study in the journal Molecular Cancer. The study, titled Novel Induction of CD40 Expression by…
BioNTech Announces First Patient Dosed in Phase 2 Clinical Trial of mRNA-Based BNT111 in Patients With Advanced Melanoma
BioNTech SE recently announced the first patient has been treated in its BNT111 Phase 2 cancer vaccine trial (2020-002195-12; NCT04526899). The study is evaluating the…
Biogen Announces First Patient Dosed in Phase 3 Systemic Lupus Erythematosus Study
Biogen Inc. recently announced the first patient has been dosed in the global clinical study, TOPAZ-1. The Phase 3 study will evaluate the clinical efficacy…
Evonik & Stanford University Sign Research Collaboration: Evonik to Market & Develop New Drug Delivery Platform for mRNA & Gene Therapy
Evonik is working with Stanford University on a technology to deliver mRNA to tissues and organs that goes beyond the capabilities of lipid nanoparticles (LNPs)…..
Jounce Therapeutics Achieves First Milestone in Exclusive License Agreement With Gilead Sciences
Jounce Therapeutics, Inc. recently announced the US FDA clearance of its Investigational New Drug (IND) application for JTX-1811, an anti-CCR8 antibody, for which Gilead Sciences, Inc. has exclusive rights….
iTeos Therapeutics & GSK Announce Development & Commercialization Collaboration
iTeos Therapeutics and GlaxoSmithKline plc recently announced an agreement to co-develop and co-commercialize EOS-448, an anti-TIGIT monoclonal antibody currently in Phase 1 development as a….
