European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Zolbetuximab


Hitesh

Astella Pharma Inc. announced that the European Medicines Agency (EMA) has accepted regulatory review of the company’s Marketing Authorization (MA) Application for zolbetuximab, an experimental first-class monoclonal antibody targeting Claudin 18.2 (CLDN18.2), for the first-line treatment of patients with locally advanced, unresectable or metastatic gastric or esophageal adenocarcinoma (GEJ) whose […]

KSQ Therapeutics Enters Worldwide License Agreement with Roche for KSQ-4279, a Clinical-Stage USP1 Inhibitor for Cancer


Hitesh

KSQ Therapeutics, Inc., a clinical-stage biotechnology company developing cancer therapies using its proprietary CRISRomics® discovery platform, today announced that it has entered into a worldwide licensing and partnership agreement with Roche to develop and commercialize the KSQ-4279. KSQ-4279 is a selective, potent, first-class small molecule inhibitor of USP1, a protein […]

Cotiviti Introduces Prepay Claim Review Solution for Coordination of Benefits (COB) Validation


Hitesh

Cotiviti, a leader in data-driven healthcare solutions, is expanding its end-to-end Coordination of Interest (COB) solution by adding the potential COB authentication capabilities. This comprehensive service allows health plans to reduce overpayments by reviewing claims and determining payment liability after arbitration but before payment, making it the ultimate service provider. […]

BrainTale Has Presented at the European Academy of Neurology and the World Parkinson Congress the Interest of Its Digital Biomarker Platform for the Early and Differential Diagnosis of Parkinson’s Disease


Hitesh

BrainTale, a medtech deciphering white matter to enable better brain care, spin-off of the Paris Region Greater Hospitals, presented preliminary results during the European Academy of Neurology (Budapest, July 1 – 4, 2023) and the World Parkinson congress (Barcelona, July 4 – 7, 2023) demonstrating the interest of its digital […]

Amneal Launches Authorized Generic for Xyrem® (sodium oxybate) and Receives FDA Approval for Five Complex Generics in the Second Quarter


Hitesh

Amneal Pharmaceuticals, Inc. announced the launch of its authorized generic for Xyrem®1 oral solution CIII in the United States. Sodium Oxybate oral solution, 0.5 g/mL is a central nervous system depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients seven years of age and older with […]

Aldeyra Therapeutics Announces Improvement from Baseline in Retinal Function in Phase 2 Clinical Trial of ADX‑2191 in Patients with Retinitis Pigmentosa


Hitesh

Aldeyra Therapeutics, Inc., a biotechnology company dedicated to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced overall positive results from Phase 2 clinical trial of ADX Intravitreal -2191 (methotrexate injection, USP), an investigational drug candidate, in patients with retinitis pigmentosa. Compared to baseline, the clinical trial […]

Vertex and Lonza to Build Dedicated Manufacturing Facility for Type 1 Diabetes (T1D) Cell Therapies


Hitesh

Vertex Pharmaceutical Corporation and Lonza announced a strategic partnership to support the production of Vertex’s portfolio of radically different insulin-producing stem cell therapies for people with T1D, currently focusing on into the VX-880 and VX-264 programs currently in clinical trials. Vertex’s first clinical program, VX-880, demonstrated the clinical proof of concept. […]