Imbrium Therapeutics L.P. (“Imbrium”), a subsidiary of Purdue Pharma L.P. (“Purdue”), has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) to evaluate sunobinop for the potential treatment of moderate to severe alcohol use…
Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company focused on developing innovative biologic therapeutics, announced today that it has received approval from the European Medicines Agency (EMA) to commence a Phase 1 clinical trial of JK06 in various solid tumors…
Amylyx Pharmaceuticals has received Orphan Drug Designation from the European Commission for AMX0035, its proprietary combination of sodium phenylbutyrate (PB) and taurursodiol (TURSO) for treating Wolfram syndrome. This designation follows a positive opinion from the Committee for Orphan Medicinal Products…
OS Therapies Announces Formation of Osteosarcoma Patient Advocacy Advisory Board OS Therapies, a biopharmaceutical company specializing in cancer immunotherapy and Antibody Drug Conjugates (ADCs), has announced the establishment of a Patient Advocacy Advisory Board (PAAB) for its osteosarcoma program. The…
Vertex Announces Q2 2024 Financial Results, Raises Full-Year Product Revenue Guidance Vertex today reported consolidated financial results for the second quarter ending June 30, 2024, and increased its full-year product revenue guidance to $10.65 to $10.85 billion. “Vertex achieved another…
Biogen, Beckman Coulter, and Fujirebio have announced a collaboration to identify and develop blood-based biomarkers for tau pathology in Alzheimer’s disease (AD). The goal is to create new tests that measure tau burden in the brain, offering crucial insights into…
Vertex Announces FDA Acceptance of Suzetrigine NDA for Acute Pain Vertex Pharmaceuticals today revealed that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for suzetrigine, an investigational oral NaV1.8 pain signal inhibitor designed to…
The interim analysis of the AMPLIFY Phase III trial revealed promising results for AstraZeneca’s Calquence (acalabrutinib) combined with venetoclax, with or without obinutuzumab, in treating chronic lymphocytic leukaemia (CLL). The study showed a significant improvement in progression-free survival (PFS) compared…
Novartis announced that the US Food and Drug Administration (FDA) has granted Priority Review status to Scemblix® (asciminib) for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). The FDA’s Priority…
Allergan Aesthetics is excited to announce the return of JUVÉDERM® Day on Wednesday, August 21. Following the success of its inaugural event, JUVÉDERM® Day offers limited-time deals, savings, and exclusive promotions through Allē, Allergan Aesthetics’ loyalty rewards program. “JUVÉDERM® Day…
Roche announced today the completion of its acquisition of LumiraDx’s Point-of-Care technology, following the necessary antitrust and regulatory approvals. The acquisition will see Roche integrate LumiraDx’s multi-assay point-of-care platform, along with its R&D, operational, and commercial sites, into Roche’s global…
Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on updating the Wegovy® (semaglutide 2.4 mg) label. This update reflects data from the SELECT cardiovascular outcomes…