HONG KONG — Akeso Inc. announced the China National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) of cadonilimab (开坦尼®, PD-1/CTLA-4 bispecific antibody, AK104) in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ)...
treatment News
TITUSVILLE, N.J. — Johnson & Johnson (NYSE:JNJ) announced today the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia. CAPLYTA® is the newest addition to Johnson & Johnson’s...
CAMBRIDGE, Mass. – Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for GSK4381562 (formerly SRF813) to proceed into a first-in-human clinical trial. GSK4381562 is a...
Ingelheim am Rhein, Germany – Boehringer Ingelheim today announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial [response difference: 64.8% (CI 51.1% – 78.6%), p<0.0001]. The trial met its...
SOUTH SAN FRANCISCO, Calif. — Sutro Biopharma, Inc (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that the randomized portion (Part 2) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), is now open for enrollment, and...
PHILADELPHIA – SwanBio Therapeutics, a gene therapy company advancing AAV-based therapies for the treatment of devastating, genetically defined neurological conditions, today announced the initiation of the CYGNET study with the enrollment of the first two participants. CYGNET is a natural history study of adrenomyeloneuropathy (AMN), a form of adrenoleukodystrophy (ALD)...
Zurich, Switzerland – Hydrogels have a variety of use cases, including contact lenses, delivering doses of medication within the body, moisturisers, water storage in soil, cleaning polluted water and as gelling and thickening agents. A hydrogel is a gel made of a type of plastic that can bind water. Researchers...
UXBRIDGE, England — Norgine, a leading European specialty pharmaceutical company, is pleased to announce that Swissmedic has approved the registration of IFINWIL® (eflornithine) as monotherapy for the treatment of paediatric patients from one year with high-risk neuroblastoma (HRNB)1. “This milestone marks a further regulatory approval of IFINWIL® for high-risk neuroblastoma, following approvals in the US, Israel and Australia,” said Jörg Plessl,...
By Raffaele Pereno – PhD, MBA AMSTERDAM, the Netherlands – SynaptixBio, a UK-based biopharmaceutical company pioneering antisense oligonucleotide (ASO) therapies for ultra-rare neurological diseases, presented its groundbreaking work on TUBB4A-related leukodystrophy (also known as H-ABC) at the World Orphan Drug Congress (WODC) in Amsterdam. CheckOrphan spoke with SynaptixBio’s CEO, Dan...
WALTHAM, Mass. — Syndax Pharmaceuticals Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced completion of enrollment in the AUGMENT-101 pivotal trial cohort of patients with relapsed/refractory (R/R) mutant nucleophosmin (mNPM1) acute myeloid leukemia (AML). Topline data is expected in the fourth...