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BEIJING, SHANGHAI and BOSTON, Mass. — Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor...
BEIJING, China and SAN FRANCISCO, Calif. — Jacobio Pharmaceuticals, a clinical-stage oncology company focusing on undruggable targets, announced data of glecirasib in patients with pancreatic cancer and other solid tumors in the oral abstract session at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (“2024 ASCO GI”). As...
LAKE FOREST, Ill. — Jaguar Gene Therapy a biotechnology company accelerating breakthroughs in gene therapy for patients suffering from severe genetic diseases, including those that affect sizeable patient populations, today announced the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) Application for JAG201, a...
As announced, initial proof-of-concept (POC) results from distinct ongoing investigator-initiated trial (IIT) in Abu Dhabi show crofelemer reduced total parenteral support in a pediatric MVID patient with intestinal failure by up to 27%; per the IIT protocol, patient was taken off crofelemer after 12 weeks of treatment for a period of...
CAMBRIDGE, Mass. — Biogen Inc. (Nasdaq: BIIB) – today announced that The Journal of the American Medical Association (JAMA) Neurology has published final results from the completed Phase 3 VALOR study and its open-label extension (OLE) study evaluating QALSODY® (tofersen) for the treatment of superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS) with over...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson announced overall survival (OS) results from the Phase 3 MAIA (NCT02252172) study showing the addition of DARZALEX® ▼(daratumumab) to lenalidomide and dexamethasone (D-Rd) resulted in a statistically significant survival benefit over lenalidomide and dexamethasone (Rd) alone in patients with newly...
The Food and Drug Administration (FDA) has updated the fact sheet for the Janssen COVID-19 vaccine to include information related to the potential increased risk of developing Guillain-Barré syndrome. Guillain-Barré syndrome is a rare neurological disorder in which the body’s immune system damages nerve cells causing muscle weakness and sometimes...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that new data for ciltacabtagene autoleucel (cilta-cel), an investigational B-cell maturation antigen (BCMA)-directed CAR-T therapy, demonstrated sustained efficacy and durable responses in heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM).[1] Updated results from the Phase 1b/2 CARTITUDE-1...
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of...