Basel, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) today announced that its collaborator MediLink released interim results from the randomised phase III TAISHAN-302 trial evaluating Tam-Peli (tambotatug pelitecan, YL201) versus topotecan in Chinese patients with relapsed small-cell lung cancer (SCLC) who progressed after prior platinum-based chemotherapy with or without...
treatment News
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options 1 First Phase III study in ES-SCLC first-line maintenance to demonstrate clinically meaningful improvements in both progression-free and overall survival 2,3 Data...
Basel, Switzerland – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new two-year data from the Phase IIIb/IV SALWEEN study of Vabysmo® (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society (APVRS) Congress in Australia.1 The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe...
CRANBURY, N.J. – Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for KRESLADI™ (marnetegragene autotemcel), an autologous hematopoietic stem cell-based gene...
CRANBURY, N.J. — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s pivotal Phase 2 trial of...
CRANBURY, N.J. — Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for KRESLADI™ (marnetegragene...
BASEL, Switzerland, LONDON, UK, NEW YORK, NY and DURHAM, N.C. — Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM). On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2...
NORTH CHICAGO, Ill. — BLR Bio, a biotechnology company in Rosalind Franklin University’s Helix 51 incubator, announced new data on its novel therapy for systemic sclerosis and lung fibrosis at the British Society for Rheumatology (BSR) Annual Conference this week in Manchester, UK. Interstitial Lung Disease (ILD) is a devastating disorder, encompassing a group of chronic lung...
EDINBURGH, Scotland — RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal diseases, today announced a strategic manufacturing partnership to support the development of BOOST Pharma’s cell therapy, BT-101, for...
SAN FRANCISCO, Calif. — FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant...