MILAN – Italfarmaco Group announced today topline data from its proof-of-concept Phase 2 trial with Givinostat, the company’s proprietary histone deacetylase (HDAC) inhibitor, in 51 adult males with Becker Muscular Dystrophy (BMD). The study was designed to evaluate the effect of Givinostat in BMD, building on the experience developed in Duchenne Muscular...
treatment News
MILAN, Italy — Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from...
ORLANDO, Florida — Until Susan Caldwell of Waxahachie, Texas, learned in 2016 that her 8-year-old son Ryan Michael had Duchenne muscular dystrophy (DMD), she had never heard of the disease—and only vaguely knew of muscular dystrophy, thanks to the Jerry Lewis Telethon. “It was devastating,” she recalled. “I had met...
HOUSTON – Iterion Therapeutics, Inc., a venture-backed, clinical stage biotechnology company developing novel cancer therapeutics, announced today that it has confirmed the safety of Tegavivint, a novel, potent and selective nuclear beta-catenin inhibitor, after completing enrollment and dosing the final patient in a multicenter Phase 1/2a dose expansion clinical study...
INDIANAPOLIS – Researchers from Indiana University-Purdue University Indianapolis (IUPUI) have developed Distributed Drug Discovery (D3), a new low-cost strategy to accelerate the discovery of drugs to treat neglected diseases such as tuberculosis, leprosy, leshmaniasis, dengue fever, and Chagas disease. Even in times of economic prosperity, the pharmaceutical industry has often...
Paris, France – Ivosidenib is under clinical development by Les Laboratoires Servier and currently in Phase II for Chondrosarcoma. According to GlobalData, Phase II drugs for Chondrosarcoma does not have sufficient historical data to build an indication benchmark PTSR for Phase II. Ivosidenib overview Ivosidenib (Tibsovo / AG-120) acts as...
Somerset, NJ – Legend Biotech announced in an SEC filing on Tuesday that the FDA will convene its Oncologic Drugs Advisory Committee to discuss the use of its Johnson & Johnson-partnered Carvykti (ciltacabtagene autoleucel) in earlier lines of treatment for multiple myeloma. The panel of external experts will evaluate J&J...
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...