PLYMOUTH MEETING, Pa. — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today announced the presentation of initial open-label extension (OLE) data from the company’s ongoing Phase 3 ARGUS trial investigating EPX-100 (clemizole hydrochloride) for the treatment of Dravet syndrome (DS), which showed clinically meaningful reductions in seizure activity in participants with...
treatment News
PLYMOUTH MEETING, PA. — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to pitolisant for the treatment of Prader-Willi syndrome (PWS). “The decision to grant Orphan Drug designation to pitolisant indicates that it could be a promising treatment option...
Chicago, Ill. – Scientists at Harvard University and the University of Illinois Chicago have developed an antibiotic that could give medicine a new weapon to fight drug-resistant bacteria and the diseases they cause. The antibiotic, cresomycin, described in Science, effectively suppresses pathogenic bacteria that have become resistant to many commonly...
MELBOURNE, Australia — Neurizon® Therapeutics Limited (ASX: NUZ; OTCQB: NUZTF) (“Neurizon” or “the Company”), a late-stage clinical biotechnology company dedicated to advancing innovative treatments for neurodegenerative diseases, is pleased to advise that enrollment has been completed in Regimen I of the Phase 2/3 HEALEY ALS Platform Trial evaluating the Company’s...
CAMBRIDGE, Mass. & BEIJING – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that BRUKINSA® (zanubrutinib) has been approved by Health Canada for the treatment of adult patients with Waldenström’s macroglobulinemia (WM). “BRUKINSA is a highly selective BTK inhibitor designed to provide a deep...
ROCKVILLE, Md. — Leadiant Biosciences, Inc. today announced that Health Canada has approved Cysklar® (cysteamine ophthalmic solution) 0.44%, a topical eye drop solution indicated for the treatment of corneal cystine crystal accumulation in people with cystinosis. Cystinosis is a rare but serious multi-system genetic disorder that leads to the accumulation of cystine crystals...
MISSISSAUGA, Canada – Health Canada has granted a Notice of Compliance (NOC) for IMFINZI® (durvalumab), as monotherapy, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT), following a priority review of the submission.1 The approval of...
MISSISSAUGA, ON – Hoffmann-La Roche Limited (Roche Canada) is pleased to announce that Health Canada has granted market authorization for Columvi® (glofitamab for injection) in combination with gemcitabine and oxaliplatin (GemOx) indicated for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma not otherwise (DLBCL NOS)...
TORONTO, Canada – BeOne Medicines, a global oncology company, today announced that Health Canada has granted a Notice of Compliance (NOC), approving TEVIMBRA® (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma (NPC). This is the first approved indication for...
DUBLIN – Jazz Pharmaceuticals plc (NASDAQ: JAZZ) today announced the Health Canada approval and availability of Vyxeos® (daunorubicin and cytarabine liposome for injection) for the treatment of adults with newly diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).[1] AML, a cancer of the bone marrow and the blood, progresses rapidly without treatment.[2]...