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...
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SOUTH PLAINFIELD, N.J. – PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced the election of Mary L. Smith to the Company’s Board of Directors. Ms. Smith has previously served as the Principal Deputy Director and CEO equivalent at the Indian Health Service, a $6 billion division of the U.S. Department of Health and Human Services (HHS) and system of hospitals providing...
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]...
TORONTO, Canada — Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a leading rare disease company, today announced that Health Canada has authorized the tablet formulation of LIVMARLI® (maralixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). LIVMARLI had previously been authorized in Canada as an oral solution for the...
TORONTO, Canada — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialisation of novel therapies for rare and ultra-rare genetic diseases, today announced that Health Canada has extended the approval of Evkeeza® (evinacumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies...