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...
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Los Angeles, Calif. – Investigators at the UCLA Health Jonsson Comprehensive Cancer Center have developed the largest collection of sarcoma patient-derived organoids to date that can help improve the understanding of the disease and better identify therapies that are most likely to work for each individual patient. The approach, detailed...
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...
BELGAUM — He is a big challenge for the medical field. A handicapped boy having innumerous fractures in his body, has been preparing to participate at the national-level swimming competition. Mohin Mustaque Junned, a 12-year-old boy is suffering from a rare disease that causes zero bone calcium. It is called...
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...
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)...
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 — 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...