SAN DIEGO, CA — Halozyme Therapeutics, Inc., today announced that argenx received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection co-formulated with Halozyme’s ENHANZE® drug delivery technology for subcutaneous (SC) use for the treatment of adult patients with generalized myasthenia gravis...
treatment News
SAN DIEGO, Calif. — Halozyme Therapeutics, Inc. (NASDAQ: HALO) (“Halozyme”) today announced that Takeda received European Commission (EC) approval for HYQVIA® [Immune Globulin Infusion 10% (Human)] co-formulated with Halozyme’s ENHANZE® drug delivery technology as maintenance therapy in patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) after stabilization with intravenous...
CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China – Harbour BioMed (“HBM”, HKEX: 02142) today announced positive topline results from its Phase 2 proof-of-concept clinical trial of batoclimab (HBM9161) in Chinese generalized myasthenia gravis (gMG) patients. Data received from the Phase 2 Study, as the first clinical evidence of anti-FcRn therapies in Chinese patients, showed...
PLYMOUTH MEETING, Pa., March 19, 2021 — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological disorders who have unmet medical needs, today announced publication of a white paper sharing outcomes from a Summit on Sleep...
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...
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...
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...