Bristol Myers Squibb (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization approval of Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple…
The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15 kg, with eosinophilic esophagitis (EoE). Dupixent is now the first and only medicine approved in…
AbbVie (NYSE: ABBV) strengthened its manufacturing capabilities by breaking ground Thursday on a new US$223 million (S$301 million) expansion of its Singapore manufacturing facility. This new investment will add more than 100 jobs and new biologics manufacturing capacity to AbbVie’s…
Bristol Myers Squibb (NYSE: BMY) today announced that it has successfully completed its acquisition of Mirati Therapeutics, Inc.® (“Mirati”). With the completion of the acquisition, Mirati shares have ceased trading on the NASDAQ Global Select Market and Mirati is now a…
Akouos, Inc., a wholly owned subsidiary of Eli Lilly and Company (NYSE: LLY), today announced positive initial clinical results from the Phase 1/2 AK-OTOF-101 study, which demonstrated pharmacologic hearing restoration within 30 days of AK-OTOF administration in the first participant, an individual…
Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from January 25-27 in San Francisco, California, highlighting the company’s progress in making long-term…
Voydeya (danicopan) has been approved in Japan for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). It is indicated in Japan in combination with C5 inhibitor therapy when patients have had an insufficient response to such C5 inhibitors.1 Voydeya is a first-in-class, oral, Factor…
Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular…
Global biotechnology leader CSL (ASX: CSL) today announced that Swissmedic has authorised HEMGENIX® (etranacogene dezaparvovec), the first and currently only gene therapy for the treatment of male adults aged >18 years with severe or moderately severe hemophilia B (congenital Factor IX deficiency).…
ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation, today launched its “Optimising biotech funding” whitepaper. This provides an overview of the current state of play for biotech companies and the research and development (R&D) strategies they can…
ICON plc, (NASDAQ: ICLR) a world-leading healthcare intelligence and clinical research organisation (CRO), finishes the second half of 2023 with positive recognition as a top-rated employer and leader in clinical trial innovation. In recognition of its Environmental, Social and Governance (ESG)…
Bayer AG and Asklepios BioPharmaceutical, Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, have announced the initiation of GenePHIT (Gene PHosphatase Inhibition Therapy), a Phase II trial of AB-1002 (also known…