INDIANAPOLIS — Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA(R) (pemetrexed for injection) as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell...
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DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced initiation of the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1 (NT1). ALKS 2680 is the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist...
DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced topline results from a phase 3, open-label extension study assessing the long-term safety, tolerability and durability of treatment effect of LYBALVI® (olanzapine and samidorphan) in patients with schizophrenia, schizophreniform disorder or bipolar I disorder for up to four years of treatment, following treatment...
DUBLIN, Oct. 23, 2023 — Alkermes plc (Nasdaq: ALKS) announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company’s novel, investigational orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability,...
CAMBRIDGE, Mass. — Alkeus Pharmaceuticals, Inc. today announced the presentation of interim data from its TEASE-3 study demonstrating that early-stage Stargardt disease patients treated with gildeuretinol acetate showed no disease progression and remained asymptomatic while on therapy ranging between two and six years. The study update was presented during the...
European Myasthenia Gravis Day will make it to the calendar for the very first time on 2 June 2023. A symbolic date that will shine the light on this neuromuscular autoimmune disease that affects between 56,000 up to almost 100.000 people in Europe1. This day, initiated by the 'All United for MG'2 coalition which unites patient associations and representatives from seven countries across Europe, aims to raise awareness of the disease and its consequences for patients and their caregivers amongst the general public, medical professionals and the European institutions.
SEATTLE and SAN RAFAEL, Calif. – The Allen Institute and BioMarin Pharmaceutical Inc. announced a collaboration today that will use technologies developed at the Allen Institute to create new gene therapies aimed at rare genetic diseases of the central nervous system. BioMarin will receive an exclusive license to each program...
Seattle, WA — With pediatric inflammatory bowel disease (IBD) diagnoses on the rise globally, a clinical trial in Seattle aims to transform treatment approaches through deep molecular profiling. Recruitment has begun for the Seattle STRIDE study, a joint effort by Seattle Children’s Research Institute and the Allen Institute for Immunology....
Chicago, Illinois – Patients with muscle-invasive urothelial cancer and a high risk of recurrence after surgery may have a new treatment option. The Alliance for Clinical Trials in Oncology today announced positive results from the phase III AMBASSADOR (A031501) trial for the adjuvant treatment of patients with localized muscle-invasive urothelial...
SOUTH SAN FRANCISCO, Calif. — Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T™) products for cancer and autoimmune diseases, announced that it has received a $15 million grant from the California Institute for Regenerative Medicine (CIRM) to support the clinical...