A patient’s death has caused the FDA to place a partial clinical hold on Alpine Immune Sciences Inc.’s phase I study NEON-2 in adults with advanced malignancies.
As Neubase Therapeutics Inc. gears up to unveil preclinical data from its myotonic dystrophy type 1 (DM1) effort during the MDA Clinical & Scientific Conference later this month, investors are watching other programs moving through pipelines – but none of the research, except for that underway by Avidity Biosciences Inc., has entered the clinic.
Hutchmed Ltd. has received a $15 million milestone payment from Astrazeneca plc for initiating a phase III trial testing the Hutchmed c-Met inhibitor Orpathys (savolitinib) in combination with Astrazeneca’s Tagrisso (osimertinib) in epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) for patients with mesenchymal epithelial transition receptor (MET) driven tumors.
Lumithera Inc. has completed the acquisition of Diopsys Inc. to expand its footprint of ocular disease care. Under the terms of the agreement, Pine Brook, N.J.-based Diopsys is now a wholly owned subsidiary of Poulsbo, Wash.-based Lumithera, with its electroretinography technology adding to Lumithera’s photobiomodulation (PBM) Valeda light delivery system for dry age-related macular degeneration (AMD) treatment.
A thin film electrode platform technology developed by Neuroone Medical Technologies Corp. could be used to treat chronic back pain according to new tests. Eden Prairie, Minn.-based Neuroone said it concluded initial testing that demonstrate the electrode could provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries.
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms.
LONDON – The U.K. Recovery trial has added a fourth drug to the list of therapies it has shown are effective in treating hospitalized COVID-19 patients, demonstrating the JAK inhibitor Olumiant (baricitinib) reduces the risk of death by 13% in seriously ill patients. That effect is in addition to treatment with dexamethasone, which became standard of care after the Recovery trial showed it reduced mortality by one-third in patients on ventilators.
PERTH, Australia – Prota Therapeutics Ltd.’s lead candidate PRT-120 induced clinical remission of peanut allergy in 51% of children in a phase IIb clinical trial. There are currently no curative therapies to treat food allergies, Prota Therapeutics CEO Mimi Tang told BioWorld. Peanut allergy in children can be particularly problematic because the only treatment is avoidance.
Shares in Glaxosmithkline plc ticked down after the U.K. pharma announced that enrolment and vaccination in three trials of its respiratory syncytial virus (RSV) maternal vaccine will stop, after a safety issue prompted a voluntary pause last week.