Partners Sanofi SA and Swedish Orphan Biovitrum AB (Sobi) said regulatory submissions are expected this year for once-weekly factor VIII therapy efanesoctocog alfa in hemophilia A following top-line success in a pivotal phase III study, which showed a clinically meaningful prevention of bleeds in people with severe disease receiving prophylaxis over 52 weeks. The drug, also known as BIVV-001, has fast track and orphan designations in the U.S., and the companies are banking on its extended half-life to go up against blockbuster bispecific antibody Hemlibra (emicizumab) from Roche Holding AG as well as a potential gene therapy from Biomarin Pharmaceutical Inc.
As the conflict in Ukraine intensifies following the Russian invasion, hundreds of clinical trials could be in jeopardy amid the chaos and destruction of war, with pharma giant Merck & Co. Inc. saying it is putting recruitment for dozens of studies on hold.
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 EGFR-mutated non-small-cell lung cancer.
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.
RSS
