Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adrenomed, Aim Immunotech, Algernon, Arcutis, Arena, Arrowhead, Aveo, Eli Lilly, Exicure, Galera, Genelux, Heron, Horizon, Immune-Onc, Knopp, Menarini, Ryvu, Springworks, Verastem, Verona.
HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.
HONG KONG – Sanofi SA has finally ended its clinical development of Hanmi Pharmaceutical Co. Ltd.’s efpeglenatide as a type 2 diabetes treatment, and the Korean firm is now considering how to move forward with developing the once-weekly GLP-1 receptor agonist, which employs Hanmi's Lapscovery delivery technology.
Shares of Marinus Pharmaceuticals Inc. climbed 51.7% to close at $3.20 on Sept. 15 following news that the company's sole clinical asset, ganaxolone, met the primary endpoint of its phase III Marigold study in CDKL5 deficiency disorder, a rare genetic condition that can leave children unable to walk, talk or feed themselves.
In August, Cala Health Inc. reported results from its pivotal PROSPECT study showing significant improvement in hand tremors with use of its Cala Trio wearable neuromodulation therapy. Now the company has real-world evidence affirming the benefit to patients with essential tremor (ET) who used Cala Trio at home over several months.
A new analysis of biomarkers, superseding confusing results released in May, appears to have re-ignited enthusiasm for the experimental Alzheimer’s disease (AD) candidate, sumifilam, the lead development candidate at Texas-based Cassava Sciences Inc.
HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.
The Astrazeneca plc and Oxford University phase III trial of their adenovirus-based coronavirus vaccine is back up and running in the U.K. after a week’s worth of study and decision-making. The company said it still plans to report data from the study by the end of this year.
LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.
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