New phase IIb clinical trial data show the antigen R-21, a malaria vaccine candidate created by the University of Oxford that uses Novavax Inc.'s Matrix-M adjuvant, demonstrated 77% efficacy in children.
LONDON – A large scale U.K. study looking at the impact of COVID-19 vaccinations on antibody responses and new infections in 373,402 people in the general population has shown a single dose of vaccine cut infections by 65%.
With phase III data due from Phathom Pharmaceuticals Inc. in the near term, investor eyes are turning to the ways that lead compound vonoprazan, a potassium-competitive acid blocker, might distinguish itself from proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD).
PERTH, Australia – Implicit Bioscience Ltd.’s lead candidate, IC-14, is the first anti-CD14 monoclonal antibody (MAb) to progress to the clinic as it enters a phase II trial in the U.S. in COVID-19 patients.
HONG KONG – Covig-19, an anti-SARS-CoV-2 hyperimmune immunoglobulin therapy that Takeda Pharmaceutical Co. Ltd. developed alongside the Covig-19 Plasma Alliance, has failed to meet its endpoints in a global phase III trial.
Challenges to ongoing efforts to provide effective aid for hospitalized patients with COVID-19 continued April 8, with two new trial failures reported. A phase III trial testing the Olumiant (baricitinib) vs. placebo, both on top of standard of care, missed its primary endpoint of progression to non-invasive ventilation, invasive mechanical ventilation or death, said drugmakers Eli Lilly and Co. and Incyte Corp. A phase II trial testing Beigene Ltd.'s Brukinsa (zanubrutinib) vs. placebo in patients hospitalized with respiratory symptoms of COVID-19 also fell short, missing its co-primary efficacy endpoints of respiratory failure-free survival or reduction in days on oxygen.
HONG KONG – In a surprisingly candid statement, the director of China’s Centers for Disease Control conceded that the efficacy of Chinese coronavirus vaccines is "not high" and may require improvements.
If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses. The new results play out against a backdrop of increased production and big revenue estimates.
Full rights to TAK-169, a CD38-targeted engineered toxin body that Takeda Pharmaceuticals Co. and Molecular Templates Inc. have been developing, are going to Molecular Templates as is the therapy’s clinical development. Making way for the new candidate, Molecular is discontinuing development of MT-3724, which is in a phase II study for treating diffuse large B-cell non-Hodgkin lymphoma but was placed on a partial clinical hold by the FDA after a treatment-related fatality in one of the subjects.
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines.
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