The numbers are staggering when it comes to the potential drug risks pregnant and breastfeeding women, as well as their babies, are exposed to and the treatments they may be denied because of the lack of data.
CAJICA, Colombia - Colombia approved two different phase II/III trials for COVID-19 vaccine candidates over the last week, advancing one candidate developed by Germany’s Curevac AG and another by China’s Clover Biopharmaceuticals Inc.
LONDON – Two new U.K. studies point to long-term persistence of COVID-19 antibodies after both natural infection and vaccination, conferring protection against subsequent infection for at least three months.
Almost three years after announcing it would quit development of its humanized immunoglobulin G1 candidate, birtamimab, in light chain (AL) amyloidosis, Prothena Corp. plc is revving the program back up with a new focus, sending shares (NASADQ:PRTA) 30.5% higher to close at $14.35 on Feb. 2.
When Cassava Sciences Inc.’s president and CEO, Remi Barbier, opened up the interim analysis of the company’s open-label study for Alzheimer’s disease candidate simufilam, he was more than pleased with the results but found himself an audience of one. His researchers had been confident about the results before the data were tallied. “I was ecstatic,” he told Bioworld. “No one’s seen this type of improvement in Alzheimer’s. But our scientists said, ‘See, I told you so.’ It was not my expectation.” The new data showed six months’ treatment with the oral, small molecule not just stabilized but improved cognition and behavior scores in AD patients.
Less than a month after informing the market of a slowdown caused by pandemic-related site closures in phase II studies with neonatal Fc receptor (FcRn)-targeting IMVT-1401, Immunovant Inc. said it’s voluntarily pausing dosing with the compound in thyroid eye disease (TED) in the study called Ascend Go-2 because of a worrisome physiological signal. The New York-based firm plans to investigate and, after seeking the FDA’s go-ahead on tweaks to the program, forge onward with development.
LONDON –The Russian COVID-19 vaccine Sputnik V now has validation from the Western science establishment, after The Lancet published full interim results of the phase III trial on Feb 2. The peer-reviewed paper confirms the 91%-plus efficacy that the vaccine’s developer, Gamaleya National Center of Epidemiology and Microbiology, claimed in its own announcement of the results in December.
Concert Pharmaceuticals Inc. is scratching further work on CTP-692 after the deuterated form of D-serine missed the primary endpoint in a phase II study in schizophrenia. The news sent shares of Concert (NASDAQ:CNCE) falling 28% Feb. 1 and shifts focus to the firm’s sole remaining clinical-stage program in the competitive alopecia areata space.
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