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Gilead says remdesivir improved mortality and clinical recovery in COVID-19 patients, but the findings come from a retrospective analysis, not a traditional clinical trial.
Moderna's vaccine has shown encouraging early results in younger adults, but over-55s and over-70s cohorts represent a bigger safety and efficacy hurdle.
Plus: the World Health Organization has commissioned an independent panel to look at pandemic responses, while the emergence of an unknown pneumonia in Kazakstan is causing concern.
The Bayesian adaptive trial design is looking to slash development times, starting with a Phase II trial of Ridgeback’s drug, a potential challenger to Gilead’s remdesivir.
Novavax has progressed into Phase I trials with relatively little funding, but backing from Operation Warp Speed makes it a stronger contender.
Coronavirus Update: Regeneron Races Into Phase III Trial Of Antibodies To Block Coronavirus Infection
Regeneron and NIAID kick off a Phase III prevention trial for antibody cocktail REGN-COV2.
Developed by Japan’s national research institute, the supercomputer has been tasked with characterizing the SARS-CoV-2 virus, identifying therapeutic molecules, modeling infection spread and socio-economic impact.
Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.
US Institute for Clinical and Economic Review lays out options ranging from the status quo (unrestricted pricing) to compulsory licensing and advanced market commitments in a new white paper.
Delay to Moderna's Phase III plans adds to the biotech's rollercoaster ride, but its CEO insists it is still on track.
Partnering with AstraZeneca, the Oxford team has opened up a clear lead in the race to enrol thousands of patients for late-stage safety and efficacy trials – but cannot make guarantees of when results might be ready.
Fujifilm Toyama seals three-way deal to accelerate the development and global supply of favipiravir, close on the heels of the arrival of a generic version of the antiviral in India under restricted emergency use for the treatment of COVID-19.
Chief executive Eric Hobbs talks about the technology needed to accelerate antibody, cell therapy and synthetic biology, and prepare for the next pandemic.
Pfizer and BioNTech appear to have the upper hand on mRNA rivals Moderna, but Phase III results will be the real test.
Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards
The FDA has released detailed guidance to COVID-19 vaccine manufacturers setting out the safety and efficacy standards required, and pledged to not cut corners.
Glenmark’s innovation spin-out initiates efforts to raise capital in the US, unfazed by mixed top-line results for its investigational atopic dermatitis treatment. Its parent firm has underscored the value proposition of the oncology franchise and proprietary bispecific antibody technology platform.
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