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If J&J’s gamble on a single dose pays off, it could rapidly advance the fight against SARS-CoV2 – but a second study will provide a safety net.
The French biotech's chances of competing with Aimmune's Palforzia in the peanut allergy market have been boosted after US regulators decided that a fresh Phase III trial for the Viaskin Peanut patch would not be required for resubmission.
The Danish company pockets $40m as the lead asset in the potential multi-billion dollar deal with AbbVie for bi-specific antibodies progresses into Phase III, and while it looks to build up its commercial infrastructure.
Vir believes its single antibody will be effective against rising mutant forms of COVID-19. Phase III data from two ongoing trials are expected in the first quarter.
Lilly took a different path to positive results in Alzheimer’s with a smaller, biomarker-driven study to test the hypothesis that rapid, robust clearance of amyloid could slow disease progression, CEO David Ricks explains at J.P. Morgan.
Pharma appears to be treading carefully when it comes to research preprints but COVID-19 has spotlighted the role of these pre-peer-reviewed papers during public health emergencies.
Lilly reported positive results from a Phase II pivotal trial of donanemab, which targets a modified form of beta-amyloid called N3pG, and has a second pivotal Phase II study under way.
After failing in five earlier trials, Actemra shows significant life-saving benefits for patients with severe COVID-19.
Any time advantage Sarepta's Duchenne muscular dystrophy gene therapy may have had over rivals, notably Pfizer, has disappeared after SRP-9001 failed to significantly improve muscle function in a closely watched trial.
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