The companies said their combination mRNA vaccine showed protection against SARS-CoV-2 and influenza A, but not influenza B.
Pfizer Inc. and BioNTech SE hit a snag in their effort to develop the combination messenger RNA (mRNA) vaccine BNT162b2+BNT161 for influenza and SARS-CoV-2 as their Phase III trial only partially met its influenza endpoint. The setback leaves the space wide open for rival Moderna, which announced positive data from the Phase III study of its candidate two months ago.
Pfizer and BioNTech said 16 August that the trial, in more than 8,000 adults aged 18-64, showed noninferiority to comparator...
One Phase III trial hits but a second study misses by a mile.
The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.
Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
Leading a field of rival potassium channel modulators, azetukalner will have a pivotal epilepsy readout early next year, with Phase III trials in depression and biopolar disorder also underway.
The investor enthusiasm that greeted initial second-quarter pharma earnings announcements was dampened by the results from Sanofi and Merck & Co. Sanofi was particularly punished by investors despite overall growth, while Merck’s revenue fall was probably baked into expectations.
Most major Japanese firms report generally positive fiscal first quarter results, led by mainstay growth and despite lower currency effects. But the future impact of any US pharma tariffs remains an overhang.
