While the so-called ‘U.K. variant’ of COVID-19 has triggered alarm, it may be a harbinger of things to come, as the novel coronavirus mutates across the world, complicating mass-vaccination efforts. Moderna (NSDQ:MRNA) detailed its plans to combat the matter in a briefing with investors. While it expects two 100-µg doses of its mRNA-1273 vaccine to be […]
Clinical Trials
Authorities investigating death of California recipient of COVID-19 vaccine
Last week, Norwegian officials raised eyebrows when they announced that they were investigating the deaths of 23 elderly patients who had recently received COVID-19 vaccine doses. Now, California authorities are investigating the death of a Placer County-based patient who received a COVID-19 vaccine dose on Jan. 21. The patient died hours afterward. Placer County officials […]
Norway investigating deaths of 23 individuals who received COVID-19 vaccine
In Norway, authorities are investigating the deaths of nearly two dozen people who received the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). To date, it has analyzed data from 13 of those individuals. The Norwegian Medicines Agency concluded that common adverse reactions to mRNA vaccines, including fever and nausea, could have contributed to deaths in elderly […]
How the clinical trial industry is making the most of COVID-19 disruption
Like most things in healthcare, clinical trials have been slow to evolve in recent decades. But the COVID-19 pandemic has forced clinical trial research teams to become more efficient, patient-centered and inclusive. Much is at stake as the pandemic has already caused significant clinical trial disruption. EY estimates that the COVID-19 impact on Phase 3 […]
10 trends that will matter for life sciences in 2021
One silver lining of the COVID-19 pandemic is that it has accelerated the rate of change for pharma and life sciences fields in general. The pandemic has forced a rethink of how to manage clinical trials and treat patients in hospitals and their homes. And the breakneck speed of vaccine development in 2020 could potentially […]
Regeneron antibody cocktail wins emergency use authorization
Regeneron Pharmaceuticals (NSDQ:REGN) has announced that the FDA has granted emergency use authorization (EUA) for the combination of casirivimab and imdevimab to treat COVID-19. The monoclonal antibody cocktail is reportedly the first treatment to show “statistically significant anti-viral activity” against COVID-19, according to its developer. In a trial, the combination of drugs cut hospitalization or emergency […]
Why the COVID-19 vaccine market won’t be ‘winner take all’
There are a dozen Phase 3 COVID-19 vaccine candidates with more than 50 in either Phase 1 or Phase 2 trials. But the fact that Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) have vaccine candidates with efficacy greater than 90% could ultimately narrow the playing field. “Efficacy matters, but I don’t think [Pfizer’s and Moderna’s efficacy rate of] greater […]
Moderna and Pfizer COVID-19 vaccines set a high bar for competitors
Moderna (NSDQ:MRNA) is now the second company to release positive preliminary results from a Phase 3 trial of a COVID-19 vaccine candidate — and it appears to be more good news. Last week, Pfizer (NYSE:PFE) announced that early data suggested its BNT162 mRNA-based vaccine was more than 90% effective at reducing symptomatic COVID-19 infections. Today, […]
7 things to know about COVID-19 vaccines
Enthusiasm surrounding COVID-19 vaccines is on the upswing after Pfizer announced preliminary data suggesting its vaccine could be 90% effective at preventing COVID-19 infections. The Bay Area Council hosted a webinar yesterday to provide more information about coronavirus vaccines. Here are seven considerations to keep in mind now that the prospect of a widely deployed COVID-19 […]
Pfizer claims its COVID-19 vaccine could be 90% effective
Pfizer (NYSE:PFE) has announced its vaccine candidate promises to be 90% effective in protecting against COVID-19 infections. The announcement included the interim analysis results of its Phase 3 trial. Pfizer had earlier suggested that it would announce those results in late October. The promising data clears the way for Pfizer to apply for emergency-use authorization from FDA […]
FDA announces regulatory updates under 21st Century Cures Act
The 21st Century Cures Act aimed – among other things – to amend the Federal Food, Drug, and Cosmetic Act to more closely align device and drug regulations. FDA is updating regulations to reflect some of the 6-month-old law’s changes. Details can be found in today’s Federal Register. Specifically, the 21st Century Cures Act amended Humanitarian Device […]