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 […]
Biotech
5 takeaways from the latest White House Coronavirus Task Force meeting
The White House Coronavirus Task Force promised a swift rollout of COVID-19 vaccines — but one of a number of takeaways from its first briefing since July. The briefing yesterday gave the task force a chance to once again urge Americans to heed COVID-19 guidance while also providing an update on vaccines and therapeutics. The […]
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 […]
5 ways Election Day could impact pharma
The pharmaceutical industry stands at a crossroads as Election Day nears in the U.S. The election could ultimately have sweeping implications for the sector, or it could yield only modest changes. While the presidential election could have a significant influence on the pharma sector, arguably more important is who gains control of Congress. A blue sweep […]
DTW Podcast: Can Fractyl Labs and Cala Health go where only drugs have gone before?
In this week’s DeviceTalks Weekly podcast, co-costs Tom Salemi and Chris Newmarker walk through this week’s “Newmarker’s Newsmakers,” the Top Five #medtech stories of the week with news coming from CureVac, Avail Medsystems, ClearMask, Thermo Fisher and Bayer. We also hear from CEO Harith Rajagopalan, MD and CFO Lisa Davidson of Fractyl Laboratories, which is […]
Windtree names Hamill as new CFO
Drug- and medtech developer Windtree Therapeutics (NSDQ:WINT) today announced it named John Hamill as SVP and chief financial officer, replacing John Tattory, who is leaving to pursue other opportunities. Hamill joins the company, which develops drug product and devices to treat acute cardiovascular and pulmonary disease, with 30 years in the pharma, biopharma and clinical […]
Philips wins 510(k) for sensor to detect COVID-19 patient deterioration
Royal Philips (NYSE:PHG) announced that it has won FDA 510(k) clearance for a wearable biosensor to help manage confirmed and suspected COVID-19 patients in the hospital. The Amsterdam-based company described the BX100 biosensor as a wireless wearable sensor designed to help healthcare providers detect when COVID-19 patients in lower-acuity units are at risk for deterioration so […]
Mammoth deal with GSK could lead to home COVID-19 test
CRISPR startup Mammoth Biosciences will partner with GlaxoSmithKline’s (NYSE:GSK) consumer healthcare division to develop a home-based diagnostic capable of detecting active SARS-CoV-2, the novel coronavirus that causes COVID-19. The collaboration will use Mammoth Biosciences’ CRISPR-based Detectr platform to design “guide-RNA” that can identify and signal the presence of viral strands obtained through a simple nasal swab, […]
