Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and […]
Pharmaceutical
U.S. plans to ship 6.4M COVID-19 vaccine doses to states in mid-December
About 6.4 million doses of the COVID-19 vaccine from Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) will ship to U.S. states in mid-December, as long as the vaccine soon receives an FDA EUA. There are also plans to quickly distribute vaccine from rival COVID-19 vaccine developer Moderna (NSDQ:MRNA), which could soon apply for an EUA, officials at the federal […]
HHS confirms involvement in presidential transition process
U.S. Health and Human Services Dept. Secretary Alex Azar confirmed that HHS is working with president-elect Joe Biden on a presidential transition. Speaking during a press briefing, Azar said HHS is in contact with the transition team after the General Services Administration formally recognized Biden as the president-elect, having previously sidestepped questions regarding the potential […]
Who would — and wouldn’t — line up for COVID-19 vaccines?
Once enough people receive effective vaccines against the novel coronavirus, experts say, the end of the pandemic may be in sight. But a new poll of older adults — one of the highest-priority groups for vaccination — suggests an uphill climb lies ahead to reach that goal. In all, 58% of adults aged 50 to […]
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 […]
BREAKING: AstraZeneca says its COVID-19 vaccine could be up to 90% effective
AstraZeneca (NYSE:AZN) announced today that one of its COVID-19 vaccine candidate dosing regimens is 90% effective in preventing the virus. Cambridge, United Kingdom-based AstraZeneca, working in collaboration with Oxford University, found the vaccine to be highly effective in preventing COVID-19 for subjects in the UK and Brazil, with no hospitalizations or severe cases of the disease […]
BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within […]
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, […]
MedTech 100 roundup: Stocks remain high after record-setting week
Medtech stocks have been on the rise since positive news regarding COVID-19 vaccines broke last week, breaking a record in the process. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 98.99 (Nov. 13), marking a 1.4% uptick from the 97.62 points registered at the […]
Vibalogics to invest $150M in Boston virotherapy facility
Vibalogics announced that it initiated the first phase of its planned $150 million investment in a virotherapy facility near Boston. The global contract development and manufacturing organization (CDMO) has a three-year investment plan which includes building a 110,000 square-foot facility, with the $150 million covering redevelopment, equipment and personnel, according to a news release. Vibalogics […]
What a Biden administration could mean for the pharma industry
While President Trump continues to refuse to concede the election, a growing number of business associations and politicians have acknowledged Biden as the president-elect. What a Biden presidency would mean for the pharmaceutical industry continues to be an open question as the Senate outcome remains undecided, but two broadly similar outcomes are likely. Get the […]
