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Tag: vaccines


Industry, Vaccines

Johnson & Johnson, Moderna COVID-19 vaccines work as intended, FDA staff say ahead of high-stakes booster meeting

October 13, 2021

Via: FiercePharma

Millions of people who received the Pfizer COVID-19 vaccine have been eligible to get a third booster dose for weeks, but those who received the other FDA-authorized shots have been waiting to see whether they’ll need another dose. They’ll soon […]


Industry, Vaccines

NIH study finds mixing COVID-19 boosters increases immune response

October 13, 2021

Via: Biopharma Dive

Scientists at the FDA and Centers for Disease Control and Prevention have been grappling with the question of who needs an additional vaccine dose, and when, for weeks now. The authorization of a third dose of Pfizer and BioNTech’s vaccine […]


Industry, Vaccines

CureVac giving up on first COVID mRNA vax, focusing on GSK-partnered 2nd attempt

October 12, 2021

Via: FierceBiotech

With more than a touch of inevitability, CureVac is abandoning its first mRNA COVID vaccine after dismal results earlier this year and switching focus to a second mRNA asset with GlaxoSmithKline. A lot was expected from the little German biotech […]


Industry, Vaccines

COVID-19 vaccine trial participants to be offered additional doses

October 11, 2021

Via: Pharma Times

Although the UK recognises those who are in COVID-19 vaccine trials as fully vaccinated for the purpose of certification, most other countries do not currently recognise clinical trial volunteers who have not had a vaccine that is approved for deployment. […]


News

Senate to cull Biden’s biomedical research agency from social care bill: Report

October 11, 2021

Via: FierceBiotech

President Joe Biden’s $3 billion Advanced Research Projects Agency for Health is in jeopardy as the Senate is set to cut the agency from its social care spending bill. This is according to sources talking to Politico over the weekend […]


Clinical Trials, Research and Development

FDA Places Clinical Hold on Allogene CAR-T Cancer Trials

October 8, 2021

Via: Genetic Engineering and Biotechnology News

Allogene Therapeutics saw its shares fall more than 40% in early trading Friday after acknowledging that the FDA had placed a clinical hold on its trials evaluating its allogeneic CAR T (AlloCAR T) therapies for cancer. Allogene said the clinical […]


Manufacturing, Research and Development

Moderna to pour $500M into Africa to meet future mRNA vaccine manufacturing demand

October 7, 2021

Via: FiercePharma

Moderna is eyeing sites in Africa where it plans to build a $500 million mRNA manufacturing facility that will be able to produce hundreds of millions of vaccine doses a year in anticipation of future vaccine demand in the wake […]


Industry, Vaccines

J&J asks FDA to clear booster dose of its coronavirus vaccine

October 5, 2021

Via: Biopharma Dive

For the past several months, one of the many questions hanging over the booster debate has ben what do with people who got J&J’s shot. The company’s application, and the FDA’s planned meeting, creates a timeline for answering that question. […]


Industry, Vaccines

AstraZeneca files for FDA green light of COVID-preventing antibody

October 5, 2021

Via: FierceBiotech

AstraZeneca has taken another step toward bringing its COVID-19 antibody cocktail to market, filing for emergency use authorization of the long-acting candidate in coronavirus prophylaxis in the U.S. Last month, AstraZeneca delivered evidence that the candidate prevents COVID-19 in people […]


Industry, Pharma

Merck’s oral COVID-19 antiviral slashes hospitalizations, prevents deaths in phase 3, sparking race to file with FDA

October 1, 2021

Via: FierceBiotech

The wait for an oral antiviral against COVID-19 may almost be over. Friday, Merck reported its prospect halved the risk of hospitalization and death in phase 3, spurring it to stop the study and race to get emergency use authorization. […]


Industry, Vaccines

AstraZeneca is nearly ready to seek approval for its COVID-19 antibody. Can it stick the landing?

September 30, 2021

Via: FierceBiotech

Across the first phase of the pandemic, AstraZeneca went from being a good example of how pharma can step up in times of need to a warning that no good deed goes unpunished. Now, AstraZeneca has a shot at putting […]


Industry, Vaccines

NIAID Awards $36 Million to Pan-Coronavirus Vaccine Development

September 29, 2021

Via: Genetic Engineering and Biotechnology News

The rapid development of the safe and effective COVID-19 vaccines currently being used will go down as one of the most impressive accomplishments in scientific history. However, the fight against coronaviruses is far from over. Not only because of the […]