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Tag: COVID-19


Industry, Vaccines

Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

March 15, 2022

Via: Drugs.com

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of an additional booster dose adults 65 years of age […]


News

FDA slaps hold on Finch’s C. diff med to get info on COVID-19 screening for donor-derived therapy

March 2, 2022

Via: FierceBiotech

Finch Therapeutics’ phase 3 trial for a Clostridioides difficile med has been placed on clinical hold by the FDA as the agency requests more information on how the biotech screens the donor-derived microbiome therapy for the virus that causes COVID-19. […]


Clinical Trials, Research and Development

Examining COVID’s impact on clinical research participant diversity

February 21, 2022

Via: Pharmaphorum

And then came COVID-19. Twenty-three percent fewer clinical trials were launched from March through May 2020 because of the pandemic, and many clinical researchers switched to focusing on COVID-19 vaccines and treatments. COVID-19 forced research organisations to adapt. With many […]


Manufacturing, Research and Development

Thermo Fisher Scientific Invests $40 Million to Expand Bioprocessing Manufacturing Site

February 17, 2022

Via: Biopharm International

Thermo Fisher Scientific announced that it is investing $40 million to expand its single-use technology manufacturing facility in Millersburg, Penn. The expansion is part of a $650 million multi-year investment to enhance the company’s ability to provide flexible, scalable, and […]


FDA, Regulations

FDA Grants Eli Lilly Drug EUA for Treatment of COVID-19

February 17, 2022

Via: Biopharm International

FDA announced on Feb. 11, 2022, that it has granted an Emergency Use Authorization (EUA) to Eli Lilly and Company for bebtelovimab, a monoclonal antibody (mAb) designed for treatment of COVID-19. The EUA covers treatment of mild to moderate COVID-19 […]


Industry, Vaccines

AZ halts development of Beta variant COVID-19 vaccine

February 10, 2022

Via: Pharmaphorum

The new vaccine – codenamed AZD2816 – started phase 2/3 trials as a booster dose for people vaccinated with Vaxzevria or mRNA vaccines from Pfizer/BioNTech and Moderna last June, when Beta was still the dominant SARS-CoV-2 variant of concern. In […]


FDA, Regulations

FDA lifts domestic inspection pause as omicron numbers begin to wane

February 7, 2022

Via: FiercePharma

The FDA said it will resume domestic inspections today, lifting the pause it put into place late last year as the omicron variant of COVID-19 was sweeping across the U.S. The pause, which started Dec. 29, applied to certain inspection […]


Industry, Vaccines

COVID-19 Vaccine Before or After Infection? For Super Immunity, It Makes No Difference

January 26, 2022

Via: Genetic Engineering and Biotechnology News

At this point in the COVID-19 pandemic, two years in, people have reached varying levels of immunity to SARS-CoV-2. And, they have taken different paths to get there. Whether the path includes vaccination, a natural infection, an infection after vaccination, […]


News

US turns to Gilead’s COVID-19 drug to help counter omicron

January 24, 2022

Via: Biopharma Dive

Two years after Gilead’s drug first emerged as an option against COVID-19, Veklury is back in the spotlight. Originally developed as a medicine for hepatitis C and Ebola, Veklury became the first drug proven effective in treating COVID-19. It is […]


Biotech, Industry

COVID Pandemic Prompts Renewed Interest in Biotech Startups

January 12, 2022

Via: Biopharm International

The momentum of biotech and biopharma companies is on the rise in anticipation of a new wave of emerging therapies moving through the industry’s development pipeline. In addition, the COVID-19 pandemic highlighted the importance of companies that can react quickly […]


Industry, Vaccines

COVID-19 tracker: Pfizer-BioNTech booster expands its OK; Johnson & Johnson shot tackles omicron

January 4, 2022

Via: FiercePharma

The FDA further expanded the emergency use authorization for a booster shot of Pfizer-BioNTech’s Comirnaty. Johnson & Johnson’s COVID vaccine showed 85% efficacy against COVID-related hospitalization caused by omicron. The worldwide case count has risen to nearly 293 million Tuesday […]


Editorial

What does the future hold for Biopharma?

December 29, 2021

Via: Abby Hallett

The COVID-19 pandemic has demonstrated that it is essential for biopharmaceutical organizations to act quickly and become flexible in production.  Experts, such as the CHEManager International team, view four factors as unsolved challenges. They claim that the first challenge is […]