Tag: COVID-19

March 30, 2022

COVID-19 vaccines appear to be safe for kids who have had a rare complication called MIS-C after being infected by the coronavirus, according to a new small study. Some kids get MIS-C — shorthand for multisystem inflammatory syndrome in children […]

March 29, 2022

In its 2023 budget request, the US Food and Drug Administration (FDA) is requesting a total of $8.4 billion from the US Government to support critical public health modernisation and core food and medical product safety programmes. If granted, this […]

March 21, 2022

The recent healthcare crisis differed from earlier emergencies because it has spread to impact most industries and multiple financial systems around the world. As the COVID-19 pandemic continued for more than two years, countries around the world struggled to keep […]

March 15, 2022

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 […]

March 2, 2022

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. […]

February 21, 2022

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 […]

February 17, 2022

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 […]

February 17, 2022

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 […]

February 10, 2022

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 […]

February 7, 2022

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 […]

January 26, 2022

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, […]

January 24, 2022

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 […]

January 12, 2022

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 […]

January 4, 2022

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 […]

December 29, 2021

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 […]

December 27, 2021

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for […]

December 23, 2021

“There is some brilliant work that takes place by some incredibly intelligent agencies and individuals, but I know how formulaic we’ve become as an industry where next year’s tactics are probably very similar to this year’s tactics,” he says. “What […]

December 22, 2021

We thought we’d finally get to see what a post-pandemic world looked like in 2022, but thanks to omicron, it seems we’re in for another round. Biotech has been shaped by the pandemic in ways that may be permanent, just […]

December 21, 2021

There’s a very low risk of heart inflammation after getting the Pfizer and Moderna COVID-19 vaccines, according to a new study that adds to previous research supporting the safety of the shots. The two mRNA vaccines had been linked in […]

December 20, 2021

The updated CDC advice follows a unanimous vote from its Advisory Committee on Immunization Practices (ACIP) which involved ‘a robust discussion of the latest evidence on vaccine effectiveness, vaccine safety and rare adverse events, and consideration of the US vaccine […]