Top

Tag: COVID-19


Editorial

How Past Infectious Diseases Can Become Future Opportunities

June 22, 2022

Via: Natalie Dunn

At the beginning of the COVID-19 pandemic, people around the world were comparing the new disease with the flu, also known as influenza. However, while both diseases cause respiratory symptoms, it soon became very clear that there are some important […]


Industry, Vaccines

EMA Starts Rolling Review of Adapted COVID-19 Vaccines

June 21, 2022

Via: Biopharm International

The European Medicines Agency (EMA) has begun a rolling review of the Spikevax vaccine that has been adapted to protect against two variant strains of SARS-CoV-2, the agency announced on June 17, 2022. The review will focus on non-clinical laboratory […]


Clinical Trials, Research and Development

FDA lifts hold on Ocugen’s COVID-19 vaccine trial. But is it too late for the shot?

May 23, 2022

Via: FiercePharma

Six weeks after slapping a clinical hold on a trial of Ocugen’s COVID-19 vaccine, the FDA has lifted it. That’s the good news for the Malvern, Pa. company, which has partnered with India’s Bharat Biotech on the shot known commercially […]


Industry, Vaccines

FDA Authorizes Pfizer Booster Shot for Kids Ages 5 to 11

May 17, 2022

Via: Drugs.com

A single booster dose of the Pfizer COVID-19 vaccine can be given to 5- to 11-year-olds, the U.S. Food and Drug Administration announced today. The third shot can be given at least five months after healthy kids complete the two-dose […]


Editorial

Is Childhood Vaccination Disrupted by Excessive Use of Antibiotics?

May 16, 2022

Via: Natalie Dunn

Nothing could make the benefits of vaccination easier to understand than the recent COVID-19 pandemic and its catastrophic effects. However, when it comes to vaccinating children and teenagers, many people around the world showed reluctance due to the potential negative […]


FDA, Regulations

FDA Warns of Counterfeit Home COVID-19 Test Kits

May 3, 2022

Via: Drugs.com

The U.S. Food and Drug Administration is warning Americans to watch out for phony at-home, over-the-counter COVID-19 tests that look a lot like the real things. The counterfeit test kits may put you at risk of unknowingly spreading the disease […]


Biotech, Industry

Emerging Plant-based Platform for Biomanufacturing

May 2, 2022

Via: Biopharm International

In the midst of new emerging therapy projects under development, the progress of innovative manufacturing technologies is also growing. One of the newest emerging platforms for biologics manufacturing is the plant made pharmaceutical platform (PMP). PMP has come on-stage recently […]


FDA, Industry, Regulations, Vaccines

Lawmakers ask FDA to lay out plans for reviewing COVID vaccines for young children

April 26, 2022

Via: FiercePharma

Even though most people in the U.S. have been eligible for COVID-19 vaccines and boosters for quite some time, children under 5 still don’t have vaccine options. Now, lawmakers are asking the FDA to lay out its plans in this […]


Industry, Vaccines

Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

April 26, 2022

Via: Drugs.com

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through […]


FDA, Regulations

FDA Approves First COVID-19 Treatment for Young Children

April 25, 2022

Via: Drugs.com

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct SARS-CoV-2 […]


Industry, Vaccines

Poor countries reject COVID vaccines from AstraZeneca because of shorter shelf life: report

April 15, 2022

Via: FiercePharma

As supplies of COVID-19 vaccines have become more plentiful in poor nations, many are tuning down certain shipments. A document from the World Health Organization’s global vaccine supply effort COVAX shows that low-income countries have declined millions of doses of […]


Industry, Vaccines

Regeneron’s bid for COVID-19 drug’s full approval hits snag as FDA extends review

April 14, 2022

Via: FiercePharma

Just as Regeneron’s COVID-19 antibody combination, REGEN-COV, is sidelined in the U.S. thanks to omicron, the drug has hit a hiccup on its quest for a full FDA nod. The FDA has extended the review of REGEN-COV by three months […]