Coronavirus

Pharma Execs Site Supply Chain Visibility To Boost Manufacturing

by Samantha McGrail

More than nine in 10 executives plan to implement a more robust digital supply chain visibility (SCV) solution over the next 12 months, according to a new report from FourKites. The Pharmaceutical...

Pfizer to Amend Clinical Study of COVID-19 Vaccine in Children

by Samantha McGrail

Pfizer and BioNTech recently announced that they will amend the clinical study evaluating the safety, tolerability, and immunogenicity of their COVID-19 vaccine in children. The Phase 1/2/3 trial...

Moderna’s COVID-19 Vaccine Booster Protects Against Omicron

by Samantha McGrail

Moderna recently announced that its COVID-19 vaccine booster increased neutralizing activity levels against the Omicron variant. The currently authorized 50-microgram booster of mRNA-1273...

CHMP Issues Positive Opinion of J&J’s COVID-19 Vaccine Booster

by Samantha McGrail

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recently issued positive opinion of Johnson & Johnson’s COVID-19 vaccine booster for...

J&J’s COVID-19 Vaccine Booster Increased Antibody, T-Cell Responses

by Samantha McGrail

Johnson & Johnson recently announced preliminary results from an independent study, which showed that a booster shot of its COVID-19 vaccine increased both antibody and T-cell responses. In the...

SAGE, WHO Support Johnson & Johnson COVID-19 Vaccine Booster

by Samantha McGrail

The Strategic Advisory Group of Experts on Immunization (SAGE) for the World Health Organization (WHO) recently supported using Johnson & Johnson’s COVID-19 vaccine booster shot in...

Roche, TIB Molbiol Develop More COVID-19 Tests To Identify Variant

by Samantha McGrail

Roche and TIB Molbiol recently added three additional research use only test kits to detect mutations present in the Omicron COVID-19 variant. The three test kits, VirSNip SARS Spike ins214EPE,...

3 Doses of Pfizer’s COVID-19 Vaccine Neutralizes Omicron Variant

by Samantha McGrail

Pfizer and BioNTech recently announced that their COVID-19 vaccine neutralized the SARS-CoV-2 Omicron variant after three doses. A month after receiving the booster vaccination, sera obtained...

J&J Considers Licensing COVID-19 Vaccine to South African Company

by Samantha McGrail

Johnson & Johnson recently announced a potential licensing agreement for its COVID-19 vaccine with Aspen SA Operations (Pty) Ltd, based in South Africa.  The companies will work towards a...

FDA Addresses Impacts of New Variant, Urges COVID-19 Vaccinations

by Samantha McGrail

FDA is working with federal partners and regulators to address potential impacts of the new Omicron variant and urges everyone to receive COVID-19 vaccinations or booster shots, according to an...

Johnson & Johnson Evaluates COVID-19 Vaccine Against New Variant

by Samantha McGrail

Johnson & Johnson recently announced that it will evaluate its COVID-19 vaccine against the new and rapidly spreading Omicron variant.  Specifically, Johnson & Johnson is testing blood...

Pfizer Confirms COVID-19 Vaccine Safety, Efficacy in Adolescents

by Samantha McGrail

Pfizer and BioNTech recently announced that their COVID-19 vaccine, BNT162b2, was 100 percent effective in adolescents 12 through 15 years of age in a longer-term analysis.  Researchers also...

CDC Expands COVID-19 Vaccine Booster Shots To All Americans

by Samantha McGrail

CDC Director Rochelle Walensky, MD, MPH, recently endorsed the CDC Advisory Committee on Immunization and Practices’ (ACIP’s) recommendation for COVID-19 vaccine booster shots to include...

US Gov’t Purchases 10M Courses of Pfizer’s COVID-19 Antiviral

by Samantha McGrail

The US government recently purchased 10 million courses of Pfizer’s COVID-19 antiviral candidate, PAXLOVID.  Under the terms of the agreement, the government will acquire 10 million...

FDA Expands Pfizer’s COVID-19 Vaccine Booster Authorization

by Samantha McGrail

FDA recently expanded the emergency use authorization (EUA) for a booster dose of the Pfizer-BioNTech COVID-19 vaccine to include individuals 18 years of age and older. Caregivers can administer the...

Pfizer, BioNTech, Zipline Deliver First COVID-19 Vaccines in Ghana

by Samantha McGrail

Pfizer, BioNTech, and instant logistics company, Zipline, collaborated to deliver authorized mRNA COVID-19 vaccines requiring ultra-cold-chain in Ghana.  The companies recently developed and...

J&J Increases Access To Its COVID-19 Vaccine Through COVAX

by Samantha McGrail

Johnson & Johnson recently entered into an agreement with the US government and Gavi, the Vaccine Alliance, to allow access to its single-shot COVID-19 vaccine through the COVAX Humanitarian...

CHMP Recommends Approval Of Roche’s COVID-19 Antibody Combination

by Samantha McGrail

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently recommended the approval of Roche’s COVID-19 antibody combination, Ronapreve. CHMP...

Merck’s COVID-19 Treatment Receives First Authorization in UK

by Samantha McGrail

Merck and Ridgeback Biotherapeutics recently announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized their COVID-19 treatment for adults. The UK’s...

Pfizer’s COVID-19 Treatment Reduces Hospitalization by 89%

by Samantha McGrail

Pfizer recently announced that its COVID-19 treatment, PAXLOVID, reduced hospitalization and death in high-risk adults with coronavirus by 89 percent compared to placebo.  In the Phase 2/3...