China’s medical products regulator has given conditional approval for Pfizer’s COVID-19 drug Paxlovid, making it the first oral pill specifically developed to treat the disease cleared in the country. The National Medical Products Administration said Paxlovid is approved to treat adults who have mild to moderate COVID-19 and high risk of progressing to a severe condition. Further study on the […]
Moderna, Inc., announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna’s mRNA COVID-19 vaccine, Spikevax, in a 50 µg dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years. The TGA authorization for the use of the COVID-19 vaccine in children 6-11 years old […]
Effective 1 January 2022 Pharmaceutical companies can now seek accelerated drug approvals in the UK using the newly launched Innovative Licensing and Access Pathway (ILAP). The new approval pathway marks a collaboration by multiple UK government entities, including the National Institute for Health and Care Excellence, the Medicines and Healthcare products Regulatory Agency (MHRA), the Scottish Medicines Consortium and the […]
Johnson & Johnson announced preliminary results from an independent study, including a subset of participants from the Janssen-sponsored COV2008 study, conducted by Dan Barouch, M.D., Ph.D., et al. of Beth Israel Deaconess Medical Center (BIDMC), which showed that a booster shot of the Johnson & Johnson COVID-19 vaccine (Ad26.COV2.S), administered at six months after a two-dose primary regimen of BNT162b2, […]
Roche has announced that the FDA has granted Emergency Use Authorization (EUA) for its COVID-19 At-Home Test. The test uses a simple anterior nasal swab sample that can be conveniently self-collected and self-tested by individuals aged 14 years and older, and by an adult for children aged 2-13 years old. The test is able to produce accurate, reliable and quick […]
Regeneron Pharmaceuticals, Inc. announced that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV in the U.S. and Ronapreve in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who […]
Moderna, Inc. provided an update that the FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s Emergency Use Authorization (EUA) request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age. The FDA has informed Moderna that the agency […]
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as 5 to <12 years). For this age group, the vaccine is to be administered in a two-dose regimen of 10-µg doses given 21 days apart. The 10-µg dose level was […]
-Moderna Inc. announced positive interim data from the Phase II/III study, called the KidCOVE study, of mRNA-1273 , the Company’s vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. Moderna plans […]
Moderna, Inc. confirmed that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and […]
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