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Pfizer has filed its application with the FDA for Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, Paxlovid, for the treatment of mild-to-moderate COVID-19 in patients at increased risk of hospitalization or death. Read More
Faced with defending its COVID-19 vaccine in the face of troubling side effects, Moderna held a conference call late last week to discuss the risk of heart inflammation in young people. Read More
The European Medicines Agency (EMA) has given the thumbs up to two COVID-19 antibody therapies from Regeneron-Roche and Celltrion Healthcare, paving the way for imminent approval by the European Commission. Read More
The European Medicines Agency (EMA) has recommended including transverse myelitis, a rare form of spinal inflammation, to the list of Johnson & Johnson (J&J) COVID-19 vaccine side effects. Read More
AstraZeneca is setting up a new business unit dedicated to overseeing its vaccines and antibody therapies as it looks to rebound from pandemic-era disappointments related to its COVID-19 jab co-developed with Oxford University. Read More
Moderna and the National Institutes of Health (NIH) are in a patent dispute over the company’s messenger RNA (mRNA)-based COVID-19 vaccine developed with the aid of government scientists. Read More
Pfizer and BioNTech are seeking an amended Emergency Use Authorization (EUA) from the FDA allowing their COVID-19 vaccine booster for general use in adults over age 18. Read More
A single dose of Regeneron’s COVID-19 antibody cocktail, REGEN-COV, slashed the risk of contracting the coronavirus by 81.6 percent up to eight months after treatment in a phase 3 trial. Read More
Following a year in which vaccine manufacturing plant Emergent BioSolutions spent many months in the headlines for botching 75 million Johnson & Johnson (J&J) COVID-19 vaccines, the federal government and the troubled company have parted ways. Read More
Pfizer’s investigational antiviral, Paxlovid (07321332 plus ritonavir) cut the risk of COVID-19 associated hospitalizations and death by 89 percent compared to placebo in an interim analysis of a phase 2/3 study, the company announced Friday. Read More
Indonesia, which has a population of more than 273 million, has already granted emergency use approval to the vaccine, to be manufactured by the Serum Institute of India. Read More
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