BioNTech
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Merck and Moderna are moving forward with a personalized cancer vaccine as Merck exercised its option to develop and commercialize mRNA-4157/V940, the companies announced Wednesday.
The FDA had a busy week, approving drugs, greenlighting clinical trials and other regulatory activities for Immuneering, Amylyx, Sarepta, Sanofi, and Regeneron and more.
The past week saw promising developments in candidate therapies for cancer, congenital hyperinsulinism, chronic cough and COVID-19 vaccines.
An AstraZeneca/Merck combination showed mostly positive ovarian cancer data, Adaptimmune posted a strong ORR in solid tumors and BioNTech revealed data from a CAR-T cell therapy.
On Wednesday, the FDA authorized new Omicron-specific booster shots for Pfizer-BioNTech and Moderna’s COVID-19 vaccines despite a lack of human data.
Moderna announced it is filing lawsuits against Pfizer and BioNTech, alleging that the companies’ COVID-19 vaccine infringes patents covering its mRNA technology.
A day after Pfizer and partner BioNTech submitted an EUA request to the FDA for their booster shot targeting Omicron variants BA.4 and BA.5, the regulator appears close to approving it.
Novavax seeks EUA for COVID-19 Booster, a 100-year-old TB vaccine may protect against the disease and public health officials struggle with fall planning.
Novavax released its second quarter financial results, showing a dramatic adjustment in its sales outlook, while BioNTech prepares to launch two variant-adopted bivalent shots.
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