BioNTech
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Pfizer and BioNTech reported positive data Friday from their Omicron BA.4/BA.5-adapted bivalent booster. This followed a similar announcement by Moderna Monday.
The FDA has numerous activities and interactions with Phanes, Prestige Biopharma, Reata, Pfizer and more, providing clearance, approving clinical trials and other regulatory actions.
Pfizer and BioNTech released early data Thursday morning from a Phase II/III trial assessing an Omicron-specific booster that showed it provided significant protection, confirming early research.
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.
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