Infectious disease

RSV
Following news of RSV lower respiratory tract infections in infants immunized with Moderna’s investigational RNA vaccines, FDA advisors said the trial investigators should continue the study, while keeping an eye out for further safety signals.
Pourhassan and Kazempour are awaiting sentencing but could face up to 20 years in prison for each count of securities and wire fraud and insider trading.
By speeding lifesaving drugs’ way to market and focusing on the underlying causes of disease, the pathway has helped save many lives.
A judge in the U.K. last month sided with Pfizer over GSK in a respiratory syncytial virus vaccine patent lawsuit, positioning both companies to compete for that market and laying down a marker for ongoing legal clashes in other parts of the world.
FDA
Novavax’s shared jumped 12% in pre-market trading on the news.
While Moderna’s Spikevax beat Wall Street estimates in the third quarter, William Blair analyst Myles Minter in a Thursday note to investors said sales of the company’s respiratory syncytial virus vaccine mRESVIA was significantly lower than expected.
BMO Capital Markets analyst Evan Seigerman in a note to investors called Gilead’s third-quarter performance “consistent” and “steady,” while noting the company continues to demonstrate “reliable strength” in its human immunodeficiency virus business.
Driven by the early approval of its updated COVID-19 vaccine, BioNTech far exceeded analysts’ expectations in the third quarter and reported its first quarterly profit in 2024. However, the German biotech also cut its outlook for the year.
CEO Albert Bourla, who is under attack from activist investor Starboard Value, got a much-needed victory on Tuesday as Pfizer reported that third-quarter revenue and adjusted profit beat the analysts’ consensus.
Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeutics’ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders.
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