AstraZeneca

FDA approves FluMist, a needle-free, at-home flu vaccine for individuals 2-49 years old, to be available for home use by fall 2025. Common side effects include fever, nasal congestion, and sore throat.

The FDA approved self-administered nasal spray flu vaccine FluMist for adults and caregivers, available for ages 2-49. It contains live-attenuated virus, effective at 45%, similar to flu shots. Home use expected by 2025, currently administered by health providers. Not recommended for pregnant women, immune-compromised, or those on aspirin. Side effects include nasal congestion and fever. Easy self-administration aims to boost vaccination rates.

New entrants challenge Novo Nordisk and Eli Lilly in the $200 billion GLP-1 market, with 68% of sales from weight loss by 2031. Novo and Lilly expected to retain 70% of the market but are viewed as overvalued. Next-gen obesity drugs from Roche, Amgen, Pfizer, AstraZeneca, Boehringer, and others will disrupt the market, pressuring pricing. Novo and Lilly's next-gen pipelines also advancing. Public and private firms accelerating obesity drug development through acquisitions and innovative startups.

S.K., D.A.M., J.P., H.S., X.Z., P.H., T.X., and H.S. have financial ties to various pharmaceutical companies, including stock ownership and advisory roles. F.C., J.D., E.V.C., H.S.W., T.Y., R.Y., and J.T. also report consulting or advisory roles and research funding from multiple institutions and companies.

UK-based Vicebio raised $100m in Series B funding led by TCGX to advance its RSV and hMPV vaccine VXB-241 to Phase I trials, utilizing its 'molecular clamp' technology for enhanced immune response.

The phase 3 TROPION-Breast01 study found datopotamab deruxtecan (Dato-DXd) did not significantly improve overall survival (OS) vs chemotherapy in HR-positive, HER2-low or HER2-negative breast cancer patients. However, Dato-DXd did significantly improve progression-free survival (PFS) with a median PFS of 6.9 months vs 4.9 months with chemotherapy. The FDA is currently evaluating a biologics license application for Dato-DXd in this patient population, with a decision expected in Q1 2025.

FDA approves first self-administered flu vaccine, FluMist, for home use. Available for ages 2-49, it requires a prescription and will be ready for next flu season. Not recommended for immune-compromised, pregnant individuals, or those with severe allergies or previous severe reactions. Common side effects include fever, nasal congestion, and sore throat.

FDA approves home use of FluMist nasal spray flu vaccine, offering convenience and accessibility. FluMist, effective for ages 2-49, addresses logistical and needle phobia issues, though not for immunocompromised or pregnant women. Available from 2024, it requires a prescription and aims to improve vaccine compliance.

AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) missed overall survival (OS) goal in Phase III TROPION-Breast01 study, despite showing significant progression-free survival (PFS) benefits. The companies will continue regulatory discussions and apply study insights to inform future clinical development.

Senator Bernie Sanders will lead a Senate HELP Committee hearing on Ozempic and Wegovy prices, focusing on price controls despite R&D costs and potential harm to medical innovation. The hearing aims to address the high cost of these diabetes medicines, but critics argue it overlooks the significant R&D investments required and the broader implications for future drug development.