BAYER AG

US-based v-Fluence Interactive, funded by the US government, profiles critics of pesticides and GM crops globally, including in India, raising privacy concerns. The firm's private social network, Bonus Eventus, contains over 500 profiles, including those of Indian activists Vandana Shiva and Debal Deb. v-Fluence denies allegations of secret profiling and misuse of data, claiming all information is publicly available. The firm's activities have sparked debate on data protection and scientific integrity in India.

Bayer submitted an sNDA to the FDA for expanded use of darolutamide with ADT in mHSPC, supported by phase 3 ARANOTE trial data showing a 46% reduced risk of progression or death. The trial demonstrated improved rPFS rates and a consistent safety profile for darolutamide plus ADT.

Bayer submits sNDA to FDA for darolutamide's third indication in mHSPC, based on ARANOTE trial results. Darolutamide, co-developed by Orion and Bayer, is already approved in mHSPC and nmCRPC, achieving blockbuster status with over €1 billion in sales.

The drug and biotech sector has outperformed the broader market, driven by new drug launches, pipeline successes, and increased M&A activity. Eli Lilly's obesity drugs have been particularly successful. Despite headwinds like pipeline setbacks and economic uncertainty, the sector has seen a surge in investments. Five large drugmakers—Pfizer, Eli Lilly, AstraZeneca, Bayer, and Sanofi—are recommended for portfolio growth, with strong financials and robust pipelines.

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Bayer submitted an sNDA to the FDA for darolutamide with ADT to treat mHSPC, supported by the ARANOTE trial showing a 46% reduced risk of progression or death. The trial met its primary endpoint with a 70.3% rPFS rate at 24 months for darolutamide plus ADT. Safety profiles were similar across treatment arms.

Bayer submitted an sNDA to the FDA for darolutamide, aiming to treat mHSPC with ADT. Darolutamide, marketed as Nubeqa™, has shown a 46% reduction in disease progression or death risk in Phase III ARANOTE trial. It's approved in over 80 markets for mHSPC and nmCRPC, with sales exceeding one billion euros by September 2024.

Avantor enters 10-year virtual power purchase agreement for 25GWh of renewable energy annually from 2026, supporting three new solar projects in Spain. The agreement reflects Avantor's commitment to reducing greenhouse gas emissions and lowering supply chain costs.

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.

A West Virginia judge rejected a preliminary injunction preventing Amgen from launching a biosimilar of Regeneron's eye drug Eylea, causing Regeneron stock to tumble. The FDA approved Amgen's Pavblu, which could launch at risk while the companies are in court. Regeneron plans to appeal, noting the decision only applies to Amgen and the standard dose of Eylea. The court battle could impact Eylea's Medicare negotiations under the Inflation Reduction Act.