Results for: Bayer

Bayer AG has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant, a potential new treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause. This follows the FDA’s acceptance of Bayer’s marketing application for elinzanetant last week. The EMA submission is based on positive results from the Phase 3 OASIS clinical trials, which demonstrated a statistically significant reduction in the frequency of hot flashes compared to placebo.

Bayer AG announced positive results from the Phase 3 ARANOTE trial for darolutamide, demonstrating a significant reduction in the risk of disease progression or death in patients with metastatic hormone-sensitive prostate cancer (mHSPC). These findings could lead to expanded use of darolutamide for mHSPC patients.

A bill that aims to protect Bayer from costly lawsuits over its weedkiller Roundup has passed the Missouri House of Representatives. The legislation, which now moves to the Senate, would declare that federally approved pesticide labeling is sufficient to satisfy any requirement for a cancer warning label. Bayer, which acquired Roundup’s original producer Monsanto, faces thousands of lawsuits alleging that the product’s key ingredient, glyphosate, causes non-Hodgkin’s lymphoma. While some studies suggest a link between glyphosate and cancer, the U.S. Environmental Protection Agency maintains that it is not likely to be carcinogenic when used as directed. Bayer has set aside $16 billion to settle claims but continues to dispute the allegations. Supporters of the legislation argue that it is necessary to protect Bayer and ensure the availability of Roundup for farmers. Opponents contend that the bill prioritizes corporate interests over public health.