BAYER AG

The global oncology precision medicine market was valued at USD 53.2 billion in 2023 and is expected to grow at a 10.4% CAGR from 2024 to 2032, driven by rising cancer incidence and increasing demand for personalized therapies. Key segments include breast cancer, oral administration, small molecules, and kinase inhibitors. North America leads in market share, with the U.S. accounting for USD 19.7 billion in 2023. Prominent companies include AbbVie, AstraZeneca, and Pfizer, with recent strategic acquisitions enhancing their oncology portfolios.

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Bayer submitted an MAA to EMA for elinzanetant, seeking approval for treating moderate to severe VMS associated with menopause or adjuvant endocrine therapy. The submission is based on OASIS phase III studies showing elinzanetant's efficacy and safety. The FDA also accepted Bayer's NDA for elinzanetant, and Bayer continues global submissions. Bayer aims to strengthen its pharmaceutical portfolio through new drug approvals.

Johnson & Johnson's cancer drug sales, led by Darzalex, exceed expectations. Bayer seeks EMA approval for elinzanetant, a menopause relief drug. FDA approves CMR Surgical's Versius System for gall bladder removal, highlighting advancements in minimally invasive surgeries.

Bayer submits application to EMA for darolutamide, an oral ARi, in combination with ADT for metastatic hormone-sensitive prostate cancer (mHSPC). Darolutamide, already approved in mHSPC and nmCRPC, aims to extend survival and delay disease progression while maintaining daily living. Phase III ARANOTE trial results show significant reduction in radiological progression or death risk by 46% compared to placebo plus ADT. Darolutamide, developed jointly by Bayer and Orion Corporation, exhibits strong antagonistic activity against the androgen receptor, minimizing side effects.

Bayer submitted a marketing authorisation application to the EMA for its menopause treatment elinzanetant, indicated for moderate to severe hot flashes, including those from adjuvant endocrine therapy. The submission follows an FDA acceptance of Bayer's NDA for elinzanetant. Elinzanetant, a non-hormonal therapy, demonstrated efficacy and safety in Phase III OASIS trials, reducing hot flash frequency and improving sleep and quality of life. Bayer aims to offer personalized care for menopausal symptoms, positioning elinzanetant to compete with Astellas' Veozah.

Bayer AG submitted an MAA to the EMA for elinzanetant to treat moderate to severe VMS associated with menopause, based on Phase 3 OASIS program results. Elinzanetant demonstrated a significant reduction in VMS frequency and improved sleep disturbances and quality of life over 52 weeks.

Bayer seeks EMA and FDA approval for darolutamide plus ADT in metastatic hormone-sensitive prostate cancer, supported by ARANOTE trial data showing significant radiographic progression-free survival benefits.