BAYER AG

CHMP recommended approval of Novartis' Kisqali for HR+/HER2- early breast cancer, based on NATALEE study data showing a 25.1% reduction in recurrence risk. Kisqali's safety profile was well-tolerated, and the EC will decide within two months. Kisqali could double eligible patients for CDK4/6 inhibitor therapy.

Rogaratinib and atezolizumab combo active in cisplatin-ineligible urothelial cancer patients overexpressing FGFR mRNA. 43% objective responses, 65% disease control. Recommended phase II dose: rogaratinib 600 mg twice daily plus atezolizumab 1,200 mg. Median PFS: 7.5 months (600 mg) vs 2.1 months (800 mg). Median OS: 16.8 months (600 mg) vs 8.3 months (800 mg).

Companies are developing radiolabeled antibody-drug conjugates (rADCs) to target cancer cells directly, reducing side effects and treatment times. rADCs, which use antibodies to deliver radiation to cancer cells, are seen as an emerging modality in oncology. Despite challenges like supply and delivery hurdles, clinical trials are progressing, with promising interim results and FDA orphan drug designations.

Roche refocuses R&D on obesity, Alzheimer's, and other major diseases to align with healthcare budget demands and market potential, following the success of drugs like Ozempic and Wegovy.

88% of EYLEA HD patients maintained ≥12-week dosing intervals at week 156, sustaining visual and anatomic improvements. EYLEA HD showed slower fluid reaccumulation and longer duration of action compared to EYLEA. Safety data remained consistent with known profiles.

FDA issued Bioresearch Monitoring Technical Conformance Guide v3.1 in Sept 2024, detailing BIMO section structure in NDA/BLA submissions, crucial for data transparency in clinical trial sections of CTD Module 5. The guide outlines Clinical Study-Level Information, Subject-Level Data Line Listings by Clinical Site, and Summary-Level Clinical Site Data Set, aiding FDA in BIMO inspections to ensure data integrity and accurate raw data location categorization.

Bayer seeks EMA approval for elinzanetant, a non-hormonal menopause drug targeting hot flashes, challenging Astellas’ Veozah. Success in Phase III trials could redefine treatment options, offering safer alternatives to hormone therapy.

Advances in precision medicine have transformed NSCLC treatment, with broad molecular testing now recommended. HER2 mutation, present in 3% of NSCLC patients, is associated with aggressive disease and brain metastases. No first-line HER2-targeted therapies are approved; current options include immunotherapy and platinum doublet. Zongertinib and BAY 2927088, oral HER2-targeted TKIs, show promise in pre-treated patients, with zongertinib demonstrating a 66.7% ORR and BAY 2927088 showing a 72.1% ORR. Both agents have been granted breakthrough therapy designation by the FDA.

Bayer will present research on menopause symptoms, focusing on sleep disturbances, at the 19th World Congress on Menopause. Elinzanetant, a nonhormonal treatment for vasomotor symptoms (VMS), is being studied for its effects on sleep disturbances. The FDA accepted Bayer's New Drug Application for elinzanetant, with a Prescription Drug User Fee Act date set for July 2025. Findings from the OASIS clinical trial program showed elinzanetant reduced VMS frequency and severity, with improvements in sleep disturbance and quality of life.

Pittsburgh Life Sciences Alliance identifies 'Data-Driven Healthcare and Connected Devices' and 'Next-Gen Therapeutics Development and Manufacturing' as growth platforms, leveraging regional strengths in AI, data science, and clinical research.