BAYER AG

The global Rx-to-OTC switches market is projected to reach USD 66.5 billion by 2033, driven by consumer convenience, cost-effectiveness, and regulatory support.

WBCSD, with PwC UK and leading pharma companies, is developing a Roadmap to Nature Positive for the pharmaceutical sector. A draft Overview is open for public consultation until 18 Nov 2024, aiming to guide the sector towards halting and reversing nature loss by 2030, with a final Roadmap expected in early 2025.

AI is revolutionizing drug discovery, from designing molecules to predicting protein structures, significantly reducing costs and timelines. AI-derived drugs have shown higher success rates in clinical trials, with companies like Exscientia and Insilico Medicine leading the charge. Key AI technologies include machine learning, deep learning, NLP, and generative models, transforming stages from target identification to clinical trials. Challenges include data quality, validation, and integration, but the future promises more personalized medicine and effective treatments.

The U.S. OTC drugs market is projected to grow from USD 42.80 billion in 2024 to USD 53 billion by 2029, driven by high Rx drug costs and increased OTC approvals. Dermatology and tablets segments are expected to lead growth. Key players include Johnson & Johnson, Novartis, Bayer, Sanofi, and Pfizer.

AstraZeneca and Ionis' Wainzua, a treatment for ATTR polyneuropathy, is set for EU approval after EMA's CHMP positive opinion. Wainzua, already approved in the US and Canada, reduces TTR levels by 82% and slows neurological impairment progression. It is also being developed for ATTR cardiomyopathy and is seen as a key drug for AZ's CVRM unit. Wainzua competes with Alnylam's Onpattro and Amvuttra, and Pfizer's Vyndamax/Vyndaqel.

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.