Bayer AG is a German multinational pharmaceutical and biotechnology company headquartered in Leverkusen, Germany. Founded in 1863, it is one of the world's largest pharmaceutical and biomedical companies.
Bayer’s sevabertinib has obtained domestic approval as an imported rare drug for HER2-mutant non-small cell lung cancer. The oral reversible HER2-targeted TKI was previously approved by the FDA for previously treated patients.
Pharmaceutical companies are delaying European drug launches due to uncertainty over U.S. pricing policies under President Trump. New drug launches in EU markets fell 35% following Trump's executive order on international reference pricing. Companies fear lower European prices could undermine their ability to maintain higher prices in the $700 billion U.S. market.
Bayer achieved its upgraded 2025 financial targets with group sales reaching 45.6 billion euros and projects solid 2026 performance. The company's pharmaceutical business shows rejuvenation with launch medicines becoming growth drivers, while Crop Science progresses in profitability improvement. Bayer continues strategic diversification in oncology and addresses litigation challenges while implementing cost-saving measures.
Bayer's Phase III FIND-CKD trial shows finerenone significantly slows kidney function decline in non-diabetic chronic kidney disease patients. The drug met its primary endpoint with improved eGFR slope over 32 months, marking its fifth consecutive positive Phase III trial. Bayer plans to submit the data to the FDA for label expansion into non-diabetic CKD.
Zydus Lifesciences launched ANYRA, India's first indigenously developed aflibercept biosimilar, on February 19, 2026, following an agreement with Regeneron Pharmaceuticals and Bayer for multiple ophthalmic indications.
The global radioligand therapy market is projected to grow from $2.6 billion in 2025 to $4.8 billion by 2030 at 13.1% CAGR, driven by FDA label expansions, earlier-line treatment positioning, and substantial private investment in isotope production infrastructure.
The FDA approved Bracco's Vueway for neonates and infants at half the standard gadolinium dose, accepted Bayer's gadoquatrane application for a 60% dose reduction, and granted Breakthrough Device designation to Radiology Partners' AI chest X-ray tool.
Maryland-based CDMO Xcellon Biologics introduces the Xcellerate Program to provide early-stage biotech companies with reduced-cost development support for complex biologics and antibody-drug conjugates, addressing the funding gap between seed stage and institutional investment.
Finerenone met its primary endpoint in reducing albuminuria in type 1 diabetic kidney disease, marking the first successful drug trial in 30 years for this population. Separately, SGLT2 inhibitors showed superior kidney protection compared to GLP-1 medications in type 2 diabetes patients.
Samsung Bioepis reached settlement agreements with Regeneron and Bayer for its aflibercept biosimilar OPUVIZ, enabling U.S. launch in January 2027 and staged international rollout beginning early 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07591038 |
PET/CT Imaging in Carriers of TTR Mutations |
NOT_YET_RECRUITING | |
| NCT07582328 |
A Study to Learn More About How Well Oxymetazoline HCl 0.05% Nasal Gel Works and How Safe It Is in Healthy Adults |
RECRUITING | PHASE2 |
| NCT07566429 |
A Study of AB-1005 Gene Therapy in Japanese Adults With Moderate Parkinson's Disease |
NOT_YET_RECRUITING | PHASE2 |
| NCT07557147 |
Single-arm, Multi-center Study Evaluating the Acceptance and Feasibility of a Digital Remote Monitoring Tool Configured for Patients With ATTR-CM: ACO-Monitor |
NOT_YET_RECRUITING | |
| NCT07554469 |
An Observational Study, Called FINEXPLORER, to Learn More About How Well Finerenone Works in Adults in Spain With Chronic Kidney Disease (CKD) Linked to Type 2 Diabetes, by Looking at Changes in a CKD Risk Score |
NOT_YET_RECRUITING | |
| NCT07538843 |
An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment |
NOT_YET_RECRUITING | |
| NCT07535112 |
A Study to Learn More About How Safe BAY 3771249 is and How Well it Works in People With Advanced or Metastatic Colorectal Cancer That Has a KRAS G12D Mutation |
RECRUITING | PHASE1 |
| NCT07515339 |
A Study to Learn More About How Safe Nurandociguat is and How it Affects the Way the Body Processes Rosuvastatin and Dabigatran in Healthy Adults |
WITHDRAWN | PHASE1 |
| NCT07490431 |
An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States |
NOT_YET_RECRUITING | |
| NCT07472595 |
Effect of Vericiguat on cardiAc Remodeling in Patients With Heart faiLure and Reduced Ejection fractioN (HFrEF): A Prospective sTudy usIng NOvel Echocardiographic Imaging Techniques (VALENTINO) |
COMPLETED |
