BAYER AG
🇩🇪Germany
- Country
- 🇩🇪Germany
- Ownership
- Public
- Established
- 1863-08-01
- Employees
- 99.7K
- Market Cap
- $30.1B
- Website
- http://www.bayer.com
Moderna Withdraws FDA Application for Flu-COVID Combo Vaccine, Plans Resubmission Later This Year
• Moderna has voluntarily withdrawn its Biologics License Application (BLA) for mRNA-1083, a combination flu and COVID-19 vaccine candidate for adults 50 and older, after consultation with the FDA.
• The company plans to resubmit the application later in 2025 after obtaining vaccine efficacy data from an ongoing Phase 3 trial of its seasonal influenza vaccine candidate, mRNA-1010.
• Interim data from the mRNA-1010 Phase 3 trial is expected to be available this summer, which will inform the resubmission strategy for the combination vaccine.
FDA Expands Jivi Approval for Hemophilia A Treatment in Children Ages 7-12
• The FDA has approved Bayer's Jivi (antihemophilic factor recombinant, PEGylated-aucl) for pediatric patients aged 7 to 12 years with hemophilia A, expanding treatment options for this age group.
• The approval was based on data from the Alfa-PROTECT and PROTECT Kids studies, which demonstrated the safety and efficacy of Jivi in pediatric patients with severe hemophilia A.
• Jivi was previously approved in 2018 for adults and adolescents aged 12 and older, and can be used for on-demand treatment, perioperative management, and routine prophylaxis to reduce bleeding episodes.
Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities
• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform.
• The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business.
• Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.
Trump's "Most Favored Nation" Drug Pricing Policy Threatens German Pharma Industry
• President Trump's executive order implementing a "Most Favored Nation" pricing policy could slash U.S. drug prices by 30-80%, sending shockwaves through the global pharmaceutical industry.
• German pharmaceutical giants like Merck and Bayer face significant threats, with Simon-Kucher consultancy projecting potential 64% drops in U.S. pharmaceutical sales and 37% global declines.
• A Deloitte study warns that a 35% U.S. tariff on drug imports could reduce German pharmaceutical exports to the U.S. by 53%, potentially causing industry losses of up to €13.4 billion over 3-4 years.
Acadia Pharmaceuticals Wins Patent Infringement Case Against Aurobindo for Parkinson's Drug Nuplazid
• A U.S. District Court ruled that Aurobindo Pharma infringes on two key patent claims held by Acadia Pharmaceuticals for its Parkinson's disease drug Nuplazid.
• The court rejected Aurobindo's arguments that Acadia's patent claims were invalid, providing significant intellectual property protection for Acadia's flagship product.
• Following the favorable ruling, Acadia's stock soared by over 34% to a one-year high of $23.61, reflecting investor confidence in the company's market position.
Armata's Bacteriophage Therapy Shows Promising Results in Treating Staphylococcus aureus Bacteremia
• Armata Pharmaceuticals' Phase 1b/2a diSArm trial demonstrated that AP-SA02, a novel intravenous bacteriophage therapy, met all primary endpoints for safety, tolerability, and clinical response in complicated Staphylococcus aureus bacteremia.
• The bacteriophage therapy significantly improved clinical outcomes compared to best available antibiotic therapy alone, with 100% of AP-SA02-treated patients responding at end of study versus 75% in the placebo group (p=0.020).
• AP-SA02 was well-tolerated with no serious adverse events related to the study drug, showing efficacy against both methicillin-sensitive and methicillin-resistant S. aureus infections, marking a breakthrough in phage therapy for systemic bacterial infections.
Pfizer to Showcase Breakthrough Cancer Therapies at ASCO 2025 with Over 60 Presentations
• Pfizer will present data from more than 60 abstracts at ASCO 2025, including 15 oral presentations highlighting advancements across breast, genitourinary, hematologic, thoracic, and colorectal cancers.
• Two late-breaking presentations will be featured in ASCO's press program, including pivotal survival data for BRAFTOVI in colorectal cancer and progression-free survival results for vepdegestrant in metastatic breast cancer.
• The company will showcase novel antibody-drug conjugate combinations with immunotherapy and present five-year survival data for XTANDI in prostate cancer, supporting Pfizer's goal of delivering eight breakthrough cancer medicines by 2030.
Vividion Therapeutics Initiates Phase I Trial of Novel RAS-PI3Kα Inhibitor for Advanced Solid Tumors
• Vividion Therapeutics has dosed the first patient in a Phase I trial of VVD-159642, an oral inhibitor targeting the RAS-PI3Kα pathway implicated in approximately 20% of all cancers.
• The study will evaluate VVD-159642 as both monotherapy and in combination with sotorasib or trametinib in patients with advanced solid tumors, potentially offering a new treatment approach for RAS-driven cancers.
• VVD-159642 represents Vividion's fourth clinical-stage program from its chemoproteomics platform, designed to selectively inhibit oncogenic signaling while avoiding toxicities that have limited previous attempts to target this pathway.
Brain Hemorrhage Treatment Market Expected to Grow Significantly by 2032 as AI Solutions Gain FDA Approval
• The brain hemorrhage treatment market is projected to experience substantial growth through 2032, driven by an aging population and increasing prevalence of risk factors such as hypertension and traumatic brain injuries.
• Recent FDA approvals for AI-based diagnostic tools, including JLK-LVO and Heuron ICH, mark significant advancements in early detection and treatment of brain hemorrhages.
• Several pharmaceutical companies including Baxter, Pfizer, and Novartis are developing promising pipeline therapies such as tissue plasminogen activator, alteplase, and BAF312 to address the significant unmet needs in brain hemorrhage treatment.
Novo Nordisk Launches Home Delivery Service for Wegovy at $499 Monthly for Cash-Paying Patients
• Novo Nordisk introduces NovoCare Pharmacy, a direct-to-patient delivery service offering all Wegovy dose strengths at $499 per month for cash-paying and eligible commercially insured patients without coverage.
• The launch comes as Wegovy supply stabilizes, with FDA confirming Novo Nordisk can now meet market demand following previous shortages that limited new prescriptions since 2022.
• Currently, over 55 million Americans have coverage for weight management medicines, with 90% of insured Wegovy patients paying $0-$25 monthly for their prescriptions.
AskBio's AB-1005 Gene Therapy for Parkinson's Disease Gains FDA RMAT Designation and Enrolls First Phase II Participants
• AskBio's AB-1005, a gene therapy for Parkinson's disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA, potentially expediting its development.
• The RMAT designation was supported by positive 36-month Phase Ib data, demonstrating a favorable safety profile and encouraging trends in clinical outcome measures.
• The Phase II REGENERATE-PD trial, evaluating AB-1005 in moderate-stage Parkinson's, has randomized its first participants across sites in the US, with plans to expand to Europe.
• AB-1005 delivers glial cell line-derived neurotrophic factor (GDNF) to promote the survival of dopaminergic neurons, addressing a critical unmet need in Parkinson's treatment.
Bayer's Elinzanetant Shows Promise in Reducing Hot Flashes for Breast Cancer Patients
• Elinzanetant met primary endpoints in the Phase III OASIS 4 trial, significantly reducing the frequency of moderate to severe vasomotor symptoms (VMS) in women undergoing endocrine therapy for breast cancer.
• The study also achieved secondary endpoints, demonstrating a reduction in the severity of VMS, improvements in sleep disturbances, and enhanced menopause-related quality of life compared to placebo.
• Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist, representing a potential non-hormonal treatment option for VMS in breast cancer patients and women at high risk.
• Bayer is advancing regulatory submissions for elinzanetant in the US, EU, and other global markets, with potential launch expected later this year, pending regulatory approvals.
Biopharma Industry Faces Continued Layoffs in 2025 Amid Strategic Realignments
• Biopharma companies continue to announce layoffs in 2025, driven by strategic realignments, pipeline reprioritizations, and challenging financial conditions.
• Several companies, including Intellia Therapeutics and IGM Biosciences, are cutting a significant portion of their workforce to focus on key programs and extend cash runways.
• These workforce reductions are often accompanied by discontinuation of certain drug development programs and a shift in strategic focus towards core assets.
• The layoffs reflect a broader trend in the industry as companies adapt to evolving market dynamics and prioritize efficiency and long-term sustainability.
mRNA Cancer Vaccines Show Promise in Clinical Trials, Aiming for Personalized Immunotherapy
• Over 60 mRNA cancer vaccine candidates are in clinical trials, signaling a transformative shift in cancer treatment.
• BioNTech's BNT111, targeting melanoma-associated antigens, shows positive Phase 2 data when combined with cemiplimab.
• Personalized mRNA vaccines, like Moderna's mRNA-4157, are being explored in combination with PD-1 therapies for various cancers.
• The first commercial mRNA cancer vaccine is expected by 2029, driven by technological advancements and increased investment.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
Pharma Stock Roundup: Novo Nordisk's Obesity Study Disappoints, Lilly's Zepbound Approved for Sleep Apnea
• Novo Nordisk's CagriSema obesity treatment showed a 22.7% weight loss in Phase III, falling short of the anticipated 25% reduction, impacting stock prices.
• Eli Lilly's Zepbound (tirzepatide) received FDA approval for moderate-to-severe obstructive sleep apnea (OSA), marking it as the first drug for obesity-related OSA.
• AstraZeneca and Daiichi Sankyo withdrew their EU application for Dato-DXd in non-small cell lung cancer (NSCLC) but pursue U.S. approval for EGFR-mutated NSCLC.
• Pfizer's Braftovi gained FDA approval in combination with Erbitux and mFOLFOX6 for first-line treatment of metastatic colorectal cancer with BRAF mutations.
Eylea HD Shows Promise in Macular Edema Following Retinal Vein Occlusion
• Eylea HD (aflibercept 8 mg) demonstrated non-inferior visual acuity gains compared to Eylea (aflibercept 2 mg) in patients with macular edema following retinal vein occlusion.
• The Phase 3 QUASAR trial showed that Eylea HD, dosed every 8 weeks, achieved similar vision improvements to Eylea, dosed every 4 weeks.
• A significant portion of patients on Eylea HD were able to maintain an 8-week dosing regimen, potentially reducing the burden of frequent injections.
• Regeneron plans to submit these data to regulatory authorities, seeking approval for Eylea HD in this indication, offering a less frequent treatment option.
Finerenone sNDA Submitted to FDA for Heart Failure with Preserved Ejection Fraction
• Bayer has submitted a supplemental New Drug Application (sNDA) to the FDA for finerenone to treat heart failure patients with LVEF ≥40%.
• The sNDA is based on the Phase III FINEARTS-HF trial, which demonstrated a 16% reduction in cardiovascular death and heart failure events.
• Finerenone is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) already approved for chronic kidney disease in type 2 diabetes.
• If approved, finerenone could address a significant unmet need in heart failure patients with mildly reduced or preserved ejection fraction.
AI Poised to Transform Pharmaceutical Industry with $208 Billion Investment by 2030
• The pharmaceutical sector is projected to invest over $208 billion in AI technologies by 2030, marking a significant shift in drug development and clinical research processes.
• Integration of AI with wearable technologies, electronic health records, and medical devices is enabling real-time patient monitoring and more efficient clinical trials.
• Despite rapid AI adoption in healthcare, nearly 50% of pharmaceutical executives report a shortage of skilled AI professionals, highlighting critical workforce development needs.
MHRA and NHS England Fast-Track Novel Prostate Cancer Treatment Darolutamide Combination Therapy
• A groundbreaking combination therapy of NUBEQA (Darolutamide) with ADT and docetaxel receives accelerated approval from MHRA through Project Orbis for metastatic hormone-sensitive prostate cancer treatment.
• Clinical trial data demonstrates significant efficacy with a 32.5% reduced risk of death in metastatic hormone-sensitive prostate cancer patients, based on the Phase 3 ARASENS study of 1,305 participants.
• NHS England becomes the first European healthcare system to provide early access to this innovative treatment while NICE assessment is pending, following a commercial agreement with Bayer.
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