Merck KGaA
German multinational science and technology company founded in 1668, the world's oldest operating chemical and pharmaceutical company; operates across Healthcare, Life Sciences, and Electronics divisions in 66 countries.
Clinical Trials
718
428 active
Approvals
15
Total approvals
Agencies
3
Regulatory bodies
Founded
1668
Active, not recruiting
427
59.5%
Approved For Marketing
1
0.1%
Completed
245
34.1%
Not yet recruiting
1
0.1%
Recruiting
2
0.3%
Terminated
36
5.0%
Unknown
1
0.1%
Withdrawn
4
0.6%
- Demand for in vitro models that more accurately reproduce native tissue environments is driving laboratories to shift from conventional cell culture to scaffold-free 3D platforms. - Scaffold-free systems let cells self-assemble into three-dimensional structures, preserving cell-to-cell interactions for cancer biology, stem cell, tissue engineering, toxicology and regenerative medicine research. - Academic institutions, hospitals, pharmaceutical manufacturers and biotechnology companies are integrating these models into research workflows, with market expansion forecast through 2033. - The market is segmented by technology, application, end use and region, with hanging drop microplates, spheroid microplates with ultra-low attachment coating and magnetic levitation as key technologies.
- TwoStep Therapeutics closed an oversubscribed $62.5 million Series A, bringing total capital raised to $71.2 million to fund oncology development. - The FDA cleared the IND for TS-104, a first-in-class multi-specific peptide-drug conjugate, allowing a first-in-human Phase 1 trial to begin. - TS-104 pairs a polyspecific integrin-binding peptide with the cytotoxic payload MMAE to target five tumor-associated integrins simultaneously. - The company says proceeds will also advance a radioligand therapy program and next-generation peptide conjugates built on the same PIP scaffold.
- EMD Serono, the US and Canada healthcare business of Merck KGaA, has acquired two AI-designed fertility programs from Boston-based PostEra for a mid-double-digit millions sum. - The programs comprise oral small molecule agonists of follicle-stimulating hormone receptor for IVF ovarian stimulation and luteinizing hormone/choriogonadotropin receptor for male infertility and ovulation trigger. - PostEra used its Proton AI platform to overcome historical hurdles in drugging these biologic-validated targets, including selectivity and metabolic stability, with both candidates still in preclinical development. - A combination of the two agonists could shift IVF protocols from injections to an all-oral regimen, while PostEra retains its polyendocrine metabolic ovarian syndrome program and plans trials next year.
- NICE has issued final draft guidance recommending mirdametinib (Ezmekly) for symptomatic plexiform neurofibromas associated with neurofibromatosis type 1 (NF1) in patients aged two to 17. - The recommendation extends drug treatment access to children as young as two for the first time, versus the prior age-three threshold for selumetinib (Koselugo). - Clinical evidence indicates mirdametinib can reduce tumour size with outcomes at least comparable to, and potentially better than, existing options, though based on indirect comparisons. - The oral MEK inhibitor, administered twice daily as a tablet or dissolvable liquid, is manufactured by Merck Serono and will require NHS funding within 30 days of formal publication.
- NetraMark Holdings Inc. has appointed Dr. Keith M. Fournier, PhD, RAC, a pharmaceutical executive with more than two decades of drug development and regulatory strategy experience, to its Board of Directors. - Dr. Fournier currently serves as Senior Vice President, Head of Regulatory Affairs at Abivax, and previously held senior leadership roles at AbbVie, EMD Serono (Merck KGaA), and MedImmune (AstraZeneca). - His experience includes leading cross-functional strategy for VENCLEXTA (venetoclax) programs and serving as Global Regulatory Lead for HUMIRA, spanning oncology, immunology, and autoimmune portfolios. - NetraMark's CEO George Achilleos stated that Dr. Fournier's regulatory and clinical development expertise will strengthen the Board as the company expands its NetraAI precision analytics platform across the pharmaceutical industry.
- GSK's new CEO Luke Miels is executing a three-year, multibillion-dollar restructuring to save roughly $2.5 billion annually ahead of looming patent expirations on blockbuster drugs like dolutegravir. - Novo Nordisk's Maziar Mike Doustdar is working to regain obesity-market momentum lost to Eli Lilly, buoyed by strong uptake of the Wegovy pill despite recent pipeline setbacks. - Sanofi's Dr. Belén Garijo is steering the company toward a post-Dupixent future, with the blockbuster facing loss of exclusivity as soon as 2031. - All three leaders took the helm within the last year at pivotal moments, each aiming to set up the next phase of growth for their companies.
- The Ministry of Food and Drug Safety of Korea (MFDS) is hosting Global Bio Conference 2026 from 26–28 August in Seoul under the theme "The Great Leap in Bio, Accelerating Innovation." - The 12th edition of the conference gathers roughly 5,000 regulators, industry leaders, and academic experts to discuss AI, advanced biopharmaceuticals, and global regulatory harmonization. - A newly launched "K-BIO Innovation Leaders Talk" session showcases Korean bio industry executives' strategies for entering global markets. - MFDS aims to strengthen international regulatory cooperation and support K-BIO innovation through science-based regulatory reform and global regulatory diplomacy.
- The global mRNA synthesis raw materials market was valued at USD 1.85 billion in 2025 and is projected to reach USD 3.89 billion by 2035, growing at a CAGR of 7.70%. - Nucleotides led the market by type with an approximate 38.50% share in 2025, while vaccine production dominated applications at roughly 85.00% of revenue. - North America held the largest regional share at approximately 38.50%, with the U.S. accounting for about 85.80% of North American revenue. - Growth is driven by expanding mRNA vaccine and therapeutic pipelines, rising demand for GMP-grade raw materials, and increasing adoption of GMP manufacturing practices.
- The global viral clearance market is valued at USD 1.0 billion in 2026 and is forecast to grow at a 16.9% CAGR, reaching USD 4.8 billion by 2036. - Viral removal methods, including filtration and chromatography, are projected to account for 51.0% of method demand in 2026, while recombinant proteins represent 34.0% of application demand. - FDA adoption of ICH Q5A(R2) in January 2024 has expanded risk-based viral safety validation requirements across established biologics and emerging modalities. - South Korea leads country-level growth at a 17.8% CAGR, supported by concentrated commercial biomanufacturing capacity projected to exceed 2.14 million liters by 2030.
- The global research use recombinant protein market is forecast to grow from USD 1.11 billion in 2026 to USD 1.55 billion by 2031, at a CAGR of 7.0%. - North America held the largest market share at 43.6% in 2025, supported by strong pharmaceutical R&D and advanced life science infrastructure. - Cytokines and chemokines dominated the product segment with a 25.9% share in 2025, driven by extensive use in immunology and cell research. - Thermo Fisher Scientific, Bio-Techne, and Merck KGaA emerged as leading market players based on strong product portfolios and market presence.
