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Factory-CRO, a medical device CRO based in the Netherlands, has announced a new early-detection program designed to help medical device companies correct poorly designed clinical trials, effectively saving the study from ultimately being rejected by the FDA or European regulators.
Eli Lilly and Immunocore, a privately owned, clinical-stage biotechnology company, have entered into a co-discovery and co-development collaboration to research and potentially develop novel T cell-based cancer therapies.
The Clinical Conductor CTMS team has launched CTMS configurations for Clinical Conductor. These configurations are designed for research sites, site networks, CROs, hospitals, health systems and sponsors. With CTMS configurations, Clinical Conductor now provides unique feature sets and functionalities required by different types of research organizations to operate most effectively.
CRO Theorem Clinical Research and Excel Life Sciences (ELS) have formed a strategic relationship to bolster Theorem’s clinical development offerings in India, including local site management experience. ELS has long-standing relationships with more than 1,000 hospitals and research centers across 25 cities throughout India, covering a broad range of therapeutic disciplines.
CEL-SCI has been awarded a phase I Small Business Innovation Research (SBIR) grant for $225,000 from the National Institute of Arthritis Muscoskeletal and Skin Diseases (NIAMS), part of the NIH. The grant will fund the further development of CEL-SCI’s LEAPS technology as a potential treatment for rheumatoid arthritis (RA), an autoimmune disease of the joints. According to Visiongain, the world RA drug market will generate revenues of $38.5 billion in 2017.
Harlan Laboratories, a privately held provider of general and specialty toxicology services through its Contract Research Services (CRS) business, and Fluofarma, a CRO specializing in high content analysis, have partnered to strengthen the companies’ drug discovery and translational medicine services.
Chiltern, a 32-year-old global CRO specializing in oncology services and a range of other therapeutic areas, has acquired Ockham, a 28-year-old oncology-focused CRO, and the two companies will merge their operations.
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)
Status: Completed, Condition Summary: Alzheimer's Disease
Veniti, a provider of innovative technology for the treatment of venous disease, announced has received approval from the FDA for an Investigational Device Exemption (IDE) to begin the VIRTUS trial of the VENITI VICI Venous Stent System. The VICI Venous Stent System was designed from inception to be compatible with the unique anatomy and pathophysiology of the venous system. Hundreds of thousands of people around the world suffer from lower-extremity venous disease, and until recently, the only treatment options available involved the use of re-purposed vascular stents originally designed for use in the arterial system.
Sunovion Pharmaceuticals Canada has announced that Health Canada approved APTIOM (eslicarbazepine acetate) for use as a once-daily adjunctive therapy for the treatment of partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy. APTIOM is not indicated for use in patients under 18 years of age.
Covance has announced two key additions to its clinical development services scientific leadership team with the appointments of Robert Wasserman, M.D., as vice president and global therapeutic area head, oncology, and Rogelio Mosqueda-Garcia, M.D., Ph.D., as global vice president, early clinical services within medical and scientific affairs. Both are based in Princeton, N.J.
Merck's biopharmaceutical division has appointed Luciano Rossetti, M.D., executive vice president and global head of R&D as of July 21.
Following discussions with AbbVie, Shirerequested and has received a further revised proposal from AbbVie on July 13 for a total offering of $53 billion.
Abbott will sell its non-U.S. developed markets branded generics pharmaceuticals business to Mylan for 105 million shares, or approximately 21%, on a fully diluted basis, of a newly formed entity that will combine Mylan's existing business and Abbott's developed markets pharmaceuticals business. The new entity will be a publicly traded company. This represents a value of approximately $5.3 billion based on Mylan's closing stock price on Friday.
HD Biosciences (HDB), a Shanghai-based, biology-focused preclinical drug discovery CRO, the Marshall Institute for Interdisciplinary Research (MIIR) and the Marshall University Joan C. Edwards School of Medicine have announced a new partnership to co-develop potential anti-cancer drugs.
inVentiv Clinical Trial Recruitment Solutions (iCTRS), created to accelerate trials, and the Alliance for Clinical Research Excellence and Safety (ACRES), an alliance-driven nonprofit organization dedicated to enhancing quality, safety, integrity and operational effectiveness in drug development and health research, are partnering to fast track the development of a global system to support responsible conduct of clinical trials according to the highest standards of safety, quality and efficiency.