Industry News

Factory-CRO launches clinical trial rescue program for medical devices

Centerwatch - Wed, 2014-07-16 09:17
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.
Categories: Industry News

Eli Lilly, Immunocore collaborate for novel cancer therapies

Centerwatch - Wed, 2014-07-16 09:15
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.
Categories: Industry News

Clinical Conductor CTMS launches configurations

Centerwatch - Wed, 2014-07-16 09:14
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.
Categories: Industry News

Theorem Clinical Research, Excel Life Sciences partner

Centerwatch - Wed, 2014-07-16 09:13
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.
Categories: Industry News

CEL-SCI receives $225,000 NIH research grant

Centerwatch - Wed, 2014-07-16 09:11
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.
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Harlan Laboratories, Fluofarma collaborate

Centerwatch - Wed, 2014-07-16 09:10
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.
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Generic Drugs: Information for Industry

FDA News - Tue, 2014-07-15 13:09
News and Announcements updated
Categories: Industry News

Chiltern acquires Ockham, strengthening oncology, CRO services, job placement

Centerwatch - Tue, 2014-07-15 11:38
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.
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Written Requests Issued

FDA News - Tue, 2014-07-15 09:04
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies
Categories: Industry News

Pediatric Exclusivity Statistics

FDA News - Tue, 2014-07-15 08:22
Updated list.
Categories: Industry News

Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)

Alzheimers - Mon, 2014-07-14 20:00
Status: Completed, Condition Summary: Alzheimer's Disease
Categories: Industry News

FDA approves IDE for VENITI VICI Venous Stent System

Centerwatch - Mon, 2014-07-14 09:33
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.
Categories: Industry News

Health Canada approves APTIOM (eslicarbazepine acetate) for epilepsy

Centerwatch - Mon, 2014-07-14 09:13
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.
Categories: Industry News

Covance adds two to clinical development services leadership team

Centerwatch - Mon, 2014-07-14 09:04
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.
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Merck's biopharmaceutical division appoints Luciano Rossetti global head of R&D

Centerwatch - Mon, 2014-07-14 08:59
Merck's biopharmaceutical division has appointed Luciano Rossetti, M.D., executive vice president and global head of R&D as of July 21.
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Shire willing to discuss AbbVie’s 5th revised proposal

Centerwatch - Mon, 2014-07-14 08:48
Following discussions with AbbVie, Shirerequested and has received a further revised proposal from AbbVie on July 13 for a total offering of $53 billion.
Categories: Industry News

Abbott to sell generics pharmaceuticals business to Mylan, form new entity

Centerwatch - Mon, 2014-07-14 08:47
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.
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HD Biosciences partners with Marshall University

Centerwatch - Mon, 2014-07-14 08:45
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.
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ACRES, iCTRS partner to promote shared global clinical research platform

Centerwatch - Mon, 2014-07-14 08:43
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.
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