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Altasciences has announced that its companies, Algorithme Pharma (Montreal, Canada) and Vince & Associates Clinical Research (Kansas), are both 2015 CRO Leadership Award recipients.
The FDA has accepted and granted Priority Review for Genentech’s, a member of the Roche Group, NDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma. The FDA will make a decision on approval by Aug. 11.
In an NIH-supported clinical trial comparing three drugs for diabetic macular edema (DME), Eylea (aflibercept) provided greater visual improvement, on average, than did Avastin (bevacizumab) or Lucentis (ranibizumab) when vision was 20/50 or worse at the start of the trial. However, the three drugs resulted in similar average improvement when starting vision was 20/40 to 20/32. Investigators found no major differences in the safety of the three drugs. The trial was funded by the National Eye Institute (NEI), part of the NIH.
Theorem Clinical Research, a global CRO based in King of Prussia, Pa., and Biomedical Systems, a provider of comprehensive centralized diagnostic services, have formed a strategic partnership to expand a suite of services available to clients worldwide.
Actavis, headquartered in Dublin, and TPG, a global private investment firm, have entered into definitive agreements under which Actavis will divest to TPG the business currently known as Aptalis Pharmaceutical Technologies (Pharmatech)—a pharmaceutical outsourcing and R&D business operating in the U.S., Canada and Europe (where the transaction is, in certain jurisdictions, still subject to local regulations, discussions and clearances). No other Aptalis businesses or products are included in the transaction. Financial terms have not been disclosed.
Alzheimer's Research U.K., a dedicated dementia research charity, has announced a $46.3 million Drug Discovery Alliance, launching three flagship Drug Discovery Institutes at the Universities of Cambridge, Oxford and University College London (UCL). The Drug Discovery Institutes will see 90 new research scientists employed in state-of-the-art facilities to fast-track the development of new treatments for Alzheimer's disease and other dementias.
CRF Health, a global provider of electronic Clinical Outcome Assessment (eCOA) solutions for the life sciences industry based in Plymouth Meeting, Pa., has announced a new partnership with Vodafone, a British multinational telecommunications company. CRF Health will use Vodafone’s global Machine-to-Machine (M2M) platform to offer an enhanced service to clinical trial operators and their patients.
Sanofi has entered into a research collaboration and license agreement with Dutch biotech Lead Pharma to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma t to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common.
Certara, a global biosimulation technology-enabled drug development and drug safety consulting company, will be launching version 8.0 of its D360 R&D big data platform for the biopharmaceutical industry.
Parexel International, a global biopharmaceutical services provider, has announced the continued expansion of its clinical trial Site Alliance Network, an extensive network of investigator sites and site management organizations (SMOs) that enables Parexel to quickly access and enroll patient populations for clients' clinical trials worldwide.
Angle, a specialist medtech company based in England, is collaborating with the MD Anderson Cancer Center to investigate the clinical use of Angle's Parsortix system as a companion diagnostic in colorectal cancer. The University of Texas MD Anderson Cancer Center is a center devoted exclusively to cancer patient care, research, education and prevention.
SIRO Clinpharm, an India-based CRO, has relocated its corporate headquarters within Mumbai, India. The move allows SIRO to consolidate its position in the Indian healthcare development space.
Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, and Ono Pharmaceutical, headquartered in Osaka, Japan, have partnered to develop a potential diagnostic test specifically for use with Opdivo in the treatment of non-small cell lung cancer. This test is being investigated for its diagnostic utility to determine which patients are most likely to respond to Opdivo.
The list has been updated through January 2015.
Karen Estelle Woodin, Ph.D., known in the clinical trials industry as a long-time industry consultant and author, passed away last week after a short bout with malignant endometrial cancer. She was 74.
The keys to successful study conduct at the site level are honesty, integrity and transparency:
Status: Not yet recruiting, Condition Summary: PTSD; Sleep Problems
Status: Completed, Condition Summary: Post-traumatic Stress Disorder
Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Status: Recruiting, Condition Summary: Sleep Disorders