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Clinical Ink, a Winston-Salem, N.C.-based provider of eSource solutions for clinical trials, has updated CentrosHealth, a mobile patient engagement platform, to include streamlined connectivity for a wide range of medical devices. Medical device connectivity is powered by the 2net Mobile Platform from Qualcomm Life, a wholly owned subsidiary of Qualcomm Inc. This new platform was developed with cooperation from Novartis and PPD, which also are supporting a pilot clinical study before broad commercial use.
The Rethink Research Competition has opened voting for the People’s Choice Award.
With drug prices for cancer and many other conditions soaring to new highs amid questions about their true value to patients, the Institute for Clinical and Economic Review (ICER) has launched a program to transform the way new drugs are evaluated and priced in the U.S.
Avista Pharma Solutions has acquired the GMP contract manufacturing, development and animal health services business of Scynexis. Avista will occupy Scynexis’ former research and GMP manufacturing facility in Durham, N.C., and hire substantially all employees associated with the contract services business.
Global CRO Parexel International launched the next generation of its Perceptive MyTrials platform with advanced analytics capabilities. With the Perceptive MyTrials Analytics solution, clinical trial sponsors now can use a mobile-enabled, single entry-point to access predictive data analytics for multiple studies simultaneously. The solution offers real-time and aggregated analytics allowing sponsors and Parexel clinical research professionals to detect key signals and trends. The Perceptive MyTrials Analytics solution also offers cross-sponsor viewing options for clients who need to evaluate data from multiple sponsors.
Evans Analytical Group (EAG), a fully integrated, independent laboratory network based in Boston, has acquired Analytical Bio-Chemistry Laboratories, of Columbia, Mo. (ABC Laboratories). EAG is a private company, majority owned by Odyssey Investment Partners. Financial terms of the transaction have not been disclosed.
Covance Drug Development has relocated its clinical research unit (CRU) in Dallas to a new, fit-for-purpose clinical research facility. The new unit, which opened earlier this month, has expanded from 72 to 100 medical beds and is located in the same building as the prior unit. In addition, a LabCorp patient service center will be co-located in the CRU, at which patients will have an opportunity to learn more about volunteering and participating in early-stage clinical trials.
Global CRO PRA Health Sciences is looking to hire new talent and is launching a new Candidate Experience initiative.
Eli Lilly plans to expand the Lilly Biotechnology Center located in San Diego. The expansion will effectively double Eli Lilly’s research presence in San Diego as the company seeks to develop new collaborations in one of the world’s leading regions for drug research and development.
FDA Drug Safety Communication: FDA limits duration and usage of Samsca (tolvaptan) due to possible liver injury leading to organ transplant or death
The U.S. Food and Drug Administration (FDA) has determined that the drug Samsca (tolvaptan) should not be used for longer than 30 days and should not be used in patients with underlying liver disease because it can cause liver injury, potentially requiring liver transplant, or death.
St. Jude Medical, a global medical device company, has received FDA approval of the St. Jude Medical Invisible Trial System. The system, which received CE Mark in June 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The system is designed to provide patients a more improved and discreet spinal cord stimulation (SCS) trial experience.
The Oxford Vaccines Group has initiated a phase II clinical study of the Ebola prime-boost vaccine regimen that combines Bavarian Nordic's MVA-BN Filo vaccine with the Ad26.ZEBOV vaccine from the Janssen Pharmaceutical Companies of Johnson & Johnson. The first volunteers have received their initial vaccine dose.
Novavax, a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, has announced positive top-line data from a phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M as part of the World Health Organization's (WHO) Fifth Teleconference on Ebola Vaccine Clinical Trials. The trial demonstrated that the Ebola GP Vaccine was highly immunogenic, well-tolerated and, in conjunction with Novavax' proprietary Matrix-M adjuvant, resulted in significant antigen dose-sparing.
Cloud Pharmaceuticals, a therapeutics company focused on cloud-based drug design and development, has added members to its advisory board. The board is comprised of four leaders from industry and academia with experience in complex molecular and macromolecular systems, biophysics, translational research and drug discovery and development. The advisors collaborate with Cloud Pharmaceuticals’ board of directors to provide insight on needs and opportunities within the pharmaceutical industry.
DrugDev has announced Melissa (Liss) Easy, company founder and current president of DrugDev SiteStart, is the 2015 Partnerships in Clinical Trials Woman of the Year.
Pharmaceutical Product Development (PPD) has achieved CEO Cancer Gold Standard reaccreditation from the nonprofit CEO Roundtable on Cancer for maintaining a strong commitment to the health of company employees.
A made-in-Singapore cancer drug has advanced into clinical trials, charting a milestone in Singapore's biomedical sciences initiative that will go towards improving the lives of cancer patients in Singapore, and worldwide. The Agency for Science, Technology and Research (A*STAR) and Duke-National University of Singapore Graduate Medical School (Duke-NUS) have announced the start of a phase I clinical trial of novel cancer drug candidate, ETC-159.
Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has been granted a U.S. Patent corresponding to its mDNA technology. mDNA is an automated management tool that identifies, distributes and manages patients and their mobile device interactivity in clinical and healthcare programs.
La FDA advierte sobre una seria condición pulmonar en niños y recién nacidos tratados con Proglycem (diazóxido)
[7-16-2015] La Administración de Alimentos y Medicamentos (FDA) está alertando sobre una seria condición pulmonar denominada hipertensión pulmonar, la cual es una alta presión en los vasos sanguíneos que van a los pulmones y reportada en niños y recién nacidos tratados con Proglycem (diazóxido) para el control de la glucemia.
Tekmira Pharmaceuticals, headquartered in Vancouver, Canada, plans to change its corporate name to Arbutus Biopharma, a therapeutic solutions company focused on developing a cure for chronic hepatitis B virus infection (HBV), to be effective on or before Aug. 3. The name change affirms the successful integration of OnCore BioPharma and Tekmira Pharmaceuticals into a combined company with the singular goal of delivering a cure for chronic HBV. The combined entity currently fields a large portfolio of HBV product candidates in the industry.