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Arena Pharmaceuticals has announced that Kevin R. Lind will join its management team as executive vice president and chief financial officer, effective June 15, 2016. Lind will report to Amit D. Munshi, Arena’s president and chief executive officer. “Kevin is an accomplished executive with significant financial expertise and will be an exceptional addition to our team,” said Munshi. “Kevin’s broad […]
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SCORR Marketing, a global health science marketing and communications firm, in partnership with Applied Clinical Trials, has released the results of a comprehensive survey on the use of paperless processes in clinical trials. The report describes current levels of paperless data collection, perspectives on the importance of paperless clinical trials and the processes that have already been […]
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The ability to use good judgment and make sound decisions in clinical research is based on experience, communication and execution. Decision making is influenced by such factors as the familiarization with regulations that govern clinical research, successful management of investigational site relationships and corrective and preventative action with issues that affect patient safety and credible […]
Takeda Pharmaceutical and M2Gen, a healthcare informatics solutions company, have established a new collaboration to generate broad genomic data from consenting cancer patients. Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) Avatar Research Program based on the Total Cancer Care Protocol, a prospective observational study enrolling patients with various cancers, and access […]
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Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, has announced a co-development partnership with Baylor College of Medicine to develop next-generation technologies for engineering immune cells with enhanced functions for the treatment of solid tumors. The collaboration provides Cell Medica with an exclusive license over several Baylor cell […]
The California Life Sciences Association (CLSA) has announced a new hire and several staff promotions in its advocacy team, further bolstering the organization’s government relations and communications efforts at the federal, state and local levels on behalf of California’s world-leading life sciences sector. CLSA is the nation’s largest statewide life sciences public policy and business solutions organization […]
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Does industry need a preclinical database? Robert Califf says yes FDA Commissioner Robert M. Califf, M.D., has suggested that establishing a government-sponsored database of preclinical studies could improve transparency in drug development and the ability of researchers to reproduce study results. Califf, who made his comments at an event co-sponsored by the National Library of Medicine, said […]
Shire and Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training. Patients with […]
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Veristat, a full service CRO, has strengthened its statistical consulting and adaptive design expertise with the appointment of Mark Chang, Ph.D., to the newly created position of senior vice president of Strategic Statistical Consulting. Dr. Chang will help clients evaluate and implement strategic, operational and technical efficiencies to advance products through the clinical trial and […]
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PaxVax has received marketing approval from the FDA for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world. “FDA […]
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La FDA refuerza las advertencias relacionadas con el riñón para los medicamentos para la diabetes canagliflozina (Invokana, Invokamet) y dapagliflozina (Farxiga, Xigduo XR)
[6-14-2016] La Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha reforzado la advertencia existente acerca del riesgo de lesión renal aguda para los medicamentos para la diabetes tipo 2 canagliflozina (Invokana, Invokamet) y dapagliflozina (Farxiga, Xigduo XR).
FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
[6-14-2016] The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).
BIND Therapeutics, a biotechnology company developing targeted and programmable therapeutics called ACCURINS, has announced the resignations of Amir Nashat, managing partner at Polaris Partners, and Amy Schulman, venture partner at Polaris Partners and chief executive officer at Arsia Therapeutics and Lyndra Therapeutics, from BIND’s board of directors. The resignations of Nashat and Schulman are not […]
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FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
[06-06-2016] The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.
Icon, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has announced research showing many pharmaceutical and CROs support the use of a ‘Bring Your Own Device’ (BYOD) approach in clinical studies, enabling patients to use their own mobile devices to collect patient-reported outcomes (PRO) data. The research highlights […]
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PSR Orphan Experts, a specialty orphan drug consulting and clinical research company, and Raremark, a new online service for families affected by rare disease, have announced a strategic partnership to accelerate the development of new treatments. The collaboration will leverage the companies’ complementary experience and capabilities, addressing the unique challenges involved in clinical research in […]
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Bioclinica, a specialty clinical trials technology and services provider, has announced two new divisions, creating an integrated offering focused on patient engagement. With the announcement comes the combination of Bioclinica’s extensive global clinical research site network and patient recruitment-retention engine under the Global Clinical Research business segment. Bioclinica President and CEO John Hubbard, Ph.D., said, “Our combined […]
Wilson Therapeutics has appointed Rick Lilley as chief regulatory officer. Lilley will report to CEO Jonas Hansson and will join the company’s management team. Lilley is a senior global regulatory executive with more than 30 years of experience in the pharmaceutical and biotech industries with a strong track record of achievements and leadership in regulatory […]
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Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has signed a three-year agreement with Pfizer. Under the terms of the agreement, Pfizer has the right to extend the term for up to an additional two years. Financial details of the agreement were not disclosed. The new agreement […]