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FDA’s proposed Expanded Access Navigator points to progress, not panacea In response to the increasing demand for access to investigational drugs, creation of a clearinghouse to provide information on the request process has been proposed by the Reagan-Udall Foundation for the FDA. Dubbed the Expanded Access (EA) Navigator, the educational tool is the government’s latest effort […]
An Efficacy and Safety Study of JNJ-54861911 in Participants Who Are Asymptomatic at Risk for Developing Alzheimer's Dementia
Status: Recruiting, Condition Summary: Alzheimer Disease
Neuralstem, a biopharmaceutical company focused on the development of central nervous system therapies based on its neural stem cell technology, announced a corporate reorganization to further align the company’s resources on advancing the NSI-189 neurogenic small molecule program, currently in a phase II clinical trial for the treatment of major depressive disorder, and to continue […]
Novartis has announced changes to focus its Pharmaceuticals Division by creating two business units reporting to the CEO: Novartis Pharmaceuticals and Novartis Oncology. These business units will form the Innovative Medicines Division at Novartis. The leader of each business will join the Executive Committee of Novartis (ECN) effective July 1, 2016. Paul Hudson will be […]
INC Research Holdings, a global phase I to IV CRO, together with the Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to engaging the public and patients as partners in the clinical research process, have announced an innovative new initiative designed to promote greater awareness of the importance of […]
The post INC Research, CISCRP launch ideathon to boost awareness of clinical research appeared first on CenterWatch News Online.
Wolfe Laboratories has expanded its senior management team through the addition of Paul Oakley, who has joined as senior vice president and general counsel. In this role, Oakley will be responsible for the company’s corporate and financial strategies and general operations. Oakley brings more than 20 years of experience as an executive and entrepreneur, building […]
The post Wolfe Laboratories adds Paul Oakley as SVP and general counsel appeared first on CenterWatch News Online.
The FDA has granted Breakthrough Therapy designation to Celator Pharmaceuticals’ Vyxeos (also known as CPX-351). Vyxeos is an investigational product in development as a treatment for acute myeloid leukemia (AML) and other blood cancers. The Breakthrough Therapy designation is primarily based upon the positive results from the pivotal phase III clinical trial in older patients with previously […]
The post Celator Pharma scores FRA Breakthrough Therapy for cancer med Vyxeos appeared first on CenterWatch News Online.
FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
[05-12-2016] The U.S. Food and Drug Administration is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections.
The FDA granted Accelerated Approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Urothelial carcinoma accounts for 90% […]
The post FDA grants Genentech’s cancer immunotherapy Tecentriq (atezolizumab) Accelerated Approval appeared first on CenterWatch News Online.
ORIG3N, a pioneer in the field of regenerative medicine, has added Melissa May as the company’s vice president of product strategy to establish partnerships and collaborations to bring in non-dilutive funding that will support R&D to develop future product offerings. In addition, May will play a role in the strategy and channel development of ORIG3N’s life science […]
Status: Not yet recruiting, Condition Summary: Internet Addiction
FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
[5-XX-2016] The U.S. Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet).
Comunicado de la FDA sobre la seguridad de los medicamentos: La FDA aconseja restringir el uso de antibióticos a base de fluoroquinolonas para ciertas infecciones sin complicaciones; advierte sobre efectos secundarios discapacitantes que pueden presentars
[05/12/2016] La Administración de Alimentos y Medicamentos (FDA, por sus siglas en inglés) advierte que los efectos secundarios graves relacionados con los medicamentos antibacterianos a base de fluoroquinolonas por lo general superan los beneficios para los pacientes con sinusitis, bronquitis e infecciones del tracto urinario sin complicaciones para los que existen otras opciones de tratamiento.
CRF Health, a global provider of eCOA solutions for the life sciences industry, has launched TrialConsent, an industry-first electronic informed consent solution fully integrated within an eCOA platform. The solution promotes better comprehension, compliance and retention rates while minimizing regulatory risk. Incorporating recommendations from the FDA’s Guidance on informed consent, TrialConsent enables sponsors, Institutional Review […]
The post CRF Health launches TrialMax extension TrialConsent appeared first on CenterWatch News Online.
KMR Group, a provider of biopharmaceutical R&D performance analytics, has announced its newest online clinical trial performance application, CRO Metrix. The tool helps clinical research organizations and sponsor biopharmaceutical companies assess the performance of CROs. Addressing outsourcing performance is increasingly necessary as more clinical trial components are being outsourced. Both sponsor companies and CROs need […]
The post KMR Group launches CRO Metrix to measure CRO performance appeared first on CenterWatch News Online.
Four new grants from the National Institutes of Health will support research on the ethical, legal and social questions raised by advances in genomics research and the increasing availability of genomic information. The awards will fund researchers at interdisciplinary centers through the National Human Genome Research Institute’s (NHGRI) Centers of Excellence in Ethical, Legal and […]
The post NIH funds new studies on the impact of genomic information appeared first on CenterWatch News Online.
La FDA advierte de nuevos problemas de control de impulsos en relación con el medicamento para tratar la salud mental aripiprazol (Abilify, Abilify Maintena, Aristada)
[05/03/2016] La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés) advierte que se ha informado de deseos compulsivos o incontrolables de apostar, atracarse de comida, comprar y tener relaciones sexuales con el uso del fármaco antipsicótico aripiprazol (Abilify, Abilify Maintena, Aristada y sus versiones genéricas).
FDA Drug Safety Communication: FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
[05-09-2016] The U.S. Food and Drug Administration (FDA) is warning that the antipsychotic drug olanzapine can cause a rare but serious skin reaction that can progress to affect other parts of the body.
Evaluation of the Efficacy and Safety of Azeliragon (TTP488) in Patients With Mild Alzheimer's Disease
Status: Recruiting, Condition Summary: Alzheimer's Disease