The California Clinical Trials Medical Group managed by PAREXEL, located in Glendale, CA is currently seeking healthy male or female volunteers to participate in a clinical research trial to evaluate an investigational medication.The study involves:1 Screening Visit1 In-House Stay for 12 Days/11 Nights1 Follow-Up Visit24 Hour CSF CollectionPlease reference study # 244665.
Mon Jul 01, 2019 00:00
Endometriosis is a disorder in which tissue that normally lines the uterus grows outside the uterus. Symptoms of endometriosis can include pain associated with menstruation, pelvic pain, and pain during or after intercourse. Meridien Research needs volunteers for a new endometriosis research study in St. Petersburg.To find out if you qualify, please contact Meridien Research.
Mon Jul 01, 2019 00:00
Do you have ulcerative colitis?Meridien Research is seeking research volunteers for a clinical study of ulcerative colitis. No medical insurance is necessary to participate. All studies are administered by board certified medical doctors.
Mon Jul 01, 2019 00:00
Experiencing abdominal pain? Don’t be embarrassed – explore your options!Researchers are evaluating an investigational medication among people with abdominal pain associated with IBS-D.To learn more, call Meridien Research in St. Petersburg.
Mon Jul 01, 2019 00:00
Meridien Research is offering an investigational capsule for relieving constipation.All study-related care is provided at no cost. No insurance is required. Call Meridien Research in St. Petersburg.
Mon Jul 01, 2019 00:00
Meridien Research is seeking volunteers who may have Nonalcoholic Steatohepatitis (NASH) or Fatty Liver Disease for a medical research study.Eligible participants will receive study-related care, monitoring and investigational medication. Reimbursement for time and travel may be available. For more information, please contact Meridien Research.
Mon Jul 01, 2019 00:00
The PROMINENT Study is researching a potential new medication (study drug) for people with type 2 diabetes and elevated triglycerides (a type of fat in the blood) to see if it can help prevent heart attacks and other heart-related problems. The study will also look at how safe the study drug is, and how it affects the level of triglycerides in the blood.
Mon Jul 01, 2019 00:00
Are they getting in the way of your social life? If each one lasts 4 hours or more, you could help us learn about a newinvestigational approach to treatment. Contact our study team and find out if you qualify for a new 3-month clinical researchstudy called BHV-3500.
Mon Jul 01, 2019 00:00
Anxiety can affect your health. So when you manage your anxiety, you’re also taking care of your physical health.PRI is evaluating an investigational medication for adults with anxiety.
Mon Jul 01, 2019 00:00
Meridien Research is looking for individuals between the ages of 50 and 90 who have Alzheimer’s Disease or are experiencing increasing memory or thinking issues for a study to see if an investigational medication can potentially slow the progression of Alzheimer’s disease.All studies administered by a board certified physician.
Mon Jul 01, 2019 00:00
The progression of otilimab (previously GSK3196165) into phase III follows the results of the phase II BAROQUE study which were announced in October 2018. Dr Hal Barron, Chief The post GSK begins phase 3 trial for otilimab in patients with rheumatoid arthritis appeared first on Pharmaceutical Business review.
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Dovato is a new once-daily, single-pill and two-drug regimen approved for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least The post EC approves ViiV Healthcare’s Dovato to treat HIV-1 infection appeared first on Pharmaceutical Business review.
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“While there is no cure for multiple myeloma, there are FDA-approved treatments to target the cancer and slow down the spread of the disease. Sadly, often over time, The post FDA approves new treatment for refractory multiple myeloma appeared first on Pharmaceutical Business review.
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The European approval for Libtayo is for such patients who are not eligible for curative surgery or curative radiation. The skin cancer drug was given the regulatory nod The post Sanofi, Regeneron bag EC approval for skin cancer drug Libtayo appeared first on Pharmaceutical Business review.
Wed Jul 03, 2019 17:22
A1AT deficiency is a genetic disorder that can cause liver disease in children and adults, leading to complications such as weight loss, fatigue, jaundice and life-threatening conditions such The post Dicerna to begin clinical development of DCR-A1AT for A1AT deficiency-associated liver disease appeared first on Pharmaceutical Business review.
Wed Jul 03, 2019 14:22
The medicine will become available immediately in 13 countries across Europe on the day the reference medicine loses market exclusivity. Sandoz will continue to expand to other countries The post Sandoz launches oncology generic gefitinib in 13 EU countries appeared first on Pharmaceutical Business review.
Wed Jul 03, 2019 11:21
The study has showed that Xofluza was well tolerated in children with flu. It also demonstrated that Xofluza is comparable to oseltamivir, a proven effective treatment for children The post Roche’s flu drug Xofluza meets primary endpoint in phase III children study appeared first on Pharmaceutical Business review.
Wed Jul 03, 2019 11:21
The fusion protein, which is being developed for NASH, utilises the HyFc technology of Genexine. It has been developed in-house by South Korean pharma company. The fusion protein The post Boehringer Ingelheim, Yuhan sign £689m NASH license deal appeared first on Pharmaceutical Business review.
Wed Jul 03, 2019 11:21
VE416 is Vedanta Biosciences’ live biotherapeutic product candidate being developed for treatment of food allergies, including persistent peanut allergy. The study, which is being conducted at MassGeneral Hospital The post Vedanta Biosciences enrols first patient in VE416 phase 1b/2 food allergy clinical study appeared first on Pharmaceutical Business review.
Tue Jul 02, 2019 14:18
The agency said that as the benefits of Evenity did not outweigh its risks, it recommended refusal of the drug’s marketing authorisation. The marketing authorisation application (MAA) of The post CHMP adopts negative opinion over osteoporosis drug Evenity appeared first on Pharmaceutical Business review.
Tue Jul 02, 2019 12:16
Puma Biotechnology submits sNDA to FDA for Neratinib to treat HER2-positive metastatic breast cancer
Neratinib was originally approved by the U.S. Food and Drug Administration in July 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, The post Puma Biotechnology submits sNDA to FDA for Neratinib to treat HER2-positive metastatic breast cancer appeared first on Pharmaceutical Business review.
Tue Jul 02, 2019 11:16
The sale of Xiidra has also provided an option to Takeda to receive up to an additional $1.9bn (£1.5bn) in potential milestone payments from Novartis. Takeda intends to The post Novartis wraps up acquisition of Takeda’s dry eye drug Xiidra appeared first on Pharmaceutical Business review.
Tue Jul 02, 2019 11:16
“We are delighted by this outcome which we regard as an important stage for Sensorion and young patients. Indeed, this approval will allow Sensorion to develop SENS-401 for The post Sensorion receives EMA agreement on the pediatric investigation plan for Arazasetron in two indications appeared first on Pharmaceutical Business review.
Mon Jul 01, 2019 14:13
“This CHMP recommendation marks a breakthrough in the treatment of triple-negative breast cancer, an aggressive type of breast cancer with high unmet medical need,” said Sandra Horning, MD, The post CHMP recommends EU approval of Roche’s Tecentriq plus Abraxane for metastatic TNBC appeared first on Pharmaceutical Business review.
Mon Jul 01, 2019 14:13
Pfizer said that Zirabev has been approved to treat five types of cancer, including metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer The post Pfizer gets FDA nod for Avastin’s biosimilar Zirabev appeared first on Pharmaceutical Business review.
Mon Jul 01, 2019 13:12
Clinical Trials, Ahead of Print. BackgroundA major goal of the National Institutes of Health’s Clinical and Translational Science Award program is to facilitate clinical research and enhance the transition of basic to clinical research. As such, a number of Clinical and Translational Science Award centers have developed services to facilitate the conduct of clinical research, including support with fulfilling regulatory requirements.MethodsThe University of Kentucky sought to establish an institutional...
Mon Jul 01, 2019 12:20
Clinical Trials, Ahead of Print. BackgroundThe need for more and better evidence to inform clinical decision making among all stakeholders has fueled calls for creating learning healthcare systems. The successful realization of a learning healthcare system seems to assume that various parties have a responsibility to participate in learning activities, including research. The objective of this study was to determine whether members of the general public perceive an ethical responsibility to participate...
Mon Jul 01, 2019 11:58
Clinical Trials, Ahead of Print. Background/AimsFor single arm trials, a treatment is evaluated by comparing an outcome estimate to historically reported outcome estimates. Such a historically controlled trial is often analyzed as if the estimates from previous trials were known without variation and there is no trial-to-trial variation in their estimands. We develop a test of treatment efficacy and sample size calculation for historically controlled trials that considers these sources of variation.MethodsWe...
Mon Jul 01, 2019 11:56
Publication date: Available online 2 July 2019Source: Contemporary Clinical TrialsAuthor(s): Laura D. Baker, Stephen R. Rapp, Sally A. Shumaker, JoAnn E. Manson, Howard D. Sesso, Sarah A. Gaussoin, Darrin Harris, Brad Caudle, Debbie Pleasants, Mark A. Espeland, for the COSMOS-Mind Research GroupAbstractBackgroundLarge simple trials are potentially efficient and cost-effective approaches to assess interventions to preserve cognitive function in older adults. High-dose cocoa flavanols supplementation...
Tue Jul 02, 2019 16:49
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