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CenterWatch : October 1, 2015 10:11 am : Centerwatch, Clinical Intelligence, Global News, Neothetics
Neothetics, a clinical-stage specialty pharmaceutical company developing therapeutics for the aesthetic market, has initiated the safety study, LIPO-202-CL-21, of LIPO-202, the first noninvasive injectable drug candidate for reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects. This is a supplemental safety study that Neothetics expects to submit to the FDA as part of the company’s NDA package for LIPO-202, which the company anticipates filing in the second half of 2016.
“This study highlights the comprehensiveness of our clinical development program that supports our NDA for LIPO-202, which is on track to be filed in the second half of 2016,” said Lincoln Krochmal, M.D., chief medical officer for Neothetics. “While we are seeking approval of LIPO-202 for use in non-obese subjects, we recognize the importance of confirming safety in special populations. Consistently our data has shown that LIPO-202 has a safety profile equivalent to placebo.”
LIPO-202-CL-21 is a double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LIPO-202 in obese subjects (BMI=30 kg/m2 but =40 kg/m2). About 120 subjects will be enrolled and randomized (in a 2:1 ratio) to one of two groups, LIPO-202 or placebo. Subjects will receive a course of treatment, which consists of 20 1-ml subcutaneous injections of LIPO-202 (total weekly dose of 0.40 mcg) once a week for eight weeks. The study is by protocol a safety study to evaluate the safety profile of LIPO-202 in obese subjects. Secondarily, Neothetics will collect efficacy data to evaluate the clinical effect of LIPO-202.
CenterWatch : October 1, 2015 10:10 am : Centerwatch, CROs/Service Providers, Global News, LSK Global, Oracle
LSK Global Pharma Services, a CRO in South Korea, has adopted cloud-based Oracle Health Science’s InForm to improve its clinical development processes, streamline data capture and make trial timelines faster.
LSK Global offers task flow, product development, regulatory consulting, project development, clinical research, data management and other CRO services. The company also conducts clinical trials for many local pharmaceutical firms. LSK Global looked to Oracle for a solution that would enable its R&D team to access real-time clinical trial data, reduce invalid data entries and expedite the availability of drug trial information.
LSK Global plans to utilize Oracle’s best-in-class technology to gain deeper and faster insight into its clinical data, which will help the company save time and effort. In turn, the CRO will be able to help sponsors improve the speed, quality and efficiency of their clinical studies.
Oracle Health Sciences InForm offers comprehensive support for industry standards, such as CDISC, to increase efficiency and time for trial design and setup and enhance data collection and reporting quality.
The post LSK Global selects Oracle’s InForm to speed clinical trials appeared first on CenterWatch News Online.
CenterWatch : October 1, 2015 10:08 am : Centerwatch, Ethics/Regulatory, Global News
Attorney General Joseph Foster has launched an investigation into the manner in which several pharmaceutical companies have marketed prescription opioids in New Hampshire.
The investigation was started after review of preliminary information indicated that drug companies may have deceptively minimized the risk of addiction from long-term use of narcotic painkillers and exaggerated their benefits for treating chronic pain. If supported, allegations of such fraudulent marketing could have misled doctors and patients and prevented them from making informed decisions about whether, when and how to use the drugs and might have caused the state to pay for potentially dangerous and unnecessary opioid prescriptions.
“As is evident to medical professionals, law enforcement and families across the state, we have an opioid crisis in which overprescribing of opioids has created a corresponding wave of abuse, diversion and addiction, with tragic results for individual patients, their loved ones and communities,” said Foster. “The increased and widespread use, abuse and misuse of opioids has had a corresponding impact on the rise of the use of heroin, to which users turn when they can no longer obtain or afford prescription drugs. The cost in individual suffering and to healthcare and law enforcement has been, quite simply, overwhelming. We have a responsibility to understand and address its causes.”
Foster’s office is involved in many aspects of the opioid crisis in New Hampshire and currently is working with a committee established by the governor to present revised rules to the New Hampshire Board of Medicine with the goal of adopting protocols that all practitioners must follow when prescribing opioids.
The post Attorney general to investigate opioid marketing practices appeared first on CenterWatch News Online.
CenterWatch : October 1, 2015 10:08 am : Centerwatch, Chiltern, CROs/Service Providers, Global News
Chiltern, a global CRO, is expanding its clinical development services in endocrinology and metabolism and has named Randy Anderson, Ph.D., as senior vice president of scientific affairs.
With nearly 30 years of industry experience, Anderson is an expert in diabetes and other endocrine/metabolism disorders. A board director for JDRF International, he also serves on multiple scientific advisory boards for pharmaceutical companies with endocrine products.
He joins Chiltern after 18 years with another major clinical research organization, where he provided scientific leadership for the endocrinology and metabolism therapeutic area and was a contributor on hundreds of trials and products. In addition to being the therapeutic area leader for endocrinology and metabolism, Anderson will serve as Chiltern’s administrative leader for its other scientific affairs experts across all therapeutic areas.
The endocrinology and metabolism area at Chiltern includes diseases of the endocrine organs and related complications: type 1 diabetes, type 2 diabetes, diabetes complications, obesity, dyslipidaemias, adrenal disorders, thyroid disorders, pituitary disorders, calcium homeostasis disorders, cardiovascular disease prevention, growth disorders, sex androgen dysfunction and other rare metabolic disease indications such as lysosomal storage disorders, Prader-Willi Syndrome and Fabry disease.
“Expanding our clinical development services for endocrinology and metabolism diseases is a direct response to client desire for collaborative partnerships in development planning, design and execution of clinical trials in this complex therapeutic area,” said Dr. Jim Esinhart, Chiltern CEO.
CenterWatch : October 1, 2015 10:06 am : 100000 Genomes Project, Centerwatch, Genomics England, Global News, NHS, R&D Trends
Berg, a Boston-based biopharmaceutical company, will join an industry collaboration with Genomics England. Formed by British Prime Minister David Cameron, Genomics England is partnering with health companies to accomplish its mission to sequence 100,000 human genomes and create a new genomic medicine service for the National Health Services (NHS) by 2017. The project focuses on patients with rare diseases and six common cancers.
Through the GENE Consortium, Berg will work on an industry trial involving a selection of whole genome sequences across cancer and rare diseases, discovering how best to collaborate with clinicians and researchers. The trial aims to identify the most effective way of bringing industry expertise into the 100,000 Genomes Project in order to realize the potential benefits for patients.
Berg, the namesake of Chairman Carl Berg—who co-founded the company with Mitch Gray and Niven Narain, utilizes deep biological profiling and Bayesian artificial intelligence as a foundation to creating the next generation of drugs and diagnostics to improve human health.
Berg aims to use its expertise in data analytics, as well as its proprietary Interrogative Biology Platform, in the development of an analytical tool that will be used to process data from the 100,000 Genomes Project.
The post Berg joins Genomics England to sequence 100,000 genomes appeared first on CenterWatch News Online.