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Here are the most relevant search results for "Southern Clinical Regulatory" found in our extensive news archives from over 250 global news sources.
In addition to our news stories we have dozens of PubMed Articles about Southern Clinical Regulatory for you to read. Along with our medical data and news we also list Southern Clinical Regulatory Clinical Trials, which are updated daily. BioPortfolio also has a large database of Southern Clinical Regulatory Companies for you to search.
FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, today announced that the first patient has been treated in its Phase 1/2 clinical trial of FLX475 in patients with various advanced cancers. FLX475 is an oral, small molecule CCR4 antagonist that selectively inhibits mi...
The recent 2016 case of R (Blue Bio) v Secretary of State for Health (acting for the Medicines & Healthcare products Regulatory Agency (“MHRA”)  EWCA Civ 554 highlights the challenges of determining what regulatory regime appli...
Zogenix announced on Thursday (July 12) that its Phase 3 trial of ZX008 in Dravet syndrome met its primary and secondary endpoints, putting both regulatory submissions for the drug’s approval on pace for Q4 2018. The post Zogenix’s Phase 3 Clinical Study Met all Endpoints appeared first on Investing News Network.
Regulatory agencies are doubling down on compliance â and withholding funds â as the clinical research industry enters an era of accountability and transparency, say NIH officials.
Premier Research has acquired Regulatory Professionals, establishing a new regulatory services division in response to customer demand.
The FDA has announced its intention to incorporate real-world data elements to a greater degree into its regulatory decision-making framework in a bid to “answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials,” according to the agency’s Commissioner Scott Gottlieb. The organisation is ...
On September 6, the Microbiome Therapeutics US conference focused on overcoming regulatory challenges and strategies to gain intellectual property (IP)...Read More... The post Regulatory and IP strategies for live biotherapeutic products appeared first on Pharmaceutical Technology.
(American College of Chest Physicians) Hospital readmissions, cost hospitals about $26 billion annually. Systems like the Hospital Readmission Reduction Program (HRRP) within the Affordable Care Act penalize hospitals with higher readmission rates for targeted diagnoses. Healthcare data reveals that healthcare facilities located in rural Southern Appalachia show readmission rates that are above th...
Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Head of Regulatory Affairs .PR-San Juan, JOB POSTING INFORMATION Job Category: Manufacturing Job Title: Head of Regulatory Affairs Job Order No.: 22864 Job Location: USA Required Education: Bachelor’s … Continue reading → Cet article #jobs #lifescience Head o...
This year the regulatory body was only awarded two contracts to serve as the lead assessor on NDAs
NDA Partners Chairman Carl Peck, MD, announced today that Dr. B. Melina Cimler, a senior quality, regulatory, and in vitro diagnostic device expert with more than 28 years of experience in the life science and FDA-regulated global diagnostic industry with a focus on precision medicine, has joined the firm as an Expert Consultant. ROCHELLE, Va. (PRWEB) September 26, 2018 NDA Partners Chairman Carl...
(Southern Methodist University) People who deeply grasp the pain or happiness of others also process music differently, say researchers at Southern Methodist University, Dallas and UCLA. The study in Frontiers in Behavioral Neuroscience compared MRI scans of low- and high-empathy people. Higher empathy people process music like a pleasurable proxy for a human encounter -- in brain regions for rewa...
The biotech sector is highly volatile and unpredictable as it is driven by regulatory and clinical trial catalysts, which can make or break the stock prices.
Growth in the CRO sector is expected to accompany growth of clinical trials, their complexity and regulatory requirements.
NewsThe CRL states that more clinical data are required to support an approval. Contributed Author:
Bird flu detected at poultry farm in southern Bulgaria https://reut.rs/2O5QrSe
The FDA faces a tough regulatory decision on e-cigarettes: is it more important to stop teens from vaping or to help adults quit smoking?
(Southern Methodist University) A mild problem-solving task improves brain functioning after a concussion, according to a new study conducted at Southern Methodist University, Dallas. Currently there are many questions about rehabilitation and treatment options, with absolute rest often the go-to treatment. But the new study suggests that a simple cognitive task as early as four days after a brain...
VistaGen Therapeutics Appoints Dr. Michael Liebowitz to CNS Clinical and Regulatory Advisory Board in Preparation for Pivotal Phase 3 Development of PH94B as the First Rapid-Acting, On-Demand Treatment of Social Anxiety Disorder
SOUTH SAN FRANCISCO, Calif., Oct. 15, 2018 (GLOBE NEWSWIRE) -- VistaGen Therapeutics Inc (NASDAQ: VTGN), a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced the appointment of Michael Liebowitz, M.D. to the Company’s CNS Clinical and Regulatory Advisory Board in preparation...
Clinical Development & Support Services Ltd (CDSS), a clinical services and CRO based in Cheshire, England , have announced a strategic partnership with Medical Device Consultants, Inc. (MDCI), a full-service regulatory consulting and contract research organization (CRO) serving the medical device and diagnostics industry. This relationship will allow clients access to the best of both o...
In clinical trials 75% of the people taking the drug responded to it. In 30% of cases Lumoxiti had a “complete durable” effect