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Latest "Southern Clinical Regulatory" News Stories - Page: 5

05:39 EDT 22nd October 2018 | BioPortfolio

Here are the most relevant search results for "Southern Clinical Regulatory" found in our extensive news archives from over 250 global news sources.

More Information about Southern Clinical Regulatory on BioPortfolio

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.

Showing "Southern Clinical Regulatory" News Articles 101–125 of 19,000+

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FLX Bio treats first patient in its Phase 1/2 clinical trial of FLX475 for treating various advanced cancers

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...


Which regulatory regime applies to your products? Do potentially overlapping regimes keep you awake at night?

The recent 2016 case of R (Blue Bio) v Secretary of State for Health (acting for the Medicines & Healthcare products Regulatory Agency (“MHRA”) [2016] EWCA Civ 554 highlights the challenges of determining what regulatory regime appli...

Probably Relevant

Zogenix’s Phase 3 Clinical Study Met all Endpoints

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.


NIH: ‘If we don’t report our results we will repeat mistakes’

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.

BIO-Europe Spring: Southern growth ambitions

Premier Research acquires CA-based firm to develop regulatory services division

Premier Research has acquired Regulatory Professionals, establishing a new regulatory services division in response to customer demand.

The global influence of localized dynamics in the Southern Ocean

FDA turns to real-world evidence to improve regulatory process

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 ...

Regulatory and IP strategies for live biotherapeutic products

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.

Every day spent in the hospital, readmission likelihood increases by 2.9 percent in rural cities

(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...

#jobs #lifescience Head of Regulatory Affairs

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...

MHRA cut out of regulatory work as Brexit looms

This year the regulatory body was only awarded two contracts to serve as the lead assessor on NDAs

Impact of the astronomical lunar 18.6-yr tidal cycle on El-Niño and Southern Oscillation

B. Melina Cimler, PhD, Former Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies, Joins NDA Partners

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...

People who deeply grasp pain or happiness of others, process music differently in brain

(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...

Do You Have These Biotech Stocks In Your Portfolio?

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.

Global CRO market to grow to $57 billion by 2024, report forecasts

Growth in the CRO sector is expected to accompany growth of clinical trials, their complexity and regulatory requirements.

FDA Rejects GlaxoSmithKline's Application for New Mepolizumab Indication

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 

Bird flu detected at poultry farm in southern Bulgaria https://reut.rs/2O5QrSe 

Project that spots city-killing asteroids expands to Southern Hemisphere

E-Cigarette Math And The FDA's Regulatory Dilemma

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?

Mild problem-solving task improves brain function after a concussion, new study suggests

(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...

CDSS Ltd announces Strategic Partnership with Medical Device Consultants, Inc.

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...

AstraZeneca leukaemia drug receives US regulatory green light

In clinical trials 75% of the people taking the drug responded to it. In 30% of cases Lumoxiti had a “complete durable” effect


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