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Latest Clinical research Stories

2014-07-30 23:14:44

The FDA has refined its understanding and validation for product, software and processes used for medical production. Protomatic demonstrates its method for adopting the four protocol: design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). Dexter, MI (PRWEB) July 30, 2014 The methods used to create a stable manufacturing process are based on multiple industrial requirements. When used for medical production, the...

2014-07-30 16:29:22

TARRYTOWN, N.Y. and PARIS, July 30, 2014 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced that the Companies intend to use a U.S. Food and Drug Administration (FDA) rare pediatric disease priority review voucher in connection with the Biologics License Application (BLA) submission for alirocumab. The priority review voucher entitles the holder to designate a BLA for priority review, which provides for an expedited...

2014-07-30 16:21:42

ARLINGTON, Va., July 30, 2014 /PRNewswire-USNewswire/ -- Today, the National Association of Chemical Distributors (NACD) submitted comments to the Food and Drug Administration (FDA) on its proposed rule titled "Sanitary Transportation of Human and Animal Food." The proposed rule would establish requirements for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food to use sanitary practices to ensure the safety of the food they...

2014-07-30 12:30:51

Step Edits Are the Most Likely Strategy to Drive Use of a Biosimilar Priced 30 Percent Less than the Reference Brand, According to Findings from Decision Resources Group BURLINGTON, Mass., July 30, 2014 /PRNewswire/ -- Decision Resources Group finds that the majority of surveyed pharmacy and medical directors in the United States believe that the key drivers of biosimilar market penetration will be the level of savings achievable by their managed care organizations (MCOs) and the expected...

2014-07-30 08:32:52

ENGLEWOOD, Colo., July 30, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced a positive written response from the FDA in regards to the company's plans to begin production of Ampion(TM) in our new drug manufacturing facility. http://photos.prnewswire.com/prnvar/20120516/MM09116LOGO Dr. Vaughan Clift, Ampio's Chief Regulatory Officer explained, "Satisfying the Chemistry, Manufacturing and Controls (CMC) requirements of a Biological License Application...

2014-07-30 08:32:08

Anticipate Topline Data in 6-8 months IRVINE, Calif., July 30, 2014 /PRNewswire/ -- AtheroNova Inc. (OTCBB: AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announces that its partner, CardioNova, has accomplished first dosing of subjects for its Phase 1b clinical trial with AtheroNova's lead compound, AHRO-001. This Phase 1b trial will be a continuation of the AHRO-001...

2014-07-29 23:15:25

White papers by Clinovo on CDISC Standards for medical devices and cloud-based eClinical technologies have been published in the latest editions of leading pharmaceutical publications Data Basics and Med Device Online Sunnyvale, CA (PRWEB) July 29, 2014 White papers by Clinovo on CDISC Standards for medical devices, and cloud based eClinical technologies, have been published by leading pharmaceutical publications Data Basics and Med Device Online. These follow a long line of white papers...

2014-07-29 23:13:58

It’s time for the 9th Annual FDA Inspections Summit, focusing on inspectional readiness. With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company. Falls Church, VA (PRWEB) July 29, 2014 9th Annual FDA Inspections Summit **Presented by FDAnews** Oct. 22-24, 2014 – Bethesda, MD http://www.fdanews.com/InspectionsSummit2014 What’s the state of FDA’s Quality Metrics Initiative? When will drug and...

2014-07-29 23:07:36

MarketOptimizer.org adds “PharmaSphere Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market” to its store. The report discusses the various regulatory frameworks under which biosimilars are currently reviewed and regulated. Dallas, Texas (PRWEB) July 29, 2014 PharmaSphere: Regulatory Frameworks and Product Pipelines in the Global Biosimilars Market report is an essential source of information and analysis on the global biosimilars industry. Using detailed...

2014-07-29 23:05:06

MarketReportsOnline.com adds "Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition)" report to its research store. Dallas, Texas (PRWEB) July 29, 2014 This Latest Guidebook for Conducting Pharma Clinical Trials in China: From Regulations to Practice (2014 Edition) not only provided a comprehensive and thorough knowledge of the latest Chinese regulations on clinical trials for imported drug registration but also introduced...


Word of the Day
drawcansir
  • A blustering, bullying fellow; a pot-valiant braggart; a bully.
This word is named for Draw-Can-Sir, a character in George Villiers' 17th century play The Rehearsal.
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