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04:44 EDT 23rd October 2014 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 7,200+

Tuesday 21st October 2014

Lisa Hodges Joins Conifer Health Solutions® as Chief Compliance Officer

Recognized Industry Leader Brings Nearly 30 Years of Experience to Conifer Conifer Health Solutions®, the nation’s leading provider of technology-enabled healthcare performance improvement services, announced today that Lisa Hodges has joined Conifer’s senior leadership team as chief compliance officer. In this role, Hodges assumes r...

Enanta declines option on AbbVie-partnered hepatitis C candidate

Enanta also says that it has reached a new agreement with AbbVie regarding royalty calculations for ABT-450-containing regimens, as well as any regimens containing ABT-493. As per their 2006 agreement, Enanta is also eligible for certain regulatory.....

Phosplatin Therapeutics Announces First Patients Enrolled in Phase I First-in-Human Clinical Trial in Solid Tumors

Phosplatin Therapeutics LLC today announced that the first cohort of patients has been successfully dosed in its Phase I first-in-human clinical study of PT-112, the lead therapeutic candidate among its phosphaplatin family of molecules. The clinical study is expected to enroll up to 80 patients across three sites: The University of Texas MD Ander...

Regulate E-Cigs Sooner, Not Later

(MedPage Today) -- Experts call for carefully crafted regulatory control of e-cigarettes.

Mauna Kea Technologies: Physicians Using Optical Biopsy with Cellvizio Discover a New Diagnostic Criterion Specific for Benign Pancreatic Cysts and Invisible with Other Imaging Technologies

Mauna Kea Technologies’ study shows that needle-based confocal laser endomicroscopy with Cellvizio confirms nature of benign serous cystadenomas with high specificity. Findings from prospective multicenter CONTACT 1 study published in peer-reviewed journal Endoscopy. Regulatory News: Mauna Kea Tech...

Emergence of RFID Technology Will Lead to Drastic Growth of Global ePedigree Software Market By 2018: TechNavio

TechNavio, a global tech-focused research firm has announced the publication of its market research report on the Global ePedigree Software Market 2014-2018. An epedigree provides the complete history of a particular drug. It is an electronic record that contains information regarding various transactions resulting from a change of

Synageva BioPharma Starts Rolling Submission Of A Biologics License Application To The FDA For Sebelipase Alfa

LEXINGTON, Mass., Oct. 21, 2014 /PRNewswire/ -- Synageva BioPharma Corp. (Synageva) (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, announced today the start of a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for sebelipase alfa as a treatment for patients with lysosomal acid lipase de...

WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test

ANAHEIM, Calif., Oct. 21, 2014 /PRNewswire/ -- Influenza will affect as many as 200,000 people this year and with flu-associated deaths in the United States as high as 49,000 people.  The main way that influenza viruses are thought to spread is from person to person in respiratory droplets of coughs and sneezes. Ebola has a serve way of death, but kills much fewer people each year than the...

Amgen Statement Regarding Third Point Investment

THOUSAND OAKS, Calif., Oct. 21, 2014 /PRNewswire/ -- Amgen (NASDAQ: AMGN) issued the following statement with respect to media inquiries concerning Third Point LLC's equity position in Amgen: Amgen maintains an active, engaged dialogue with all shareholders. Amgen has always appreciated the perspectives of all of its shareholders, including Third Point, and welcomes constructive input toward our...

Presence Health Selects Access To Replace Preprinted Forms with Bar-Coded E-Forms That Will Be Integrated into MEDITECH’s EHR

Largest Catholic health system in Illinois will simplify and speed the process of getting patient forms into patient records with electronic forms that are generated on demand with bar-codes and demographics applied, and then scanned into MEDITECH’s Scanning and Archiving Solution. Sulphur Springs, Texas (PRWEB) October 21, 2014 When Presence Health decided to implement MEDITECH’s Scanning an...

Viability PCR — the next level in PCR-based pathogen testing

The webinar will introduce viability PCR as a fast and powerful tool to analyze food samples for the presence of potentially harmful microbes. Viability real-time PCR uses the DNA-masking compound propidium monoazide (PMA). PMA enters dead and membra...

CA Hospitals, Nurse Leaders Issue Statement in Response to Ebola Outbreak

SACRAMENTO, Calif., Oct. 21, 2014 The following statement was issued today by C. Duane Dauner, President/CEO of the California Hospital Association, Tricia Hunter, Executive Director of the American Nurses Association-California, and Pat McFarland, CEO of the Association of California Nurse Leaders: "The California Hospital Association, the Association of California Nurse Leaders, American Nurses...

India's Intas under Vietnamese regulatory lens?

Intas may be the latest to join dozens of Indian generic companies being investigated for the supply of low quality generic drugs.

Latest Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial in China: From Regulations to Practices (2014 Edition)

LONDON, Oct. 21, 2014 /PRNewswire/ -- Executive SummaryChina's regulatory framework for medical devices is undergoing radical changes. The country's new leaders have recognized that the regulations for supervision and administration of medical devices are far from perfect along with rapid population growth and thriving economy over the past 30 years. Chinese state council issued the latest "Regula...

CEL-SCI Corporation to Raise $1 Million in Registered Direct Offering

CEL-SCI Corporation (NYSE MKT: CVM), a late-stage oncology company, has agreed to sell common stock and warrants in a registered direct offering to European investors at a combined price of $0.76 for aggregate gross proceeds of a little over $1 million. For every four shares sold, we will issue to investors in this offering one warrant to purchase a share...

Brightree Announces CareToCash for Enhanced Revenue Cycle Management

Software and services offering enables post-acute care providers to optimize financial performance, adhere to regulatory requirements and improve the patient experience Brightree®, the leading provider of cloud-based clinical, business management and billing software solutions for the post-acute care industry, today at the

Cambridge Design Partnership: Long Term Commitment to Quality Results in Rapid Accreditation to ISO 13485

Innovative technology and design consultancy Cambridge Design Partnership has been awarded certification to ISO13485 and ISO9001, the internationally recognised standards for quality management. As part of a long term commitment to quality, the company was able to go through the accreditation process rapidly to achieve certification in just six months. ...

The business of collaboration

Lab+Life Scientist: What led you to study agriculture? Professor Tony Peacock: I grew up in Sydney and am the youngest of seven children. We owned a hobby farm of 250 acres in the Watagan Mountains north of Sydney and of the seven kids I was the only one who had an interest in agriculture so I spent a lot of time there. The farm was quite well designed. My father was an engineer and was often tr...

PHT Corporation Hosts New Educational Webinar, “Benefits and ROI of eCOA Data Collection in Clinical Trials”

Leading provider of patient-driven eData systems for clinical research joins Celgene Corporation to convey importance of using eClinical technologies to improve clinical programs PHT Corporation, the leading provider of technologies used to collect

Immunotech Laboratories, Inc. Enters into Agreement to Market Potential Ebola Virus Disease (“EVD”) Treatment and Implement Strategy for Company's ITV-1 Infectious Diseases Treatment in Africa

Company Begins Research of Potential EVD Application of the Patented Proteins Immunotech Laboratories, Inc. (OTC PINK: IMMB) (“Immunotech” or the “Company”) and wholly-owned subsidiary Immunotech Laboratories, BG (IMMB-BG) today announced that they have successfully completed negotiations with Uldic Investment Pvt. Ltd. (Uldic), located in ...

Ivera Medical Corporation Successfully Completes FDA Inspection

SAN DIEGO, CA--(Marketwired - Oct 21, 2014) - Ivera Medical Corporation is pleased to report that it successfully completed several days of an exhaustive and intensive review by the Food and Drug Administration (FDA) of Ivera's manufacturing practices, quality control and regulatory filings. At the conclusion of the inspection, which was prompted by a complaint filed by a competitor (Catheter Conn...

Exalenz Bioscience Launches Pivotal Study of World’s First Breath-Based Test to Diagnose Clinically Significant Portal Hypertension

Portal hypertension is the most common complication of cirrhosis, accounting for significant morbidity and mortality Multinational study to be conducted in Europe and the U.S. Exalenz Bioscience (TASE:EXEN), a leader in developing and marketing non-invasive medical devices for diagnosing and monitoring a range of gastrointestinal and liver dis...

Salix’s TARGET 3 Study Examines the Safety and Efficacy of Repeat Treatment with Rifaximin 550 mg for Irritable Bowel Syndrome with Diarrhea

Study Results Presented at the American College of Gastroenterology (ACG) Scientific Meeting in Philadelphia on October 21st Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) announced today that Dr. Anthony Lembo of Beth Israel Deaconess Medical Center will present the results of TARGET 3 in a late-breaking podium presentation at the American College o...

Kamada Announces Study in Support of Alpha-1 Antitrypsin for the Treatment of Type-1 Diabetes Published in the Journal of Diabetes Science and Technology

Anti-inflammatory activity of AAT may modulate immune system to prevent it from attacking pancreatic beta cells Kamada Ltd. (Nasdaq: KMDA) (TASE: KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces that a comprehensive review of the data available in the literature in support of the mechanism of action of Alpha...

Synergy Pharmaceuticals Presents Positive Phase 2b Study Results for Plecanatide in Patients with Irritable Bowel Syndrome with Constipation

Data Presented at the American College of Gastroenterology Annual Scientific Meeting Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced the presentation of results from a phase 2b dose-ranging study assessing plecanatide’s safety and efficacy in 424 adult patients (mITT population= 423) with irritable bowel syndrome with constipation (...


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