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Regulation News: Breaking Regulation News, Comments and Articles. - Page: 3

01:46 EDT 1st August 2014 | BioPortfolio

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

Wednesday 30th July 2014

China’s Tigermed Acquires 70% Stake in Frontage Labs of US

Hangzhou Tigermed, a clinical-stage CRO, completed its $50 million acquisition of a 70% stake in Frontage Labs, following regulatory approval. Frontage, which is headquartered in Pennsylvania and has a lab in Shanghai’s Zhangjiang Hi-Tech Park,...

SciClone Pharmaceuticals to Report Financial Results for the Second Quarter 2014 on August 11th

FOSTER CITY, CA -- (Marketwired) -- 07/31/14 -- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that it plans to report financial results for the second quarter 2014 on Monday, August 11, 2014. SciClone will host a conference call and webcast to provide a business and product update at 4:30 pm ET (1:30 pm PT) that day. The call will be hosted by Friedhelm Blobel, Ph.D., President an...

European cancer research could be at risk

The European Society For Medical Oncology (ESMO) has expressed concern that the proposed EU General Data Protection Regulation could make cancer research impossible and add a significant burden to both doctors and cancer patients.The European Parliament, European Council and the European Commission have been working on a new legislative text on data protection, a General Data Protection Regul...

K2M Continues Momentum with Complex Spine & Minimally Invasive Line Extensions & Regulatory Clearances

LEESBURG, Va., July 31, 2014 (GLOBE NEWSWIRE) -- K2M Group Holdings, Inc. (Nasdaq:KTWO) (the "Company" or "K2M"), a global medical device company focused on designing, developing and commercializing innovative and proprietary complex spine technologies, techniques and minimally invasive procedures, today announced the Company's recent product highlights, which include 510(k) clearance from the U....

Sirona Biochem Announces Successful Synthesis of Anti-Inflammatory Compound for Bloom Burton & Co. Joint Venture

VANCOUVER, BC--(Marketwired - July 31, 2014) - Sirona Biochem Corp. (TSX VENTURE: SBM) (OTCQX: SRBCF) (FRANKFURT: ZSB), (the "Company") announces the achievement of the first batch of compound in the joint venture with Bloom Burton & Co. ("Bloom Burton") Compounds developed within the framework of the JV will be entering development in the areas of rare inflammatory and infectious diseases....

Emmi Solutions Contracts With the Department of Surgery at The Johns Hopkins Hospital to Provide Interactive Patient Programs

CHICAGO, IL -- (Marketwired) -- 07/31/14 -- The Department of Surgery at The Johns Hopkins Hospital has selected Emmi Solutions, a leader in outcomes-driven patient engagement, to be a part of their continued innovation around patient-centered care. Through the use of Emmi Solutions' personalized and interactive multi-modal programs, patients are engaged to be informed participants and decision-m...

Benefits of E-Cigarettes May Outweigh Harms, Study Finds

WEDNESDAY, July 30, 2014 -- Strict regulation of electronic cigarettes isn't warranted based on current evidence, a team of researchers says. On the contrary, allowing e-cigarettes to compete with regular cigarettes might cut tobacco-related deaths.....

KAE609 shows promise as next generation treatment for malaria

Novartis International AG / KAE609 shows promise as next generation treatment for malaria . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement. KAE609 is the first antimalarial drug candidate with a novel mechanism of action to achieve positive clinical proof-of-concept in over 20 years  KAE609 was tested in adult pa...

A mathematical theory proposed by Alan Turing in 1952 can explain the formation of fingers

(Center for Genomic Regulation) Researchers from the Centre for Genomic Regulation in Barcelona, show that BMP and WNT proteins are the so-called 'Turing molecules' for creating embryonic fingers. Findings explain why polydactyly -- the development o...

FDAnews Workshop: Conducting Advanced Root Cause Analysis CAPA Investigations, Sept. 17-18, 2014, Raleigh, NC

The FDA's enforcement plan makes it clear: Developing a successful CAPA program has never been more important. FDAnews and Immel Resources are offering an advanced version of their previous CAPA investigations class, fully updated to meet tough FDA scrutiny in 2014. Falls Church, VA (PRWEB) July 30, 2014 Conducting Advanced Root Cause Analysis CAPA Investigations Understanding Advanced Criti...

UPDATE 2-Sanofi, Regeneron cholesterol drug may cut heart risk, trial hints

(Adds that companies seeking priority regulatory review, updates shares)

Drug Firms Buy $67.5 Million Voucher to Speed FDA Review

Regeneron Pharmaceuticals and Sanofi are spending $67.5 million to buy a special voucher held by BioMarin Pharmaceuticals in a bid to hasten regulatory review of their new cholesterol drug.

AIBioTech Teams with Leidos for Air Force Contract

Focus is on Research and Development for Technical Area Tasks AIBioTech®, a comprehensive contract research organization, is pleased to announce that it is acting as a subcontractor to Leidos, which was awarded a contract by the U.S. Air Force to provide research, development, testing and evaluation for Homeland Defense and Security Technical Area Tas...

Enclara Adds an Additional 10,000 ADC Through the First Half of 2014, While Assisting its Customers Through the Turbulent Challenges of Medicare Part D

Leading Hospice Pharmacy Service Provider Grows its National Footprint with 51 New Clients West Deptford, NY (PRWEB) July 30, 2014 Enclara Health, LLC (“Enclara”), a leading hospice pharmacy services provider, continues to grow its national footprint with 51 new clients, comprising more than 10,000 patients (ADC) added thus far in 2014. Enclara recently announced its partnership with Conson...

Hospira beats Street, plans EPO biosimilar submission

Hospira Inc. (NYSE:HSP) gained $4.31 to $56.21 on Wednesday after reporting 2Q14 financial results that beat the Street. Adjusted diluted EPS for the quarter was $0.72, beating the Street's $0.57 estimate and up from $0.55 in 2Q13. Hospira reported n...

WHO proposes 'biological qualifier' system for biosimilars

The World Health Organization published a draft proposal for a global system to assign "biological qualifiers" to biologics and biosimilars. A biological qualifier is a random four-letter code assigned to a biologic manufactured at a specified site....

Agri-Pulse Asserts that Regulatory Delays are Smothering Biotech Innovation

Agri-Pulse recently published a notable guest opinion editorial by Mark Wagoner,a third generation farmer in Walla Walla County, Washington, and a volunteer board member for Truth About Trade & Technology. Titled Biotech Regulatory Delays Smothe...

AUA Responds to Important New IOM Report on Graduate Medical Education Funding and Governance

BALTIMORE, July 30, 2014 /PRNewswire-USNewswire/ -- The American Urological Association (AUA) today issued a statement in response to the new Institute of Medicine (IOM) July 29 report, "Graduate Medical Education that Meets the Nation's Health Needs." The below statement is attributable to AUA Public Policy Council Vice Chair Dr. Christopher Gonzalez. "The AUA applauds the Institute of Medicine...

Anika Therapeutics Announces U.S. Commercialization Partnership for Hyalomatrix® with Wound Care Leader Medline Industries, Inc.

Anika Therapeutics, Inc. (Nasdaq: ANIK) today announced that it has entered into a new agreement with Medline Industries, Inc. to commercialize the Company’s advanced

Synageva BioPharma™ Reports Second Quarter 2014 Financial Results

LEXINGTON, Mass., July 30, 2014 /PRNewswire/ -- Synageva BioPharma Corp. ("Synageva") (NASDAQ: GEVA), a biopharmaceutical company developing therapeutic products for rare disorders, today reported second quarter 2014 financial results, and provided other business updates.  Second Quarter 2014 Financial Results For the quarter ended June 30, 2014, Synageva reported a net loss of $50.2...

Marathon Pharmaceuticals Names Jeanine Swalec Vice President of Regulatory Affairs

Marathon Pharmaceuticals today announced Jeanine M. Swalec has joined the company as its vice president of regulatory affairs. Swalec, 45, most recently served as the senior director for global regulatory affairs for Lundbeck Pharmaceuticals, which acquired Ovation Pharmaceuticals in 2009. Her 11-year career there began with Ovation Pharmaceutical...

Cepheid Updates Status Of Premier Group Purchasing Organization (GPO) Agreement

SUNNYVALE, Calif., July 30, 2014 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that its group purchasing contract with Premier will end on September 30, 2014.  Customers currently purchasing through the Premier GPO will be able to continue their relationship with Cepheid through other GPOs including Amerinet, Baycare, HPA, MedAssets, Novation, and ROi, in addition to the recentl...

Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission

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...

American Telemedicine Association Welcomes Two New Members to the Board of Directors

Naomi Fried, PhD, and Alexis Gilroy, JD, have recently joined the Board of Directors of the American Telemedicine Association (ATA). The Board provides guidance for the Association, which has a mission to promote professional, ethical and equitable improvement in healthcare delivery through telecommunications and information technology. Washington, DC (PRWEB) July 30, 2014 Naomi Fried, PhD, and A...

Siemens Showcases New Workflow, Testing and Training Solutions at AACC

Today Siemens Healthcare reveals its newest in vitro diagnostics innovations at the 2014 AACC Annual Meeting and Clinical Lab Expo, Chicago, July 27-31. Visitors to the Siemens exhibit – themed “Test smarter. Run faster.” – can explore Siemens’ portfolio of solutions, including new products and value-added services designed to enhance workflow, f...


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