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20:30 EST 25th November 2014 | BioPortfolio

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Showing "regulation regulatory" News Articles 51 to 75 of 7,400+

Monday 24th November 2014

Comment on Tufts Figures on Drug Development Spark Debate by Regulatory Expert

"Factors leading to higher costs, researchers say, include more extensive and complex clinical trials....." This report is terribly flawed on several factors! The most critical one being that the authors have never actually were involved in drug development in their lives!!! This is why we will never know the actual reasons as to why the drug development is getting expensive! The only w...

RNA helicase DDX21 coordinates transcription and ribosomal RNA processing

DEAD-box RNA helicases are vital for the regulation of various aspects of the RNA life cycle, but the molecular underpinnings of their involvement, particularly in mammalian cells, remain poorly understood. Here we show that the DEAD-box RNA helicase...

Cellectis Announces Upcoming Presentations at the 56th Annual Meeting of the American Society of Hematology (ASH)

Regulatory News : Cellectis SA (Paris:ALCLS) (Alternext: ALCLS.PA), a biopharmaceutical company focused on developing immunotherapies based on gene edited engineered CART-cells (UCART), today announced that three abstracts on the Company’s CART-cell development programs were accepted for presentation at the 56th Annual Meeting and Exposition of ...

Massive man versus mouse genome project publishes results

A comprehensive international study has revealed striking similarities as well as some significant differences between the regulation of mouse and human genomes...

Onxeo Announces Positive DSMB Recommendation for Its Phase III Trial with Livatag in Primary Liver Cancer

Regulatory News OnxeoSA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announ...

Implanet Stands out at the North American Spine Society (NASS) Annual Meeting and Signs Six New Distribution Agreements

Regulatory News: IMPLANET (Paris:IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, reports that its JAZZ implant was the object of significant interest from specialized spine professionals and distributors at the recent North American Spine Society (NASS) Annu...

Onxeo Announces Positive DSMB Recommendation for Its Phase III Trial with Livatag® in Primary Liver Cancer

Regulatory News : Onxeo SA (Paris:ONXEO) (NASDAQ OMX:ONXEO) (Euronext Paris, NASDAQ OMX Copenhagen - ONXEO), an innovative company specializing in the development of orphan oncology drugs, today announced that the European Independent Board of Experts (Data Safety and Monitoring Board, DSMB) in charge of the safety monitoring of the Livatag® Phas...

Global Diabetes Market Report 2014 Edition Now Available at MarketReportsOnline.com

MarketReportsOnline.com adds "Global Diabetes Market Report: 2014 Edition" report to its research store. Dallas, TX (PRWEB) November 24, 2014 People with diabetes are more likely to have conditions that increase the risk of heart attacks or have strokes at an earlier age than other people. If a person is middle-aged and have type 2 diabetes, then there is a chance of having a heart atta...

News and press releases: Regulatory information – EMA releases practical guidance on access-to-documents requests

Process reviewed to provide tailored service for requesters

Cepheid Receives FDA Clearance for Xpert Flu/RSV XC

SUNNYVALE, Calif., Nov. 24, 2014 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert® Flu/RSV XC, an on-demand molecular test for accurate and reliable determination of Flu A, Flu B, and differentiation of RSV infection. Xpert Flu/RSV XC runs on Cepheid's GeneXpert® System, the world'...

Terahertz device could strengthen security

We are all familiar with the hassles that accompany air travel. We shuffle through long lines, remove our shoes, and carry liquids in regulation-sized tubes. And even after all the effort, we still wonder if these procedures are making us any safer. ...

Leveraging Lab Data is Essential in the New Marketplace. New Research from G2 Intelligence Reveals Where to Begin — and How to Succeed.

Labs and pathologists have a unique opportunity to become leaders in patient data and synthesis. Get up to speed today! G2 Intelligence — a 30+ year leader in research, reporting, and analysis on the business of the diagnostic laboratory industry — announces the release of

Prosensa's muscular dystrophy drug attracts BioMarin in $840 mln deal

Prosensa Holding (NASDAQ:RNA) shot up in today’s trades after the Dutch drug developer agreed to be sold to BioMarin Pharmaceuticals (NASDAQ:BMRN), a U.S. drugmaker, for about $840 million. The deal is a bet that regulators will approve Prosens...

Trimel sells Natesto rights to Endo

Trimel Pharmaceuticals (TSE:TRL) advanced to a near four-month high after the Canadian specialty pharmaceutical company said its wholly-owned unit Trimel BioPharma provided an affiliate of Endo International plc (TSE:ENL) with rights to market Natest...

INTERPHEX Announces Launch of New INTERPHEX Exhibitor Awards for 2015

-Recognizing Cutting-Edge Technology and the Outstanding Efforts of Companies that Support Pharmaceutical and Biopharmaceutical Development and Manufacturing- International Pharmaceutical Expo (INTERPHEX), the premier pharmaceutical and biopharmaceutical event dedicated to innovation, technology and knowledge, and sponsored by the Parenteral Drug ...

Ocata Therapeutics Receives Advanced Therapy Medicinal Product Designation from the European Medicines Agency

Advanced Medicinal Product Designation Granted for its Retinal Pigment Epithelium Programs, in clinical trials for Stargardt’s Macular Degeneration (SMD) and dry Age-related Macular Degeneration (AMD) Ocata Therapeutics, Inc., (OTCBB:OCAT) today announced that it has been granted Advanced Therapy Medicinal Product (ATMP) designation for its RPE thera...

Gamma Medica to Now Offer Philips MicroDose SI for a More Comprehensive Breast Cancer Solution

LumaGEM and MicroDose SI will bolster breast imaging suites’ screening offering in North America Gamma Medica today announces the company will now offer Philips MicroDose SI, the first full-field digital mammography (FFDM) system that supports single-shot, non-invasive spectral imaging, as a complement to its market leading LumaGEM Molecular Breast I...

PHT Corporation is the Only Provider Authorized by Scale Developer to Provide Rater Training on the Electronic M.I.N.I.

Rater training instructs on the widely used M.I.N.I. and the electronic implementation of the M.I.N.I. PHT Corporation is the first and only electronic clinical outcome assessment (eCOA) provider approved to train raters on the electronic Mini International Neuropsychiatric Interview (M.I.N.I.) for clinical trials. PHT is the leading provider of...

Leaders from Proteus Digital Health and Hogan Lovells Elected to California Healthcare Institute Board of Directors

New board appointments extend CHI network and bring new industry expertise in digital health and reimbursement policies LA JOLLA, Calif. (PRWEB) November 24, 2014 California Healthcare Institute (CHI) announced today the election of two senior leaders to serve on its board of directors: Beth Roberts, partner, Hogan Lovells US LLP and George Savage, M.D., chief medical officer, Proteus Digital Hea...

Bristol-Myers Squibb and Five Prime Therapeutics Announce Exclusive Clinical Collaboration to Evaluate the Combination of Investigational Immunotherapies Opdivo (nivolumab) and FPA008 in Six Tumor Types

Bristol-Myers Squibb Company (NYSE:BMY) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb’s investigational PD-1 (programmed death-1) immu

BioRestorative Therapies Schedules Pre-IND Meeting with FDA

Company Submits Pre-IND Package for brtxDISC™ Clinical Development Meeting with FDA BioRestorative Therapies, Inc. ("BRT" or the "Company") (OTCBB:BRTX), a life sciences company focused on adult stem cell-based therapies for various personal medical applications, announced that a Pre-IND (Investigational New Drug) meeting with the ...

Teduglutide Granted Orphan Drug Designation in Japan

NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted teduglutide orphan drug designation for the treatment of Short Bowel Syndrome (SBS). Also, due to ...

Merck Submits New Drug Application to the Japanese Pharmaceuticals and Medical Devices Agency for Omarigliptin, an Investigational Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the company has submitted a new drug application for omarigliptin, its investigational once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes, to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). “Merck is committed to helping patien...

Biopolitics for understanding social regulation and control

People, as the biological beings that we are, can be socially regulated by mechanisms such as taxes, property or family relationships. This constitutes part of the social policy that the Roman government put into practice during its expansion through...

Merck and NewLink Genetics Enter Into Licensing and Collaboration Agreement for Investigational Ebola Vaccine

Clinical Development, Manufacturing Expertise, and Scale Critical to Success Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NewLink Genetics Corporation (NASDAQ:NLNK), announced today that they have entered into an exclusive worldwide license agreement to research, develop, manufacture, and distribute NewLink’s investigation...


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