ENP Newswire- 15 September 2014. Release date- 12092014- The Association of the British Pharmaceutical Industry and the Department of Health have today announced the second quarter payment of GBP76m by industry to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme. Commenting on the announcement, Steph
Acura Pharmaceuticals Inc., announced today that it has submitted a formal dispute resolution request with the FDA for Vycavert , its abuse deterrent formulation of hydrocodone and acetaminophen tablets. By taking this action, Acura is availing itself of the FDA's established appeal process whereby disagreements with conclusions reached by a...
By a News Reporter-Staff News Editor at Clinical Trials Week Allergan, Inc. announced that the European Commission has extended the Marketing Authorization for OZURDEX to treat adult patients with visual impairment due to diabetic macular edema who are pseudophakic, or who are considered insufficiently responsive to, or unsuitable for...
Drug inspectors will launch a crackdown against unregistered companies manufacturing herbal medicines after the deadline for application of registration ends on October 1, Ministry of Health Drug Regulations Pharmaceutical Legal Expert Noor Muhammad Mahar said on Sunday. Mahar said owners of firms that violate the Act could be fined and imprisoned
Amgen Submits Marketing Authorization Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The European Medicines Agency. By a News Reporter-Staff News Editor at Clinical Trials Week Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized...
New Pharmaceuticals market report from Global Markets Direct: " Aprea AB- Product Pipeline Review- 2014" Boston, MA 09/15/2014 Global Markets Direct's,' Aprea AB- Product Pipeline Review- 2014', provides an overview of the Aprea AB's pharmaceutical research and development focus. This report provides comprehensive information on the current t
In the article "Evaluating Health Care Delivery Reform Initiatives in the Face of' Cost Disease'," Steven Thompson, PhD, University of Richmond, VA, Rajiv Kohli, PhD, College of William and Mary, Craig Jones, MD and Nick Lovejoy, Vermont Blueprint for Health, and Katharine McGraves-Lloyd and Karl Finison, Onpoint Health Data, analyzed claims by pat
Avanir Pharmaceuticals, Inc. today announced positive results from its phase II clinical trial evaluating the safety and efficacy of AVP-923 for the treatment of agitation in patients with Alzheimer's disease. "This is an exciting advancement in Alzheimer's disease research," said Jeffrey Cummings, MD, director of the Cleveland Clinic Lou Ruvo Cen
Mobility is equally preserved in cancer patients suffering from malignant spinal cord compression who receive a single dose of 10 Gy of radiation therapy, compared to patients who receive five daily doses of 4 Gy of RT each, according to research presented today at the American Society for Radiation Oncology's 56th Annual Meeting. Malignant spinal
SUMMARY: The Food and Drug Administration is proposing in this administrative order to reclassify the external pacemaker pulse generator devices, a preamendments class III device into class II, and to amend the device identification and reclassify the pacing system analyzers into class II. FDA is proposing this reclassification based on new informa
In that document, FDA proposed to reclassify the external pacemaker pulse generator devices, a preamendments class III device into class II. In response to the requirements under the Food and Drug Administration Safety and Innovation Act and new information received during a panel meeting, FDA is withdrawing the proposed rule and issuing a proposed
Cardiovascular Systems, Inc., unveiled new data about the treatment of arterial calcification at the 2014 Transcatheter Cardiovascular Therapeutics conference in Washington D.C. Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease and it can lead to significant complications.
By a News Reporter-Staff News Editor at Clinical Trials Week Cerenis Therapeutics, the biopharmaceutical company developing CER-001, an engineered human apoA-I-containing pre-beta HDL mimetic, for the treatment of cardiovascular disease, announced that it has received two separate Orphan Drug Designations from the European Medicines Agency for th
Cochlear Limited, the global leader in implantable hearing solutions, announced today that the US Food and Drug Administration approved the use of 2.4 GHz wireless connectivity with the Cochlear? Nucleus 6 Sound Processor. The Cochlear Wireless portfolio includes three accessories designed to help bring Nucleus 6 System recipients closer to
Mukesh Kumar will be held on October 16-17, 2014 in Durham, North Carolina. This seminar will provide step by step instructions to create SOPs for FDA- regulated organizations based on the instructor's extensive FDA compliance training experience. He has been a part of over 100 clinical trials in more than 40 countries, presented hundreds of US FDA
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Consumer Watchdog said that a one-minute radio advertisement released by health insurance companies opposed to Prop 45' s health insurance rate regulation provisions fraudulently misrepresents the advertisement's backers, the ballot measure, and the current state of the law govern
NantBioScience, a NantWorks company focused on the discovery and development of innovative treatments for diseases with high unmet medical need, announced today a research collaboration and an exclusive worldwide licensing agreement with the University of Colorado for the development and commercialization of anti-cancer agents designed to target...
A new study by researchers at CVS Health and Brigham and Women's Hospital published today in the Annals of Internal Medicine, is the first to investigate whether starting on a generic versus a brand-name drug for the treatment of high cholesterol is associated with improved health outcomes. "We know that medication non-adherence is complex and v
Data on Cardiovascular Research Described by Researchers at University Hospital. According to news reporting originating from Bonn, Germany, by NewsRx correspondents, research stated, "Transcatheter mitral valve repair is a treatment option in patients with symptomatic functional or degenerative mitral regurgitation at high surgical risk.
By a News Reporter-Staff News Editor at Clinical Trials Week DelMar Pharmaceuticals, Inc. announced that the United States Patent and Trademark Office has issued a notice of allowance for patent application number 13/ 933,751, covering improved methods for synthesizing VAL-083, DelMar's lead drug candidate, which is currently in a Phase I/II clin
Dyax Corp. today announced that the U.S. These newly issued patents contain broad composition of matter claims which provide important long-term exclusivity for DX-2930, especially its binding properties to human plasma kallikrein, which we believe is a critical target in the treatment for hereditary angioedema, said Gustav Christensen, Presi
By a News Reporter-Staff News Editor at Clinical Trials Week Regulatory News: ERYTECH Pharma, the French biopharmaceutical company that develops innovative' tumor starvation' treatments for acute leukemia and other oncology indications with unmet medical needs, announces that an independent Data and Safety Monitoring Board completed its second sa
By a News Reporter-Staff News Editor at Pharma Business Week Esaote North America announced that its new MyLab Six ultrasound system has received 510 clearance from the U.S. Food and Drug Administration and is now available for sale in the United States. "Today's practices need ultrasound systems that deliver high quality images across a broad s
Today, Analysts Review released its research reports regarding Amgen Inc., Biogen Idec Inc., Salix Pharmaceuticals Ltd., Covidien plc and Shire plc. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/6458-100free. Amgen Inc. Research Reports On September 10, 2014, Amgen Inc. announced that it wil
Vernalis plc and Tris Pharma, Inc. are pleased to announce that the U.S. Food and Drug Administration has confirmed that the New Drug Application for Tuzistra? XR has been accepted for full review. Under the exclusive licensing agreement announced in February 2012, Tris is developing, on behalf of Vernalis, up to six unique extended release equ