It was recently announced by Biotronik that patients with implantable cardioverter-defibrillators who need a magnetic resonance image scan can safely undergo the procedure thanks to a successful collaboration with leading Electrophysiologists. Clinical trial results were submitted to the U. S Food and Drug Administration and are awaiting approval..
Audentes Therapeutics reported that AT001, an investigational product in development for the treatment of X-Linked Myotubular Myopathy, has been granted orphan designation by the US Food and Drug Administration and the European Medicines Agency. The FDA and EMA Orphan Drug programs provide orphan designation to drugs and biologics that are intended
By a News Reporter-Staff News Editor at Pharma Business Week Boston Scientific Corporation has received Food and Drug Administration approval for the Innova? Vascular Self-Expanding Stent System, an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery.
ALEXANDRIA, Va., Aug. 31 Cardiac Pacemakers, St. Paul, Minnesota, has been assigned a patent developed by two co-inventors for a "method and apparatus for enabling data communication between an implantable medical device and a patient management system." The co-inventors are Scott T. Mazar, Inver Grove Heights, Minnesota, and Yatheendhar D. Manic
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Clinica Tepeyac announced it has been awarded Federally Qualified Health Center Status. Clinica Tepeyac is one of four health center sites in Colorado that has been awarded a total of $2.3 million in federal grants in Affordable Care Act funds, which is projected to increase acces
Dublin- Research and Markets has announced the addition of the "FDA Drug Approval Process" conference to their offering. This seminar, by a US lawyer with over 40 years of experience dealing with pharmaceutical regulation in the United States and Europe, will provide a general introduction to all aspects of the US drug approval process. It will als
FDA Presents Breakthrough Therapy Designation to Exelixis' Cabozantinib for the Treatment of Renal Cell Carcinoma in Patients Who Received One Prior Therapy. Exelixis reported the U.S. Food& Drug Administration has granted Breakthrough Therapy Designation to cabozantinib, Exelixis' lead compound, as a potential treatment for patients with advanced.
Dr. Lesko was Director of the Office of Clinical Pharmacology in the Center for Drug Evaluation and Research at the Food and Drug Administration for 16 years until his retirement in July 2011. "We are delighted that Dr. Lesko has joined our Simcyp SAB," said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. Dr. Lesko added, "We are definitel
India and China produce a large percentage of a majority of the APIs and intermediates produced in the world currently. While countries such as Japan and Singapore are signatories to the ICH Q7 regulation, India and China follow their national GMP guidelines. The efficiency and expertise of Asian contract manufacturers have positioned them in a ver
By a News Reporter-Staff News Editor at Clinical Trials Week GlySens Incorporated announced that it has secured FDA approval for extending the current human clinical evaluation of its fully implantable continuous glucose monitoring system from the originally approved six-month duration to the system's commercially-intended operational duration...
By a News Reporter-Staff News Editor at Managed Care Weekly Digest PHILADELPHIA- Websites for national and state health insurance marketplaces show evidence of improved efforts to assist patients in choosing health insurance plans, such as providing decision support tools, experts from the Perelman School of Medicine at the University of Pennsylv
Cytovance Biologics reported that they have entered into a definitive agreement by which Hepalink USA will acquire Cytovance Biologics, a biopharmaceutical contract development manufacturing company. According to a release from the company, the addition of Cytovance Biologics to Hepalink USA Inc. and its parent company Shenzhen Hepalink...
By a News Reporter-Staff News Editor at Pharma Business Week The National Organization for Rare Disorders has announced the full agenda for its 2015 Rare Diseases& Orphan Products Breakthrough Summit, the largest multi-stakeholder event dedicated to rare diseases and the only rare disease conference co-sponsored by the Food and Drug Administratio
By a News Reporter-Staff News Editor at Pharma Business Week Lannett Company, Inc. announced that its Silarx Pharmaceuticals, Inc. subsidiary has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Aripiprazole Oral Solution 1 mg/mL, the generic version of the antidepressant drug ABILIFY.
Medivation and BioMarin Pharmaceutical reported they have entered into an asset purchase agreement under which Medivation will acquire all worldwide rights to talazoparib, a highly-potent, orally-available poly ADP ribose polymerase inhibitor currently in a Phase 3 study for the treatment of patients with deleterious germline BRCA 1 or BRCA 2...
By a News Reporter-Staff News Editor at Pharma Business Week Mylan N.V. confirmed that the company has been sued by BTG International Ltd., Janssen Biotech, Inc., Janssen Oncology, Inc., and Janssen Research& Development, LLC in connection with the filing of an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Abirat
Partnerships, Licensing, Investments and M&A Deals and Trends for May 2015 in Pharmaceuticals- Analysis of Partnership and Licensing Deals Based on Clinical Stage of Development of Products. By a News Reporter-Staff News Editor at Pharma Business Week Research and Markets has announced the addition of the "Partnerships, Licensing, Investments and
By a News Reporter-Staff News Editor at Journal of Engineering Quartet Health, a healthcare technology company partnering with health plans and providers to improve the integration between behavioral and medical care, announced the addition of two executives to the company's leadership team. Juliana Ekong will lead clinical program development fo
According to news reporting from Lille, France, by NewsRx journalists, research stated, "Over the past two decades, the use of multiple biomarkers has changed cardiovascular disease management." Our news journalists report that additional information may be obtained by contacting G. Schurtz, Lille University Hospital, SAMU, F-59037 Lille, France.
By a News Reporter-Staff News Editor at Hematology Week Investigators publish new report on Cardiovascular Diseases and Conditions. According to news reporting originating from Jiangsu, People's Republic of China, by NewsRx correspondents, research stated, "Extramedullary disease in multiple myeloma patients is an uncommon event and more attentio
The news correspondents obtained a quote from the research from Mt. Sinai Hospital, "The mean age of the patients was 66.7 years, with a mean follow-up of 33 months. For more information on this research see: Reconstruction of chronic abductor deficiency after revision hip arthroplasty using an extensor mechanism allograft. Bone& Joint Journal, 201
RetroSense Therapeutics reported that the Company's Investigational New Drug application for RST-001 received clearance from the United States Food and Drug Administration. This brings us one step closer to realizing our ambition of improving vision in those individuals with currently incurable blindness, "said Sean Ainsworth, CEO of RetroSense...
RetroSense Therapeutics reported the Company's Investigational New Drug application for RST-001 received clearance from the United States Food and Drug Administration. In 2014, the FDA granted Orphan Drug designation for RST-001 based on its development as a treatment of RP, a rare disease that affects an estimated 100,000 people in the United Stat
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Medicare patients in rural areas have lower rates of follow-up care after leaving the hospitalwhich may place them at higher risk of emergency department visits and repeat hospitalizations, according to a study in the September issue of Medical Care. "This study provides eviden
Sarepta Therapeutics reported that the U.S. Food and Drug Administration has filed the New Drug Application for eteplirsen for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping. According to a release, the FDA has completed its filing review and has determined that our application is sufficiently complete to permit a substan