ABILITY Network and DecisionHealth are pleased to announce the 2016 HomeCare Elite , recognizing the top-performing home health agencies in the United States. HomeCare Elite is a market-leading analysis that identifies the top 25 percent of all Medicare- certified home health agencies and further highlights the nation s top 100 and top 5
Aduro Biotech, Inc., a biopharmaceutical company with three distinct immunotherapy technologies, announced today that it has received notice from the U.S. Food and Drug Administration that trials with investigational agents based on its LADD platform have been placed on partial clinical hold to pause new patient enrollment. The partial hold was i
SUMMARY: The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. All comments should be identified with the OMB control number 0910-0672. Also include the FDA docket number found in brackets
aTyr Pharma, Inc., a biotherapeutics company engaged in the discovery and development of Physiocrine-based therapeutics to address severe, rare diseases, today announced that its product candidate Resolaris? was granted Fast Track designation by the US Food and Drug Administration for the treatment of facioscapulohumeral muscular dystrophy, mak
aTyr Pharma shares are 7% higher mid-day after the biotherapeutics company this morning said its product candidate Resolaris? was granted Fast Track designation by the FDA for the treatment of facioscapulohumeral muscular dystrophy, making it the first known therapeutic candidate for the treatment of FSHD to receive the designation.
BERG, a biopharmaceutical company uncovering health solutions through a data-driven, biological research approach, today announced that it has entered into a Cooperative Research and Development Agreement with partners of the Department of Defense's Clinical Breast Care Project including Walter Reed National Military Medical Center, The Windber..
There are two big news from the staple of Merck& Co., Inc. during the weekend. While the first related to KEYNOTE-045 meeting primary endpoint, the second is in respect of FDA approval for ZINPLAVA to reduce recurrence of clostridium difficile infection in adults. As far as ZINPLAVA, Merck disclosed that the drug candidate is indicated to cut down
Braeburn Pharmaceuticals and Camurus today announced the expansion of their collaboration and license agreement from 2014 to include buprenorphine combination products. We are pleased to announce this extension of our successful partnership with Camurus. The partnership with Braeburn Pharmaceuticals is a strong platform for the further global...
Martindale Pharma, the UK- based international specialty pharmaceutical company, today announced the regulatory approval of its clobazam oral suspension product, Epaclob in France, Ireland, Germany and Italy and Silocalm in Denmark, Spain and Iceland following the successful completion of a decentralised procedure. Epaclob/Silocalm are based
By a News Reporter-Staff News Editor at Pharma Business Week Clovis Oncology announced the oral presentation of the primary efficacy and safety data from its NDA dataset for rucaparib at the 2016 ESMO Congress in Copenhagen. Rucaparib is currently under priority review with FDA for the monotherapy treatment of advanced ovarian cancer in patients
By a News Reporter-Staff News Editor at Managed Care Weekly Digest Seventy-six percent of respondents felt the best life stage for consumers to gain an understanding of health insurance was before or during high school or college, according to a national survey commissioned by FAIR Health and conducted by ORC International. Of the respondents fav
By a News Reporter-Staff News Editor at Robotics& Machine Learning Corindus Vascular Robotics, Inc., a leading developer of precision vascular robotics, announced the appointment of Suzette Jaskie as Vice President Global Medical Affairs. As Vice President Global Medical Affairs at Corindus, Ms. Jaskie will develop and execute best in class medic
Corizon Health Chief Executive Officer Karey Witty today announced Scot Ward as Executive Vice President and Chief Administrative Officer. Ward has more than 20 years experience as a healthcare leader, specializing in technology and analytics, including medical analytics, health informatics, predictive modeling, Medicare, and Medicaid.
Data on Lung Cancer Described by Researchers at Cantonal Hospital. By a News Reporter-Staff News Editor at Cancer Gene Therapy Week A new study on Oncology- Lung Cancer is now available. According to news reporting originating from St. Gallen, Switzerland, by NewsRx correspondents, research stated, "Controversy exists about the integration of erl
DaVita Kidney Care, a division of DaVita Inc., the leading independent provider of integrated health and kidney care services in the United States, today announced that since the inception of the Centers for Medicare& Medicaid Services Five-Star Rating System, and for the third year in a row, it has been recognized as a clinical leader in the pro
DaVita Kidney Care, a division of DaVita Inc., the leading independent provider of integrated health and kidney care services in the United States, today announced that since the inception of the program and for the third year in a row, it has been recognized as the clinical leader in the Centers for Medicare& Medicaid Services Five-Star Quality
Release date- 21102016- Astellas Pharma Inc. and Pfizer Inc. today announced the U.S. Food and Drug Administration approved a supplemental New Drug Application to update the U.S. product labeling for XTANDI capsules to include new clinical data versus bicalutamide from the TERRAIN study. According to the American Cancer Society, each year approxima
By a News Reporter-Staff News Editor at Diabetes Week Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has accepted a supplemental Biologics License Application and granted Priority Review for Lucentis for the treatment of myopic choroidal neovascularization, a complication of severe near-sightedness
Findings from RAND Broaden Understanding of Managed Care. By a News Reporter-Staff News Editor at Managed Care Weekly Digest Research findings on Managed Care are discussed in a new report. According to news reporting out of Santa Monica, California, by NewsRx editors, research stated, "The purpose of this project was to examine the policy implic
By a News Reporter-Staff News Editor at Pharma Business Week Fresenius Kabi announced it has received FDA 510 clearance for the Aurora? Xi Plasmapheresis System. "The Aurora Xi system features a proprietary filtration-separation method that enables the faster collection of Source Plasma. The system helps to improve plasma center efficiency and
Wellbridge Health and Gateway Health proudly announce a dynamic collaboration that will bring innovative digital health solutions to Medicare and Medicaid plan members with specific high risk needs. Poverty, isolation, cognitive issues, and depression are often barriers to self-management, "said Cynthia Zydel, CEO of Wellbridge Health.
SUMMARY: The Food and Drug Administration is announcing the extension of the comment period and correcting a notice that appeared in the Federal Register of Monday, September 26, 2016. In that Federal Register notice, FDA requested comments on the draft recommendations related to the reauthorization of the Generic Drug User Fee Amendments of 2012.
Global Blood Therapeutics, Inc., a biopharmaceutical company developing novel therapeutics for the treatment of grievous blood-based disorders with significant unmet need, today announced that it has reached agreement with the U. S. Food and Drug Administration regarding the design of its pivotal trial for GBT440 in adults and adolescents with si
-Regulatory submissions in the EU and Canada remain on track for 2016. GlaxoSmithKline plc today announced that it has submitted a Biologics License Application for its candidate shingles vaccine, ShingrixTM, to the United States Food and Drug Administration, seeking approval for the prevention of herpes zoster in people aged 50 years or over.
LONDON- GlaxoSmithKline plc announced it has submitted a Biologics License Application for its candidate shingles vaccine, Shingrix, to the U.S. FDA, seeking approval for the prevention of herpes zoster in people aged 50 years or over. The regulatory submission is based on a phase III clinical trial programme evaluating efficacy, safety and immunog