LONDON- Advanced Oncotherapy PLC said Friday that the Food and Drug Administration approval process for its LIGHT cancer treatment technology is expected to be completed with the next 15 months, according to its product development committee, in a statement ahead of its annual general meeting. The LIGHT radiotherapy system is based around technolog
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for IndustryPharmacogenomic Data Submissions. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Guidance for IndustryPharmacogenomic Data Submissions" has been approved by the Office of...
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Potential Tobacco Product Violations Reporting Form. SUMMARY: The Food and Drug Administration is announcing that a collection of information entitled "Potential Tobacco Product Violations Reporting Form" has been approved by the Office of Management
Bakersfield Heart Hospital opened their outpatient wound healing program to address the growing need for wound care and help patients overcome issues related to various types of wounds. According to a media release, Bakersfield Heart Hospital's Center for Wound Healing is located directly across the street from the hospital at 3012 Sillect Avenue.
LONDON- A regulatory application for malaria vaccine candidate, RTS, S, submitted to the European Medicines Agency by GlaxoSmithKline plc has been accepted for review, thus becoming the world's first malaria vaccine candidate to undergo regulatory review. AGEN rose 11.15% to close Thursday's trading at $3.39. Cynosure Inc.' s flagship product PicoS
Corgenix Medical will present at the American Association for Clinical Chemistry Annual Meeting and Clinical Lab Expo 2014 in Chicago. Corgenix will have an additional presence in partner ELITech Group's booth. The Hyaluronic Acid Test Kit has not been cleared or approved for diagnostic use in the United States by the U.S. Food and Drug Administrat
Cytonics Corp. has reported that an Investigational New Drug application for a phase I/II clinical trial of the company's APIC Cell-Free System has been approved by the FDA. According to a release from the company, the system is indicated for the rapid preparation of concentrated protease inhibitors in plasma, specifically Alpha-2-Macroglobulin, fo
Derma Sciences reported that Amnioexcel, its novel human amniotic membrane allograft, has been approved by the Veterans Administration for inclusion in its Federal Supply Schedule V797P-2000D. "Inclusion in the Federal Supply Schedule is an important milestone for our newly acquired Amnio product line as we continue to position Derma Sciences as a
MedicalMine Inc. reported that ChARM EHR has been tested and certified under the Drummond Group's Electronic Health Records Office of the National Coordinator Authorized Certification Body program. Drummond Group's ONC-ACB certification program certifies that EHRs meet the Meaningful Use criteria for either eligible provider or hospital...
Pharmacyclics, Inc. today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending the granting of full marketing approval for IMBRUVICA in the European Union. IMBRUVICA is being jointly developed and commercialized in the United States by Pharmacyclics and Jansse
Findings from Children's Hospital in Scoliosis Reported. By a News Reporter-Staff News Editor at Health& Medicine Week A new study on Musculoskeletal Diseases and Conditions is now available. The news reporters obtained a quote from the research from Children's Hospital, "Summary of Background Data.
Genentech reported that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application and granted Priority Review for Avastin plus chemotherapy for the treatment of women with recurrent platinum- resistant ovarian cancer. "We look forward to working with the FDA to bring this potential option to women
By a News Reporter-Staff News Editor at Drug Week GlycoMimetics, Inc. announced the addition of Mark A. Goldberg, M.D. to its Board of Directors. Goldberg is Executive Vice President, Medical and Regulatory Strategy at Synageva BioPharma Corporation and holds appointments at Brigham and Women's Hospital and Dana Farber Cancer Institute.
British drug-maker GlaxoSmithKline has applied for regulatory approval for the world's first vaccine against malaria. The drug, GSK says, is designed for use in children in Africa. They added the shot, called RTS, S, is intended exclusively for use outside the European Union but will be evaluated by the European Medicines Agency in collaboration wi
The pharmaceutical company GlaxoSmithKline has applied to the European Medicines Agency for regulatory approval for its RTS, S malaria candidate vaccine. EMA will now work with the World Health Organisation to assess the quality, safety and efficacy of the vaccine, which is the first to offer protection against malaria. The vaccine was trialled in
Before joining Aetna, Paz served as chief executive officer of Penn State Hershey Medical Center and Health System, senior vice president for Health Affairs for Penn State University, dean of its College of Medicine and professor of medicine and public health sciences for eight years. Prior to his appointment to Penn State, he served as dean of the
Iroko Pharmaceuticals reported that its affiliate, Iroko Pharmaceuticals Inc., signed a licensing agreement with Calox De Costa Rica S.A. for the rights to market and sell Zorvolex capsules in specified countries in Latin America. In a release, the Company noted Calox will be responsible for obtaining regulatory and pricing approval, as well as the
Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorisation for IMBRUVICA (TM) in the European Union. Ibrutinib is being co-developed by Janssen and Pharmacyclics Switzerland GmbH.
Ligand Pharmaceuticals Inc. reported that its partner Sage Therapeutics Inc., reported that the U.S. Food and Drug Administration has granted fast track designation to the SAGE- 547 development program. According to a release, SAGE-547 is an allosteric modulator of GABAA receptors in development for the treatment of adult patients with refractory s
Ligand Pharmaceuticals reported that its partner Sage Therapeutics Inc. reported that the U.S. Food and Drug Administration has granted fast track designation to the Sage-547 development program. "Sage illustrates the important role Ligand can play in helping our partners to develop new drug candidates," said John Higgins, President and Chief Exec
MAXIMUS, a leading provider of government services worldwide, announced today that its wholly owned subsidiary, Health Management Limited, will operate the new Health and Work Service program on behalf of the United Kingdom s Department for Work and Pensions. The service will launch on a phased basis beginning with the North of England, Midlands
By a News Reporter-Staff News Editor at Health& Medicine Week Data detailed on Health and Medicine have been presented. According to news reporting from Rochester, Minnesota, by NewsRx journalists, research stated, "Studies have suggested that patients with acute ischemic stroke who present to the hospital during off-hours may or may not have wor
FOR FURTHER INFORMATION CONTACT: Mark Kreitz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. In accordance with section 513 of the Federal Food, Drug, and Cosmetic Act, devices that were not in commercial distribution before May 28, 1976, generally referred to as postamendments devi
New Orthopedic Trauma Study Findings Reported from Washington Hospital Center. According to news reporting out of Washington, District of Columbia, by NewsRx editors, research stated, "Our present study examines the complications of pediatric patients treated with plate fixation for forearm fractures. Our news journalists obtained a quote from the.
Orange Health Solutions published a case study revealing the results of a post-acute care partnership with MedSolutions. In a release, the Company noted MedSolutions worked in partnership with Orange Health Solutions and Orange Accountable Care to make the fragmented post-acute care experience more coordinated for Medicare Fee for Service patients.