By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Dipexium Pharmaceuticals, Inc., a late-stage pharmaceutical company focused on the development and commercialization of Locilex , a novel, broad-spectrum, topical antibiotic peptide, announced that it has completed the patient enrollment objective in the OneStep-2 pivotal Ph
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA H3 Biomedicine Inc., a biopharmaceutical company specializing in the discovery and development of precision medicines for oncology and a member of the Eisai Group, announced that the U.S. Food and Drug Administration accepted the company's Investigational New Drug application
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA CSL Behring announced it has been granted seven years of marketing exclusivity by the U.S. Food and Drug Administration for IDELVION. The FDA grants marketing exclusivity for innovative, first-to-market orphan drugs, such as IDELVION. IDELVION was approved by the FDA in March
During a London presentation, the executives, led by chief executive Susan Cameron, discussed the company's reaction to the FDA regulations that were finalized May 5. It's clear Reynolds- at least for now- is not interested in taking legal action against the FDA for the new rules as have as least two small vaping companies. Cameron said she was ple
Tenders are invited for Statewide Medicaid Comprehensive Hemophilia Management Program Purpose: The Agency is seeking a qualified Vendor or Vendors to develop, implement, and provide a disease management program for a Statewide MCHM program in the State of Florida. The Vendor shall demonstrate specific knowledge and expertise in hemophilia disease.
Request for quotations: supply of medical devices for the needs of state fiscal health institutions of the tver region tver regional clinical tb dispensary The initial contract price: 94520.00 russian rouble Requirements for participants: not installed restricting participation in the definition of the supplier, established in accordance with the..
WESTON- AbbVie, a research-based biopharmaceutical company, and Biogen late Friday announced that the U.S. Food and Drug Administration or FDA approved ZINBRYTA, a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis or RMS. The FDA approval of ZINBRYTA is primarily based on results from two clinical
CAMBRIDGE, Mass.& NORTH CHICAGO, Ill. The U.S. Food and Drug Administration approved ZINBRYTA TM, a new once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis, Biogen and AbbVie announced today. Clinical data showed ZINBRYTA significantly reduced relapses and brain lesions for up to three years compare
Intercept Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration has granted accelerated approval to Ocaliva for the treatment of primary biliary cholangitis, previously know
Drugmaker Cipla has won regulatory approval in India for the sale of its version of Truvada as a preventive that healthy people can use to lower their risk of getting HIV. Commonly called PrEP in the healthcare industry, Truvada, sold by US drug manufacturer Gilead, is the sole medicine approved worldwide as a preventive in handling HIV. The recent
The Food and Drug Administration has informed BioPorto A/S that the registration application for The NGAL Test? has been rejected on the grounds that the submission does not provide adequate clinical and analytical data to support a reasonable assurance of approval of the device.. FDA's response means that BioPorto cannot begin commercialization
United Kingdom: AstraZeneca receives Complete Response Letter from US FDA for sodium zirconium cyclosilicate for oral suspension for treatment of hyperkalaemia. AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for sodium zirconium cyclosilicate, the...
The U.S. Food and Drug Administration today approved Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence. An independent FDA advisory committee supported the approval of Probuphine in a meeting held earlier this year. Expanding the use and availability of medication-assisted treatment options like...
The U.S. Food and Drug Administration today approved Axumin, a radioactive diagnostic agent for injection. Prostate cancer is the second leading cause of death from cancer in U.S. men. Imaging tests are not able to determine the location of the recurrent prostate cancer when the PSA is at very low levels, said Libero Marzella, M.D., Ph.D., director
Oasmia Pharmaceutical AB has announced its plan to identify global marketing, distribution, and development partners to ease entry into several key markets following expected but pending approval from regulatory bodies in Europe, the United States, and other regions across the world. The Company sees this step as a key objective following its recen
By a News Reporter-Staff News Editor at Health& Medicine Week Reston, Va.- A recent study reported in the May issue of the Journal of Nuclear Medicine demonstrates that Ga-68 DOTATATE PET/CT scans are superior to In-111 pentetreotide scans, the current imaging standard in the United States for detecting neuroendocrine tumors, and could significan
Asserting its role as "a neutral organization that highly values its...'honest broker reputation,' " AAMI has submitted comments to the FDA concerning medical device repair and refurbishment in advance of the agency's June 3 deadline. The 18-page letter, followed by nearly 40 more pages of attachments, notes the dangers of silo-based thinking and a
AbbVie, a global biopharmaceutical company, announced today that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for HUMIRA for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids or in
-AIM Health, a new hybrid primary care clinic that offers both a concierge and traditional patient model in West Linn, Oregon, announces the addition of a new family practitioner, Dr. Kathryn Kolonic, formerly at Providence Health in Canby. Dr. Kolonic will began accepting new patients at AIM Health starting May 23, 2016.
Amgen today announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion to extend the current indication for Kyprolis to include treatment in combination with dexamethasone alone for adult patients with multiple myeloma who have received at least one prior therapy.
LONDON- AstraZeneca said that the US Food and Drug Administration has issued a Complete Response Letter or CRL regarding the New Drug Application or NDA for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. AstraZeneca and ZS Pharma
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter regarding the New Drug Application for sodium zirconium cyclosilicate, the investigational medicine being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of AstraZeneca. AstraZeneca and ZS Pharma are...
A federal Bankruptcy Court judge has set a hearing for June 24 to determine whether to allow Stokes County to take over the operations- including 200- plus employees- of Pioneer Community Hospital of Stokes County. The bankruptcy court in the Southern District of Mississippi is handling Pioneer's Chapter 11 filing of March 31. Health care systems n
-Coherus BioSciences, Inc., a leading pure-play, global biosimilars company with late-stage clinical products, today announced that the United States Patent and Trademark Office issued to Coherus U.S. Patents 9,340,611; 9,340,612 and 9,346,880. These patents generally concern formulations of adalimumab, the active biological ingredient in Coherus..
Cordata Healthcare Innovations today announced a partnership with PatientBond, LLC. This partnership benefits our hospital and health system clients in multiple ways, from focusing care coordination resources on the interactions that matter most, to helping patients overcome barriers to care and stick to their treatment plans, said Gary Winzenread,