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
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
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...
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,
Welsh Assembly The expectation is that at least 65% of responses to red calls should arrive within eight minutes. "In the face of steadily rising demand, the Welsh Ambulance Service has once again exceeded the eight minute response time target for life-threatening calls. The Welsh Ambulance Service is working hard to improve its clinical perform
Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company s Marketing Authorization Application for Epclusa , an investigational, pan-genotypic, once-daily tablet containing the nucleotide analogue polym
The US Food and Drug Administration approved the first implantable opioid addiction treatment on Thursday. We must do everything we can to make new, innovative treatment options available that can help patients regain control over their lives, said FDA commissioner, Robert M Califf, in a statement. An FDA advisory committee voted 12-5 in favor o
The U.S. Food and Drug Administration approved the first implant for treatment of opioid dependency, a six-month treatment of low-level buprenorphine that may be more effective for patients because it is easy to use. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health, said in a press release.
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., direc
The FDA on Thursday filed a motion to vacate all action in the lawsuit brought by Eugene "Neil" Fachon against the agency challenging a hold it placed on a clinical study of an investigational drug being conducted by Burzynski Research Institute in Houston, Texas. Fachon, 20, was the only person enrolled in the study when the FDA moved to halt it.
Findings from A. Gracia and Colleagues Update Understanding of Environmental Research and Public Health. By a News Reporter-Staff News Editor at Health& Medicine Week Data detailed on Environmental Health have been presented. According to news reporting originating from Dallas, Texas, by NewsRx correspondents, research stated, "Determine any disp
The FDA clearly indicates in its responses that the safety and efficacy data from the registration program for Zilretta are acceptable to support filing of an NDA submission. Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes. Michael Clayman, M.
Expanding Medicaid had no noticeable effect on low-income adults' smoking, heavy drinking or binge drinking in 2014, but it might have been good for their teeth, and their ability to work. Kosali Simon, a health economist at the University of Indiana, and two of her colleagues have published a paper on the health effects of the Patient Protection a
TORONTO, May 27, 2016 Intellipharmaceutics International Inc., a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced the pricing of an underwritten public offering of 3,229,814 units of common shares and warrants, at