Laval, Quebec, CANADA- Acasti Pharma Inc., a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre for the treatment of severe hypertriglyceridemia, today clarified the proposed term of the transaction contemplated by its recently announced non-binding term sheet with a leadi
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Cerus Corporation announced it has received an investigational device exemption approval from the U.S. Food and Drug Administration to initiate ReCePI. ReCePI is one of the three Phase III clinical trials we will be conducting to support our planned submission to the FDA for U.S. l
Used by more than 10,000 providers nationwide, Compulink's MACRA-ready all-in-one system supports the entire practice workflow? This stamp of approval designates that Compulink's solutions offer functionality to help providers meet the ever-evolving clinical practice improvement and care coordination activities that are required for successful...
Data from Harvard School of Medicine Provide New Insights into Internal Medicine. According to news reporting originating from Boston, Massachusetts, by NewsRx correspondents, research stated, "Financial ties between physicians and the pharmaceutical and medical device industry are common, but little is known about how patient trust is affected by
Data on Osteonecrosis Reported by Researchers at Hospital of Santa Maria. By a News Reporter-Staff News Editor at Health& Medicine Week Current study results on Musculoskeletal Diseases and Conditions- Osteonecrosis have been published. According to news reporting out of Lisbon, Portugal, by NewsRx editors, research stated, "Risk factors for...
Lausanne, Switzerland- Debiopharm International SA, part of Debiopharm Group, a Swiss-based global biopharmaceutical company, announced today the launch of its new clinical trials website patients.debiopharm.com. The website provides patients and their caregivers with helpful information on Debiopharm's clinical trials and studies.
Visiongain, a research firm, issued the following report:. Digital Therapeutics- our new study reveals trends, R&D progress, and predicted revenues Where is the Digital Therapeutics market heading? If you are involved in this sector you must read this newly updated report.
The European Medicines Agency is to relocate from London to Amsterdam after Brexit. It beat competition from countries including Athens, Barcelona, Brussels, Copenhagen, Dublin, Helsinki, Porto, Sofia, Stockholm, Malta, Warsaw and Zagreb to become the EMA`s new host. The decision was met with concerns over the number of highly skilled jobs that wil
Princeton, NJ; Hong Kong- Eleison Pharmaceuticals, Inc., a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, and China Oncology Focus Limited, a subsidiary of Lee's Pharmaceutical Holdings Ltd. have jointly announced that a partnership is formed, to develop and commercialize the pancreatic drug candidate...
The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where the
The U.S. Food and Drug Administration today approved the RxSight Inc. Light Adjustable Lens and Light Delivery Device, the first medical device system that can make small adjustments to the artificial lens' power after cataract surgery so that the patient will have better vision when not using glasses. Cataracts are a common eye condition where the
The U.S. Food and Drug Administration today approved Juluca, the first complete treatment regimen containing only two drugs to treat certain adults with human immunodeficiency virus type 1 instead of three or more drugs included in standard HIV treatment. 'Limiting the number of drugs in any HIV treatment regimen can help reduce toxicity for patien
The lens and device are the first medical device system approved by the FDA to make small adjustments to the artificial lens after cataract surgery. The FDA approved the device after it passed the safety and efficacy clinical test on 600 patients. Until now, refractive errors that are common following cataract surgery could only be corrected with g
Findings in the Area of Radiation Therapy Reported from Food and Drug Administration. According to news reporting originating from Silver Spring, Maryland, by NewsRx correspondents, research stated, "Development and progress of cancer is a very complex disease process to comprehend because of the multiple changes in cellular physiology, pathology,
This report gives us an overview of the Flow Cytometers - Medical Devices Pipeline Marketwhich is classified on the basis of product and its various applications. It also mentions the key area where the demand fo...
Glenmark's current portfolio consists of 129 products authorized for distribution in the U.S. marketplace and 58 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio
GlaxoSmithKline issued the following news release:. GlaxoSmithKline plc and Innoviva, Inc. today announced the filing of a supplemental New Drug Application with the US Food and Drug Administration for the use of Trelegy Ellipta for an expanded indication for the maintenance treatment of airflow obstruction and reduction of exacerbations in patient
By a News Reporter-Staff News Editor at Drug Week Ignyta, Inc., a biotechnology company focused on precision medicine in oncology, announced company highlights and financial results for the third quarter ended September 30, 2017. "We are pleased with the continued development and regulatory progress of our lead product candidate, entrectinib-an.
ROSTOCK, GERMANY/ ACCESSWIRE/ November 24, 2017/ Immungenetics AG, a German based biopharmaceutical company focusing on innovative treatments that address unmet medical needs in the field of neurodegenerative, autoimmune diseases and aging, announces the initiation of DrainAD, a Phase II proof-of-concept study for the diagnosis and therapy of...
TITUSVILLE, N.J- Janssen Therapeutics, Division of Janssen Products, LP, today announced that the U.S. Food and Drug Administration has approved JULUCA, the first, complete, single-pill, two-drug regimen for the treatment of human immunodeficiency virus type 1 infection in certain adults living with the disease who are virologically suppressed.
Janssen-Cilag International NV announced the submission of a Type II variation application to the European Medicines Agency, for the immunotherapy Darzalex. This submission to health authorities takes us one step closer to our goal of redefining combination therapy in multiple myeloma, with the potential to make daratumumab available to more patien
BEERSE, BELGIUM- Janssen-Cilag International NV today announced the submission of a Type II variation application to the European Medicines Agency, for the immunotherapy DARZALEX. 'This submission to health authorities takes us one step closer to our goal of redefining combination therapy in multiple myeloma, with the potential to make daratumumab.
RARITAN, NJ- Janssen Biotech, Inc. today announced that it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration for DARZALEX. As part of the application, Janssen has requested Priority Review, which the FDA grants to investigational therapies that, if approved, may offer significant improvements in the
Results of the randomized clinical trial of the dietary combination, conducted by researchers at the Johns Hopkins University School of Medicine, were published in the Nov. 12 issue of Journal of the American College of Cardiology. 'Our results add to the evidence that dietary interventions are as effective as-or more effective than-antihypertensiv
Rehovot, Israel- Kamada Ltd., a plasma-derived protein therapeutics company focused on orphan indications, today announced that the Company and Chiesi Farmaceutici S.p.A., a fully integrated European Pharmaceutical company focused on respiratory disease and special care products, have mutually agreed to terminate the parties' European distribution.