AbbVie, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved HUMIRA for the treatment of non-infectious intermediate, posterior and panuveitis. HUMIRA is now the first and only FDA- approved non-corticosteroid therapy available for adults with non infectious intermediate, posterior and.
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today preliminary results from its ongoing Phase 2 open-label extension studies with patisiran and revusiran, both investigational RNAi therapeutics targeting transthyretin for the treatment of hereditary TTR-mediated amyloidosis. These new clinical data are being...
WASHINGTON- After seeing initial strength, shares of Array BioPharma have given back some ground but remain firmly positive in afternoon trading on Friday. Array is currently up by 2.8 percent. The gain by Array comes after the biopharmaceutical company submitted a New Drug Application to the FDA for binimetinib in patients with advanced NRAS-mutan
MARCY L ?TOILE, France Regulatory News:. bioMrieux, a world leader in the field of in vitro diagnostics, today announced that it has received 510 clearance from the U.S. Food and Drug Administration to expand the use of the VIDAS B? R? A? H? M? S PCT? assay using the change in PCT levels over time to aid in the management o
By a News Reporter-Staff News Editor at Drug Week HedgePath Pharmaceuticals, Inc., a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced that BUYINS.NET, http://www.buyins.net/, a leading provider of Regulation SHO compliance monitoring, short sal
Citius Pharmaceuticals, Inc., a specialty pharmaceutical company dedicated to acquiring, developing and commercializing adjunctive cancer care and critical care drug products, announced today it was discontinuing Suprenza, its FDA- approved phentermine-based product for weight loss. Myron Holubiak, CEO of Citius said, "Suprenza no longer meets ou
June 30 RALEIGH More babies born in Bladen County could survive their first year and live healthier lives if their mothers got health care before pregnancy through Medicaid expansion, according to a new report by NC Child. The report finds one in five women of reproductive age statewide are uninsured, more than half of whom fall in the health i
By a News Reporter-Staff News Editor at Drug Week Comprehensive Pharmacy Services, the leading provider of pharmacy services for hospitals and health systems, has launched a new proven Medication Reconciliation Program that helps hospitals reduce adverse drug events and patient medication issues that lead to hospital readmissions and higher costs
According to news originating from Oakland, California, by NewsRx correspondents, research stated, "Thalassemia is a chronic inherited blood disorder that reduces hemoglobin production, causing chronic hemolytic anemia. Our news journalists obtained a quote from the research from Children's Hospital, "Patients diagnosed with the most severe form of
DURECT Corporation today announced that its licensee, Pain Therapeutics has announced that the U.S. Food and Drug Administration has determined that an Advisory Committee meeting for REMOXY , which had been tentatively scheduled for August 5, 2016, is unnecessary and will not be held. In December 2002, DURECT licensed to Pain Therapeutics the r
SUMMARY: The Food and Drug Administration is announcing the availability of a document entitled "Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry." The guidance document provides investigational new drug application sponsors with recommendations regarding IND...
By a News Reporter-Staff News Editor at Drug Week Espero Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration has approved GONITRO? sublingual powder for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. "The FDA approval of GONI
Californians have gotten an unpleasant taste of the policy complexities caused when Big Pharma sets sky-high prices for life-changing drugs: State health officials say they need to set aside $1 billion to pay for increasing numbers of qualified patients on the states Medi-Cal program to receive a costly new treatment for Hepatitis C.
In addition to Sequana Medical, Mr. Classon currently serves on the Boards of NYSE and Zurich Stock Exchange- listed companies, Catalent Pharma Solutions, Fresenius Medical Care, Hill-Rom Holdings, Inc. and Tecan Group Ltd., and recently stepped down from the Boards of Aerocrine AB and Auxilium Pharmaceuticals, Inc. after successful sale of the com
As a result, the study shows, the last year of life for this large group of seniors costs the Medicare system five times as much as the care received by the much smaller group of seniors who have a sudden burst of very expensive care in their last few weeks of life. The study shows four clear patterns of end-of-life spending, newly identified throu
GeoVax Labs, Inc., a biotechnology company developing human vaccines, announced today the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for the conduct of the next human clinical trial of GeoVax's preventive HIV vaccine. HVTN 114 will enroll up to 100 individuals who participated in the HVTN 205 Phase
Helsinn, the Swiss pharmaceutical Group focused on building quality cancer care, today announces that the Company has signed an agreement, with Vifor Pharma for the promotion and distribution of Aloxi , an anti-nausea therapeutic medicine used to help prevent symptoms of chemotherapy-induced nausea and vomiting, in Spain. Under the terms of the n
According to news reporting from Singapore, Singapore, by NewsRx editors, the research stated, "Cervical cancer is the most common gynecological cancer encountered in pregnancy. Our news journalists report that additional information may be obtained by contacting A. Ilancheran, Singapore National University Hospital, Dept. of Obstet& Gynaecol, Div
Safe Med LA, a public/private prescription drug abuse coalition in Los Angeles County, today announced the launch of an initiative to implement safe prescribing guidelines at 80 urgent care clinics operated by 10 major physician groups and health systems throughout the county, including Kaiser Permanente and the Los Angeles County Department of Hea
By a News Reporter-Staff News Editor at Drug Week According to Kalorama Information, companion diagnostic testing continues to grow as new partnerships are formed and new tests marketed. In its report the firm uses a broad definition of companion diagnostics market, including both FDA- defined companion diagnostics and other personalized medicine
By a News Reporter-Staff News Editor at Drug Week Lannett Company, Inc. announced that it has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Neomycin Sulfate Tablets USP, 500 mg, the therapeutic equivalent to the reference listed drug, Neomycin Sulfate Tablets USP, 500 mg, of Teva Pharmace
BALLERUP, Denmark, July 1, 2016/ PRNewswire/ LEO Pharma is a significant step closer to realising its vision of becoming the preferred dermatology care partner following a strategic partnership with AstraZeneca announced today. By expanding our portfolio to include both biologics and topicals, LEO Pharma is set to become the world dermatology lea
By a News Reporter-Staff News Editor at Drug Week Mallinckrodt plc, a leading global specialty biopharmaceutical company, announced it has submitted an Investigational New Drug application for Synacthen Depot to the U.S. Food and Drug Administration. Mallinckrodt has invested substantially in the research program, including completing the...
-Sepsis Alliance, the nations leading sepsis patient advocacy group, is calling attention to a recent U.S. government study that reveals annual costs for treating sepsis in hospitals have increased over $3.4 billion over a two-year period. The study, which analyzed billings from 2013, revealed that sepsis accounts for nearly $24 billion in annual c