All life-saving medicines for critical diseases, such as anti-retrovirals, anti-tuberculosis, pediatric formulations and fixed-dose combinations, might soon come under the government's price control. The National Pharmaceutical Pricing Authority has prepared a detailed note with recommendations to revise the NLEM list to include therapeutic areas..
Bracco Diagnostics recently reported that the U.S. Food and Drug Administration approved its new ultrasound contrast agent Lumason for injectable suspension, indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Bracco Diagnostics recently reported that the U.S. Food and Drug Administration has approved its new ultrasound contrast agent Lumason for injectable suspension, indicated for use in adults with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Marie Paule Kieny, told reporters that the clinical trials will be conducted on the two "most advanced" vaccines and "at least 5 more vaccines" will be in the clinic in the first months of 2015. Kieny said the pharmaceutical companies developing these vaccines "are committing to ramping up the production capacity to millions of doses to be availabl
Concert Pharmaceuticals recently reported Phase 1 data of CTP- 354, a novel, non-sedating, once-daily oral treatment for spasticity. According to a release from Concert Pharmaceuticals, the Company presented the findings October 10 during a poster session at the American Neurological Association's Annual Meeting in Baltimore, Maryland.
Eisai recently reported that the U.S. Food and Drug Administration accepted the company's sNDA for rufinamide and granted it priority review designation as an adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients from 1 to 4 years of age. Priority Review designation was assigned to this sNDA because FDA...
Ebola vaccine trials are to start in west Africa in December, a month earlier than planned, and hundreds of thousands of doses will be available by mid-2015, the World Health Organisation says. The first vaccinations of health workers and others at high risk, including burial teams, are likely to take place in Liberia, with Sierra Leone not far beh
Gilead Sciences recently reported that the U.S. Food and Drug Administration has approved Harvoni, a once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults. Gilead Sciences reported in a release that Harvoni combines the NS5A inhibitor ledipasvir with the nucleotide analog polymerase inhibitor...
Valby, Copenhagen, 2014-10-25 11:30 CEST In the per-protocol population desmoteplase was associated with better functional outcome compared to placebo as assessed by the modified Rankin Scale In additional data analyses it is suggested that magnetic resonance imaging is more sensitive than computed tomography scanning for identifying appropri
By a News Reporter-Staff News Editor at Investment Weekly News Research and Markets has announced the addition of the "The Overview of Biosimilar Market in Japan" report to their offering. The market for biosimilars is expected be around 4.5 billion JPY in 2012. A total of only three products including human growth hormone and erythropoietin were
Pfizer presented data from a Phase 1/ Phase 2 study evaluating the safety, tolerability and immunogenicity of a single-dose vaccine of Pfizer's investigational 4- antigen Staphylococcus aureus candidate vaccine in healthy adults. Kathrin Jansen, senior vice president of the Vaccine Research and Early Development unit for Pfizer. IDWeek 2014 is an a
Pharmatech Associates appointed Richard Aleman as vice president of Regulatory Compliance. Bikash Chatterjee, Pharmatech's president and CSO, said, "Richard is an outstanding addition to our expert executive team in terms of FDA and international requirements, and our customers will benefit greatly from his wealth of insight." While at the FDA, Ale
Provectus Biopharmaceuticals recently retained INC Research, a global Phase I to IV contract research organization, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV- 10.. In the first phase, INC Research Quality and Compliance Consulting will undertake a regulatory document inventory and evaluation of the contents
By a News Reporter-Staff News Editor at Investment Weekly News Rigrodsky& Long, P.A.: Do you, or did you, own shares of Pacira Pharmaceuticals, Inc.? Rigrodsky& Long, P.A., including former Special Assistant United States Attorney, Timothy J. MacFall, announces that a complaint has been filed in the United States District Court for the District o
By a News Reporter-Staff News Editor at Investment Weekly News Research and Markets has announced the addition of the " Russia& CIS Health and Pharmaceuticals Weekly" subscription to their offering. This report, Russia& CIS Health and Pharmaceuticals Weekly, contains materials on the state and prospects of the pharmaceutical industry in Russia an
Targeted Medical Pharma recently reported the results of a clinical trial studying the amino acid based medical foods, Sentra AM and Sentra PM in Veterans suffering from symptoms associated with Posttraumatic Stress Disorder. In a release, Targeted Medical Pharma noted that the purpose of this pilot study was to examine the benefit of nutritional..
The outbreak of the deadly Ebola virus in West Africa that has killed thousands of people so far has only become an issue of concern since reports of individuals from the West being infected with the disease have surfaced. Stephen Hall, a CEO of a pharmaceutical company explains why: "Traditional investors have not been enthusiastic about funding t
Cegedim Relationship Management said that Veloxis Pharmaceuticals is deploying its cloud-based Mobile Intelligence, the Customer Relationship Management platform, and MI Touch, for their Medical Science Liaison and Specialty teams. In its release, Cegedim said that Veloxis selected Mobile Intelligence over the competition for the Company's rapid...
"We are elated following the FDA's approval of our IND application for MT-3724 and are eager to begin the next steps of our clinical journey with Veristat. Veristat will support the initiation of our Phase I program, which will assess the safety, pharmacokinetics, pharmacodynamics and clinical activity of MT-3724 in patients with non-Hodgkin's B-Ce
By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Gibson, Susan P.; Vanhove, Geertrui F., filed on March 27, 2014, was made available online on October 9, 2014, according to news reporting originating from Washington, D.C., by NewsRx correspondents. This patent application is assigned to Jazz Pharmaceuticals,
By a News Reporter-Staff News Editor at Health& Medicine Week Experiments in mice with a bone disorder similar to that in women after menopause show that a scientifically overlooked group of cells are likely crucial to the process of bone loss caused by the disorder, according to Johns Hopkins researchers. A summary of their work will be publishe
AbbVie's HUMIRA adalimumab Receives U.S. By a News Reporter-Staff News Editor at Health& Medicine Week AbbVie announced that the U.S. Food and Drug Administration has approved the extension of the HUMIRA indication for moderately to severely active polyarticular juvenile idiopathic arthritis to reducing signs and symptoms in patients ages 2 an
By a News Reporter-Staff News Editor at Health& Medicine Week Actavis plc, a leading global specialty pharmaceutical company, and Durata Therapeutics, Inc., an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, announced that they have
By a News Reporter-Staff News Editor at Health& Medicine Week Aphios Corporation announced that it has been granted United States Patent No. 8,703,727 entitled "Nanotechnology Formulation of Poorly Soluble Compounds," for difficult to formulate and deliver drugs. These techniques can be applied to a number of existing drugs as well as to several
LONDON- UK pharmaceutical company AstraZeneca PLC has received approval from the European Medicines Agency for its drug Lynparza, paving the way for the UK pharmaceutical company to start marketing the treatment to ovarian cancer patients. "We are delighted that the CHMP has recommended Lynparza as a first-in-class treatment option for women with.