ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, presented data today from its Phase III program with pimavanserin for Parkinson's disease psychosis, including data from its pivotal -020 Study and the related,...
ACADIA Pharmaceuticals Inc., a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, presented data today from its Phase III program with pimavanserin for Parkinson s disease psychosis, including data from its pivotal -020 Study and the related,..
China Pharmaceutical Guidebook Series 2013 Edition. In China, the development of biopharmaceutical industry is far behind the developed countries. In China, the pharmaceutical regulatory authority the SFDA divided the biopharmaceuticals for registration application into two classifications, i.e. the therapeutic biological products and the...
BioAlliance Pharma, a developer of orphan oncology products and supportive care products, has announced the initiation of its Phase II clinical trial evaluating the efficacy and safety of Validive in the United States in patients with chemoradiation therapy-induced oral mucositis with head and neck cancer, as scheduled in the advancement calendar o
Livatag is in a Phase III study, RELIVE, which is expected to render final results in 2016. The report identifies a number of earlier catalysts, including the potential partnering of Sitavig for cold sores, which was approved by the FDA in April 2013. Edison has valued BioAlliance at EUR109m based on a risk-adjusted net present value model. Edison
Paper offers innovative approaches to bringing drugs to market faster and reducing development costs Raleigh, N.C., June 18, 2013- INC Research, LLC, a therapeutically focused global clinical research organization with a Trusted Process for delivering reliable results, today announced it has released a new white paper titled, "Clinical Process..
Today, Wall Street Reports announced new research reports highlighting Gilead Sciences, Inc., Health Management Associates Inc., IDEXX Laboratories, Inc., ISIS Pharmaceuticals Inc., and Trius Therapeutics Inc.. On June 7, 2013, Gilead Sciences Inc. announced that the US Food and Drug Administration has granted priority review to the New Drug Applic
Saint Laurent, Quebec- IntelGenx Corp. today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act action date of February 3, 2014 for the review of the Company's New Drug Application for the marketing approval of IntelGenx' Anti-Migraine VersaFilm? oral film product. The FDA confirmed that IntelGenx
Lexicon Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering breakthrough treatments for human disease, announced today that John Northcott has joined the company as its vice president of marketing, commercial strategy, and operations. Mr. Northcott brings extensive commercial experience to Lexicon, including both pre-launch...
Dublin- Research and Markets has announced the addition of the "Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs" report to their offering. As China joins the World Trade Organization and integrates more completely into the global
MEI Pharma, Inc., an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patients have been dosed in a Phase II clinical trial of its lead drug candidate Pracinostat in combination with Vidaza in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome.
MEI Pharma, Inc., an oncology company focused on the clinical development of novel therapies for cancer, announced today that the first patients have been dosed in a Phase II clinical trial of its lead drug candidate Pracinostat in combination with Vidaza in patients with previously untreated intermediate-2 or high-risk myelodysplastic syndrome.
A Michigan- based clinical research organization that focuses on regulatory submission support for the pharmaceutical, biotech, and medical device industries, has selected BioPharm Systems to implement a multi-tenant version of Argus Safety and Interchange, along with Empirica Topics, to strengthen the company s pharmacovigilance and regulatory.
The newly FDA- approved TRULIGN? Toric Intraocular Lens is the first ever Toric IOL that corrects astigmatism and, unlike other standard Toric lenses, has the additional capacity to improve vision across a natural range of focus. In the FDA clinical trials, the TRULIGN? Toric was shown to be exceptionally stable in correction of astigmatism and
OncoSec Medical Inc., a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumor cancers, announced the completion of patient enrollment in a Phase II clinical trial of ImmunoPulse for metastatic melanoma patients. We have shown great adoption of ImmunoPulse with the clinical centers...
Oxygen Biotherapeutics, Inc., is a development stage biomedical company currently focused on developing its perfluorocarbon-based intravenous oxygen carrier, Oxycyte , as a treatment for traumatic brain injury, stroke and other conditions where critical tissues are oxygen starved. Oxycyte is currently in Phase IIb clinical trials for TBI in Israe
PhaseBio Pharmaceuticals, a clinical-stage biopharmaceutical company focused on diabetes and cardiovascular diseases, today announced the successful completion of a Phase 1 trial of Vasomera?, the first once-weekly investigational, VPAC2 selective receptor agonist for the treatment of cardiopulmonary diseases. Vasomera offers a unique combinat
The RHB-103 New Drug Application for marketing approval in the U.S. is subject to a standard 10- month review period and will have a Prescription Drug User Fee Act action date of February 3, 2014 The Company recently received from FDA a PDUFA fee waiver and a subsequent refund of $979,400 RHB-103 is a proprietary, oral thin film formulation of riza
RegeneCure announced today the start of a clinical study using the company's proprietary AMCA Guided Bone Regeneration Dental Membrane as a bone stimulating aid for patients requiring dental implants. A common problem encountered when patients have a tooth replaced with a dental implant is the lack of sufficient bone volume to house the implant.
Research and Markets has announced the addition of the "Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs" report to their offering. As China joins the World Trade Organization and integrates more completely into the global economy
The Schneider Centre for Plastic Surgery is pleased and excited to announce the Fort Myers plastic surgery practice s adoption of recently FDA- approved silicone breast implants from Sientra. This new breast implant technology offers the patients of The Schneider Centre for Plastic Surgery a new and innovative option for Fort Myers cosmetic surg
TAIPEI, Taiwan, June 17, 2013/ PRNewswire/ TWi Biotechnology, Inc. today announced that it has completed the patient enrollment in a phase II trial of AC-201 for Gout Flare Prophylaxis during urate-lowering therapy. This randomized, double-blind, placebo-controlled Phase II study is conducted in 8 major medical centers in Taiwan. Prof. Chung-Tei
US WorldMeds has begun enrolling patients in a Phase III clinical trial that will complete the development program for lofexidine hydrochloride as a new therapeutic for the treatment of withdrawal symptoms associated with opiate detoxification. US WorldMeds acquired a license for Lofexidine from Britannia Pharmaceuticals in 2003. Lofexidine has...
Actavis' ANDA product is a generic version of Fresenius Kabi's Diprivan, which is an intravenously administered sedative and anesthetic. Fresenius Kabi USA, LLC filed suit against Actavis on June 6, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration
By a News Reporter-Staff News Editor at Clinical Trials Week The drug ingenol mebutate has been approved in Germany since November 2012 as a gel for the treatment of certain forms of actinic keratosis in adults. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products the German Institute for Quality a
