|Quidel Receives FDA Clearance for Its AmpliVue(R); Portola Pharma Initiates Phase 2 Study of Andexanet Alfa|
|By Staff and Wire Reports|
|Thursday, 27 March 2014 20:00|
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2.
The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared AmpliVue assays, the AmpliVue HSV 1+2 Assay does not require investment in expensive thermocycling equipment. Using AmpliVue can therefore significantly lower a laboratory's cost to adopt and maintain molecular testing methods.
The Centers for Disease Control and Prevention (CDC) estimate that there are almost 800,000 new cases of herpes in the United States each year, and about 1 in 6 Americans aged 14 to 49 have a genital HSV 2 infection.(1)
"We are pleased to launch our third AmpliVue assay and are certainly delighted by the acceleration in the pace of AmpliVue product development by our organization since BioHelix's acquisition in May of last year," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "Hospitals are becoming increasingly aware of the AmpliVue brand, and we plan to build on that momentum with even more AmpliVue product introductions later this year."
The AmpliVue product line now enables laboratories of all sizes to perform highly sensitive and specific molecular tests for four pathogens -- two viruses and two bacterial species -- without incurring the significant expense that is usually required to adopt and maintain molecular testing methods on-site. The AmpliVue HSV 1+2 is Quidel's third assay to launch in its hand-held, disposable format. The AmpliVue C. difficile assay for the molecular detection of toxigenic Clostridium difficile bacterial DNA received FDA clearance in December of 2012. The AmpliVue GBS Assay for the molecular detection of Group B Streptococcus infections received FDA clearance in December of 2013. All three assays are now available for sale throughout the U.S. and Europe, with several other assays currently in development.
Portola Pharmaceuticals (Nasdaq: PTLA) announced it has initiated a Phase 2 proof-of-concept study to evaluate andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent, as a reversal agent for Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban in healthy volunteers. Portola is developing andexanet alfa, an FDA-designated breakthrough therapy, as a potential first-in-class antidote to reverse the anticoagulation activity of Factor Xa inhibitor-treated patients who are suffering a major bleeding episode or who require emergency surgery. The Company is pursuing an Accelerated Approval pathway for andexanet alfa, which is the only agent that has demonstrated reversal of the anticoagulation activity of Factor Xa inhibitors as measured by biomarkers, including anti-Factor Xa activity, in human studies.
"Portola was one of the first companies to identify an important unmet need for an agent to reverse the anticoagulation activity of the Factor Xa inhibitor class of drugs. Our development team leveraged our cutting-edge science in the area of thrombosis to create andexanet alfa as a possible solution," said John T. Curnutte, M.D., Ph.D., executive vice president, research and development at Portola. "The initiation of this new Phase 2 study with edoxaban moves us closer to our goal of bringing andexanet alfa to market as a universal antidote for Factor Xa inhibitors."
In the randomized, double-blind, placebo-controlled, cohort dose-escalation Phase 2 study, healthy volunteers will be treated on days 1-6 with edoxaban 60 mg once a day and then randomized in a 6:3 ratio to intravenous andexanet alfa or placebo on day 6. The first dose cohort will evaluate a 600 mg bolus dose of andexanet alfa or placebo in 9 healthy volunteers. Pharmacodynamic and safety data will be collected through day 48.
Portola announced in June 2013 that it had entered into a clinical collaboration agreement with Daiichi Sankyo for the Phase 2 study. Daiichi Sankyo provides funding for the study while Portola retains full worldwide commercial rights to andexanet alfa.
Abiomed Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, will be attending and exhibiting at the American College of Cardiology (ACC) annual 2014 scientific sessions, scheduled from March 29 - 31, at the Walter E. Washington Convention Center in Washington, DC.
Akers Biosciences, Inc. (LSE:AKR) (Nasdaq:AKER), a leading designer and manufacturer of rapid diagnostic screening and testing products, announces the appointment of Edwin C. Hendrick as Executive Vice President, Sales and Marketing.
Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of developing therapies for rare and orphan diseases, today announced that John F. Crowley, Chairman and Chief Executive Officer, will present a corporate overview at the 13th Annual Needham Healthcare Conference on Wednesday, April 9, 2014 at 3:40 p.m. ET.
Anavex Life Sciences Corp. (OTCQB:AVXL), a clinical stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's, diseases of the central nervous system (CNS) and various types of cancer, today announced that a report in the current issue of peer-reviewed International Pharmaceutical Industry Journal ("IPI Journal") predicts that ANAVEX 2-73 will have a meaningful effect in Alzheimer's disease based on the Alzheimer's Disease Assessment Scale-Cognitive ("ADAS-Cog"), especially when combined with donepezil (Aricept®), the world's best-selling Alzheimer's drug.
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today reported financial results for the fourth quarter and year ended December 31, 2013 and provided an update on the Company's clinical programs.
Cerner Corp. (Nasdaq:CERN) and OTTR (Organ Transplant Tracking Record) Chronic Care Solutions will integrate their products and services to enhance the workflows and processes required to support solid organ, blood and marrow transplant care delivery teams.
ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, announced today that it has appointed Anne-Marie S. Duliege, M.D., M.S., to a newly created position within the Company.
Conatus Pharmaceuticals Inc. (Nasdaq:CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the fourth quarter and full year ended December 31, 2013, and provided updates on its clinical development programs.
In December 2013, Emergent Health Corp. (Pink Sheets:EMGE) announced there exists an agreement of sale executed on November 12, 2013 by its controlling shareholder for Company control to be passed on to a controlling shareholder group including Clover Capital and Parcae Capital Corp.
Endocyte, Inc. (Nasdaq:ECYT) announced the pricing of an underwritten public offering of 4,500,000 shares of its common stock at a price to the public of $21.00 per share.
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that data related to FP-1039 (GSK3052230), an FGF ligand trap in a global, multi-arm Phase 1b study, and FPA144, a monoclonal antibody against the FGF receptor 2b, will be presented at the American Association for Cancer Research (AACR) Annual Meeting.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the year-ended December 31, 2013.
Foundation Healthcare, Inc. (OTCQB:FDNH), which focuses on the development and management of surgical hospitals and ancillary service lines, today reported its financial results for the year and quarter ended December 31, 2013.
Global Links Corp. (OTC:GLCO), today announced that the Company's wholly-owned subsidiary, Hemp Life Today, LLC, is adding over 50 new products to its online marketplace through a recently announced partnership with Hemp, Inc. (OTC:HEMP).
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the home care setting, today reported financial results for the three and twelve months ended December 31, 2013.
Medical Marijuana, Inc. (OTC:MJNA), a leading cannabis and industrial hemp industry innovator, today announced the release of its quarterly financial and shareholders report (Post 03/27/2014 - OTC Markets).
M Line Holdings, Inc. (OTCQB:MLHC), a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled ("CNC") Equipment, announced today that following the confirmation yesterday of the firm commitment for $30,000,000 funding, M Line has chosen three of the six prospective acquisition targets to focus on.
Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB), announced today that reconstruction of its Sherbrooke, Quebec, Canada production facility will be completed April 7, 2014.
Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), today announced the appointment of Sharon Barbari to its board of directors, effective March 26, 2014.
OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced that data from three studies related to its early stage scientific programs will be presented at the Annual Meeting of the American Association of Cancer Research (AACR) being held April 5-9, 2014 at the San Diego Convention Center in San Diego, CA.
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that it has initiated a Phase 2 proof-of-concept study to evaluate andexanet alfa, the company's investigational Factor Xa inhibitor reversal agent, as a reversal agent for Daiichi Sankyo's oral, once-daily, direct Factor Xa inhibitor edoxaban in healthy volunteers.
The Spectranetics Corporation (Nasdaq:SPNC) today announced early success of the EXCITE ISR clinical trial, achieving highly significant statistical superiority in both safety and efficacy.
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced that data from its novel SMAC-Mimetic program will be presented during presentations at the American Association for Cancer Research (AACR) Annual Meeting being held April 5-9, 2014 at the San Diego Convention Center in San Diego, California.
Ultragenyx Pharmaceutical Inc. (Nasdaq:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced the presentation of preliminary data from the Phase 1/2 study of recombinant human beta-glucuronidase (rhGUS, UX003), an investigational therapy for the treatment of mucopolysaccharidosis 7 (MPS 7, Sly syndrome).