|Teleflex Receives FDA 510(k) Clearance for Nylus™ PICC; NewLink Genetics Receives European Orphan Designation for Algenpantucel-L Immunotherapy|
|By Staff and Wire Reports|
|Wednesday, 14 November 2012 20:16|
Teleflex Incorporated (NYSE:TFX), a leading global provider of medical devices for critical care and surgery, has announced its Semprus BioSciences subsidiary has been granted 510(k) clearance for the Companys innovative vascular access catheter, the Nylus" Peripherally Inserted Central Catheter (PICC) with Semprus Sustain" Technology. The Nylus PICC is indicated to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The FDA clearance follows the products European market clearance in July, 2012.
The Nylus PICC uses a long-lasting polymer surface modification designed to reduce the attachment of platelets and blood proteins at the surface of the medical device. This provides benefits to the patient, the caregiver and the health care system. The Nylus PICC has been shown to reduce platelet adhesion and thrombus accumulation by 99% in both in vitro and acute animal testing.1
Teleflex is pleased to obtain FDA clearance for the Nylus PICC, which is the first generation of the Semprus Sustain platform technology to move through the FDA 510(k) process, said Benson Smith, Chairman, President and CEO of Teleflex Incorporated. We continue to be excited about the technologys potential to reduce thrombus-related complications for patients in a variety of applications.
With both U.S. and European market clearance, we are advancing a new standard of care for PICC catheters, in which improved patient outcomes and lower health care costs creates a win-win situation for patients and the healthcare delivery system, said David L. Lucchino, VP and co-founder of Semprus BioSciences.
NewLink Genetics Corporation (NASDAQ:NLNK) announced the European Commission (EC) has designated HyperAcute-Pancreas® Immunotherapy (algenpantucel-L) as an orphan medicinal product under Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16 December 1999 on Orphan Medicinal Products. NewLink filed the application for orphan designation in June 2012. A positive opinion was adopted by the Committee for Orphan Medicinal Products (COMP) and was formally accepted by the EC. Finalization of the Public Summary is projected for November, 2012. Algenpantucel-L is an "off-the-shelf" product candidate currently being studied in IMPRESS (Immunotherapy Pancreas Resected Survival Study), an open-label, randomized, controlled, multi-center, Phase 3 clinical trial of approximately 700 Stage I and Stage II surgically-resected pancreatic cancer patients, which is being performed under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA).
As a result of the orphan designation NewLink will have access to multiple incentives for the development of the drug in the EU, including reduced fees during development, access to the centralized authorization procedure (a single application for all EU countries), ten years of market exclusivity, and reduced fees for marketing authorization applications, pre-marketing inspections and multiple post-approval fees. Currently, algenpantucel-L has both orphan drug designation and Fast-track status in the United States.
"As emphasized during National Pancreatic Cancer Awareness Month in November, there is a desperate need for new treatment options for this disease and the European Commission's decision to grant orphan drug designation to algenpantucel-L should help us to address this unmet medical need," said Dr. Charles Link, CEO and Chairman of NewLink Genetics. "We believe that orphan designation in the European Union will significantly enhance our ability to bring this product globally to patients who have pancreatic cancer."
"Orphan drug designation provides significant incentives for us to accelerate clinical development in the EU," said Dr. Nick Vahanian. "We believe that this designation, in combination with data from our ongoing 700 patient IMPRESS Phase 3 study of algenpantucel-L, will expedite advancement of this product through the approval process in Europe.
Amarantus BioSciences, Inc. (OTCQB: AMBS), a biotechnology company developing new treatments and diagnostics for Parkinson's disease and Traumatic Brain Injury centered on its proprietary anti-apoptosis therapeutic protein MANF, today announced it has secured over $1.1 million in funding through two separate transactions.
Atossa Genetics, Inc. (NASDAQ: ATOS) announced today the closing of its initial public offering of 800,000 shares of its common stock at an initial public offering price of $5.00 per share.
Bavarian Nordic A/S (NASDAQ OMX: BAVA) announced today that the U.S. Department of Homeland Security (DHS) Science and Technology Directorate and the National Institutes of Health (NIH) have awarded the company two new contracts valued at up to $18.9 million for the development of recombinant Modified Vaccinia virus Ankara (MVA)-based vaccines, building on the company's MVA-BN® platform.
Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today reported results for the three and nine months ended September 30, 2012.
Cytomedix, Inc. (OTCQX: CMXI) (the "Company"), a leading developer of biologically active regenerative therapies, today reported financial results for the three and nine months ended September 30, 2012.
Discovery Laboratories, Inc. (Nasdaq: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced it has appointed John R. Leone to the Company's Board of Directors, effective immediately.
EastBridge Investment Group (OTCQB: EBIG) today announced that it has entered into an agreement to merge with Cellular Biomedicine Group Inc. (CBMG), a translational medicine company with serial preclinical and clinical research projects and multiple planned clinical trials in the Greater China market.
GenVec, Inc. (Nasdaq: GNVC) announced today that data were presented on GenVec's malaria vaccine program at the American Society of Tropical Medicine and Hygiene (ASTMH) 61st Annual Meeting, which took take place in Atlanta, Georgia on November 11-15, 2012.
GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing vaccines to prevent and treat HIV/AIDS, announced its financial results for the nine months ended September 30, 2012 and provided a business update.
MetaStat, Inc. ("MetaStat" or the "Company") (OTCBB: MTST), a life science company focused on the development and commercialization of proprietary clinical diagnostics that predict the probability of systemic hematogenous (blood borne) metastasis, as well as companion therapeutics to prevent this deadly spread, today announced that its common stock has been approved for quotation on the OTC Bulletin Board ("OTCBB") commencing with the start of trading on November 14, 2012.
Nu Skin Enterprises, Inc. (NYSE: NUS) announced today that it has signed an agreement to acquire NOX Technologies, Inc., a biotechnology and biodiagnostic company based in Malvern, Pennsylvania for $12.5 million.
OncoSec Medical Inc. (OTCBB: ONCS), a company developing its advanced-stage ImmunoPulse DNA-based immunotherapy and NeoPulse therapy to treat solid tumors, announced positive interim results from a Phase IV trial investigating the use of NeoPulse in skin cancer patients at the 6th World Meeting of Interdisciplinary Melanoma/Skin Care Centres & 8th EADO Congress.
ProPhase Labs (NASDAQ: PRPH) (www.ProPhaseLabs.com) today reported net sales of $5.4 million and $13.3 million for the three month and nine month periods ended September 30, 2012, compared to net sales of $5.1 million and $10.0 million for the three month and nine month periods ended September 30, 2011.
Response Biomedical Corp. (TSX:RBM)(OTCBB:RPBIF) today reported financial results for the three and nine months ended September 30, 2012.
Revolutions Medical Corporation (OTCQB: RMCP) will exhibit the Company's RevVac™ Auto-Retractable Vacuum Safety Syringe at the World Medicine Forum and annual conference for 2012 MEDICA November 14-17 in Düsseldorf, Germany ("MEDICA").
AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today announced its intention, subject to market and other conditions, to commence a public offering of its common stock.
SpectraScience, Inc. (OTCQB: SCIE), a San Diego based medical device company, today announced that it will hold a conference call on Tuesday, November 20, 2012 at 4:30 p.m. Eastern (1:30 p.m. Pacific) to provide an update on its business and conduct a question and answer session with investors.
Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics and innovative medicines for serious infections and diseases, today reported financial results for the three and nine months ended September 30, 2012 and summarized operational highlights.
Volcano Corporation (Nasdaq: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today announced that results from the largest study of its kind show that stent procedures guided by intravascular ultrasound (IVUS) resulted in better patient outcomes and fewer complications at 30 days and 12 months compared to procedures without IVUS, and were safe.
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that Paul Bisaro, Watson's President and Chief Executive Officer, will provide an overview and update of the Company's business at the 2012 Piper Jaffray Health Care Conference on Wednesday, November 28, 2012 at 11:00 am EST at the New York Palace Hotel in New York.