Boston Scientific Corp is recalling RotaWire ‘Elite’ core wires because they may crack and separate from the rest of the Rotablator Rotational Atheroctomy System and cause serious injury such as tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body.
The company has received three reports of this issue occurring, including one patient death following medical intervention to remove the broken wire. Other interventions have included purposefully blocking off (occluding) the affected artery, placing stents into the affected artery, and emergency heart surgery.
The use of affected product may cause serious adverse health consequences, including death. read more
Medtronic Enhances Utility of Professional Continuous Glucose Monitor (CGM) by Launching Pattern Snapshot for iPro®2 Professional CGM
DUBLIN – November 30, 2015 – Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the availability of a new CareLink® iPro report called Pattern Snapshot for iPro2 Professional CGM system. The new one-page report provides a health care professional (HCP) with information for quick interpretation of detailed glucose data over time. The identified patterns are based on advanced algorithms that automatically identify an individual’s top glucose control issues and their possible causes. The report information and visuals also serve as a teaching tool to help educate people with diabetes about their own glucose profile. read more
FDA approved elotuzumab (EMPLICITI, Bristol-Myers Squibb Company) in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. November 30, 2015. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm474719.htm
Boston Scientific Receives FDA Approval And CE Mark For AngioJet™ ZelanteDVT™ Thrombectomy CatheterCatheter used to treat deep vein thrombosis to be commercialized in U.S. and Europe
MARLBOROUGH, Mass., Nov. 30, 2015 /PRNewswire/ — Boston Scientific (NYSE: BSX) has received United States (U.S.) Food and Drug Administration (FDA) approval and CE Mark for the AngioJet™ ZelanteDVT™ thrombectomy catheter to treat deep vein thrombosis (DVT) in large-diameter upper and lower limb peripheral veins. read more
HiberGene Launches Meningitis Test
DUBLIN–(EON: Enhanced Online News)–HiberGene Diagnostics, a company focused on the application of molecular technology to infectious disease testing, has completed CE marking of its first test, HG Meningococcus, a rapid test for a severe form of bacterial meningitis, Meningococcal disease (MD), caused by the bacterium Neisseria meningitidis.
“The HG Meningococcus test meets a significant unmet clinical need using advanced and proven technology. Meningococcal disease can be a particularly devastating illness if not treated rapidly, but by utilising the HiberGene product, physicians now have a test which can ensure the best possible care for patients.”
The test meets a significant unmet clinical need and allows physicians to rapidly and accurately test for the presence of meningococcal bacteria, in a near patient setting, ensuring that suspected cases are rapidly diagnosed and the appropriate treatment administered earlier read more
Intertek Researches Formulation Strategies to Repurpose Biologic Drugs
Achieving improvements in safety, efficacy and convenience for patients by using inhalation as an administration route
CAMBRIDGE, England–(BUSINESS WIRE)–Intertek, a leading quality solutions provider to industries worldwide, is researching the potential improvements in safety, efficacy and convenience for patients that can be achieved through the redevelopment of biologic medicines so that they can be administered to patients through inhalation. read more
U.S. FDA ACCEPTS NDA FOR ONCE-DAILY FORMULATION OF ANTIOBESITY AGENT BELVIQ®
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for a once-daily formulation of its antiobesity agent BELVIQ® (U.S. brand name, generic name: lorcaserin hydrochloride, “lorcaserin”) which has the potential to offer patients the convenience of once-daily treatment. read more
Teleflex to focus on showcasing its Intraosseous and Central Vascular Access portfolio featuring chlorhexidine based technologies at GAVeCeLT 2015 – December 1-3, in Milan, Italy
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, is committed to connecting clinicians with technology in a way that improves clinical practice and advances patient outcomes. Teleflex will attend the GAVeCeLT conference in Milan, Italy on December 1-3, 2015 read more
ProMetic confirms PBI-4050’s efficacy in patients suffering from type 2 diabetes and metabolic syndrome
LAVAL, QC, Dec. 1, 2015 /CNW Telbec/ – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that it has decided to close patient enrollment in its phase II open label study in patients suffering from type 2 diabetes and metabolic syndrome and will transition to a pivotal placebo-controlled phase II study in patients suffering from type 2 diabetes.
This decision is based on the statistically and clinically significant decrease in HbA1C observed in the first 11 patients enrolled that have completed 12 weeks in the study. Ten of the 11 patients experienced improved blood glucose control as measured by HbA1C (average decrease of -0.6 p=0.03), a decrease that compares favorably to other drugs already approved for the treatment of diabetes.read more
Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For SB-FIX, First In Vivo Protein Replacement Platform Program For Treatment Of Hemophilia B
RICHMOND, Calif., Dec. 1, 2015 /PRNewswire/ — Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for SB-FIX, a potentially curative, single treatment therapy for hemophilia B. SB-FIX is the first in vivo genome editing application to enter the clinic and is based on Sangamo’s proprietary In Vivo Protein Replacement Platform™ (IVPRP™). The IND is now active and enables Sangamo to initiate a Phase 1/2 clinical study (SB-FIX-1501) designed to assess safety, tolerability and potential efficacy of SB-FIX in adults with hemophilia B. read more
ImmunoCellular Therapeutics Establishes Agreement with EORTC for ICT-107 Phase 3 Registrational Trial in Glioblastoma
LOS ANGELES, Dec. 1, 2015 /PRNewswire/ — ImmunoCellular Therapeutics, Ltd. (“ImmunoCellular”) (NYSE MKT: IMUC) announced today the establishment of an agreement with the European Organisation for Research and Treatment of Cancer (EORTC) for the phase 3 registrational trial of ICT-107 in patients with newly diagnosed glioblastoma (GBM). The EORTC contributed to the trial design and will assist ImmunoCellular Therapeutics in facilitating accrual of patients for this trial in Europe. read more