Recalls have been issued for the following three medical devices.
Draeger Perseus A500 Anesthesia Workstation – Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer serious adverse health consequences, including injury or death. The company has received one report of this issue occurring, with no injuries and no deaths.
Insulet Corporation OmniPod Insulin Management System – The Pod’s needle mechanism may fail or delay in inserting the needle. If the needle mechanism fails or there is a delay, the needle will not be inserted in the patient’s skin and insulin delivery will not begin. The interruption of insulin delivery may lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death. The firm has received 10 cases where the malfunction occurred. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Boston Scientific Corporation, Chariot Guiding Sheath – Boston Scientific has received fourteen complaints of the shaft of the device separating. This can cause small pieces to break off the device and enter the patient’s bloodstream. This could obstruct blood flow and require additional interventions to remove device fragments. Obstructed blood flow can result in serious patient injuries such as stroke, kidney damage, damage to the intestines or limbs, or can cause patient death.
Cellectis Files First Clinical Trial Application for UCART19, an
This study aims to include CD19-positive Acute Lymphoblastic Leukemia (ALL) patients. Other eligibility criteria to enter clinical trials will be assessed by the investigators. read moreCellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS) today announced the submission of a clinical trial application (CTA) to the Medicines & Healthcare products Regulatory Agency (MHRA) requesting approval to initiate UCART19 First-in-Human clinical investigation in leukemia in the United Kingdom.
CMV Vaccine Created at City of Hope is Found Safe, Effective in Patients Receiving Stem Cell Transplants
DUARTE, Calif.–(BUSINESS WIRE)–Infections caused by cytomegalovirus, or CMV, are a leading cause of complications in patients who undergo stem cell transplants. Antiviral drugs may reduce the risk of CMV infection, but they also cause toxic side effects and increase the chances of opportunistic bacterial or fungal infections. read more
Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula
WOODCLIFF LAKE, N.J.–(BUSINESS WIRE)–Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) announced today that the U.S. Food and Drug Administration (“FDA”) has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Eagle entered into an exclusive licensing agreement with Teikoku Pharma USA Inc. in October 2015 to market, sell and distribute Docetaxel Injection in the U.S. read more
Novartis announces publication of two landmark studies in NEJM demonstrating efficacy of Cosentyx® in patients with ankylosing spondylitis
EAST HANOVER, N.J., Dec. 23, 2015 /PRNewswire/ — Novartis announced today that the results of the MEASURE 1 and MEASURE 2 Phase III studies for Cosentyx® (secukinumab) in ankylosing spondylitis (AS) were published in The New England Journal of Medicine (NEJM). These pivotal studies demonstrated significant clinical improvements with Cosentyx versus placebo in reducing the signs and symptoms of active AS – a long-term, painful and debilitating inflammation of the spine.1,2 read more