ALISO VIEJO, Calif.–(EON: Enhanced Online News)–Ambry Genetics (Ambry), a leader in clinical genetic diagnostics and genetics software solutions, today announced new data affirming the effectiveness of multi-gene panel testing (MGPT) in identifying TP53 gene mutations in people who might otherwise not have been tested. The findings, presented as a poster at the American Society of Human Genetics (ASHG) 2015 Annual Meeting in Baltimore, includes data collected from more than 25,000 individuals having TP53 testing, of which 187 were positive. The tested cohort is the largest to date from a single testing laboratory. read more
Boston Scientific Launches Online Competition For New Digital Health Technologies
MARLBOROUGH, Mass., Oct. 7, 2015 /PRNewswire/ — Boston Scientific (NYSE: BSX) this week announced the start of the Boston Scientific Connected Patient Challenge, an open innovation contest designed to encourage advancements in the use of remote patient monitoring to enhance patient care. Until January 5, 2016, clinicians, engineers, designers and entrepreneurs can submit their ideas and collaborate on solutions through Medstro’s social networking site (www.Medstro.com). read more
Supplemental New Drug Application for Use of KALYDECO® (ivacaftor) in People with Cystic Fibrosis Ages 2 and Older who have One of 23 Residual Function Mutations Accepted for Priority Review by U.S. FDA
BOSTON–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the use of KALYDECO® (ivacaftor) in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations. The FDA granted Vertex’s request for Priority Review of this sNDA, and a target review date of February 6, 2016 was set under the Prescription Drug User Fee Act (PDUFA) for the FDA’s decision on the sNDA. The submission was based on preclinical and clinical data showing the effect of ivacaftor on CFTR function in certain residual function mutations. read more
GenVisc 850 Approved by the FDA for Treatment of Osteoarthritis Knee Pain – Disruptive medical device reducing healthcare cost
DOYLESTOWN, Pa.–(EON: Enhanced Online News)–OrthogenRx Inc. has announced the US Food and Drug Administration (FDA) approval of GenVisc 850® (sodium hyaluronate) for the treatment of patients with osteoarthritis (OA) knee pain. GenVisc 850® is a solution of purified hyaluronic acid (sodium hyaluronate; HA), similar to the normal knee fluid. HAs replace the fluid in the knee that has degraded with the development of OA. Commonly injected 3-5 times weekly into the knee, in clinical studies HAs have been shown to provide patients up to 6 months pain relief. read more
Merck KGaA, Darmstadt, Germany, and Pfizer Announce Investigational Immunotherapy Avelumab Receives FDA Fast Track Designation for Metastatic Merkel Cell Carcinoma
Merck KGaA, Darmstadt, Germany, and Pfizer today announced that the US Food and Drug Administration (FDA) has granted avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.1,2 This announcement builds on the recent FDA Orphan Drug designation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The Fast Track designation is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need. read more
PharMerica Enters into Voluntary Settlement Agreement
LOUISVILLE, Ky.–(EON: Enhanced Online News)–PharMerica Corporation (NYSE:PMC), a national provider of institutional, specialty home infusion, and oncology pharmacy services, today announced that it has reached a voluntary civil settlement with the Department of Justice (DOJ) related to a previously disclosed investigation into allegations that, during the January 1, 2001 through December 31, 2008 time period, certain of the Company’s agreements with the manufacturer of the pharmaceutical Depakote violated the False Claims Act or the Anti-Kickback Statute. The Company denied the government’s allegations and fully cooperated with the DOJ throughout this investigation.
LONSURF® (trifluridine and tipiracil) Approved for Refractory Metastatic Colorectal Cancer, Available at Biologics, Inc.
CARY, N.C.–(EON: Enhanced Online News)–Biologics, Inc., is pleased to announce that it has been selected by Taiho Oncology, Inc. as a specialty pharmacy provider for LONSURF® (trifluridine and tipiracil). LONSURF was approved by the U.S. Food and Drug Administration on September 22, 2015, for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. read more
Marathon Pharmaceuticals Receives Rare Pediatric Disease Designation from FDA for Deflazacort as a Potential Treatment of Duchenne Muscular Dystrophy
NORTHBROOK, Ill.–(EON: Enhanced Online News)–Marathon Pharmaceuticals, a biopharmaceutical company that develops new treatments for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designation for deflazacort, a potential treatment for patients with Duchenne muscular dystrophy (DMD). read more
Medtronic Launches superDimension™ Lung Navigation Software With Suggested Fiducial Marker Placement
Further underscoring its ongoing commitment to lung health, Medtronic (NYSE:MDT) today unveiled a next-generation version of its superDimension™ navigation system software. The superDimension™ navigation system enables a minimally invasive approach to access difficult-to-reach areas of the lung, and can aid in the diagnosis of lung diseases. Using the patient’s CT scan, the superDimension™ planning software generates a 3D virtual bronchial tree and allows physicians to map pathways to reach pulmonary targets during the electromagnetic navigation bronchoscopy procedures (also known as ENB™ procedures).