FDA Approves Boston Scientific's Emblem MRI S-ICD System Read more: http://www.nasdaq.com/article/fda-approves-boston-scientifics-emblem-mri-s-icd-system-cm665426#ixzz4HUScugNr
The U.S. Food and Drug Administration (FDA) recently granted marketing approval for Boston Scientific Corporation 's BSX Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, in line with management's expectations. This approval added another device to this medical technology giant's expanding product line of magnetic resonance imaging (MRI) - safe devices.
EDWARDS INTUITY Elite Rapid Deployment Valve Receives FDA Approval
Edwards Lifesciences Corporation (EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced U.S. Food and Drug Administration approval of the advanced EDWARDS INTUITY Elite valve system, a rapid deployment device for surgical aortic valve replacement. Built on the trusted PERIMOUNT tissue valve platform and incorporating innovations from transcatheter heart valves, the EDWARDS INTUITY Elite valve system is designed to facilitate minimally invasive surgery and streamline complex aortic valve replacements, thereby offering a cutting-edge treatment option for patients with aortic valve disease. The device is now commercially available.Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7895651-edwards-intuity-elite-fda-approval/
Emergent BioSolutions Receives FDA Approval for Large-Scale Manufacturing of BioThrax in Building 55
GAITHERSBURG, Md., Aug. 15, 2016 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application (sBLA) for the manufacture of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55, the company’s large-scale manufacturing facility located in its 12.5-acre campus in Lansing, Michigan.“FDA approval of Building 55 is the culmination of more than a decade of investment and collaboration by Emergent and the U.S. government towards the ability to manufacture anthrax vaccines at large scale to protect the nation,” said Daniel J. Abdun-Nabi, president and chief executive officer of Emergent BioSolutions. “This milestone represents the U.S. government’s continued commitment to anthrax preparedness and its belief in the company’s core competency in manufacturing and the potential of this facility. The expanded capacity of Building 55 also positions the company to potentially supply anthrax vaccines to allied governments in support of their preparedness plans.”
ARMO BioSciences Announces Publication of AM0010 Clinical Data in Advanced Solid Tumor Patients in Journal of Clinical Oncology (JCO)
RNewswire/ -- ARMO BioSciences, Inc., a clinical-stage biotechnology company, announced that the Journal of Clinical Oncology (JCO) has published clinical safety and efficacy data on the Company's lead investigational immuno-oncology drug AM0010 (PEGylated Interleukin-10) in patients with advanced solid tumors. The peer-review article titled "Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients with Advanced Solid Tumors" was first published today in the online version of the JCO (http://jco.ascopubs.org/).
Nemaura Pharma Limited Awarded the Prestigious 2016 Frost & Sullivan Award for Best Practices in Enabling Technology Leadership in Transdermal Drug Delivery
LOUGHBOROUGH, England--(BUSINESS WIRE)--Nemaura Pharma has been awarded the prestigious 2016 Frost & Sullivan award for best practices in Enabling Technology Leadership in the Transdermal Drug Delivery Industry.
LONDON--(BUSINESS WIRE)--The MyOptique Group, a major European online optical retailer with annual revenues of GBP 57 million, announces today that it has entered into a definitive agreement to be acquired by Essilor International, the world leader in ophthalmic optics.Subsequent to the transaction the management of MyOptique will remain in place, and will leverage Essilor International's capabilities to continue growing its leading position in Europe. As part of Essilor, MyOptique will leverage Essilor’s global supply chain and collaborate with its other operating businesses to improve the reach and effectiveness of its business across Europe.
Vedanta Biosciences Granted U.S. Patent Broadly Covering Pharmaceutical Compositions for Microbiome Therapeutics Based on Bacterial Consortia
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences, pioneering the development of a novel class of therapies designed to modulate pathways of interaction between the human microbiome and the host immune system, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,415,079. The patent broadly covers pharmaceutical compositions and mixtures of Clostridium live bacterial strains and builds on Vedanta’s patent issuances in Japan. The issued patent is exclusively licensed worldwide to Vedanta under an agreement with the University of Tokyo and provides coverage through at least 2031.
ASTRAZENECA COMPLETES GLOBAL LICENCING AGREEMENT WITH LEO PHARMA FOR TRALOKINUMAB
AstraZeneca today announced that it has completed the licensing agreement with LEO Pharma A/S (LEO Pharma), a specialist in dermatology care, for the global licence to tralokinumab in skin diseases. Tralokinumab is an IL-13 monoclonal antibody that has completed a Phase IIb trial for the treatment of patients with atopic dermatitis, an inflammatory skin disease resulting in itchy, red, swollen and cracked skin. Upon completion of the agreement, LEO Pharma made a payment to AstraZeneca of 5 million for the exclusive, global rights to tralokinumab in atopic dermatitis and any future additional dermatology indications. As AstraZeneca will retain a significant ongoing interest in tralokinumab, the upfront payment, along with all future commercial milestone and royalty payments, will be reported as Externalisation Revenue in the Company's financial statements.
Vertex Provides Update on Ongoing Phase 3 Program for VX-661 in Combination with Ivacaftor for the Treatment of Cystic Fibrosis
BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today provided an update on its ongoing Phase 3 development program of its investigational compound VX-661 in combination with ivacaftor, which includes four studies that together are expected to enroll more than 1,000 people with cystic fibrosis (CF). Based on a planned interim futility analysis conducted by the study's independent Data Safety Monitoring Board (DSMB), Vertex plans to stop the study of VX-661 and ivacaftor in people with one copy of the F508del mutation and one copy of a mutation that results in minimal CFTR protein function (F508del het/min).
Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present in the coating of the recalled wire guide units.