Healthcare Sales & Marketing Network: Regulatory : Medical Device and Pharmaceutical News

Healthcare News Roundup: Regulatory

HSMN NewsFeed - 27 Dec 2013
European Medicines Agency (EMA) Accepts Otsuka's Marketing Authorisation Application (MAA) for Tolvaptan, an Investigational Compound for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Biopharmaceuticals Regulatory

HSMN NewsFeed - 23 Dec 2013
European Commission Approves Update of Erbitux Metastatic Colorectal Cancer Labeling to Patients With RAS Wild-Type Tumors
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 23 Dec 2013
European Medicines Agency Accepts Marketing Authorization Application for The Medicines Company's Cangrelor
Biopharmaceuticals Cardiology Regulatory

HSMN NewsFeed - 20 Dec 2013
Baxter Completes CE Mark Approval for VIVIA Hemodialysis System in Europe
Devices Regulatory

HSMN NewsFeed - 19 Dec 2013
Genzyme’s Lemtrada(TM) Approved in Australia for Treatment of Multiple Sclerosis
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 19 Dec 2013
Reverse Medical(R) Corporation Announces CE Mark Approval and Initial Clinical Use of the BARREL(R) Vascular Reconstruction Device for the Treatment of Intracranial Bifurcation Aneurysms
Devices Interventional Regulatory

HSMN NewsFeed - 17 Dec 2013
Boston Scientific Announces CE Mark Approval And First Implants Of Its Next-Generation X4 Quadripolar CRT-D Systems
Devices Cardiology Regulatory

HSMN NewsFeed - 13 Dec 2013
Genzyme’s Lemtrada(TM) Approved in Canada for Treatment of Multiple Sclerosis
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 12 Dec 2013
St. Jude Medical Gains CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve
Devices Interventional Cardiology Regulatory

HSMN NewsFeed - 6 Dec 2013
Sorin Group Launches Intensia Family of ICD and CRT-D Devices Featuring DF-4 High Voltage Connector
Devices Cardiology Regulatory

HSMN NewsFeed - 5 Dec 2013
23andMe, Inc. Provides Update on FDA Regulatory Review
Diagnostics FDA

HSMN NewsFeed - 5 Dec 2013
Medtronic Announces CE Mark and TGA Listing for the Symplicity Spyral(TM) Multi-Electrode Catheter and Symplicity G3(TM) Generator
Devices Interventional Cardiology Regulatory

HSMN NewsFeed - 3 Dec 2013
Sense4Baby, Inc.(TM) receives 510(k) clearance and CE mark for commercializing smartphone-based maternal/fetal monitoring system in the U.S. and Europe
Devices Monitoring FDA Regulatory

HSMN NewsFeed - 27 Nov 2013
Sorin Group Announces CE Mark Approval and First Implant of KORA 100, a New MRI Compatible Pacing System
Devices Cardiology Regulatory

HSMN NewsFeed - 27 Nov 2013
GW Pharmaceuticals plc Announces Sativex(R) Regulatory Approval in Switzerland
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 26 Nov 2013
Echo Therapeutics Announces Positive CE Mark Regulatory Trial Results of Symphony(R) CGM System
Devices Monitoring Regulatory

HSMN NewsFeed - 25 Nov 2013
CASMED Receives China Food and Drug Administration Approval for FORE-SIGHT(R) Cerebral Oximeter
Devices Monitoring Regulatory

HSMN NewsFeed - 25 Nov 2013
Sorin Group Announces CE Mark Approval for the XL Version of the Perceval(TM) Sutureless Aortic Valve
Devices Cardiology Regulatory

HSMN NewsFeed - 22 Nov 2013
Tivicay(R) (dolutegravir) receives positive CHMP opinion in Europe for the treatment of HIV
Biopharmaceuticals HIV/AIDS Regulatory

HSMN NewsFeed - 22 Nov 2013
Sorin Group Announces CE Mark Approval and First Implant of the New Solo Smart(TM) Biological Aortic Pericardial Heart Valve
Devices Cardiology Regulatory

HSMN NewsFeed - 22 Nov 2013
EYLEA(R) (aflibercept) Injection Approved For The Treatment of Macular Edema Following Central Retinal Vein Occlusion In Japan
Biopharmaceuticals Ophthalmology Regulatory

HSMN NewsFeed - 21 Nov 2013
Otsuka and Lundbeck's Once-Monthly Abilify Maintena(R) (Aripiprazole) Now Approved in Europe for Maintenance Treatment of Schizophrenia in Adult Patients Stabilized with Oral Aripiprazole
Biopharmaceuticals Regulatory

HSMN NewsFeed - 20 Nov 2013
Health Canada Approves Genzyme's AUBAGIO(R) (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Remitting Multiple Sclerosis
Biopharmaceuticals Neurology Regulatory

HSMN NewsFeed - 20 Nov 2013
ImmunoGen, Inc. Announces Approval of Roche’s Kadcyla(R) in the European Union
Biopharmaceuticals Drug Delivery Oncology Regulatory

HSMN NewsFeed - 19 Nov 2013
Boston Scientific Vercise(TM) Deep Brain Stimulation System Receives CE Mark Approval for Treatment of Dystonia
Devices Neurosurgery Regulatory

HSMN NewsFeed - 18 Nov 2013
Merck’s New Drug Application for an Investigational Intravenous (IV) Formulation of NOXAFIL(R) (posaconazole) Receives FDA Priority Review
Biopharmaceuticals FDA Regulatory

HSMN NewsFeed - 15 Nov 2013
Lumenis Receives US FDA and Japanese MHLW Clearance for Array(TM) LaserLink(TM) Pattern Scanning Device for Multi-Spot Retinal Laser Treatment
Devices Ophthalmology FDA Regulatory

HSMN NewsFeed - 14 Nov 2013
Defibrotide Granted Orphan Drug Status in Australia
Biopharmaceuticals Regulatory

HSMN NewsFeed - 12 Nov 2013
Bayer receives approval for Eylea(R) as new drug to treat wet Age-Related Macular Degeneration Patients in Canada
Biopharmaceuticals Ophthalmology Regulatory

HSMN NewsFeed - 7 Nov 2013
BioCer Announces CE Approval for Mastectomy "Bra" plus FDA Approval for Hernia repair system TiO2Mesh(TM)
Devices Regulatory

HSMN NewsFeed - 7 Nov 2013
GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis Is First Dedicated System of Its Kind Approved in Europe
Devices Interventional Regulatory

HSMN NewsFeed - 5 Nov 2013
Avedro Announces CE Mark Clearance for its KXL II (TM) Advanced Cross-linking System
Devices Ophthalmology Regulatory

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