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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: Regulatory

 HSMN NewsFeed - 23 Nov 2016
Exact Imaging Receives CE Mark Approval for its ExactVu(TM) Micro-Ultrasound System for Prostate Imaging and Biopsy
Devices Oncology Urology Regulatory
 HSMN NewsFeed - 22 Nov 2016
Amedica Announces New Sales Leadership and Provides Regulatory Updates
Devices Neurosurgery Orthopaedic Personnel
 HSMN NewsFeed - 17 Nov 2016
Xenoscope(TM), the Revolutionary Cost-Effective Laparoscope Receives CE Mark
Devices Surgery Regulatory
 HSMN NewsFeed - 17 Nov 2016
HeartFlow FFRct Analysis Receives Regulatory Approval in Japan
Devices Cardiology Regulatory
 HSMN NewsFeed - 14 Nov 2016
AbbVie's HUMIRA(R) (Adalimumab) Receives CHMP Positive Opinion to Treat Adolescents with Hidradenitis Suppurativa, a Chronic Inflammatory Skin Disease
Biopharmaceuticals Dermatology Regulatory
 HSMN NewsFeed - 11 Nov 2016
CHMP Adopts Positive Opinion to Include Self-administration for RUCONEST(R)
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 10 Nov 2016
IBRANCE(R) (palbociclib) Receives Approval in European Union for the Treatment of Women with HR+/HER2- Metastatic Breast Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 7 Nov 2016
St. Jude Medical Gains CE Mark Approval for MRI Labeling of its Quadra Allure MP Cardiac Resynchronization Therapy Pacemaker
Devices Cardiology Radiology Regulatory
 HSMN NewsFeed - 7 Nov 2016
Myriad Will Seek Japanese Regulatory Approval for BRACAnalysis CDx(R)
Diagnostics Oncology Regulatory
 HSMN NewsFeed - 7 Nov 2016
Abbott's Absorb(TM) Bioresorbable Stent Approved as the First Fully Dissolving Heart Stent in Japan
Devices Interventional Cardiology Regulatory
 HSMN NewsFeed - 3 Nov 2016
Eisai Welcomes Positive NICE recommendation for Halaven(R) (eribulin) for Patients with Locally Advanced or Metastatic Breast Cancer
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 31 Oct 2016
European Medicines Agency Validates the Marketing Authorization Application for Avelumab for the Treatment of Metastatic Merkel Cell Carcinoma
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 20 Oct 2016
Medtronic Announces Health Canada Licence of the MiniMed(TM) 630G System with New User-Friendly Insulin Pump Design and SmartGuard(TM) Technology
Devices Drug Delivery Endocrinology Regulatory
 HSMN NewsFeed - 19 Oct 2016
GeneFirst Announces CE Marking and Release of Papilloplex(R) HR-HPV, a PCR Based Molecular Diagnostic Test for Genotyping 14 High Risk Human Papillomaviruses from Cervical and Urine Samples
Diagnostics Regulatory Product Launch
 HSMN NewsFeed - 19 Oct 2016
CollPlant Receives CE Mark for Vergenix(TM)STR for Treatment of Tendinopathy
Devices Regenerative Medicine Regulatory
 HSMN NewsFeed - 18 Oct 2016
Corbus Pharmaceuticals Receives Orphan Designation for Resunab for the Treatment of Cystic Fibrosis in the European Union
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 18 Oct 2016
Shire Granted EU Marketing Authorization of Onivyde(R), in Combination With 5-Fluorouracil (5-FU) and Leucovorin (LV),for the Treatment of Metastatic Adenocarcinoma of the Pancreas in Adult Patients Who Have Progressed Following Gemcitabine-Based Therapy
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 17 Oct 2016
Teva Receives Positive Opinion from European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to Extend Indication of Trisenox(R) for First Line Treatment of Low- to Intermediate Risk Acute Promyelocytic Leukemia (APL)
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 14 Oct 2016
Intercept Pharmaceuticals Receives Positive CHMP Opinion for Ocaliva(R) (Obeticholic Acid) for the Treatment of Primary Biliary Cholangitis in the European Union
Biopharmaceuticals Regulatory
 HSMN NewsFeed - 14 Oct 2016
Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin
Biopharmaceuticals Oncology Regulatory
 HSMN NewsFeed - 14 Oct 2016
BTG and Mirada Medical Announce CE Mark Certification for Simplicit90Y(TM) Dosimetry Software in Europe
Devices Oncology Regulatory
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