PTCommunity News September 2014

Docs Urge Caution as Payments Database Debuts
Cardiac ‘Patch’ Could Replace Transplants, Researchers Say
U.S. Has First Case of Ebola Virus
Nine-Valent HPV Vaccine May Prevent Nearly 90% of Cervical Cancers
FDA Takes Steps to Strengthen Cybersecurity of Medical Devices
FDA Expands Indication for Methylnaltrexone Bromide (Relistor)
Benzodiazepine Sedatives Linked to Higher Mortality Rates Compared With Propofol
New Device Lets Docs 'Tune In' to Brain Blood Flow During Cardiac Surgery
FDA Changes Omalizumab (Xolair) Labeling, Cites Risk of Heart and Brain Problems
Afatinib (Gilotrif) Superior to Erlotinib (Tarceva) in Late-Stage Lung Cancer Trial
Pertuzumab (Perjeta) Regimen Extends Survival in Women With Metastatic Breast Cancer
Study: Kidney Drug Fenoldopam (Corlopam) Does Not Reduce Need for Dialysis
Survey: Payers Expect to Limit Hospital Use of New Premium-Priced Antibiotics for Gram-Negative Infections
FDA Expands Adalimumab (Humira) Label to Include Pediatric Patients With Crohn’s Disease
Sovaldi’s High Price Reflects a Trend, Not an Exception to the Rule
Bevacizumab/Capecitabine Combo Shows Promise in Women With HER2-Negative Metastatic Breast Cancer
Only Half of U.S. Adults Over 45 Are Screened for Diabetes
MIT Scientists Use Anthrax to Deliver Cancer Drugs
FDA Clears Glucose Monitoring System for Use in Critical Care Units
Positive Late-Stage Data Reported for Glaucoma Candidate Vesneo (Latanoprostene Bunod)
Study: Hypercalcemia Blood Test Could Be Used for Early Cancer Diagnosis
Secukinumab Meets Key Objectives in Phase III Trials
Scientists Develop Simple Breath Test for TB
Psoriatic Arthritis Drug Apremilast (Otezla) Approved for Treatment of Plaque Psoriasis
Oral Testosterone Replacement Therapy Meets Phase III Goals
FDA Agrees to Review Brexpiprazole for Treatment of Schizophrenia and Major Depression
Single-Tablet HIV Regimen Shows Promise in Late-Stage Studies
FDA Approves First Test to Identify Yeast Pathogens in Blood Sample
Phase III Study Evaluates Ultrasound Device for Emergency Treatment of Ischemic Stroke
Old Drug May Be Key to New Antibiotics
Report: Insurers Hesitant to Cover High-Priced Proton Beam Therapy
New Guidelines for Prevention and Detection of Sexually Transmitted Infections
Guidelines Issued for Managing Perioperative and Postoperative Atrial Fibrillation
Amgen Submits FDA Application for Blinatumomab for Acute Lymphoblastic Leukemia
Elusys Completes Phase III Studies Of Anthrax Anti-Toxin
Access to Tekmira’s Ebola Treatment Widened
AAP Outlines Flu Vaccine Recommendations for Children
Eylea, Lucentis Equally Likely to Be Covered on Commercial and Medicare Advantage Plans for Wet AMD
‘Sharkskin’ Surfaces Could Limit Hospital ‘Superbugs’
Radiation Oncology Group Questions Five Treatments
Study: Prostate Cancer Screening Recommendations Have Little Effect
FDA Approves Trulicity to Treat Type-2 Diabetes
Pancreatic Cancer Drug Simtuzumab Fails Mid-Stage Study
Expert Says Airborne Ebola Transmission Is Not Impossible
Ramucirumab/Paclitaxel Improves Survival in Second-Line Gastric Cancer Patients
Positive Results Reported for Insulin Degludec/Insulin Aspart (Ryzodeg) in Phase III Diabetes Trial
FDA Expands Labeling for Fast-Acting Erectile Dysfunction Drug, Stendra (Avanafil)
Urine HPV Test Could Offer Alternative to Conventional Smear
Study Finds Drop in Sovaldi Use
Survey: RA Drug Market Driven by Uptake of Oral Jak Inhibitors and Non–TNF-Alpha Biologics
Insulin Degludec (Tresiba) Demonstrates Long-Term Efficacy in Children and Adolescents With Type-1 Diabetes
Naloxegol (Movantik) Approved for Opioid-Related Constipation
Eating Disorder Treatment Lisdexamfetamine (Vyvanse) Gets Priority Review
Report: Schizophrenia Not a Single Disease But Several Distinct Disorders
Positive Phase III Data Reported for Osteoporosis Drug Odanacatib
FDA Grants Tentative Approval to Budesonide (Uceris) Rectal Foam for Treatment of Distal Ulcerative Colitis
Medical Field Urged to Look Within for Solution to Opioid Addiction
CDC Warns of Severe Respiratory Illness Associated With Enterovirus D68
FDA Approves Hyqvia (Immune Globulin Infusion 10%) for Adults With Primary Immunodeficiency
Ivabradine Shows Promise in Phase III Heart Failure Trial
FDA Expands Labeling for Rixubis (Coagulation Factor IX [Recombinant]) to Include Children With Hemophilia B
Study: Kids Prescribed Antibiotics Twice as Often as Needed
Positive Results Reported for Ramucirumab (Cyramza) in Phase III Second-Line Colorectal Cancer Study
FDA Advisors Give ‘Thumbs Up’ to Liraglutide (Saxenda) for Treatment of Obesity
One-Minute Point-of-Care Anemia Test Shows Promise in New Study
Scientists Develop Non-Toxic Strategy to Treat Leukemia
Fingolimod (Gilenya) Achieves ‘No Evidence of Disease Activity’ in MS Patients
‘Electronic Skin’ Could Improve Early Breast Cancer Detection
Xtandi (Enzalutamide) Gets New Indication for Men With Metastatic Castration-Resistant Prostate Cancer
Two-Year Data Confirm Efficacy of Plegridy (Peginterferon Beta-1a) in MS Patients
Positive Phase III Results Reported for Humira (Adalimumab) in Treatment of Inflammatory Skin Disease
FDA Approves Weight-Management Pill Contrave (Naltrexone/Bupropion)
Task Force Recommends Low-Dose Aspirin for Women at High Risk for Preeclampsia
FDA Reminds Health Care Professionals Not to Use Sterile Products From Downing Labs/NuVision Pharmacy of Texas
Study: Hypertension ER Visits Jumped 25% in 2006–2011
FDA Advisors Say ‘No’ to Nebivolol/ Valsartan Combo for Hypertension
New Guidance for Managing Sickle Cell Disease
Asthma Drug Mepolizumab Shows Promise in Phase III Studies
Sodium’s Influence on Blood Pressure Statistically Insignificant
Nausea and Vomiting Treatment Rolapitant Submitted for FDA Review
Variation in Hospitalizations From ERs Offers Opportunity to Save Billions, Authors Say
Report: Department of Homeland Security Unprepared for Pandemic
FDA Allows Marketing of First Test to Assess Risk of Developing Acute Kidney Injury
Kidney Drug Ferric Citrate Approved With Warning
Peramivir Injection Shows Promise Against Influenza
Once-Daily Ultibro Breezhaler Superior to Twice-Daily Seretide Accuhaler in Reducing COPD Flare-Ups
Report: Bureaucracy Consumes One-Quarter of U.S. Hospitals’ Budgets — Twice As Much As Other Nations
Generic Baraclude (Entecavir) Tablets Launched in U.S.
Positive Phase III Results Reported for Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients
Breast-Conserving Therapy Shows Survival Benefit Compared With Mastectomy in Early-Stage Patients
FDA Approves Pembrolizumab (Keytruda) for Advanced Melanoma
U.S. Officials Arrest Pharmacist Tied to Deadly 2012 Meningitis Outbreak
Study: Sepsis Patients Fare Better in Hospitals With Higher Case Volumes
FDA Approves 3-D Mammography Device
Extended-Release Hydrocodone/ Acetaminophen Combo Shows Efficacy Against Acute Pain
Basal Insulin Peglispro Superior to Insulin Glargine in Phase III Studies
Report: U.S. Obesity Rates Reach Historic Highs
World Losing Battle to Contain Ebola, Health Agency Says
FDA Accepts NDA Filing for Eluxadoline
Positive Phase III Results Reported for Anti-Cancer Agent Xilonix
Northera (Droxidopa) Available for Treatment of Neurogenic Orthostatic Hypotension
New Treatment Guidelines for Advanced Breast Cancer
Harvard Study: Quality of U.S. Diet Remains Poor
Cabozantinib (Cometriq) Fails to Meet Primary Endpoint in Pivotal Study of Men With Metastatic Prostate Cancer
New Indication for Anti-Epileptic Drug Lacosamide (Vimpat)
High-Dose Rosuvastatin (Crestor) Shrinks Coronary Plaque in Heart Attack Patients
Company Responds to FDA’s Concerns About Rifaximin (Xifaxan) for Repeat Treatment of IBS With Diarrhea
FDA Removes Clinical Hold on Early Trials of Cancer Drug Vantictumab
Engineered Cartilage Regenerates Joints
Irinotecan-Based Therapy Shows Promise in Subset of Stage III Colon Cancer Patients
New Bedside Scanning Device Ensures Patients Get Correct Pills
Generic Equivalent of Avara Receives FDA Nod

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PTCommunity News September 2014