PTCommunity News September 2016

Need to Replace EpiPens Regularly Adds to Cost Concerns
Big-Name Hospitals Get Low Marks for Preventing C. difficile Infections
HCV Regimen Receives Breakthrough Therapy Designation
Oral, First-in-Class Schizophrenia Drug Stumbles in Phase 3 Trial
More Positive Data Reported for Lupus Nephritis Treatment Voclosporin
Congress Finally Approves Funding to Fight Zika Virus
FDA Expands Orkambi Label to Include Cystic Fibrosis Patients Ages 6 Through 11
FDA Approves First Automated Insulin Delivery Device for Type-1 Diabetes
Migraine Drug Erenumab Succeeds in Phase 3 Trial
Research Sheds Light on Mechanism That Leads to Drug-Resistant ‘Superbugs’
CDC Teams Up With Dialysis Groups to Reduce Infections
Expert Demoted After Questioning CDC’s Zika Test
FDA Approves Diabetes Sensing System
Researchers Discover How Resveratrol Reduces Airway Inflammation
FDA Accepts Application for Osteoporosis Drug Romosozumab
New Collaboration Will Evaluate Combination of Opdivo and NKTR-214
Experts Recommend Continuous Glucose Monitors for Adults with Type-1 Diabetes
Kyprolis Combo Fails to Meet Endpoint in Phase 3 Multiple Myeloma Trial
Do Gut Microbiomes of Hispanics/Latinos Influence Their Diabetes Risk?
Workplace Depression Across Eight Countries Said to Cost $246 Billion
FDA Approves Amjevita, the First Humira Biosimilar
Stelara Receives FDA Approval for the Treatment of Crohn's Disease
Dupilumab Application Accepted for FDA Priority Review
FDA Expands Indications for Ilaris for Three Rare Diseases
NIH Funds Research Network Focused on HIV-Infected Youth
Tattoo Therapy for Chronic Diseases
Anticipated Alzheimer’s Drug Fails in Late-Stage Study
Injection Drug Use Blamed for Rise in Heart Infections
Ceritinib (Zykadia) Succeeds in Lung Cancer Trial
How Does Tecfidera Work?
Report: Medicare EpiPen Spending Up 1,100%
Did Abbott Sales Reps Help Spur the Opioid Epidemic?
UnitedHealth Trims Drug Coverage
Bundled Payments May Have Unintended Consequences
Newron Pharma Resubmits Application for Parkinson’s Drug Safinamide (Xadago)
Approval of Muscular Dystrophy Drug Causes Uproar at FDA
Survey: Most Physicians Downbeat About Future of Medicine
Report: Capping Copays Will Raise Premiums and Drug Prices
FDA Approves Invokamet XR for Treatment of Adults With Type-2 Diabetes
Low-Dose Phentermine (Lomaira) Wins FDA Nod for Weight Loss
FDA Approves Disposable Colonoscope
Wearable Device Helps Reduce Hypoglycemia
FDA Places Clinical Hold on Leukemia Drug
CDC Study: Hospitals Still Use Too Many Antibiotics
Kratom: Innocuous Pain Reliever or Dangerous Drug?
Report: Antimicrobial Resistance May Wipe Out a Century of Health Care Progress
FDA Grants Accelerated Approval to First Drug for Duchenne Muscular Dystrophy
Contraceptive Device Kyleena Wins FDA Nod
Romosozumab Reduces Fractures in Postmenopausal Women With Osteoporosis
Cytomegalovirus Vaccine Flops in Mid-Stage Trial
Candidates Decry High Drug Prices, But Offer Few Options
World Should Prepare for Global Microcephaly ‘Epidemic,’ Authors Warn
Erenumab Shows Promise for Treatment of Chronic Migraine
Respiratory Virus Vaccine Flunks Phase 3 Study
Simple Compound Could Provide First New Therapy for Myeloid Leukemia in 40 Years
FDA Advisors Recommend Dropping Boxed Warning in Chantix Label
Yosprala Wins FDA Nod for Secondary Prevention of Cardio- and Cerebrovascular Events in Patients at Risk for Aspirin-Induced Gastric Ulcers
Sublingual Sufentanil Found Safe in Late-Stage Trial
Study: Shingles Vaccine Remains Effective After Four Years
Bladder Cancer Drug Apaziquone (Qapzola) Not Effective, FDA Panel Says
Report: EpiPen Execs Are Second-Best Paid in the Industry
CDC: Poor Blood Pressure Control Puts Five Million Older Americans at Risk
Common Breast Cancer Test May Not Be Worth the Cost
FDA Approves Cuvitru for Treatment of Primary Immunodeficiencies
Stem Cell Therapy Shows Promise in Spinal Cord Paralysis
Study: Opioid-Related Health Spending Jumped More than 1,300% in Four Years
FDA Report: Cancer Drug Websites Skimp on Safety Data
Idebenone (Raxone) Improves Inspiratory Function in Patients With Duchenne Muscular Dystrophy
Snail Venom: The Key to Better Diabetes Treatments?
NMDA Receptor Modulator Wins Fast-Track Designation for Treatment of Diabetes-Related Neuropathic Pain
Study: Discarding Unused Surgical Supplies Wastes Millions of Dollars
FDA Panel Unimpressed by Varenicline (Chantix) Smoking-Cessation Study
FDA Approves Obalon Balloon System
Scientists Identify Previously Undiscovered Role of Enzyme in Regulating Blood Pressure
Aveo Quietly Terminates Ficlatuzumab Study
Behind the EpiPen Monopoly: Lobbying Muscle, Faltering Competition
Affordable Care Act Puts the Squeeze on EDs
FDA to Skip Review Panel for Cancer Drug Candidate Rucaparib
Study Could Herald New Treatment for Muscular Dystrophy
Oral Sotagliflozin Succeeds in Phase 3 Diabetes Trial
Reuters Report: U.S. Fails to Track Rising ‘Superbug’ Toll
Senate to Probe EpiPen Pricing
Blue Ribbon Panel Offers Recommendations for Improving Cancer Outcomes
Patients With Advanced Lymphoma in Remission After T-Cell Therapy
Company Prepares to Submit Cannabis-Based Epilepsy Treatment to FDA
Senate Fails to Pass Zika Funding Bill––Again
Study Ranks Best and Worst States for Health Care Costs, Access
Keytruda Wins Priority Review for First-Line Treatment of Advanced Lung Cancer
Lasmiditan Achieves Key Endpoints in Pivotal Migraine Study
Paralyzed Man Regains Use of Arms and Hands After Experimental Stem Cell Therapy
Saline Could Work as Well as Drugs for Preventing Nosebleeds
Survey Finds Gaps in Americans’ Knowledge About Zika
Positive Phase 3 Results for Benralizumab in Severe Asthma
Tiotropium Respimat Improves Lung Function in Children With Asthma
Home Noninvasive Ventilation Therapy Reduces Risk of Rehospitalization and Death in COPD
Merck Halts Odanacatib Development Program
FDA Approves Blinatumomab for Use in Pediatric Patients With Ph– Relapsed or Refractory B-Cell Precursor ALL
FDA Issues Final Rule on Safety and Effectiveness of Antibacterial Soaps
HHS Awards $19.8 Million to Japanese Company to Accelerate Development of a Zika Vaccine
Study: Extreme Preemies Must Watch Blood Sugars and Weight
FDA Strengthens Warning on Opioid/Benzodiazepine Combinations
After FDA Rejection, New Data Offered on Factor Xa Inhibitor Antidote AndexXa
Experimental Alzheimer’s Treatment Is Potential “Game Changer”
FDA Accepts Application for Melanoma Drug Binimetinib
Experimental P. aeruginosa Vaccine Bites the Dust
New Drug Application Will Be Submitted for Paclitaxel Poliglumex as First-Line Monotherapy for Women With Advanced Non-Small Cell Lung Cancer

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PTCommunity News September 2016