PTCommunity News August 2016

FDA Strengthens Warning on Opioid/Benzodiazepine Combinations
Experimental Alzheimer’s Treatment Is Potential “Game Changer”
FDA Accepts Application for Melanoma Drug Binimetinib
Experimental P. aeruginosa Vaccine Bites the Dust
Study Data Support New Use for Bone Drug Denosumab (Prolia)
Lung Cancer Drug Brigatinib Submitted for FDA Review
More Trouble for Theranos: Company Halts Zika Test After FDA Inspection
Researchers Identify Multidrug-Resistant E. coli Bacteria in New Jersey Patient
FDA Gives Nod to Erelzi, Biosimilar Version of Etanercept (Enbrel)
CMS Report: Fewer Than One-Third of ACOs Qualified for Medicare Bonuses
America’s Other Drug Problem: Multiple Prescriptions for Hospitalized Elderly
U.S. Study: Adult Mosquitoes Can Pass Zika to Their Offspring
FDA Accepts Application for ALS Drug Edaravone
Thrombocytopenia Drug Fostamatinib Meets Primary Endpoint in Phase 3 Study
Mylan to Launch Generic EpiPen at Half the Price of Branded Product
Team Makes Zika Drug Breakthrough
FDA Approves Afluria Quadrivalent Flu Vaccine for Adults
Potential Blockbuster Alirocumab (Praluent) Scores in Late-Stage Trial
Mixed Results Reported for Pacritinib in Myelofibrosis
FDA Advises Testing for Zika Virus in All Donated Blood and Blood Components in U.S.
FDA Warns of Problems With Programmable Syringe Pumps
Diabetic Foot Ulcer Spray Fails Phase 3 Test
Illinois Attorney General Accuses Insys Therapeutics of Deceptively Marketing Fentanyl Painkiller
Eleven Drug Makers Whose Pricing Power Is Off the Charts
Mylan Lowers Price of EpiPen After Backlash
Researchers Question Process for Reimbursing ‘Off-Label’ Cancer Drugs
FDA Rejects Application for Calcimimetic Agent Etelcalcetide (Parsabiv)
Siponimod Succeeds in Phase 3 Multiple Sclerosis Trial
Exablate Neuro System Reduces Essential Tremor in Pivotal Study
Can U.S. Drug Costs Be Contained?
CMS Identifies Hospitals Paid Nearly $1.5B in Medicare Billing Settlement
CDC: Saving Patients From Sepsis Is a Race Against Time
Rucaparib Wins Priority Review for Treatment of Advanced Ovarian Cancer
New Imaging Test Can Detect Amyloid-Related Heart Failure
Health Officials Struggle to Identify Sepsis Before It Turns Deadly
Closed Formulary Helps Reduce Costs, Opioid Use in Texas
Study: After Fragility Fracture, Patients Often Continue Meds That Increase Fracture Risk
Researchers Discover New Inflammatory Disease––Otulipenia
Mylan Hikes EpiPen Price by 400%
Zika Transmission Identified in Miami Beach
FDA Approves Abuse-Deterrent, Extended-Release Oxycodone/Naltrexone (Troxyca ER) for Pain Management
FDA Expands Label for Trokendi XR to Include Migraine Prophylaxis in Adults
Sanofi Submits New Data on Insulin Glargine/Lixisenatide Pen for Diabetes
Company to Seek Marketing Approval for First New Sickle Cell Treatment in Nearly Two Decades
Zika Virus Attacks Adult Brain Cells, Researchers Find
Provider-Sponsored Health Plans Poised for Comeback
FDA Clears Clinical Trial of New Antibody in HER2-Expressing Cancers
Study: Full Medication Adherence Reduces Costs in CVD Patients
FDA Expands Use of Heart Valves
Medtronic Warns Doctors About Aortic Valve Insertion Device After 19 Deaths
FDA Rejects Andexanet Alfa (AndexXa) for Reversal of Anticoagulation
Janssen Seeks Expanded Indication for Myeloma Drug Daratumumab (Darzalex)
Osteoporosis Treatment Abaloparatide Succeeds in Postmenopausal Women
Tinnitus Drug Keyzilen Misses Main Endpoints in Phase 3 Trial
Affordable Care Act in Trouble as Big Insurance Companies Pull Out
Report: Company-Sponsored Studies Understated Harms of Popular Weight-Loss Drug
FDA Issues Safety Reminder on Endoscope Reprocessors
Buprenorphine Monthly Depot Succeeds in Treatment of Opioid Use Disorder
Researchers Work on ‘Super Vaccine’ That Guards Against All Strains of Pneumococcal Disease
Fewer Pharmacies May Mean More Readmissions
Report: PCSK9 Inhibitors Not Cost-Effective, Could Substantially Raise U.S. Health Care Bills
Vertex Discontinues One Study of VX-661/Ivacaftor Combo in Cystic Fibrosis
Custirsen Fails to Improve Prostate Cancer in Phase 3 Trial
Gene Editing: New Therapeutic Approach for Blood Disorders
HHS Declares Zika Public Health Emergency in Puerto Rico
Doctors Struggle With Medical Marijuana Knowledge Gap
Lupus Nephritis Drug Voclosporin Meets Primary Endpoint in Phase 2 Study––But Deaths Cause Concern
Sublingual Sufentanil Shows Promise in ER Pain Trial
Researchers Discover How MRSA ‘Superbug’ Kills Influenza Patients
Mixed Results Reported for Venetoclax (Venclexta) in AML Patients
U.S. Researchers Identify Key Weapon of Zika Virus
Study: Addiction Risk Low in Seniors Taking Postoperative Opioids
Amisulpride (Baremsis) Shows Promise for Treatment of Postoperative Nausea and Vomiting
Ready-to-Use Rescue Pen Successfully Treats Hypoglycemia in Diabetes Patients
DEA Refuses to Change Classification of Marijuana as Dangerous Drug With No Medical Use
Survey: Health Care IT Costs Top $32,500 Per Physician
Study Finds One in Five Hospital Patients Discharged With Unstable Vital Signs, Adding to Readmissions
FDA Accepts Applications for Muscular Dystrophy Drug Deflazacort
Task Force Finds Insufficient Evidence to Screen for Lipid Disorders in Children, Adolescents
Report: Elderly Patients Leave Hospitals More Disabled Than When They Arrived
Joint Disorder Added to List of Potential Zika Effects
FDA Approves Extended-Release Granisetron (Sustol) for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Study Supports Added Benefit of Nivolumab (Opdivo) in Renal Cell Carcinoma
Cell Therapy Provides Positive Results in Biologic-Refractory RA
New Engineered Skin Substitute for Pediatric Burns
Anticocaine Vaccine Approved for Clinical Study in Humans
Utah Hospital Cuts Wasteful Testing, Saves $10M a Year on Health Care
FDA Gives Green Light to Phase 3 Trials of New Alzheimer’s Drug
Selumetinib Fails to Improve Survival in Lung Cancer Study
Study: ICU Use Associated With More Invasive Procedures, Higher Costs
Lawsuit Claims Sexual Dysfunction Drug Cialis Tied to Skin Cancer
FDA Expands Keytruda Label to Include Patients with Head-and-Neck Squamous Cell Carcinoma
FDA Advisors Schedule Meeting to Review Hepatitis B Vaccine
Asthma Pill Shows Promise in Small Clinical Trial
CVS Formulary Drops Drugs With “Egregious” Price Hikes
Study: Postpartum Readmissions on the Rise
FDA Panel Backs Approval of Abuse-Deterrent Painkiller Arymo ER
Nivolumab (Opdivo) Flunks Lung Cancer Trial
Companies Develop First Ingestible X-Ray Capsule for Colorectal Cancer Screening
FDA Approves Generic Tamiflu
First Subject Receives Experimental Hypertension Treatment
New Biochip-Based Blood Test Detects Increased Risk for Alzheimer’s Disease
Ohio Medical Group Hacked, More Than 100,000 Documents Stolen
New York’s Attorney General Cracks Down on Phony “Zika-Preventive” Products
Medicare’s Readmission Penalties Hit New High
Study: Hospitals That Send the Most Heart Patients to the ICU Get the Worst Results
FDA Approves Flonase Sensimist as OTC Allergy Treatment
Ribociclib Receives Breakthrough Therapy Designation for Advanced Breast Cancer
Scientists Block Superbug’s “Sticky Fingers,” Prevent Drug Resistance
Gallup Survey: Opioids Seen as Most Serious Local Drug Problem
Study Bodes Well for Biosimilars
Incretin-Based Diabetes Drugs Linked to Bile Duct, Gallbladder Disease
Nonaddictive, Nonsedating Pain Medication Shows Promise in Diabetic Neuropathy
Pracinostat Receives Breakthrough Therapy Designation for Leukemia
Opioid Dependence Leads to ‘Tsunami’ of Medical Services
FDA Approves Reconstitution System for Hemophilia Treatment Adynovate
FDA Grants Interleukin 21 Orphan Drug Status
FDA Agrees to Design of Phase 3 Trial of Ancrod

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PTCommunity News August 2016