BREAKING NEWS

M7824 Receives Orphan Drug Designation for Biliary Tract Cancer
BTC Is a Group of Rare Gastrointestinal Cancers With Limited Treatment Options, Poor Outcomes
Oxybutynin Reduces Hot Flashes, Improves Breast Cancer Survivor Quality of Life
Study Demonstrates Rapid Response in Patients, and Doesn’t Affect Tamoxifen Efficacy
Mobile App Helps Patients With Opioid Use Disorder Remain in Recovery
Prescription App Can Serve As Training, Monitoring, and Reminder Tool
New, One-Time Corticosteroid for Post-Surgical Ocular Pain Approved
Resorbable Dextenza is the First Intracanalicular Insert for Drug Delivery
Lemtrada Can Cause Serious, But Rare, Risk of Stroke and Tears in Artery Lining
Patients with MS Suffered Stroke, Blood Vessel Tearing in Head and Neck After Receiving Drug
FDA Approves Truxima for Non-Hodgkin’s Lymphoma
First Biosimilar For Adults With CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma
Symptoms of Differentiation Syndrome Going Unrecognized with Idhifa
Life-Threatening Side Effect of Drug for Acute Myeloid Leukemia
Firdapse Approved for Treatment of Lambert-Eaton Myasthenic Syndrome
First Drug for Rare Autoimmune Disorder That Affects Nerve, Muscles Connection
Xospata Approved for Acute Myeloid Leukemia With FLT3 Mutation
Hope For Patients With Highly Aggressive Form of AML

P&T December 2018
Table of Contents

Features

Health Care Price Transparency Initiatives Are All the Rage
But Burgeoning Efforts Suffer from Myriad Shortcomings
Americans worry more about the cost and availability of health care than any other major societal issue. Clarity in treatment costs could help alleviate stress.
Health Care & Law
Use of Regulations, Laws, Standards, and Best Practices When Prosecuting and Defending Hospitals in Drug Injury Lawsuits
The authors underscore the importance of understanding standards and procedures as they discuss two lawsuits that arose from drug injury.
Case Report
Reversal of Dabigatran Bleeding and Coagulopathy Using Idarucizumab in a Patient With Acute Kidney Injury
After being treated with idarucizumab, coagulation parameters in a patient with AKI reverted to normal within 24 hours.
Pipeline Plus
Promising Multiple Sclerosis Agents In Late-Stage Development
Developing drugs with enhanced safety profiles and improving treatment affordability are vital for patients with MS. The author reviews some encouraging new agents in late-stage development.
The Extraordinary Importance of Sleep
The Detrimental Effects of Inadequate Sleep on Health and Public Safety Drive an Explosion of Sleep Research
New sleep deprivation studies confirm the relationship between inadequate sleep and a wide range of disorders, such as hypertension, obesity and type-2 diabetes, cardiovascular disease, impaired immune functioning, and more.
A Bitter Pill to Swallow: Why Medication Safety Is Critical in Hepatitis C Treatment
Treating patients with HCV provides many opportunities for medication errors to occur. These may involve regimen selection, adherence, dispensing, and drug–drug interactions. The authors offer ten safety recommendations.

Departments

Medication Errors
Partially Filled Vials and Syringes in Sharps Containers Are a Key Source of Drug Diversion
Leftover or improperly discarded drugs are easy prey for diversion and are fueling the opioid abuse epidemic. ISMP offers safe practice recommendations to prevent drug misuse.
Prescription: Washington
P&T Committees Get New Leeway to Control Part C and Part D Drug Costs
As the door opens to more step therapy and indication-based formularies, P&T committees must walk a fine line between managing treatment costs and providing access to critical drugs.
Drug and Device News December 2018
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update December 2018
Mulpleta (lusutrombopag) for thrombocytopenia; ajovy (fremenezumab-vfrm) for migraine; takhzyro (lanadelumab-flyo) for hereditary angioedema attacks
Drug Forecast
Ertugliflozin (Steglatro): A New Option for SGLT2 Inhibition
Steglatro (ertugliflozin) for glycemic control in adults with type-2 diabetes mellitus
Research Briefs December 2018

Industry Announcements

Zynerba Pharmaceuticals Announces Sustained Improvements in Emotional and Behavioral Symptoms of Fragile X Syndrome through 12 Months of Treatment with ZYN002
Synthorx Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares
Idera Pharmaceuticals to Provide ILLUMINATE-204 Clinical Data Update on Friday, December 14, 2018
VBI Vaccines Announces Proposed Public Offering of Common Shares
AGTC Announces Topline Interim Six-Month Data from Phase 1/2 X-Linked Retinoschisis Clinical Study; Termination of Biogen Collaboration
Improved Accuracy and Speed for Disease Research, Two Genomic Companies Integrate Kits and Software to Enable Deep Exploration of Epigenetic Data
Alkaline Water: A Well-Known Brand Enters the CBD Space -- CFN Media
Advanzeon Solutions, Inc.’s Wholly-Owned Subsidiary Pharmacy Value Management Solutions, Inc. Announces Medical Director and Members of Its Medical Advisory Board Voted Top Doctors by Peers
Easton Pharmaceuticals Provides Company Update Including Hotel Acquisition in Toronto, BAYER Agreement and Casino Resort in Greece
Ambu A/S: Articles of Association December 2018
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