BREAKING NEWS

Xarelto Approved for Chronic Coronary Artery Disease, Peripheral Artery Disease
COMPASS Trial Shows 24% Reduction in Major CV Events
FDA Approves Yutiq to Treat Chronic Noninfectious Uveitis
Only 18.7% of Patients Treated Had Uveitis Recurrence
Cancer Protected by the “Orderly” Pax5
Protein Organizes and Stores DNA for B Cells in Methodical Fashion
Patients' Gut, Not Medical Professionals’ Dirty Hands, Causes Many Bloodstream Infections
Patients’ Bodies Most Common Source of Hospital-Acquired Bloodstream Infections
Mortality Rates for Youths Drop
Growing opioid crisis fueling suicide increase according to study
FDA Expands Use of Gardasil 9 For Individuals Aged 27 to 45 Years 
Vaccine Prevents Some Cancers, Diseases Caused by 9 HPV Types
Post-Chemotherapy Cognitive Decline Linked to Alzheimer’s Risk Gene
In Future, Providers May Screen for APOE4 Before Treatment 
New Process Would Add Agility, Speed to Drug Manufacturing Process
MIT Professor Working to Produce Thousands of Drugs on Demand
FDA Thwarts Drug Companies That Abuse Citizen Petitions
Agency Scrutinizes Attempts to Block Generics
Progression-Free Survival for Cancer Patients May Not Reflect Good Quality of Life
Other Means Required to Measure Effectiveness of Expensive New Therapies 

P&T October 2018
Table of Contents

Features

Views Conflict on Trump’s Drug-Pricing Blueprint
Most Actions Face Political, Legal, and Technical Roadblocks
President Donald Trump’s wide-ranging Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs has implications for P&T committees, PBMs, drug manufacturers, insurers, and of course, patients. As with everything else involving health care, it’s complicated.
Enoxaparin Dosing and AntiXa Monitoring in Specialty Populations: A Case Series of Renal-Impaired, Extremes of Body Weight, Pregnant, and Pediatric Patients
Due to limited retrospective data, the use of enoxaparin in specialty populations—including those with renal dysfunction, extremes of body weight, pregnant patients and pediatric patients–has not been studied in clinical trials. The authors discuss the challenges in predicting the pharmacokinetics of enoxaparin dosing in these patients and the difficulty in obtaining antiXa levels in hospitalized patients.
Pipeline Plus
Emerging Therapies for Patients With Difficult-to-Treat Migraine
The landscape of migraine therapy is set to change with the introduction of new classes of medications aimed at providing options for patients who have not responded to previous therapies. However, the pricing of the new agents will likely be a key determinant in the extent of their use in clinical practice.
Meeting Highlights
European Society of Cardiology Congress 2018
We review sessions on large-scale aspirin and anticoagulation trials, weight loss therapies, fish oil, gout, endocarditis, and cardiomyopathy, with important implications for health care providers.

Departments

Medication Errors
Selected Medication Safety Risks That Can Easily Fall Off the Radar Screen—Part 2
Part 2 of a 3-part series discusses medication safety risks related to labeling, patient education, and medication storage.
Prescription: Washington
FDA Finalizes Drug Communication Guidance
The FDA has made it easier for P&T committees to make formulary coverage decisions by expanding the health care economics information that drug manufacturers can provide to them.
New Drugs/Drug News
Drug and Device News October 2018
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update October 2018
Ivosidenib (Tibsovo) for acute myeloid leukemia; elagolix (Orilissa) for endometriosis; and mogamulizumab-kpkc (Poteligeo) for mycosis fungoides or Sézary syndrome
Drug Forecast
Naldemedine (Symproic) for the Treatment Of Opioid-Induced Constipation
Naldemedine (Symproic) for opioid-induced constipation
Research Briefs October 2018

Industry Announcements

Transactions in relation to share buyback program
South Texas Veterans Health Care System Joins Test Validation Trial of bioAffinity’s CyPath® Lung
Tabula Rasa Healthcare to Announce Third Quarter 2018 Operating Results and Host Conference Call on Tuesday, November 6, 2018
AroCell AB announces the appointment of a new CEO
Precipio Expands ICE COLD-PCR™ Menu for Breast, Colon and Endometrial Cancers
Admera Health Expands Liquid Biopsy Offering to Include Detection of Copy Number Variation and Microsatellite Instability
New U.S. Patent Allowance Granted to AXIM® Biotechnologies for Suppository Formulations Comprised of Cannabinoids
Obalon Schedules Third Quarter 2018 Financial Results Conference Call for November 2, 2018 at 8:30 a.m. Eastern Time
Medtronic Receives FDA Approval for Valiant Navion(TM) Thoracic Stent Graft System
Acasti Pharma Announces Closing of C$27.6 Million Underwritten Public Offering of Common Shares Including the Exercise of the Over-Allotment Option
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