BREAKING NEWS

Thousands of Foster Kids Receive Psychiatric Drugs Without Safeguards
Conversely, Kids Who Need Drugs Go Untreated
New Device Will Treat Acute Coronary Artery Perforations
May Reduce the Need for Open-Heart Surgery
A Second Impurity Found in Recalled Valsartan Drug Products
NDEA, a Known Carcinogen, Discovered During FDA Testing
Lumoxiti Injection Approved for Hairy Cell Leukemia
Cleared for Adults with Relapsed or Refractory Disease
New Dosage of Buprenorphine and Naloxone Sublingual Film
Approved as Maintenance Treatment for Opioid Dependence
Colorado’s Attorney General Sues Purdue Pharma
Says Company’s OxyContin Had “Significant Role” in Opioid Epidemic
Mood-Reading Brain Algorithm Has Potential to Treat Depression
Study Uses Experimental Software to Decode Variations in Mood
FDA Announces Voluntary Recall of Montelukast Tablets
Mixup with Losartan Discovered in Bottles

P&T TV

Zip Code is Still Destiny, In Philadelphia and Across the United States

On the 10th anniversary of the Jefferson College of Population Health, Dr. David Nash reflects on the progress of the first college of population health, its influence around the country, and how social determinants still play a major role in patient outcomes and life expectancy.

August 2018 interview

P&T September 2018
Table of Contents

Features

Congress Readying User Fee Program for OTC Products
Money Needed to Dig FDA Out of Its Review Ditch
Questions about the safety and efficacy of cough and cold medicines and numerous other over-the-counter (OTC) products—along with an overwhelmed, understaffed FDA—are the driving force behind Congressional action to put a first-ever OTC user fee program in place.
Health Care & Law
Challenges to the U.S. Health Care System From Legal and Regulatory Changes in the Donald Trump Era
Despite a slow legislative start by President Trump, new federal and state regulatory health care changes will have important implications for pharmacists, P&T committees, and patients.
Poly (ADP-ribose) Polymerase Inhibitors in the Management of Ovarian Cancer: A Drug Class Review
Epithelial ovarian cancer is the leading cause of death due to a gynecological malignancy in the United States. The authors review the pharmacology, safety, efficacy, and role of poly adenosine diphosphate [ADP]-ribose polymerase (PARP) inhibitors in the treatment and maintenance of relapsed, advanced ovarian cancer.
Meeting Highlights
23rd Congress of the European Hematology Association 2018
We review key sessions on multiple myeloma, chronic lymphocytic leukemia, Hodgkin lymphoma, Epstein-Barr virus-positive post-transplant lymphoma, and follicular lymphoma.

Departments

Medication Errors
Selected Medication Safety Risks That Can Easily Fall Off the Radar Screen
Part 1 of a 3-part series discusses 3 medication safety risks that can easily fall off the radar screen in hospitals and doctors’ offices.
Prescription: Washington
Wide-Ranging Trump Drug Price Reduction Blueprint
President Trump’s American Patients First plan to reduce drug prices has some innovative aspects but might face political roadblocks.
Drug and Device News September 2018
Approvals, new indications, regulatory activities, and more
Pharmaceutical Approval Update September 2018
Baricitinib (Olumiant) tablets for rheumatoid arthritis; plazomicin (Zemdri) injection for complicated urinary tract infections; and cannabidiol (Epidiolex) oral solution for seizures with Lennox-Gastaut syndrome and Dravet syndrome
Research Briefs September 2018

Industry Announcements

Nightstar Reports Positive Proof of Concept Data from Dose Escalation Study in XIRIUS Trial for NSR-RPGR in XLRP Patients
Novartis to file for new Lucentis® (ranibizumab) indication in retinopathy of prematurity (ROP), a rare disease in premature infants that often leads to blindness
New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD
BeiGene Announces Preliminary Results from the Phase 1 Clinical Trial of Zanubrutinib in Chinese Patients with B-Cell Lymphoma at Annual Meeting of the Chinese Society of Clinical Oncology
G1 Therapeutics Announces Closing of Offering of Common Stock
argenx announces closing of U.S. public offering for gross proceeds of approximately $300.6 million
Grant of Restricted Stock Units and Warrants to Genmab employees
Sharecare teams up with Walmart to help people across the country take control of their health at Walmart Wellness
Advanced Bifurcation Systems Files Pre-Submission With FDA to Define Clinical Pathway; Outlines Regulatory and Clinical Strategy for Europe to Obtain CE Mark
Advanced Bifurcation Systems Granted Four Additional Patents
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