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Clinical Trials
- Multiple Sclerosis Drug Fails Phase III Trial
Arbaclofen placarbil has no effect on spasticity (May 20) - Positive Phase III Results for Myelofibrosis Treatment
JAK2 inhibitor reduces spleen volume (May 17) - Breast Cancer Drug, EndoTAG-1, Shows Promise in Phase II Trial
Paclitaxel/lipid combo targets blood supply to tumors (May 16) - Positive Phase III Data for New Leukemia Drug, Obinutuzumab
Disease progression, death significantly reduced versus chlorambucil (May 16) - Positive Phase II Results Reported for Ovarian Cancer Vaccine
Time to recurrence more than double that of standard treatment (May 15)
Guidelines
- All Hospitals Should Require Drug, Alcohol Tests for Physicians
Johns Hopkins experts offer recommendations (May 7) - New Lung Cancer Guidelines Recommend Screening for High-Risk Individuals
Older, heavy smokers should have CT scan (May 7) - AHA Statement: Understanding Heart Patients’ Quality of Life Can Improve Outcomes
Health care providers urged to use feedback from patient surveys to personalize care (May 6) - New Guidelines for Managing Fibromyalgia
Experts address diagnosis, treatment, and follow-up for first time (May 6) - New Clinical Guideline on Prostate Cancer Screening
Men aged 55 to 69 urged to talk with doctors about benefits, harms of testing (May 3)
Industry Trends
- Report: Market for Pancreatic Cancer Therapies Expected to Double to $1.3 Billion Over Next Decade
Growth fueled by three new agents (May 7) - Physicians Expect Xtandi (Enzalutamide) to Become Treatment Leader for Metastatic Prostate Cancer
Survey finds rapid uptake since product launch (May 6) - Report: All-Oral, IFN-Free Regimen Is Major Unmet Need in HCV Patients
Sofosbuvir/ledipasvir/ribavirin combo has advantages over current therapies (May 2)
P&T TV
Who Will Pay for High-Cost Biologics?
Insurance coverage was never meant to handle new pharmaceutical breakthroughs on the radar — breakthroughs that can cost anywhere from $90,000 to $300,000 a year per patient, says F. Randy Vogenberg, RPh, PhD, principal of the Institute for Integrated Healthcare and a member of P&T’s Editorial Board. There will be pressure on everybody to find a way to somehow control these costs.Drug Safety Issues
- FDA Warns Against Use of Migraine Prevention Drugs in Pregnant Women
Maternal use of valproate may lower IQ scores in children (May 6)
Research News
- Study Finds Older Whooping Cough Vaccine More Effective Than Newer Version
Whole-cell pertussis vaccines better than acellular vaccines (May 20) - Vitamin D Could Provide New Treatments for Asthma
Researchers see new way to reduce steroid therapy (May 20) - iPhone App Helps Diagnose Heart Attacks
System may be faster and more reliable than e-mailed photo images (May 17) - Physical and Emotional Impairments Often Untreated in Cancer Patients
Review calls rehabilitation critical, cost-effective (May 17) - Nanotechnology Could Help Fight Diabetes, Scientists Say
Injectable ‘toothpaste’ releases insulin (May 16) - Study: Depression Doubles Stroke Risk in Middle-Aged Women
Researchers call for greater awareness of depression as preventable risk factor for stroke (May 16) - AHA Report: Risk of Hospital Readmission Prolonged After Heart Attack, Heart Failure
Risk can extend well beyond 30 days after discharge (May 16) - Researchers Identify U.S. ‘Hotspots’ for Infection and Sepsis-Related Mortality
First map of its kind reveals key areas for targeted interventions (May 15) - Scientists Develop ‘Magic Bullet’ for Acute Lung Injury
Discovery could ‘revolutionize’ management of ICU patients (May 15) - Flu in Pregnancy May Quadruple Child's Risk for Bipolar Disorder
More Evidence of Overlap with Schizophrenia (May 13)
Approvals, Launches,
and New Indications
- FDA Approves Radium Drug Xofigo for Metastatic Prostate Cancer
Drug delivers radiation directly to bone tumors (May 15) - Arthritis Drug Simponi (Golimumab) Gets Expanded Indication for Ulcerative Colitis
Treatment blocks abnormal inflammatory and immune responses (May 15) - FDA Approves Diagnostic Test for Lung Cancer
New use for Tarceva (erlotinib) also approved (May 14) - FDA Approves Liptruzet (Ezetimibe/Atorvastatin) to Lower Cholesterol
Drug indicated as adjunct to dietary measures (May 3) - FDA Approves Wider Indication for Sustiva (Efavirenz) in HIV-Infected Pediatric Patients
Treatment can be used in infants as young as 3 months (May 3)
Agency Actions
- FDA Alert: Lack of Sterility Assurance for Drug Products From ‘The Compounding Shop’
Agency tells Florida firm to withdraw products from the market (May 8) - FDA Warning: Nonproprietary Name for Breast Cancer Drug Could Cause Medication Errors
Possible confusion between Kadcyla and Herceptin (May 6) - FDA Advisors Give ‘Thumbs Down’ to Renal Cancer Drug, Tivozanib
Additional safety data needed (May 2)
Health Care Reform
- Feds Make It Easier for States to Enroll Poor Under Health Law
About 13 million people expected to be added to Medicaid rosters next year (May 18) - Administration Allocates $1 Billion for ‘Health Care Innovation Awards’
HHS seeks new ideas for improving care and lowering costs (May 15) - Administration Offers Consumers a Look at Hospital Charges
Rates for inpatient services vary widely across the country (May 8) - Report: State Spending Could Have ‘Huge Impact’ on Implementation of Health Care Law
Marketplace enrollment off to rocky start (May 5)
