The FDA's Sentinel Initiative uses big data and broad networks to detect and respond to risks associated with prescription drugs. In the June 4th Health Affairs' Health Policy Brief, the FDA describes how the Sentinel Initiative improves on the FDA's Adverse Event Reporting System (FAERS) database.
FDA’ s Endocrinologic and Metabolic Drugs Advisory Committee recommended this week to approve cholesterol-lowering drug evolocumab (Repatha) from Amgen in a 15-0 vote. It also voted 13-3 in favor of FDA approving Sanofi and Regeneron's Praluent (alirocumab), but most panel members called for a restricted label in high-risk patients with genetic conditions causing elevated cholesterol, rather than wider use in the general elevated cholesterol population.
The Healthcare Supply Chain Association (HSCA) recently sent a letter to FDA urging timely implementation of the remaining provisions of the Generic Drug User Fee Amendment (GDUFA).
Earlier this year, the Obama Administration announced a 5-year plan to combat antibiotic resistance. The Forum on Antibiotic Stewardship was created to meet this "growing public health threat" and to reduce the misuse of antibiotics.
CVS Health is integrating HHS' Healthfinder.gov app into its web space under the name myHealthFinder.
The real value of population health management lies not in the data it generates but in the interventions it drives, according to Jay Rajda, MD., medical director of Aetna's Innovation Lab.
FDA has expanded the indication for topiramate (Qudexy XR, Upsher-Smith Laboratories) extended-release capsules within the pediatric population.
Results of a new study on combination drugs used to treat melanoma were presented at the 2015 American Society of Clinical Oncology meeting in Chicago. Researchers showed that a combination of ipilimumab and nivolumab stopped the advancement of melanoma for nearly a year in 58% of cases.
FDA’s approval of the first generic version of Copaxone for treating patients with relapsing forms of multiple sclerosis has industry insiders contemplating the impact on the generics market as well as payer coverage strategies.
Leading cancer drugs reduced the risk of death by half for people with lung cancer and assisted patients with HER2-positive breast cancer live longer without the disease recurring. The findings were just two of the numerous important study results presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, Ill., this week.
Here are 10 things managed healthcare executives should know about cloud computing and how it could impact their organizations.
Organizations that want to achieve deal success should try to focus on three areas: planning, organizational change, and target management.
Payers and providers must consider the key differences between two consolidation models: "horizontal consolidations" and "vertical consolidations." Here's why.
AHIP presentation: What should payers and providers be doing with all of the data they are collecting?
The FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.
In this blog post, David Calabrese RPh, MHP and Andrea Marks, MS discuss Catamaran's research on opioid abuse. Catamaran is concerned about opioid misuse and is moving forward with plans to combat opioid abuse.
In patients with advanced squamous cell carcinoma (SCC), afatinib significantly improved overall survival (OS) compared to erlotinib, according to data presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Waivers offer states an opportunity to expand programs beyond traditional services, giving them greater flexibility and innovation in care delivery and payment models.
The Patient-Centered Outcomes Research Institute (PCORI) recently awarded more than $2 million to the University of Pennsylvania for research on opioid addiction treatment and relapsing in the Philadelphia Prison System. The study assesses the effectiveness of naltrexone to prevent relapse.
FDA approvals for the first week of June 2015.
Mobile health (mhealth) has many benefits for patient care, but lack of oversight and regulatory concerns could raise problems.
Managed healthcare executives can set the table for future economic expansion of interoperability capabilities by following a few simple, straightforward tips.
The National Association of Insurance Commissioners recently released “guidance” on cybersecurity. Here's what healthcare executives should know.
Lymphangioleiomyomatosis (LAM) is a rare, progressive lung disease that primarily affects women of childbearing age. The FDA has approved sirolimus (Rapamune, Pfizer) as the first drug to treat LAM. Rapamune was originally approved to prevent organ rejection.
FDA approved once-daily tiotropium bromide and olodaterol (Stiolto Respimat, Boehringer Ingelheim) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Sarilumab may be an effective option for patients with moderately-to-severely active rheumatoid arthritis (RA) according to topline results from a new study.
Because lung function can be substantially reduced by the time most chronic obstructive pulmonary disease (COPD) patients first see a physician, maintenance treatment should be considered at the time of diagnosis, according to new data analyses presented at the American Thoracic Society (ATS) 2015 International Conference.
The Centers for Medicare and Medicaid Services recently instituted a billing code that finally reimburses providers separately for non-face-to-face services.
Rather than reducing unnecessary, preventable emergency department visits, some healthcare experts say the Affordable Care Act has actually caused them to increase.
