News

The Food and Drug Administration (FDA) and PatientsLikeMe will work together to determine how patient-reported data can give new insights into drug safety.

Infants and children who are given prescription acid-reducing medications face a substantially higher risk of developing Clostridium difficile infection, according to a study published recently in the online edition of Clinical Infectious Diseases.

Synergy Pharmaceuticals’ drug for chronic idiopathic constipation (CIC) has garnered very positive results in a phase 3 clinical trial, the company reported this week.

A large chunk of what insurers spend can be saved by improving medication adherence through medication therapy management done right.

Any day now, the Supreme Court will decide the highly anticipated King v. Burwell, which will determine the viability of a central mechanism of the Affordable Care Act.

Once-weekly dulaglutide is an effective treatment option for patients with type 2 diabetes who need to advance to injectable therapy, according to results from a Japanese study presented at the 2015 American Diabetes Association Scientific Sessions in Boston

A summary of five FDA actions taken within the last few weeks.

The FDA’s Pulmonary-Allergy Drugs Advisory Committee recently recommended approval of GlaxoSmithKline Plc's drug mepolizumab (Nucala) for severe asthma patients 18 and older.

Here are three ways to help your organization improve the patient experience through better communication between healthcare staff and patients.

FDA has issued a drug safety communication on GlaxoSmithKline's anti-seizure drug ezogabine (Potiga). Side effects of the the drug, which may include vision loss due to eye pigment change and skip discoloration, can be "adequately managed" by following the label, reports the FDA.

Here are six steps experts say are necessary for success as an accountable care organization (ACO).

FDA has approved eltrombopag (Promacta, Novartis) for the treatment of children aged 6 years and older with chronic immune thrombocytopenia.

FDA researchers are calling for greater transparency from drug companies when their drug is rejected by the agency, according to a study in the British Medical Journal.

Drug shortages are significant public health threats. They can delay, or even deny, critical care for patients. Here are the four drugs in shortage that are among the most problematic.

The FDA has granted breakthrough therapy designation to tocilizumab (Actemra, Genentech) for the treatment of systemic sclerosis, a rare and potentially life-threatening disease with no FDA-approved therapy.

This week, Florida Governor Rick Scott signed the Emergency Treatment for Opioid Overdose Act into law, allowing first responders to possess, store, and administer naloxone.

Ibrutinib may be a safe and potentially effective treatment for patients with chronic graft-versus-host-disease (cGVHD) who were refractory to steroid treatment or steroid-dependent, suggested interim data presented at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

Patients for Biologics Safety & Access (PBSA) sent a letter to FDA addressing safety concerns about final FDA guidance documents issued for biosimilars.

Suvorexant (BELSOMRA) was an effective and well-tolerated treatment of insomnia, according to a new study presented at SLEEP 2015 in Seattle, Washington.

Certain Protein-pump inhibitors (PPIs) such as omeprazole (Prilosec) are associated with a short-term risk of heart attacks and other cardiac events, according to a new study.

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.