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.
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.
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.
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.
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.
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.
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.
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.
