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.
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.
In patients with moderate-to-severe chronic obstructive pulmonary disease (COPD), investigational indacaterol/glycopyrronium (QVA149) bromide significantly improved lung function compared to the single bronchodilators, according to data presented at the American Thoracic Society (ATS) International Conference in Denver, May 15 to 20.
FDA has joined nonprofit National Forum for Heart Disease and Stroke Prevention to advance the cause of a heart-healthy and stroke-free society in a first-of-its-kind cooperative public education program to reduce the burdens of heart disease and stroke.
Because of overuse and misuse, some antibiotics are losing effectiveness against highly resistant bacteria.
The FDA approved Eli Lilly’s Humalog 200 units/mL KwikPen (insulin lispro 200 units/mL; U-200), the company announced on May 27.
Among the many poster sessions being presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL, are several on the latest trials that are planned to evaluate potential treatment options for breast cancer. These trials include 1 phase 2 study and 3 phase 3 studies.
The FDA approved two new treatments to treat irritable bowel syndrome with diarrhea (IBS-D), Viberzi (eluxadoline) and Xifaxan (rifaximin), this week.
FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations
A significant spike in prescription drug costs helped drive healthcare costs for families covered under an average employer's health insurance plan up an estimated 6.3% in 2015, according to the Milliman Medical Index (MMI) report.
CVS Health’s acquisition of Omnicare for $12.7 billion is expected to significantly expand the drug chain’s business in specialty pharmacy, generics and long-term care.
This summer, Amgen and Regeneron Pharmaceuticals/ Sanofi will battle it out in the competitive cholesterol market. Repatha and Praluent, respectively, are expected to be approved by the FDA this summer.
