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PCSK-9 inhibitors achieve next milestone, plus 4 more FDA actions

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

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The 4 most problematic drug shortages

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.

Florida passes naloxone law

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.

Heartburn drugs linked to heart attacks

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.

FDA's Sentinel Initiative identifies drug safety problems

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 panel recommends approving Repatha, Praluent to lower cholesterol

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.

Combo therapy yields intriguing results in melanoma progression

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.

Continued advances in cancer outcomes unveiled at ASCO

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.

[BLOG]: Use and abuse of opioids: FDA responds

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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.

PCORI awards prison system $2M to study naltrexone benefit in opioid abuse

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.

Drug approved for rare, lung disease that strikes younger women

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.

Once-daily maintenance combo drug approved for COPD

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.

COPD fixed-dose combo enhances lung function

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.

Grassroots FDA partnership aims to reduce heart disease deaths

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.