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FDA grants priority review to expand use of Brilinta

The FDA has granted Priority Review for ticagrelor (Brilinta, AstraZeneca) for patients with a history of heart attack.

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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.

Breast cancer drug research roundup from ASCO

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.

FDA approves 2 new IBS-D treatments

The FDA approved two new treatments to treat irritable bowel syndrome with diarrhea (IBS-D), Viberzi (eluxadoline) and Xifaxan (rifaximin), this week.

FDA drug approvals-May 2015

FDA actions in brief, complete response, breakthrough therapy designation, fast-track designations, orphan drug designations

High healthcare costs driven by spike in Rx costs

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.

Battle of the cholesterol drugs expected

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.

Harvoni could save US, Europe $3.2 billion

The higher cure rate of treating hepatitis C patients with a combination of ledipasvir and sofosbuvir (Harvoni) led to substantially better work productivity, according to a new study. In fact, improved work productivity and lack of absenteeism could save the United States and 5 European countries more than $3.2 billion a year.

J&J-Achillion partner to develop hep C drugs

Johnson & Johnson is expanding its reach in the lucrative hepatitis C drug market after announcing it will collaborate with Achillion Pharmaceuticals to develop its HCV drugs.

Biosimilars need better labeling: Physicians

In FDA's 2012 Draft Guidance on Biosimilars, the Agency called for "labeling of a proposed product to include all the information necessary for a health professional to make prescribing decisions," including clear statements of a product's approval as a biosimilar to a reference product and whether or not it has been determined to be interchangeable.

Hep C patient sues Blue Cross for denying Harvoni coverage

A Hepatitis C patient is suing Blue Cross because the payer will not cover her Harvoni medication. According to the complaint, filed this week in Los Angeles Superior Court by Shernoff Bidart Echeverria Bentley LLP, Blue Cross has arbitrarily chosen to give the treatment only to those patients suffering from the worst stages of liver damage.

SGLT2 inhibitors for diabetes may cause ketoacidosis, FDA warns

The FDA is warning that the type 2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization.

Economist: $37 billion needed to combat “superbugs”

Global pharmaceutical manufactures need to invest billions of dollars to prevent antibiotic-resistant “superbugs”, according to Jim O’Neill, an economist leading a UK government review into antimicrobial resistance.