Clinical News

New drug indication could net more than $1 billionFDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Breast cancer biosimilar shows equivalency to brand
Breast cancer biosimilar shows equivalency to brandTwo new major studies on a biosimilar to trastuzumab (Herceptin, Genentech) to treat HER2-positive metastatic breast cancer and HER2-positive gastric cancer demonstrated equivalency.
FDA approves 2 injectable diabetes drugsTwo new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
Multidrug-resistant HIV drug on the horizonAfter a successful phase 3 study, a breakthrough therapy to treat multi-drug resistant (MDR) HIV-1 is expected to launch in the United States in 2017.
Novel drug reduces monthly migraine daysA global phase 3 study of erenumab (Amgen and Novartis) showed that the drug was able to prevent migraines headaches.
Gilead promises generic versions of new hepatitis drugAfter Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.
Breakthrough lymphoma drug on the horizonFDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
Insulin makers accused of price collusionU.S. congressmen last week asked the Department of Justice and the Federal Trade Commission to investigate three insulin makers for price collusion—the latest in concerns over insulin prices.
First olmesartan generics approved for hypertensionIn a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).
Statin prescribing varies in patients with diabetesWide variation exists in practice-level statin prescribing for patients with diabetes, according to a new study.