DEA slashes opioid drug production October 09, 2016 By Christine Blank The US Drug Enforcement Administration (DEA) has reduced the amount of almost every Schedule II opiate and opioid medication that may be manufactured in the US by 25% or more. Cystic fibrosis drug approved for younger patients October 02, 2016 By Christine Blank FDA recently expanded the use of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals) to treat cystic fibrosis in children aged 6 to 11 years who have two copies of the F508del mutation. First "artificial pancreas" for diabetes approved, plus 2 more FDA actions September 28, 2016 By Christine Blank FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals. Aggressive blood sugar control slows diabetic eye disease progression NIH-funded study shows less diabetic retinopathy progression among those who underwent intensive glycemic control. Know these barriers to reduce type 2 diabetes costs IMS Health study: Up to 15% of healthcare system costs avoidable and effective patient activation by multiple stakeholders is key to driving improvement. FDA approves biosimilar to Humira September 25, 2016 By Christine Blank FDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month. Invokamet extended-release approved for diabetes September 25, 2016 By Christine Blank FDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014. New drug approved for heart patients September 18, 2016 By Christine Blank FDA approved once-daily Yosprala (Aralez), a fixed-dose combination of aspirin, an anti-platelet agent and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.Here are the top 5 facts to know about Yosprala. FDA approves first drug for Duchenne muscular dystrophy September 18, 2016 By Christine Blank Even though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September. New biosimilar for RA to save millions September 07, 2016 By Christine Blank FDA’s approval of a new biosimilar—the third FDA-approved biosimilar—stands to save the US healthcare system millions of dollars.