CLINICAL

Cystic fibrosis drug approved for younger patientsFDA 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.
Aggressive blood sugar control slows diabetic eye disease progressionNIH-funded study shows less diabetic retinopathy progression among those who underwent intensive glycemic control.
Know these barriers to reduce type 2 diabetes costsIMS 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 HumiraFDA’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 diabetesFDA 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 patientsFDA 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 dystrophyEven 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 millionsFDA’s approval of a new biosimilar—the third FDA-approved biosimilar—stands to save the US healthcare system millions of dollars.
Cheaper generic EpiPen doesn't quiet criticsDespite offering a generic version of its EpiPen, Mylan has been unable to curb the backlash that began in late August over the cost of its epinephrine injection.
Abuse-deterrent opioid pain drug approvedFDA recently approved the only oxycodone with oral abuse-deterrent features.

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