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IN THE PIPELINE

FDA approves first once-monthly injection to lower cholesterolFDA approved evolocumab (Repatha, Amgen) Pushtronex system, the first monthly single-dose injection of a PCSK9 inhibitor. Repatha was already approved by FDA as the only PCSK9 inhibitor with a monthly dose last August.
Top 4 ways US is combating opioid epidemic
Top 4 ways US is combating opioid epidemicExpanding access to buprenorphine, a medication to treat opioid use disorder, is one of several new actions announced by Health and Human Services (HHS) to combat the opioid epidemic. Here are the top 4 new provisions from HHS.
FDA approves cannabis-derived drugFor the first time, FDA approved dronabinol oral solution (Syndros, Insys Therapeutics), a liquid formulation of the pharmaceutical cannabinoid dronabinol, a pharmaceutical version of tetrahydrocannabinol ("THC").
The GOLD guidelines and COPD treatmentThe results of a study indicated that only 36% of COPD patients were prescribed treatment according to the GOLD guidelines. The patients that were on GOLD-recommended pharmacological therapy had a moderate improvement in symptoms and health resource utilization.
Cheaper hep C drug enters competitive market
Cheaper hep C drug enters competitive marketA new drug approved by FDA to treat chronic hepatitis C virus (HCV) infection this week enters a competitive, lucrative market headed up by Gilead Science’s Sovaldi and Harvoni, as well as AbbVie’s Viekira Pak. FDA granted priority review and breakthrough therapy designation to Gilead’s combination product, Epclusa (sofosbuvir 400 mg/velpatasvir 100 mg).
Zika vaccine on the horizonThe U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) plans to help bring a vaccine for the Zika virus to market immediately via Emergent BioSolutions Inc., which also developed the anthrax vaccine.
Patient navigators can benefit diabetes outcomesStudy seeks to determine whether significant improvement in glycemic control can be achieved when regular coaching is part of the process.
Empowered patients more likely to stick to diabetes treatmentsEmpowerment is an important factor to address everyday aspects of dealing with a chronic disease, including diabetes, according to a study that evaluated the effect of diabetes empowerment on medication adherence and self-care behaviors in adults with type 2 diabetes.
FDA approves rare liver disease drugFDA recently granted accelerated approval for obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc.) for the treatment of primary biliary cholangitis.
FDA approves first treatment for acute GVHDFDA just granted Breakthrough Therapy Designation for the first treatment for acute graft-versus-host disease (GVHD): ruxolitinib (Jakafi, Incyte Corp.).