Sage’s drug meets phase 3; Blocking 2 key pathways help in tackling TNBC; FDA clears Paragonix; FDA gives a nod

The oral depression drug of Sage Therapeutics meets phase 3 efficacy

A phase 3 trial of oral treatment of Sage Therapeutics for postpartum depression (PPD) has hit its primary endpoint. The drug, SAGE-217, showed significant improvements on a depression score and saw no fainting cases. SAGE-217 is an allosteric modulator of GABAA receptors. A phase 3 trial of SAGE-217 indicates the convenience has not come at the cost of safety or efficacy. A number of women with severe PPD, SAGE-217 surpassed placebo against multiple measures of depression, including the Hamilton Rating Scale for Depression (HAMD-17) score.

Blocking 2 key survival pathways help in tackling triple-negative breast cancer

Triple-negative breast cancer (TNBC) is the most difficult disease to treat because it lacks estrogen and progesterone receptors and it doesn’t over-express HER2, which make it insensitive to targeted treatments. A team of researchers led by Princeton University has evidence regarding a recombinant protein that could block two pathways triple-negative cancer cells. The treatment is Tinagl1.

FDA clears pediatric donor heart transport system of Paragonix

The FDA has cleared a new insulated organ transport system designed for guiding small and pediatric hearts from donors to transplant recipients. The latest version- SherpaPak of Paragonix Technologies, Cardiac Transport System includes connectors covering most aorta sizes that allow both adult and pediatric hearts to be carried in its proprietary suspension system.

FDA gives a nod to integrated digital rescue inhaler of Teva

Teva Pharmaceutical Industries got approval from FDA for patients with asthma and chronic obstructive pulmonary disease. It is equipped with built-in sensors and a fully integrated digital inhaler. Its ProAir Digihaler, containing albuterol sulfate, connects to a companion smartphone application to track medication usage.