Novartis

Rhizen Pharmaceuticals have entered into an exclusive, worldwide license agreement, with Novartis for the development and commercialization of Rhizen’s, inhaled dual PI3K - delta gamma inhibitor and its closely related compounds for  various indications.

Novartis announced  that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart.

The European Commission (EC) has approved Novartis' Cosentyx (secukinumab) for the treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). For AS, this is the first new treatment advance in 16 years since the development of the current standard of care, anti-tumour necrosis factor (anti-TNF) therapy.

Vital Therapies Inc, a biotherapeutic company developing ELAD, a cell-based therapy targeting the treatment of liver failure, announced that it has received written responses from the US FDA to its Type C meeting request on the planned VTL-308 phase 3 clinical trial.

Sandoz, a Novartis company and the global leader in biosimilars, announced  that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen's US-licensed Neulasta® (pegfilgrastim) - a recombinant human granulocyte colony-stimulating factor (G-CSF).