Pharmaceuticals, Biotechnology and Life Sciences
Janssen Biotech, Inc. and Janssen-Cilag International NV (Janssen) are seeking approval from the U.S. and European authorities for Chron’s disease drug Stelara.
Horizon Pharma and its affiliate, Horizon Therapeutics, has gotten the European Commission’s (EC’s) approval for Ravicti – glycerol phenylbutyrate – Oral Liquid for use as an adjunctive therapy for chronic management patients with six subtypes of Urea Cycle Disorders (UCDs).
Impax Laboratories has been granted by the European Commission (EC) authorization to market its Numient oral capsule formulation for the symptomatic treatment of adult patients with Parkinson’s disease.
Eli Lilly has gotten the U.S. Food and Drug Administration (FDA) approval for cancer drug Portrazza, which comes in a form of injection for intravenous use, 800 mg/50 mL, in combination with gemcitabine and cisplatin.
US FDA has given Lupin a go to market Blisovi Fe 1/20 Tablets and Blisovi 1.5/30 Tablets market generic versions of Warner Chilcott’s Loestrin Fe 1/20 Tablets and Loestrin Fe 1.5/30 Tablets.
Futura Medical, a transdermal technology specialist, has received by an European regulator clarity on the regulatory pathways for its two topical pain relief products, TPR100 (diclofenac) and TIB200 (ibuprofen).
European Commission has approved Switzerland-based Novartis’ Entresto tablets for treating adult patients with symptomatic chronic heart failure with reduced ejection fraction.
The U.S. Food and Drug Administration has approved Bristol-Myers Squibb-marketed Opdivo (nivolumab) to treat patients with advanced form of kidney cancer.
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil…
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.