Category: Approval

May 23, 2017 Off

Sanofi and Regeneron win FDA approval for its rheumatoid arthritis drug

By Dino Mustafić

The U.S. Food and Drug Administration (FDA) has approved Sanofi’s and Regeneron Pharmaceuticals’s Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX).

May 19, 2017 Off

100 Healthy Years – Are Kids Prepared?

By Dino Mustafić

Merck, one of the worlds most renown science and technology companies, summoned experts from worlds organizations such as UN, UNICEF, UNAIDS, World Obesity Federation and McKinsey at the the company’s headquarters in Darmstadt, Germany, to discuss questions about the most urgent threats to our children’s long-term health, or what can be done both inside and outside the classroom? And how do schools, parents and communities share responsibility?

May 19, 2017 Off

Arix bags $65 million in a B series investment round

By Dino Mustafić

Arix Bioscience on Friday said that its new business group, Iterum, has raised $65 million by closing a Series B investment round. “Arix is delighted to have led this $65m funding round comprising many of the biotech sector’s leading specialist investors,” said…

May 18, 2017 Off

FDA OK’s Vertex’s cystic fibrosis drug

By Dino Mustafić

U.S. Food and Drug Administration (FDA) has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

May 17, 2017 Off

Sobi’s hereditary tyrosinemia drug approved in Saudi Arabia

By Dino Mustafić

The Saudi Food and Drug Administration (SFDA) has approved Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone) capsules in all strengths (2 mg, 5 mg, 10 mg and 20 mg) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.