Wednesday, 15 August 2018 - 6:52
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CHMP – Committee for Medicinal Products for Human Use

Psoriasis: positive opinion in Europe on Almirall’s Skilarence

EMA Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending a marketing authorization for Almirall’s Skilarence, for the treatment of psoriasis. The product will be available as 30-mg and 120-mg gastro-resistant tablets. Its active ingredient…

CHMP: green light to Sanofi/Regeneron’s Kevzara for rheumatoid arthritis

Sanofi and Regeneron Pharmaceuticals have announced that EMA CHMP has adopted a positive opinion for the marketing authorization of Kevzara (sarilumab), recommending its approval for the treatment of adult patients with moderate-to-severe rheumatoid arthritis. Kevzara is a monoclonal antibody whose…

CHMP: OK to Biogen’s Spinraza for SMA

Biogen has announced that EMA CHMP has adopted a positive opinion on Spinraza (nusinersen) for the treatment of SMA (spinal muscular atrophy). The Agency has reviewed the product under its accelerated assessment program, designed to facilitate access to medicines likely…

CHMP, positive opinion on Pfizer’s Trumenba

EMA CHMP adopted a positive opinion to grant a marketing authorization for Pfizer’s Trumenba. The product is intended for prophylaxis against group B meningococcal infections. It will be available as a suspension for injection. The active substances of the product…

CHMP, green light for Intercept’s Ocaliva

EMA CHMP has adopted a positive opinion to grant a conditional marketing authorization to Intercept Pharma’s Ocaliva (obeticholic acid) for the treatment of primary biliary cirrhosis. Ocaliva has been granted Orphan Drug Designation in July 2010. It will be available…