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First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Europe Drug Review

Chikungunya Vaccine, Hemophilia B Gene Therapy Among 14 Products On Track For EU Approval

The EU is on track to get its first vaccine for preventing the disease caused by chikungunya virus. Thirteen other products have also been recommended for pan-EU approval. 

Europe Drug Review

Sandoz And Bio-Thera Get EU Nod For Bevacizumab

At its May meeting, the EMA’s CHMP has issued positive opinions for Sandoz and Bio-Thera’s Avzivi partnered biosimilar rival to Avastin, as well as five generics that included a trio of pomalidomide products.

Approvals Biosimilars

One Foot In The Door? Trio Look To Reenter Annulled EU Generic Tecfidera Market

A topsy-turvy legal battle going back some years led to a raft of Tecfidera generics being pulled from the market in December last year. Now, three of the affected companies are a step closer to reentering the market, which is set to remain a Tecfidera monopoly until February 2025.

Drug Review Generic Drugs
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