News Gilead rescinds orphan status request for COVID-19 drug Gilead has rescinded its request for orphan status for its potential COVID-19 antiviral remdesivir amid a furore over its pricing should it get to market.
News Shire plans filing for HAE drug after phase 3 success Lanadelumab could revolutionise treatment of swelling disease.
News EUSA Pharma approval fills gap in neuroblastoma market Company can move in after United Therapeutics withdrew its product Unituxin
News EU regulators back two more orphan drugs, question of pricin... Two orphan medicines are heading towards the European market, after regulators recommended rare disease drugs from Biogen and BioMarin.
News Novartis and Allergan to combine drugs in NASH Swiss pharma also aims for new CAR-T therapy indication.
News FDA names a new CDER director, choosing a biotech vet The FDA has rounded out its senior leadership by naming biopharma industry executive George Tidmarsh to the role of CDER director.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face