Advanced Medical Optics, Inc.
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Latest From Advanced Medical Optics, Inc.
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.
Final Funding Blow For J&J’s Spravato In England, Despite Reimbursement In 26 Other Countries
J&J says it has “exhausted all current viable avenues” to get its antidepressant nasal spray Spravato reimbursed on England’s National Health Service, after NICE decided against re-appraising the drug following numerous funding rejections.
EU’s Innovative Drug Approval Tally Shows Sharp Decline
The numbers may be down, but Europeans will in future be able to gain access to a number of highly innovative medicines, including several products for hard-to-treat cancers, a gene therapy for severe and moderately severe hemophilia B, and two vaccines against disease caused by respiratory syncytial virus.
EMA Turns Down Minoryx’s Orphan Drug Nezglyal & Apellis’ Syfovre, OKs Three Others
The European Medicines Agency has recommended against the pan-EU marketing approval of two new medicines, while three others received positive opinions on marketing authorization.
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