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Drug Approvals

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Latest From Approvals

Clovis Confident, Portola Not: CHMP Decides On EU Marketing Applications

Eight EU marketing authorization applications are up for an opinion this week from the CHMP, the European Medicines Agency committee that recommends whether or not products should be approved.

Drug Review Approvals

The Sarepta Precedent: The Good, The Bad, And The Ugly

Podcast discussion of three broader precedents stemming from US FDA's original Exondys 51 approval.

Drug Approval Standards FDA

US Launch Of Sensipar Generics May Await Patent Case Even After FDA Approval

Aurobindo remains embroiled in litigation with Amgen on a Sensipar formulation patent, while Cipla settled ahead of  bench trial. Generic firms won approval of cinacalcet generics after two federal courts denied Amgen's emergency request for an injunction in dispute with FDA over pediatric exclusivity.

Generic Drugs Pediatrics

GC Pharma/Biocon Eye Low Price Strategy As Biosimilar Insulin Glargine Approved In Korea

GC Pharma/Biocon are set to adopt a low price strategy for their biosimilar insulin glargine, which has just received regulatory approval in South Korea, to better compete with rival products.

Approvals Biosimilars

Seven New Drugs Approved In EU In First Two Months of 2018

Seven products containing a new active substance were approved in Europe in the first two months of 2018: Shire's Adynovi and Roche/Chugai's Hemlibra for hemophilia A, Roche's Ocrevus for multiple sclerosis, Kyowa Kirin's Crysvita for hypophosphatemia, AstraZeneca's Fasenra for asthma, Novo Nordisk's Ozempic for diabetes, and MSD's Prevymis for prophylaxis of cytomegalovirus infection.
Approvals Europe

European CHMP Opinions And MAA Updates

A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Performance Tracker Approvals
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