Search Results for Orphan Designation

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EMA Backs Six Drugs, One Biosimilar for EU Approval By Michael Mezher - Published 10 November 2017

The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval.

Categories: News, Europe, EMA, Biologics and biotechnology, Drugs, Submission and registration

Tags: Marketing Authorization Applications, CHMP, Accelerated Assessment, Orphan Designation, Biosimilar, Jorveza, Prevymis, Ocrevus, Adynovi, Fasenra, Intrarosa, Mvasi

FDA Plots Elimination of the Orphan Drug Designation Request Backlog By Zachary Brennan - Published 29 June 2017

With a flood of new orphan drug designation requests, the US Food and Drug Administration (FDA) on Thursday released its new plan to eliminate the backlog of requests in 90 days and to respond to 100% of all new orphan drug designation requests within 90 days.

Categories: News, US, FDA, Drugs, Government affairs, Orphan products, Regulatory intelligence, Regulatory strategy

Tags: orphan drug, orphan medical product, orphan designation, orphan designation backlog

European Commission Clears up Questions on Orphan Drug Regulation By Michael Mezher - Published 05 January 2017

Following a public consultation in November 2015, the European Commission (EC) has released a new communication intended to clarify some lingering questions about the EU's Orphan Regulation.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products

Tags: Orphan Regulation, Orphan Drugs, Orphan Designation

Report: Competition Quickly Follows First-In-Class Approvals By Michael Mezher - Published 03 November 2015

By the time "first-in-class" drugs receive marketing approval in the US, nearly all later iterations of those products have begun clinical testing or filed a new drug application with the US Food and Drug Administration (FDA), according to a new study by Tufts Center for the Study of Drug Development.

Categories: News, US, FDA, Biologics and biotechnology, Clinical, Drugs, Orphan products, Regulatory strategy, Research and development

Tags: First-in-class, Marketing approval, Priority review, Orphan designation

EMA Wants to Help Drugmakers Show Their Orphan Products' Benefits By Michael Mezher - Published 04 September 2015

The European Medicines Agency (EMA) is looking help sponsors developing new orphan drugs by clearing up questions on how they can demonstrate their product's improvement over existing therapies.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products, Research and development, Submission and registration

Tags: Orphan products, Orphan designation

Orphan Drugs in the EU: A Record-Breaking Year By Michael Mezher - Published 13 January 2015

The European Medicines Agency (EMA) recommended 17 drugs with orphan product designation for approval in 2014, the most ever in a single year.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Orphan products, Submission and registration

Tags: Orphan Drugs, Rare Disease, Orphan Designation, COMP, Orphan Product Designation