Regulatory Trends in the US Pharma/Biotech Industry

Regulatory Trends in the US Pharma/Biotech Industry

Efficiency of the FDA Review Process Expedites Access to Care

RELEASE DATE
26-Feb-2015
REGION
Global
Deliverable Type
Market Research
Research Code: 9AB9-00-1C-00-00
SKU: LS00070-GL-MR_16911
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Description

This market insight provides an analysis of the regulatory trends occurring in the US pharma/biotech industry for 2014. Included in this deliverable is an analysis of the new molecular entities (NME) approved by the US Food and Drug Administration in 2014 and predictions for 2015. Trends are showing that the US Food and Drug Administration is moving towards greater efficiency and expedited review periods, which will lead to faster access to care.

Table of Contents

Key Findings

NME Trends Show a Significant Increase in Regulatory Filings and Approvals

Increase in Orphan Drug Approvals

Increase in First-in-class Designation

Most Approved NMEs Evaluated as an Expedited Review

High Number of First Cycle Approval Continues

Oral Therapies Continue Dominating the Pharma/Biotech Industry

NMEs Approved in 2014

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

NMEs Approved in 2014 (continued)

Frost & Sullivan Predictions for 2015

Legal Disclaimer

The Frost & Sullivan Story

Value Proposition: Future of Your Company & Career

Global Perspective

Industry Convergence

360º Research Perspective

Implementation Excellence

Our Blue Ocean Strategy

This research service focuses on existing therapeutics and product pipeline for the treatment of Parkinsons Disease using Dopamine Replacement Therapies, Dopamine Agonists, MAO-inhibitors, COMT-inhibitors and other pharamcolgical approaches for current global interest. This research service does not cover vaccines. A product and pipeline assessment is provided for marketed and investigational products and combination regimens for Parkinsons Disease therapeutics. Segmentation by drug class is provided along with additional supporting information such as clinical trial timelines and results, historical and projected launch timelines, and epidemiology.
More Information
Deliverable Type Market Research
No Index No
Podcast No
Author Jennifer Lazar
WIP Number 9AB9-00-1C-00-00
Is Prebook No