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.
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
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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.
| Deliverable Type | Market Research |
|---|---|
| No Index | No |
| Podcast | No |
| Author | Jennifer Lazar |
| WIP Number | 9AB9-00-1C-00-00 |
| Is Prebook | No |
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
26-Feb-2015
REGION
Global
Global
Deliverable Type
Market Research
Market Research
Research Code: 9AB9-00-1C-00-00
SKU: LS00070-GL-MR_16911
$1,500.00
In stock
SKU
LS00070-GL-MR_16911