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Yeliva receives FDA orphan drug status for cholangiocarcinoma

07-04-2017 10:29 AM CET | Health & Medicine

Press release from: Kuick Resarch

Yeliva receives FDA orphan drug status for cholangiocarcinoma

US Food and Drug Administration has granted orphan drug designation to Yeliva a first-in-class, orally administered, sphingosine kinase-2 selective inhibitor with anticancer and anti-inflammatory activities, for the effective treatment of cholangiocarcinoma. The drug is developed by RedHill Biopharma. The investigation suggested that the drug is well endured and can be safely administered to patients suffering from the disease. The action of mechanism for Yeliva includes circulation in the patient’s body to create a therapeutic activity.

Presently, the company is planning to investigate the drug under Phase1b clinical study as a radio protectant for the prevention of mucositis in patients with head and neck cancer undergoing therapeutic radiotherapy, as well as a phase 2 study of the drug to treat patients with moderate to severe ulcerative colitis.

FDA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such as incentives to the developing company. These benefits include market exclusivity for the marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.

“Global Orphan Drug Clinical Pipeline Insight 2022” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.

For Report Sample Contact: neeraj@kuickresearch.com or +91-11-47067990

Report Table of Contents

1. Introduction to Orphan Drug

2. Favorable Market Dynamics for Orphan Drugs Commercialization
2.1 Economic Viability
2.2 Drug Patent Expiry
2.3 Financial & Non-Financial Incentives
2.4 Patent & Market Exclusivity
2.5 R&D Investment

3. Global Orphan Drug Market Overview

4. Global Orphan Drug Market Segment Analysis
4.1 Biological & Non-Biological Orphan Drugs
4.2 Therapeutic Segmentation
4.3 Regional Segmentation

5. Global Orphan Drug Clinical Pipeline Overview

6. US Orphan Drug Market Overview
6.1 Orphan Drug Designation Criteria
6.2 Market Overview
6.3 Reimbursement Policy

7. Europe Orphan Drug Market Overview
7.1 Orphan Drug Designation Criteria
7.2 Market Overview
7.3 Reimbursement Policy

8. Asia Orphan Drug Market Overview
8.1 Orphan Drug Designation Criteria
8.2 Market Overview
8.3 Reimbursement Policy


9. FDA Regulation for Clinical Trials Orphan Designated Drugs
9.1 Content & Format of a Request for Written Recommendations
9.2 Provision for Granting & Refusing Written Recommendations
9.3 Content and Format of a Request for Orphan Drug Designation
9.4 Verification of Orphan Drug Status & Resident Agent for Foreign Sponsor
9.5 Timing of Requests for Orphan Drug Designation & Designation of Already Approved Drugs
9.6 Deficiency Letters and Granting Orphan Drug Designation
9.7 Refusal to Grant Orphan Drug Designation
9.8 Amendment & Change in Ownership to Orphan Drug Designation
9.9 Publication & Revocation of Orphan Drug Designations
9.10 Annual Reports of Holder of Orphan Drug Designation
9.11 Scope & FDA Recognition of Orphan Drug Exclusive Approval
9.12 Protocols for Investigations & Availability of Information

10. EMA Regulations for Clinical Trials of Orphan Designated Drugs
10.1 Committee for Orphan Medicinal Products
10.2 How to Apply for Orphan Designation in Europe
10.3 Marketing Authorization & Market Exclusivity
10.4 Transferring an Orphan Designation to another Sponsor
10.5 Mandatory Submission of Annual Report On Development
10.6 Incentives for Micro, Small and Medium-Sized Enterprises
10.7 Fee Reductions for Designated Orphan Medicinal Products
10.8 Procedure for Orphan Designation & Incentives for R&D (Regulation (EC) No 141/2000)

11. Asian Regulations for Clinical Trials of Orphan Designated Drugs
11.1 Taiwan Rare Disease and Orphan Drug Act
11.2 Japan Orphan Drug Regulation

12. Global Orphan Drugs Clinical Pipeline Insight & Patent Analysis by Company, Country, Indication & Phase
12.1 Unknown
12.2 Research
12.3 Preclinical
12.4 Clinical
12.5 Phase-I
12.6 Phase-I/II
12.7 Phase-II
12.8 Phase-II/III
12.9 Phase-III
12.10 Preregistration
12.11 Registered

13. Marketed Orphan Drugs Clinical Insight & Patent Analysis by Company, Country & Indication

14. Discontinued & Suspended Orphan Drugs in Clinical Trials
14.1 No Development Reported
14.2 Discontinued
14.3 Preregistration-Submission Withdrawal
14.4 Market Withdrawal
14.5 Suspended

15. Competitive Landscape
15.1 AOP Orphan
15.2 Agenus
15.3 Alexion
15.4 Bristol Myers Squibb
15.5 Biogen Idec
15.6 Celgene
15.7 Eli Lilly
15.8 Genethon
15.9 Genzyme Corporation
15.10 Glaxosmithkline
15.11 Merck
15.12 Novartis Pharmaceuticals
15.13 Orphan Europe
15.14 Pfizer
15.15 Prosensa
15.16 Rare Disease Therapeutics
15.17 Roche
15.18 Sanofi
15.19 Shire
15.20 Teva Pharmaceutical

Download Report: https://www.kuickresearch.com/page-Pharmaceutical%20and%20Healthcare.php

Kuick Research is a market research and analytics company that provides targeted information for critical decisions at business, product and service levels. We are quick, predictive and known by the recommendations we have made in the past. Our result-oriented research methodology offers understanding of multiple issues in a short period of time and gives us the capability to keep you full with loads of practical ideas. By translating research answers into strategic insight and direction, we not only rate the success potential of your products and/or services, but also help you identify the opportunities for growth in new demographies and find ways to beat competition.

Neeraj Chawla
neeraj@kuickresearch.com
KuicK Research
Avanta Business Center 4th Floor,
Statesman House Barakhamba Road,
Connaught Place New Delhi – 110 001, India
+91-11-47067990

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