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Orphan Drug
The Rise of Orphan Drugs
FDA Approval Summary
Orphan Drug Act and the Development of Products for Rare Diseases
Quantum of Effectiveness Evidence in FDA's Approval of Orphan Drugs
Orphan Drugs: Understanding the FDA Approval Process
Johnson & Johnson NAME of PERSON RELYING on EXEMPTION
Redesigning the Orphan Drug Act: Examining the Government’S Use of Subsidy and Exclusivity for Incentivizing Drug Development
Risk and Reward in the Orphan Drug Industry
Articles Article: Non-Statin Treatments for Managing LDL Cholesterol and Their Outcomes Download
50-718/S-019
SOLIRIS® (Eculizumab) As a Treatment for Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD).” Alexion Pharmaceuticals, Inc, 22 Feb
Cerenis Therapeutics Receives EMA Orphan Drug Designation for CER- 001 for the Treatment of Apaoa-I and ABCA-1 Deficiencies
Soliris® (Eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Myasthenia Gravis
Orphan Drug Designations and Approvals List As of 06‐02‐2014 Governs July 1, 2014 ‐ September 30, 2014
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common
Orphan Drug Designation for Pancreatic Cancer
Insights Into Rare Disease Drug Approval: Trends and Recent Developments
A CRITICAL INCENTIVE – NOT a BARRIER! How IP Incentives Spur Biopharmaceutical Innovation and the Creation of New Health Technologies SECTION
Top View
Robbing the Cradle: the Implications of Depleting Financial Incentives For
Download the Issue Brief (PDF)
Oncologic Orphan Drugs Approved in the EU – Do Clinical Trial Data Correspond with Real-World Effectiveness? Yvonne Schuller1*, Marieke Biegstraaten1, Carla E
Soliris® (Eculizumab) Granted Orphan Drug Designation in Japan for the Treatment of Patients with Neuromyelitis Optica
Orphan Drugs in the United States
Orphan Drugs in the United States Exclusivity, Pricing and Treated Populations Introduction
Tax Policy and Pharmaceutical Innovation
Orphan Drug Tax Credit on Treatments for Rare Diseases
December 2020
Accelerating Astrazeneca's Strategic and Financial Development
Media Update
CY 2014 CDER Rare Disease and Orphan Drug Designated Approvals
How Pharmaceutical Companies Can Capture Value in the Orphan Drug
Symphogen and Swedish Orphan Biovitrum Receive U.S. Orphan Drug Designation for Rozrolimupab in ITP
July 28, 2021
Download the Orphan Drug Report 2020
TAG Mail – 17 Dec 2020
Orphan Drugs: FDA Could Improve Designation Review Consistency
Rare Disease and Clinical Trials
Eltrombopag Induced Myelofi- Tablished
Office of Orphan Products Development: Financial Incentives for CDER Medical Products
FDA Approves Soliris® (Eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (Gmg)
The Orphan Drug Act Implementation and Impact
The Case of Eculizumab: Litigation and Purchases by the Brazilian Ministry of Health
What Drives Innovation? Lessons from COVID-19 R&D
Statins Overview of Drug Class
Vaccinating the World Waiving Intellectual Property Rules on COVID-19 Products
Orphan Drug Report 2019
Meeting the Need: Rare Diseases and the Orphan Drug Act Overview
Developing and Paying for Medicines for Orphan Indications in Oncology: Utilitarian Regulation Vs Equitable Care?
ORPHAN DRUGS in the UNITED STATES: an Examination of Patents and Orphan Drug Exclusivity a NORD® Commissioned Report with Avalere®
Orphan Drugs in the United States Providing Context for Use and Cost
Selumetinib Granted Orphan Drug Designation in Japan for Neurofibromatosis Type 1
The Most Expensive Drug in the World: to Continue Or Discontinue, That Is the Question
ITP Immune Thrombocytopenia
Medicines in Development ꟷ Infectious Diseases