Orphan Drug Exclusivity - Pharma

Relevant Publications

Repurposing of rituximab biosimilars to treat B cell mediated autoimmune diseases.

Issue Release: 2024

Orphan drug policy analysis in China.

Issue Release: 2024

\'Totality of Evidence\' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.

Issue Release: 2024

Analysis and comparative evaluation of expedited programs for gene therapy products: insights from the United States, the European Union, Japan, and South Korea.

Issue Release: 2024

THE CARDINAL TRIAL OF BARDOXOLONE METHYL IN ALPORT SYNDROME: WHEN MARKETING INTERESTS PREVAIL OVER PATIENTS CLINICAL NEEDS.

Issue Release: 2023

Catalyst Pharms., Inc. v. Becerra: When the Food and Drug Administration Repeatedly Ignores the Plain Language of the Orphan Drug Act (ODA).

Issue Release: 2023

Why Does the Inflation Reduction Act Exclude Expensive Cancer Treatments in Price Negotiations?

Issue Release: 2023

Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.

Issue Release: 2023

Exploring the Potential Challenges for Developing Generic Orphan Drugs for Rare Diseases: A Survey of US and European Markets.

Issue Release: 2023

Orphan drug development in alpha-1 antitypsin deficiency.

Issue Release: 2022

Approvals and Timing of New Formulations of Novel Drugs Approved by the US Food and Drug Administration Between 1995 and 2010 and Followed Through 2021.

Issue Release: 2022

Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies.

Issue Release: 2022

Incentives to promote the US pharmaceutical innovation: empirical research based on the case of Epogen.

Issue Release: 2021

Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union.

Issue Release: 2021

A review of the experience with pediatric written requests issued for oncology drug products.

Issue Release: 2020

Effective Market Exclusivity of New Molecular Entities for Rare and Non-rare Diseases.

Issue Release: 2020

Market Exclusivity for Drugs with Multiple Orphan Approvals (1983-2017) and Associated Budget Impact in the US.

Issue Release: 2020

A crisis in US drug pricing: Consequences for patients with neuromuscular diseases, physicians and society, part 1.

Issue Release: 2020

Predictors of orphan drug coverage restrictions in Medicare Part D.

Issue Release: 2020

Rising Drug Costs for Neurologic Diseases.

Issue Release: 2020

What Education and Training Do Pharmacists Need?

Why is Transitional Care Important in Pharma?

How are ADEs Detected and Reported?

What is Geriatric Care in Pharma?

What are the Phases of Clinical Trials?

What are the Key Challenges?

What Roles Do Pharmacists Play in Pharma?

What Challenges Exist in Patient Education?

What are Chronic Conditions?

What is an Abbreviated New Drug Application (ANDA)?

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