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Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact
Opinion Deep Dives Regulatory

Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact

August 23, 2025August 23, 2025
Orphan Drug Profits vs. Patients: The Orphan Drug Act of 1983 was meant to encourage…
Britain’s Big Pharma Showdown: NHS Drug Levy Sparks £11 Billion R&D Exodus Threat
Market Watch Opinion Regulatory

Britain’s Big Pharma Showdown: NHS Drug Levy Sparks £11 Billion R&D Exodus Threat

August 23, 2025August 23, 2025
LONDON, June 4, 2025 – A storm is brewing between the UK’s National Health Service…
Dirty Pills and Empty Shelves: How Outsourcing Broke America’s Drug Supply
Supply Chain Market Watch

Dirty Pills and Empty Shelves: How Outsourcing Broke America’s Drug Supply

August 23, 2025August 23, 2025
Imagine being told your chemotherapy is postponed because the only factory making the drug was…
When Trust Fails in Pharma: How Data Corruption in API Manufacturing Will Trigger a Billion-Dollar Investor Exodus in 2025–2026
Case Files Exposés

When Trust Fails in Pharma: How Data Corruption in API Manufacturing Will Trigger a Billion-Dollar Investor Exodus in 2025–2026

August 23, 2025August 23, 2025
In the high-stakes world of active pharmaceutical ingredient (API) manufacturing, where precision is paramount and…
Paper Cuts: Dossier Mistakes That Stopped Big Drugs Cold
Regulatory Case Files

Paper Cuts: Dossier Mistakes That Stopped Big Drugs Cold

August 22, 2025August 23, 2025
Introduction: Nothing stings quite like a regulatory refusal in the high-stakes world of drug development.…
Gaming Generic Drug Approvals: Legitimate Loopholes and Illicit Tactics
Deep Dives Regulatory

Gaming Generic Drug Approvals: Legitimate Loopholes and Illicit Tactics

August 22, 2025August 23, 2025
Introduction: Generic drugs and their global counterparts are meant to break monopolies and drive down…
Unmet Opportunities: Analyzing the FDA List of Drugs Without Approved Generics
Market Watch Signals

Unmet Opportunities: Analyzing the FDA List of Drugs Without Approved Generics

August 22, 2025August 23, 2025
The FDA’s Off-Patent, Off-Exclusivity Drugs without an Approved Generic list highlights pharmaceutical products that are…
505(b)(2): The Fast Track to Innovation in Pharma
Regulatory Deep Dives

505(b)(2): The Fast Track to Innovation in Pharma

August 22, 2025August 23, 2025
Connecting the Past and Future of Drug Development 505(b)(2): Towards the Future, While Reflecting the Past While…

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