Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact
Orphan Drug Profits vs. Patients: The Orphan Drug Act of 1983 was meant to encourage…
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Cracking Down on Orphan Drug Abuse: The ORPHAN Cures Act and Its Impact
Orphan Drug Profits vs. Patients: The Orphan Drug Act of 1983 was meant to encourage treatments for rare diseases, but…
Physician Enthusiasm for Novo’s Wegovy Suggests Swift Uptake in Rezdiffra-Dominated MASH Market
Recent surveys conducted by Spherix indicate a notable enthusiasm among physicians for Novo’s Wegovy, particularly in the context of the MASH (Metabolic Dysfunction-associated Steatotic Liver Disease) market, which is currently dominated by Rezdiffra. This enthusiasm is attributed to Wegovy’s mechanism of action, which appears to be well-suited for patients experiencing moderate disease manifestations. Gastroenterologists and […]
Zydus Therapeutics Secures Phase 2b/3 Victory in Liver Disease: A Strategic Move Against Gilead and Ipsen
Zydus Therapeutics has achieved a significant milestone with its phase 2b/3 trial success in treating primary biliary cholangitis (PBC), positioning itself as a formidable competitor to established players like Gilead Sciences, Intercept Pharmaceuticals, and Ipsen. This development not only enhances Zydus’ portfolio but also signals a potential shift in market dynamics for PBC treatments. With […]
BeOne Advances Sonrotoclax: A Potential Breakthrough in Rare B Cell Lymphoma Treatment
BeOne Medicines has announced promising topline results from its Phase 1/2 trial of sonrotoclax, a BCL2 inhibitor targeting a rare and aggressive form of B cell lymphoma. The candidate successfully met its primary endpoint, demonstrating a significant overall response rate, which positions it as a potential treatment option for patients with limited alternatives. The implications […]
Outlook’s Wet AMD Candidate Faces Second FDA Rejection
Outlook Therapeutics has received a second rejection from the FDA for its wet age-related macular degeneration (AMD) candidate, marking a significant setback in its pursuit of entry into the US retinal disease market. This follows a previous denial, prolonging the company’s wait for approval while it simultaneously seeks to expand its presence in the European […]
A New Dawn for GCA Treatment
In the realm of chronic autoimmune disorders, giant cell arteritis (GCA) has long been a formidable adversary. Patients have often faced a daunting journey, navigating the complexities of treatment options. But now, a significant breakthrough has emerged: Health Canada has issued a Notice of Compliance (NOC) for AbbVie’s Rinvoq (upadacitinib), heralding a new chapter in […]
Ongoing Cases
Britain’s Big Pharma Showdown: NHS Drug Levy Sparks £11 Billion R&D Exodus Threat
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
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
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
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
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
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
Connecting the Past and Future of Drug Development 505(b)(2): Towards the Future, While Reflecting the Past While…