A Two-Player Game
Two pharmaceutical companies, both headquartered in countries smaller than most American states, have built a competitive position in obesity and ...
The Bottleneck Is the Needle
A semaglutide molecule contains 31 amino acids assembled in a precise sequence with a fatty-acid side chain anchored at a ...
How To Strengthen Quality Control in Pharma Processes
Maintaining consistent product quality in pharmaceutical manufacturing is both a regulatory requirement and a patient safety imperative. For healthcare professionals ...
After the Shortage
When the FDA declared the semaglutide shortage resolved in February 2025 and the tirzepatide shortage resolved in October 2024, an ...
One Dose, Many Decades
Casgevy and Lyfgenia, the two FDA-approved gene therapies for sickle cell disease, list at $2.2 million and $3.1 million respectively, ...
The Orphan’s Inheritance
An orphan disease in 1983, when the legislation was drafted, was something close to a forgotten condition: a small patient ...
Importing the Reference
A drug priced at $400 in the United States and $80 in Germany is a shorthand the policy debate has ...
The Biosimilar That Wouldn’t
The first Humira biosimilar entered the European market in 2018. By 2020, the originator's market share had collapsed to roughly ...
The 340B Coalition
In 1992, when Congress created the 340B Drug Pricing Program as a quiet rider on a Veterans Affairs reauthorization, the ...
PBMs and the Theater of Reform
If a single legislative paragraph could expose the rebate that flows from a manufacturer to a plan sponsor through a ...
The Negotiated Price as Liability
On January 1, 2026, the maximum fair prices Medicare negotiated for ten of its costliest drugs will take effect, and ...
How Smart Kitchen Renovations Support Healthy Habits and Wellness
Healthcare professionals and wellness-minded patients often work hard to support patient wellness, yet daily food choices still get derailed by ...
FDA Evaluation of Certain Bulk Drug Substances in Compounding: Clinical Interpretation
Clinicians increasingly encounter patients using or requesting peptide-based therapies sourced through compounding pharmacies. The U.S. Food and Drug Administration has identified a subset of bulk drug substances, including certain peptides, that may present significant safety risks when used in compounded formulations. The clinical question is whether these regulatory signals reflect meaningful patient-level risk and how they should influence prescribing behavior. This matters because compounded peptides often sit outside traditional approval pathways, creating uncertainty around quality, dosing consistency, and safety. Understanding...
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