The FDA’s Public Accusation Against uniQure Is a Precedent-Setting Threat to Scientific Dialogue
The FDA just accused a sponsor of pushing distorted data to conceal a failed gene therapy — publicly, on...
Why 2026 is the Best of Times for Big Pharma and the Worst of Times for Biotech
In Washington, the ink was barely dry on a landmark domestic manufacturing deal for Pfizer. In San Diego, a...
The $1.3 Trillion Cannibal: Why 2026 is the Year of Big Pharma’s Great Buffet
The mid-sized oncology biotech firm was blindsided. After three years of aggressive expansion and a pipeline bolstered by the...
Why Most Drug Launch Strategies Fail Before Phase III
The leadership team thought they were ahead of their drug launch schedule. Phase II data were in. The mechanism...
Europe Has World-Class Biotech Science. This Is the Law Admitting Everything Else Is Broken.
The company had done everything right. Strong translational science. Clean Phase 2 data. Positive scientific advice from the EMA....
Can Biotechs Ever Be Free of Big Pharma? Inside the Thought Experiment That’s Reshaping R&D
I’ve been asking myself a question that’s almost heretical in this industry. Could biotechs ever be free of Big...
Why Pharma AI Pilots Fail — And How Medical Affairs & Commercial Can Actually Win
At first glance, it looks like a paradox: pharma companies pour billions into AI pilots, and yet the success...
The OTC System That Let Safety Risks Linger for a Decade — And the FDA’s Quiet Move to Fix It
In 2023, more than 300 children died across multiple countries—Gambia, Uzbekistan, and Cameroon—after taking contaminated cough syrup. The syrups...
SSRIs in Pregnancy: FDA’s Blind Spot and the Battle Over Maternal Mental Health
She thought she was doing the right thing. At 29, newly married and planning to start a family, her...