Regulatory reform can unlock access to biosimilars
Every day, I think about the patients waiting for medicines that could change, or even save, their lives.…
FDA reviewers didn’t get to vote on first priority voucher drug
WASHINGTON — The Food and Drug Administration has promised companies that earn a Commissioner’s National Priority Voucher a one-…
We’re reading about Trump and patent policies, a new malaria drug
Top of the morning to you, and a fine one it is. Blue skies and comfortable breezes are…
Mark Cuban tries to shake up biosimilar pricing with a version of J&J’s Stelara
In its latest bid to shake up the prescription drug market, the Mark Cuban Cost Plus Drug Company…
New FDA priority review vouchers go to Lilly, Novo, Vertex
WASHINGTON — The Food and Drug Administration on Thursday announced the second batch of companies being granted a “Commissioner’s…
Microdosing GLP-1s could help telehealth firms more than patients
Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the…
Launch prices for new drugs ‘significantly’ exceed inflation, analysis says
Amid intensifying angst over prescription drug prices, a new analysis found that the median net price for 154…
Parents flock to Tylenol alternatives amid Trump autism claims
When President Trump warned that pregnant women and children should avoid taking Tylenol, the wellness industry was ready…
Acadia Pharmaceuticals drug for rare genetic condition fails late-stage study
Adam Feuerstein is a senior writer and biotech columnist, reporting on the crossroads of drug development, business, Wall…
FDA cracks down on prescription drug ads but lacks staff
WASHINGTON – In an unprecedented move, federal regulators published about 100 warning letters sent to pharmaceutical companies and health…
Let the rulemaking begin: Why direct-to-consumer drug ads deserve a closer look
Call it death by disclosure. After nearly 30 years in which prescription drug ads have become a fixture…
Statins should be available over the counter
Welcome to The Workup, a new First Opinion column from Vishal Khetpal. There’s a saying in medicine: Statins…