A pharma journalist since 2017, Manas is interested in all aspects of the pharma industry and writes stories across all development phases. He may not look it, but he enjoys a mosh pit, is a beginner open-water swimmer, and loves sci-fi and fantasy.
The US still has the biggest market and the deepest regulatory expertise but early-stage sponsors are increasingly starting somewhere else.
A melanoma advisory committee backs Replimune's RP-1 while pressing the field for better endpoints; Novo Nordisk's IL-6 inhibitor fails a 6,300-patient cardiovascular outcomes trial; and Rocket clears its first Danon disease patients under a revised protocol.
Capricor and the FDA read HOPE-3 in opposite directions. Wednesday's committee decides which reading survives, with the agency's own call due August 22.
GSK's camlipixant failure marks the third P2X3 setback in chronic cough, wiping out the Phase III pipeline and leaving 2–3 million US patients with no branded option in sight.
A challenger in liver disease, a cancer head-to-head, and a biosimilar bet on doing the extra work. Each is wagering that the trial, not the head start, decides who wins.
Who, and what, gets trusted with the next decade of drug discovery. The answers, so far: an AI résumé, and in China, a shrug.
The needle-shy are the prize now, and four companies showed up to ADA with a pill and a percentage.
Daraxonrasib doubles survival in pancreatic cancer, BMS puts numbers behind its CELMoD bet, and the trial count quietly falls again.
For the first time in ASCO's history, China-only data occupies the plenary slot. A hazard ratio of 0.40 in pancreatic cancer. And Lilly moving the obesity ceiling above bariatric surgery. Chicago has a lot to answer for this week.
Here is a thought experiment: where would we be if the FDA and other regulators did not allow trial flexibility?
