One edition, every weekday. The story behind the headlines, and how to act on them before your next call.
Published by Norstella's News & Insights division, the team behind Pink Sheet, Scrip, In Vivo and the rest of the industry's most-read mastheads.
The names with the most money in AAV are leaving. Eric Kelsic's bet is that they left too early, and he's licensing the tools to argue that first-generation capsids and broken economics, not the vector, emptied the field.
An ADC with ambitions across five tumor types. A £1.9bn cost cut to fund a pipeline push. And a breast cancer drug caught between a stalled FDA review and a European pricing standoff.
As the US FDA cycled through lots of leadership drama, Europe simply extended Emer Cooke’s mandate as head of EMA. Stability bought the EU a great deal, but hasn’t offered answers on vaccine trust, shortages, pricing, or AI.
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.
Aphaia's obesity data leads the pack, Connect's acute-asthma topline lands in September, Kyverna's CAR-T filing by year end. What each result decides, and who's waiting to write the check.
Carboplatin and cisplatin sit in the comparator arms of the oncology studies meant to replace them. ASCO's chief medical officer says a missing generic can halt a trial and delay the approval behind it.
Today is a quiet kind of vindication story, the sort the industry doesn't hand out often. A founder spent 15 years insisting that the junk stretches of the
US FDA says it is offering firms formatting and structure advice on how best to respond to a Form 483 to speed the clearance process. Industry worries the agency is in fact creating new GMP obligations.
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.
France fined Novo Nordisk and Eli Lilly for obesity "awareness" campaigns that, it ruled, were illegal ads. The sums are trivial. The precedent is not: a campaign that never names the drug can still count as promoting it, and India is already further down the same road.
