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 US still has the biggest market and the deepest regulatory expertise but early-stage sponsors are increasingly starting somewhere else.
The discovery engine now runs twice as fast. A new chief executive is culling late-stage assets and raising the Phase II bar, so the bet rides on whether faster also means better.
Twin trials erased acute pancreatitis in high-risk patients, and Arrowhead priced its drug just above Ionis's, not below. The full readout lands at ESC on Aug 30, where analysts settle the score.
Three nine-figure private raises and a royalty deal worth up to $425m in a two-week run last month, with almost nothing in the $50m to $100m band between them and the seed stage. The companies that need that rung are learning to route around it.
The research exemptions written into the AI Act, amended in July, were meant to protect science. A KU Leuven and Stanford paper warns they may also be the easiest place to hide, and that even honest researchers may not be able to tell whether their work counts as research or something more.
Novo Nordisk absorbs two trial failures and signals bolt-on deals, while Eli Lilly counts 31 transactions in seven months this year as it plays offense without the pressure of having to “buy revenue”.
New Part D figures show the negotiation squeeze has been less tight than pharma may have feared, but program costs are spiking, meaning industry will continue to be in the crosshairs.
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.
Bristol Myers and AstraZeneca are reported to be talking. While that plays out, argenx, J&J and Caldera each put real money behind a thesis last week.
