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Trial Tuesday: The Number Arrowhead Wasn't Looking For
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.
Milestone Monday: In Biopharma Venture Funding, The Middle Round Goes Missing
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 Long View: Where Medical AI Leaves The Lab For The Clinic
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.
Therapeutic Thursday: Plasters, Stitches And A $57bn War Chest
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”.
Watchdog Wednesday: Good (Or Maybe Bad) News On Medicare Price Controls
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.
Trial Tuesday: A Design Brief, A Heart Miss And A Restart
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.
Milestone Monday: A $400bn Question, And The Deals That Actually Got Signed
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.
The Long View: Pharma Is Walking Out On Gene Therapy. Dyno Is Walking In.
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.
Therapeutic Thursday: GSK Bets Big, And Europe's Pricing Problem Gets A Face
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.
Watchdog Wednesday: Europe’s Top Drug Regulator Rides Off, Slowly
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.
Trial Tuesday: Same Trial, Two Verdicts, As Deramiocel Meets The FDA Panel
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.