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.
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.
US FDA has resumed posting its complete response letters, but the CRL for AbbVie’s Botox follow-on, the last one issued before the agency’s pause, is still worth lingering over because of what it says about drug development and government reimbursement.
Novo's denecimig heads into US and European decisions this quarter as a once-monthly rival to Roche's Hemlibra, while Incyte and Hemab try to give von Willebrand patients the convenient prophylaxis hemophilia A already takes for granted.
A strong start to the year, booming M&A, and the tariff and pricing worries off the boil. The question, starting with J&J on Wednesday, is whether the cautious 2026 forecasts get raised.
