AbbVie’s Juvmo Won FDA Approval Three Days Before ICER Holds a Public Meeting on Its Value
AbbVie now has to name a price for Juvmo into a benchmark that ICER set before the drug was even approved.
By technology
Merck’s $4 Billion Daiichi ADC Pact Takes Its Third FDA Setback in Three Years
The $4bn deal’s first return keeps slipping toward 2028, the year Keytruda begins to lose protection.
Kodiak’s Zenkuda Put 54% of Wet AMD Patients on Six-Month Dosing, Four Years After an Extended-Dosing Miss
The molecule that failed on long intervals in 2022 now holds vision with most patients on six-month dosing.
Tuznue Won Brazil Approval a Month After Its Plant Passed Anvisa Inspection, Nearly 20 Months After Filing
In Brazil the constraint on Prestige’s Herceptin biosimilar was not the dossier. It was the factory inspection.
Merck Is Taking a $400 Million Charge for a Preclinical KRAS G12D Drug After Backing Off Revolution
Merck is buying into KRAS G12D at the start line, well behind the company it reportedly tried to buy in January.
Bahrain Licensed Foundayo Six Months After the FDA as Lilly Takes Its Oral GLP-1 Global
Bahrain is small. The move matters as evidence of the global rollout Lilly argued a small-molecule GLP-1 would allow.
FOP Now Has Three Approved Drugs for About 300 US Patients, Two of Them in 37 Days
Three drugs now divide an ultra-rare disease by mechanism, route and age, and the newest competes on convenience and safety.
Europe Approved Leriglitazone for Boys With cALD Two Years After the EMA Recommended Refusal
A drug the EMA refused two years ago is now approved, on a narrow label and under exceptional circumstances, with Europe first.
Genentech Bets $1.5B+ on Earendil’s Bispecifics With $55M Upfront
The one clean upfront among this week’s discovery deals, and Earendil keeps more of the early clinical risk than most.
J&J Is Using Two Tecvayli Trials to Own Myeloma’s First Relapse Whether or Not Patients Had Darzalex
J&J’s frontline success with Darzalex is manufacturing the monotherapy market for Tecvayli at first myeloma relapse.