China Cleared Jaypirca in Frontline CLL on a Win Over Chemotherapy and Non-Inferiority to Ibrutinib
The label reaches frontline CLL, but against a modern BTK inhibitor the evidence so far is a response rate.
Approval
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.
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.
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.
Biocon Makes It, a Consultancy Holds the Licence, and Sandoz Sells It
Three parties, three functions, and Biocon holds only the middle one. Treat the caretaker MAH structure as the Japanese default, not the exception.
Avulux Won a De Novo and Created the Category Its Competitors Will File Into
Going first through a De Novo builds the road behind you. Avulux owns the claim today and has created the category rivals will file 510(k)s into.
The MHRA Authorised Two Obesity Drugs in Two Days. Neither Is on the NHS.
Two MHRA authorisations in two days. One drug is too common to fund, the other too rare to prioritise. Neither is on the NHS.
The FDA Approved Orzeyful and Handed the Approval Date to the DEA
FDA’s letter says the approval date is whenever the DEA publishes scheduling. Takeda holds a first-in-class approval it cannot sell yet.
Agilent Has Built an Annuity on Merck’s Clinical Programme, One Indication at a Time
Agilent won its eighth CE-marked companion diagnostic indication for a single PD-L1 assay, each one riding on a label expansion Merck paid to generate.