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.
Approval
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.
China Approved the World’s First Once-Daily Oral Factor B Inhibitor, and a US Small-Cap Licensed It a Month Early
China approved Haisco’s ciprocopan for PNH, the world’s first once-daily oral complement Factor B inhibitor, a month after a US small-cap licensed ex-China rights.
One Robot, Three Ways In: Momentis Clears Multiport a Day After J&J Shrank the Footprint
Momentis won FDA clearance for multiport surgery, making Anovo the first robotic platform cleared for natural orifice, single-port and multiport approaches.