Scholar Rock Filed With Two Fill-Finish Sites. One Just Failed, and the Date Held.
Catalent Indiana failed its FDA inspection. Scholar Rock had named a second fill-finish site in the same BLA, so the PDUFA date did not move.
Antibody
Argenx’s $2.2 Billion Bought a Phase 1b With Ten Patients on Placebo
FB102’s entire human efficacy dataset in vitiligo is 42 patients, ten of them on placebo. argenx paid $2.2 billion in cash, with no milestones.
The EPO Revoked BMS’s 480mg Opdivo Patent Because the Trial Behind It Dosed by Weight
BMS claimed a 480mg flat dose. The only clinical example in its filed application dosed by weight. The EPO revoked the patent on added matter.
Dr. Reddy’s Developed, Made and Filed the Rituximab. Fresenius Only Sells It.
Fresenius describes an end to end biopharma business. Dr. Reddy’s developed, made and filed this rituximab. Fresenius is only the channel.
A B7-H3 Antibody Drug Conjugate Just Won a Second Phase 3, in a Second Tumour
A second positive Phase 3 in a second tumour makes Ris-Rez the only B7-H3 antibody-drug conjugate with late-stage wins across more than one cancer.
ADCs Graduated From Salvage to First Line, Twice in a Week
Enhertu with pertuzumab and Trodelvy with Keytruda both won CHMP opinions for first-line metastatic breast cancer, moving ADCs from last resort to standard.
The Cheapest Drug in Retina Just Became a Branded Product
LYTENAVA becomes the first FDA-approved ophthalmic bevacizumab for wet AMD, with 12 years of exclusivity, on a molecule already used in most first-line treatment.
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.
Crysvita Reaches One-Month-Old Infants in the EU, and Buys Two More Years of Orphan Exclusivity
The European Commission approved Crysvita for infants as young as one month with XLH, a decision that also buys Kyowa Kirin two more years of orphan exclusivity.
Lilly taps InduPro’s proximity-guided platform in up to $950M oncology deal
Eli Lilly and Company has entered a global strategic collaboration, licensing agreement, and equity investment with InduPro Therapeutics, betting up to $950 million on a proximity-guided approach to discover first-in-class bispecific and multispecific oncology therapeutics. Under the agreement, the companies will collaborate on up to three oncology targets, with Lilly also taking an equity stake … Read more