Shots:
The US FDA has approved Breyanzi (lisocabtagene maraleucel; liso-cel) for the treatment of adults with r/r MZL who have received ≥2L of systemic therapy
Approval was supported by MZL cohort data from the P-II (TRANSCEND FL) trial assessing Breyanzi in pts with r/r indolent B-cell non-Hodgkin lymphoma incl. follicular lymphoma & MZL
In…
Shots:
The US FDA has granted conditional approval to Exzolt Cattle-CA1 to prevent & treat New World screwworm (Cochliomyia hominivorax) larvae (myiasis) & cattle fever tick (Rhipicephalus microplus)
Exzolt Cattle-CA1, a systemic fluralaner pour-on available in 1L & 5L presentations, is approved for use in beef cattle (≥2mos.) & replacement dairy heifers (<20mos.), with US availability…
Shots:
Crescent granted Kelun exclusive rights to research, develop, manufacture & commercialize CR-001 in Greater China, while Kelun granted Crescent similar exclusive rights for SKB105 globally (excl. Greater China)
Kelun will receive $80M upfront, ~$1.25B in milestones, tiered mid–single to low-double-digit royalties & potential change-of-control payments, while Crescent will get $20M upfront, ~$30M in milestones…
Shots:
Lupin has entered into an exclusive licensing agreement with Valorum Biologics for Armlupeg, a biosimilar version of Neulasta (pegfilgrastim)
As per the deal, Valorum will be responsible for the commercialization and distribution of Armlupeg in the US, while Lupin will handle manufacturing & supply of the product
In return, Lupin will receive an upfront…
Shots:
The US FDA has granted clearance to Hugo robotic-assisted surgery (RAS) system for use in minimally invasive urologic surgical procedures, incl. prostatectomy, nephrectomy, & cystectomy
The Hugo RAS system met its primary safety & efficacy endpoints in the Expand URO IDE study, showing performance in urologic procedures consistent with outcomes reported in published literature…
Shots:
Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region
As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…
Shots:
Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US
Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…
Shots:
Iolyx has granted Théa exclusive global rights (excl. Asia) to develop & commercialize ILYX-002 for Dry Eye Disease associated with systemic autoimmune disorders & other ocular surface conditions
Iolyx will receive ~$280M in clinical, regulatory, & commercial milestones; tiered royalties up to ~21%; & R&D cost reimbursement. Iolyx will design P-III trials, handle manufacturing,…
Shots:
The US FDA has approved label expansion of Jaypirca (pirtobrutinib; 100 & 50mg) for the treatment of adults with r/r CLL/SLL who were previously treated with a covalent BTK inhibitor & converted the accelerated approval of Dec 2023 to a full approval
Label expansion was based on the P-III (BRUIN CLL-321) study assessing Jaypirca…
Shots:
Formosa has entered into an exclusive licensing agreement with Rxilient to commercialize APP13007, a 0.05% clobetasol propionate ophthalmic suspension for the treatment of inflammation & pain after ocular surgery
As per the deal, Rxilient will gain exclusive rights to commercialize the suspension across key ASEAN markets, incl. Indonesia, Philippines, Singapore, & Thailand, with the deal…

