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Health Canada has approved Portela for alleviating osteoarthritis pain in cats. The company plans to launch Portela commercially in Canada and the EU in 2026
In a nine-month European trial, Portela eased OA pain and was well tolerated, including in cats with IRIS stage 1–3 kidney disease. Approved in the EU
Portela is a…
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CARsgen reported that early clinical results of CT0596, in Pts with R/R MM, were shared in ASH’25. The company plans a P-Ib registrational study in 2026, following an IND submission expected in H2'25
The P-I trial enrolled 8 pts with R/R MM who received CT0596, with a median of 4.5 prior therapy lines. Enrollment…
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Natera has acquired Foresight Diagnostics, adding its PhasED-Seq phased variant technology with LOD95 of 0.3ppm & detection below 0.1ppm, further enhancing Natera’s capabilities in solid tumor MRD and expanding its IP portfolio of >500 issued/pending patents
As per the agreement, Natera completed the acquisition in an all-stock transaction incl. $275M upfront & up to…
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The US FDA has granted FTD to HMI-115 for the treatment of mod. to sev. pain associated with endometriosis
Designation was based on the global P-II dose-finding study assessing HMI-115 vs PBO for 12wks. in 108 females with surgically diagnosed endometriosis across the US, Poland & China, showing significant improvement
Trial showed that HMI-115…
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Neurimmune has entered into an exclusive global collaboration & licensing deal with Alexion to develop NI009, a preclinical human mAb for the treatment of AL amyloidosis
Alexion will obtain an exclusive global license to Neurimmune’s AL amyloidosis–targeting Abs, incl. NI009, with Neurimmune handling preclinical activities, early manufacturing & the FIH study, while Alexion will…
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Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS)
Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function
Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…
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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…
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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…
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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…
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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…

