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Astellas has partnered with Vir Biotechnology to advance VIR-5500, a PRO-XTEN dual-masked CD3 T-cell engager targeting PSMA, for the treatment of prostate cancer
As per the deal, Astellas will fund 60% & Vir 40% of global development costs; Vir will continue the P-I trial until transition, after which Astellas will assume development. Also, Vir will…
NEWS
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Gilead Sciences has entered into a definitive agreement to acquire Arcellx, incl. anito-cel from their 2022 collaboration & Arcellx’s D-Domain CAR technology platform, for the implied equity value of $7.8B
As per the deal, Gilead, which owns ~11.5% of Arcellx, will launch a tender offer for $115/share, plus a non-transferable CVR of $5/CVR tied…
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J&J has reported the long-term data from the QUASAR LTE trial in pts with mod. to sev. active ulcerative colitis, showing lasting disease control for patients
The P-IIb/III (QUASAR) trial assessed Tremfya (IV induction: 200mg Q4W; SC maintenance: 100mg, Q8W or 200mg, Q4W) vs PBO in UC pts
At Wk. 140, ~89% completed treatment,…
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Partner Therapeutics has reported post-hoc analysis from the eNRGy study assessing zenocutuzumab (marketed as Bizengri in the US) in pts with advanced NRG1+ NSCLC
In 27 pts with NRG1+ NSCLC treated with zenocutuzumab (≥3 doses) beyond radiographic progression, 81% had oligoprogression & 19% diffuse progression, extending median exposure to ~10 vs ~7mos. pre-progression.
Additionally,…
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The EC has approved Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab)
Ranibizumab is a recombinant humanized IgG1 antibody fragment that inhibits VEGF-A and is used to treat wet AMD, macular edema due to retinal vein occlusion, diabetic macular edema, proliferative diabetic retinopathy, and choroidal neovascularization
Sandoz and Lupin Limited partnered in August 2025 to develop and…
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The US FDA has accepted 351 (k) BLA for DRL_AB (IV), a proposed interchangeable biosimilar to Orencia (abatacept)
Upon approval, DRL_AB will be indicated for adults with mod. to sev. active rheumatoid arthritis, adults with active psoriatic arthritis, & pts (≥6yrs.) with mod. to sev. active polyarticular juvenile idiopathic arthritis
BLA was supported by extensive…
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The US FDA has approved Calquence (acalabrutinib) + venetoclax for the treatment of adults with 1L CLL & small lymphocytic lymphoma; regulatory review is ongoing in other regions
Approval was based on the P-III (AMPLIFY) trial assessing the Calquence regimen ± Gazyva vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation
Trial…
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FDA has approved Bysanti, an active metabolite of iloperidone, as a 1L therapy for acute treatment of adults with manic or mixed episodes associated with bipolar I disorder & for schizophrenia, with the latest patent expiring in 2044 & commercial availability expected in Q3’26
In clinical trials, Bysanti showed bioequivalence to Fanapt (iloperidone) across the full…
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The US FDA has accepted Roche’s NDA for giredestrant in combination with everolimus to treat adults with ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on prior endocrine-based therapy
NDA acceptance is based on P-III (evERA) study data showing giredestrant + everolimus reduced the risk of disease progression or…
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Candel Therapeutics has entered into a $100M royalty funding agreement with RTW Investments, contingent on FDA approval of Aglatimagene Besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer
As per the deal, RTW will receive a capped, tiered single-digit percentage of US annual net sales of aglatimagene. Candel Plans to submit a BLA for…

