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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 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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Novartis AG has signed an agreement with ChrysCapital to divest its 70.68% stake in Novartis India Limited (NIL), following a strategic review initiated in Feb 2024
The transaction, subject to customary closing conditions, is expected to close in Q3’26; the Board of NIL was formally notified post-signing
Post-divestment, Novartis will further its transition into…
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The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM
At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…
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The EMA has validated the Type II Variation MAA for Enhertu as a monotx. for the treatment of adults with HER2+ (IHC 3+ or ISH+) breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment
MAA was backed by the global P-III (DESTINY-Breast05) trial assessing Enhertu (5.4mg/kg) vs trastuzumab emtansine in 1,635…
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Cencora & Covetrus have entered into a definitive agreement to merge Covetrus with MWI Animal Health, forming a unified company delivering a comprehensive animal health platform
The deal values MWI at a $3.5B enterprise value, with Cencora receiving $1.25B in cash, $800M in preferred equity, & $1.45B in common equity, securing a 34.3% non-controlling…

