Shots:
The US FDA has approved Inqovi (decitabine & cedazuridine) + venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) pts, who are 75yrs. or older, or ineligible for intensive induction CT
Approval was backed by P-II (ASCERTAIN-V) trial in adults with newly diagnosed AML ineligible for intensive induction CT
Trial showed a…
Shots:
The US FDA has granted accelerated approval to BeOne's Beqalzi for the treatment of adults with r/r mantle cell lymphoma, after ≥2L of systemic therapy, incl. a BTK inhibitor; regulatory review is ongoing in the EU
Approval was supported by the global P-I/II (BGB-11417-201) assessing Beqalzi in r/r MCL pts (n=125), which showed 52%…
Shots:
Fosun Pharma & AriBio have entered into an exclusive global option agreement for the development, registration, manufacturing, & commercialization of AR1001 for AD, expanding their partnership beyond Greater China & 10 ASEAN countries
AriBio will receive a $60M option fee & retain the right to exercise the option within the agreed period, while Fosun…
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The EC has approved Pfizer's Hympavzi (marstacimab; QW, SC) for the treatment of pts (≥12yrs., ≥35kg) with hemophilia A with FVIII inhibitors or hemophilia B with FIX inhibitors, based on P-III (BASIS) study
During the active treatment period, Hympavzi achieved a 93% reduction in mean treated ABR vs on-demand therapy (1.39 vs 19.78), plus…
Shots:
Cepheid has received IVDR CE marking for the Xpert GI Panel, a multiplex PCR assay designed to detect 11 clinically relevant GI pathogens from a single stool sample using the 10-color multiplexing technology on GeneXpert Systems
The assay simultaneously identifies bacterial, viral, & parasitic pathogens directly from stool specimens in Cary-Blair transport media, requiring…
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The GATHER1 & GATHER2 studies assessed Izervay (QM) vs sham in pts with GA secondary to AMD for 18 & 12mos., respectively, where in GATHER2, pts were later re-randomized to Izervay QM or Q2M for 24mos.
In the driving-eligible pts (BCVA of ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility…
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Trial assessed eneboparatide (ENB; QD, SC) vs PBO for 24wks. in 202 adults with HypoPT on active vitamin D & oral Ca supplements; Pts then continued ENB (ENB/ENB) or switched from PBO to ENB (PBO/ENB) in a 28wk. OLE
Trial met its composite 1EP, with 31.1% pts achieving normalized albumin-adjusted sCa levels & independence…
Shots:
Isomorphic Labs has reported a $2.1B Series B financing round led by Thrive Capital, with participation from existing investors Alphabet & GV alongside new backers MGX, Temasek, CapitalG, & the UK Sovereign AI Fund
The company plans to use the capital to further develop & deploy its AI-powered drug discovery platform, IsoDDE, accelerate internal…
Shots:
BI has entered into a global licensing agreement with Immunitas for a preclinical antibody program being developed for chronic inflammatory & autoimmune diseases
As per the deal, BI will obtain global rights to develop, manufacture, & commercialize the antibody program in exchange for an upfront payment, up to €407.5M (~$479.6M) in development, regulatory, &…
Shots:
Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer.
As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…

