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The US FDA has accepted an sNDA for Voxzogo (vosoritide) for full approval in children with achondroplasia (PDUFA: Feb. 28, 2027)
The sNDA was supported by long-term safety & efficacy data from the ongoing 111-205, 111-208, & 111-302 studies, demonstrating clinically meaningful improvements in growth & key skeletal measures, incl. body proportionality & arm span…
NEWS
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Formycon and OneSource Specialty Pharma have entered into a strategic manufacturing partnership for biosimilars
As per the deal, OneSource will act as Formycon’s strategic manufacturing partner, providing integrated Drug Substance (DS) and Drug Product (DP) manufacturing from its advanced biologics facility in Bangalore, India
The collaboration combines Formycon’s biosimilar development expertise with OneSource’s end-to-end biologics manufacturing capabilities to advance Formycon’s global biosimilar programs
Ref: Formycon | Image:…
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HistoSonics has reported CE Mark approval of its Edison System for the non-invasive mechanical destruction of liver tumors, incl. the partial or complete destruction of unresectable liver tumors using histotripsy
Approval was supported by clinical evidence, incl. HOPE4LIVER trial, which demonstrated a 90% local tumor control rate at 12mos. across liver tumor types with…
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Dizal has entered into a global exclusive license agreement with AstraZeneca for Zegfrovy (sunvozertinib) for the treatment of pts with lung cancer; closing is expected in H2’26
As per the deal, AstraZeneca will acquire worldwide rights to develop & commercialise Zegfrovy in exchange for $600M upfront, & ~$900M in development, regulatory & sales milestones, with tiered royalties…
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The US FDA granted 510(k) clearance to the UB ERP System for electroencephalography & event-related potentials-based brain function assessment, with commercial launch expected later this year
To support clinical expansion, the company initiated US & Japan studies in depression to evaluate brain function before & after 1L antidepressant treatment, and develop objective brain function…
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The US FDA has approved an sBLA for Leqembi Iqlik (lecanemab‑irmb, SC) as an initiation dose administered as 500mg given QW as two 250mg injections, each delivered in ~15secs for the treatment of early Alzheimer's disease
Approval was supported by clinical data across multiple studies, with Clarity AD LTE sub-studies showing QW SC Leqembi…
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The US FDA has accepted NDA of mezigdomide (PO) + carfilzomib & dexamethasone (MeziKd) for the treatment of pts with r/r multiple myeloma (PDUFA: May 13, 2027)
NDA was supported by the P-III (SUCCESSOR-2) trial data assessing MeziKd in 2 stages, where in stage 2, 479 pts with r/r MM were randomized to either MeziKd…
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GSK has reported global P-II (AZUR-1) trial data assessing Jemperli (dostarlimab) (500mg, IV, Q3W for 9 cycles) in 154 pts with stage II/III mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) locally advanced rectal cancer
Trial met its 1EP, with a meaningful & sustained clinical complete response rate at 12mos. Interim AZUR-1 data will be shared with global…
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Henlius has dosed the first U.S. patient in the global P-I HLX15-SC (HLX15-SC-NDMM-001) trial, a biosimilar version of Darzalex Faspro, as a 1L treatment for newly diagnosed multiple myeloma (NDMM)
The study will compare HLX15-SC vs. US-licensed Darzalex Faspro in transplant-ineligible NDMM patients, evaluating PK similarity, safety, tolerability, immunogenicity, and efficacy in combination with lenalidomide & dexamethasone (Rd)
HLX15 is an anti-CD38 daratumumab biosimilar candidate for…
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Bayer has signed an agreement with Apollo to secure €3B (~$3.4B) in equity capital as part of a strategic financing initiative to strengthen its capital structure
Apollo-managed funds will acquire a minority, non-controlling stake in Bayer’s new long-acting reversible contraceptives entity, while Bayer retains majority ownership, operational control, & full financial consolidation within its…

