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The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoing
In…
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The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand
In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…
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The US FDA has granted 510(k) clearance to Felix NeuroAI Wristband for the treatment of essential tremor in the upper limbs of the adults; available in select US states in 2025, with nationwide availability anticipated in 2026
Clearance was supported by TRANQUIL study assessing Felix wristband vs sham device, which showed reduced tremors & improved…
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BioVersys & Shionogi have entered into a global research & exclusive license option agreement to co-develop novel ansamycin compounds from BioVersys’ BV500 program into clinical candidates for treating NTM infections
Shionogi will gain access to BioVersys’ ansamycin chemistry platform & BV500 program, with an exclusive option to license selected molecules for clinical development &…
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Apotex has reported Health Canada's approval of Aflivu (aflibercept), a biosimilar to Eylea in PFS and vials
Aflivu is indicated for wet age-related macular degeneration, macular edema from retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization
Aflivu expands Apotex's biosimilar portfolio, which already includes Grastofil (filgrastim), Lapelga (pegfilgrastim), and Bambevi (bevacizumab)
Ref: PRNewsWire | Image:…
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Alvotech has entered into a supply & commercialization agreement with Advanz Pharma for AVT10, a biosimilar version of Cimzia (certolizumab pegol)
Alvotech & Advanz Pharma have previously partnered on biosimilars for over 10 reference biologics, with a plan to launch their first biosimilars in the EU by Q4’25
Cimzia binds with both soluble &…
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Unnatural Products (UNP) & argenx have entered into a strategic multi-target research collaboration to identify & develop oral macrocyclic peptide drugs for hard-to-target diseases leveraging UNP’s drug discovery platform
As per the deal, UNP will receive upfront payment, equity investment, near-term, & R&D payments, plus ~$1.5B in research, development, regulatory, & commercial milestones as well as…
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The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapy
Approval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…
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HanchorBio entered into an out-licensing agreement with Shanghai Henlius Biotech and granted exclusive rights to develop and commercialize HCB101 in Greater China, Southeast Asia, and MENA
Under the terms and agreement, HanchorBio will receive $10M upfront and up to $192M in development and regulatory milestones, plus tiered royalties
Henlius will also oversee development, production,…
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AbbVie has entered into a definitive agreement to acquire Capstan Therapeutics, including its P-I CPTX2309 and proprietary tLNP platform for in vivo RNA delivery to treat B-cell-mediated autoimmune diseases
As per the deal, Capstan will receive up to $2.1B in cash, pending customary closing conditions and regulatory approvals
CPTX2309 is a tLNP delivering mRNA…

