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VectorBuilder and Lir Therapeutics Partner to Develop AAV Capsids
Shots: VectorBuilder & Lir have collaborated to develop AAV capsids, leveraging VectorBuilder’s DeepCap platform & expertise & Lir’s nAAVigator AI platform Lir will use its platform & lab-in-the-loop workflow to enhance capsids discovered through DeepCap, targeting higher productivity, full-capsid yield, quality, robustness, lower doses, & greater tissue specificity with reduced off-target delivery & immune recognition …
August 19, 2026
Masimo Secures CE Mark for smartSedLine to Advance Anesthetic Management
Shots: Masimo has received CE Mark approval for smartSedLine, a brain function monitor featuring an AI-powered Patient State Index (PSi) algorithm designed to provide greater responsiveness to brain activity & improved stability during anesthesia smartSedLine continuously displays four real-time bilateral frontal EEG waveforms & key parameters, incl. the 0–100 PSi reflecting sedation level, supporting more…
August 19, 2026
BioMarin to Acquire Alesta Therapeutics for ~$490M
Shots: BioMarin has entered into a definitive agreement to acquire Alesta Therapeutics, incl. its P-I/II asset ALE1, an oral small molecule for the treatment of hypophosphatasia As per the deal, BioMarin will acquire Alesta, with Alesta shareholders receiving $275M upfront & ~$215M in development & regulatory milestone payments Before closing, Alesta will spin out all non-ALE1…
August 19, 2026
Harbour BioMed Reports NMPA IND Approval for HBM7004 to Treat Solid Tumors
Shots: The NMPA has approved the IND application for HBM7004 for the treatment of advanced solid tumors HBM7004 is a B7H4xCD3 bispecific antibody developed using HBM’s HBICE platform, designed to offer a differentiated cancer immunotherapy approach with potential efficacy & safety benefits  In preclinical studies, HBM7004 induced B7H4-dependent intratumoral T-cell activation & demonstrated strong anti-tumor…
August 18, 2026
Biocon Secures FDA Approval for Yesintek (Biosimilar, Stelara) 
 Shots:  The US FDA has approved Yesintek 45 mg/0.5 mL and 90 mg/mL single-dose prefilled autoinjectors, a biosimilar version of Stelara (ustekinumab)  Yesintek is indicated for mod. to sev. plaque psoriasis and active psoriatic arthritis in patients aged 6 years and older, and for mod. to sev. active Crohn’s disease and ulcerative colitis in adults  Yesintek was initially approved in November 2024  Ref: Biocon…
August 18, 2026
Bio-Thera Partners with Avalon Pharma to Commercialize BAT2406 (Biosimilar, Dupixent) in Saudi Arabia and MENA
 Shots:  Avalon Pharma and Bio-Thera Solutions have signed commercialization and licensing agreements for BAT2406 (dupilumab), a proposed biosimilar of Dupixent, covering Saudi Arabia and the broader MENA region  As per the deal, Bio-Thera will handle BAT2406’s development, manufacturing, and supply, while Avalon Pharma will manage regulatory approvals and commercialization across the licensed territory  BAT2406 is…
August 18, 2026
AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL
Shots: AbelZeta has received FDA clearance for the IND application for C-CAR039 (prizloncabtagene autoleucel), an anti-CD20/CD19 bispecific CAR-T therapy, for r/r large B-cell lymphoma (LBCL) AbelZeta regained global development, regulatory, manufacturing, & commercialization rights to C-CAR039 in Jul 2026 & is working with the FDA to finalize clinical protocols for 3L or later LBCL pts…
August 18, 2026
UroGen Pharma
UroGen Submits NDA for UGN-103 to the US FDA for Recurrent LG-IR-NMIBC
Shots: The US FDA has received an NDA for UGN-103 (mitomycin; intravesical) to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) The NDA is supported by the P-III (UTOPIA) trial in adults with recurrent LG-IR-NMIBC, where UGN-103 achieved a 77.8% 3mos. CR rate & a 94.5% 6mos. DoR by Kaplan-Meier estimate, consistent…
August 18, 2026
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