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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
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
OmniAb and Eli Lilly Partner on New Ion Channel Discovery Program
Shots: OmniAb has entered a global collaboration & license agreement with Eli Lilly for a new ion channel program, leveraging OmniAb’s discovery & screening platform to identify next-generation therapeutics targeting ion channels The therapeutic target and modality remain undisclosed, while OmniAb will contribute its established expertise and technology in ion channel discovery & screening As…
August 17, 2026
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