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Alvotech and Lotus Partner to Commercialize AVT34 (Biosimilar, Imfinzi) and AVT87 (Biosimilar, Hemlibra) Across the US and 8 Asian Countries

Shots: Alvotech has entered a strategic licensing & commercialization agreement with Lotus Pharmaceutical for AVT34, a proposed Imfinzi (durvalumab) biosimilar, & AVT87, a proposed Hemlibra (emicizumab) biosimilar, in the US & selected Asian markets Under the US semi-exclusive deal, Alvotech & Lotus will jointly commercialize AVT34 and AVT87, with Lotus commercializing the products through Alvogen;…
August 24, 2026

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Johnson & Johnson Receives EC Approval for Tecvayli Combination for R/R Multiple Myeloma

Shots: The EMA has approved a label extension of Tecvayli (teclistamab) + Darzalex (daratumumab) for the treatment of adults with r/r multiple myeloma (RRMM) who have received ≥1 prior therapy Approval was supported by the P-III (MajesTEC-3) trial evaluating Tecvayli + Darzalex (SC) vs investigator’s choice of Darzalex (SC) & dexamethasone with either pomalidomide or bortezomib in…
August 24, 2026

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DeepCyte Launches AI Toxicology Atlas to Predict Drug Safety Risks

Shots: DeepCyte has launched DeeTox Atlas, the first single-cell metabolomic reference atlas for drug toxicity mechanisms, with enterprise pilots set to begin soon & three of the top 20 pharma companies already in pilot discussions Platform is built from 2 independent studies covering ~100 toxicant compounds, 300k cells & ~500 metabolites/cell, generating 3,000+ single-cell measurements…
August 19, 2026

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Merck and Moderna Report the INTerpath-001 Trial Data on Intismeran Autogene + Keytruda for Completely Resected Stage IIB-IV Melanoma

Shots: Merck & Moderna have reported the P-III (INTerpath-001) trial data assessing adj. intismeran autogene (1mg, Q3W for 9 doses) + Keytruda (400mg, Q6W up to 9 cycles) vs Keytruda alone in 1,137 pts with high-risk (stage IIB-IV) resected cutaneous melanoma Intismeran plus Keytruda as adj. therapy showed improvements in RFS (1EP) and DMFS (2EP)…
August 19, 2026

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ivWatch Seeks 510(k) Clearance for its SmartTouch+ Sensor to Expand Continuous IV Monitoring to White-Opaque Infusates

Shots: The US FDA has received a 510(k) application for the SmartTouch+ Sensor to detect infiltration & extravasation events associated with both clear and white-opaque fluids early The SmartTouch+ Sensor expands ivWatch’s monitoring to lipid-based fluids like TPN & propofol, with the Patient Monitor performing 18,000+ checks/hour to detect infiltration or extravasation & alert clinicians,…
August 19, 2026

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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

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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

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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

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