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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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Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery  Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…
August 18, 2026

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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

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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

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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

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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

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