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…

ByRidhi Rastogi3 days ago

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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)…

ByRidhi Rastogi3 days ago

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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,…

ByRidhi Rastogi3 days ago

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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 …

ByRidhi Rastogi3 days ago

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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…

ByRidhi Rastogi3 days ago

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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…

ByRidhi Rastogi3 days ago

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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…

ByRidhi Rastogi4 days ago

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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…

ByRidhi Rastogi4 days ago

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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…

ByRidhi Rastogi4 days ago

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LEO Pharma to Acquire Global Rights to Tanabe Pharma’s Dersimelagon for ~$435M

Shots: LEO Pharma has entered into an agreement to acquire worldwide rights to dersimelagon from Tanabe Pharma for the treatment of erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) As per the deal, Tanabe Pharma will receive up to $435M in upfront & near-term milestone payments together with potential downstream milestones and tiered royalties on net…

ByRidhi Rastogi4 days ago

Ridhi Rastogi

DeepCyte Launches AI Toxicology Atlas to Predict Drug Safety Risks

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

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

VectorBuilder and Lir Therapeutics Partner to Develop AAV Capsids

Masimo Secures CE Mark for smartSedLine to Advance Anesthetic Management

BioMarin to Acquire Alesta Therapeutics for ~$490M

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

Harbour BioMed Reports NMPA IND Approval for HBM7004 to Treat Solid Tumors

AbelZeta Gains FDA IND Clearance for Bispecific CAR-T C-CAR039 in LBCL

LEO Pharma to Acquire Global Rights to Tanabe Pharma’s Dersimelagon for ~$435M

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