The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

Shots: The US FDA has granted IND clearance to initiate the P-I trial assessing the safety, tolerability, PK, & anti-tumor activity of Harbour Biomed's HBM7004 in advanced solid tumors Preclinical studies showed that HBM7004 induced B7H4-dependent intratumoral T-cell activation, strong anti-tumor activity, in vivo stability, & reduced systemic toxicity, while combination with a B7H4x4-1BB BsAb…

ByRidhi Rastogi17 hours ago

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GSK Partners with Halozyme to Develop SC Formulation of Multiple Oncology Drugs

Shots: GSK has entered into a global collaboration & license agreement with Halozyme to develop & commercialize SC formulation of multiple oncology targets, incl. ADCs, as well as an option for additional future drug targets As per the deal, GSK will license Enhanze drug delivery tech from Halozyme in exchange of upfront payment, as well…

ByRidhi Rastogi18 hours ago

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Bausch + Lomb Launches Bi-Blade+ Vitrectomy Cutter in the EU on Stellaris Elite Platform

Shots: Bausch + Lomb has launched Bi-Blade+ advanced dual-port vitrectomy cutter on the Stellaris Elite Vision Enhancement System in the EU for anterior & posterior segment procedures requiring vitreous removal Bi-Blade+ delivers a 25% higher flow rate for more efficient vitreous removal compared to Bi-Blade & demonstrated a 62% reduction in cutter vibration, aimed at…

ByRidhi Rastogi19 hours ago

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ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Shots: ALX Oncology presented data from exploratory analyses of P-Ib/II trial assessing evorpacept + Ziihera in pts with heavily pre-treated HER2+ mBC, all of whom had received prior Enhertu therapy, at ESMO Breast Cancer 2026 Exploratory analyses in 24 pts treated with evorpacept + Ziihera at dosages of 20mg/kg (n=3) or 30mg/kg (n=21), showed a…

ByRidhi Rastogi21 hours ago

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Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Shots: Beacon has reported the 12mos. data from P-II (DAWN) trial assessing laruparetigene zovaparvovec (laru-zova) in pts with XLRP who have previously been treated with an AAV vector-based gene therapy delivering the full-length RPGR protein Data showed sustained improvements in low luminance visual acuity (LLVA) & microperimetry mean sensitivity through Mos. 12, with 50% of…

ByRidhi Rastogi22 hours ago

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Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

Shots: The P-III (TRuE-AD4) study assessed Incyte's Opzelura cream (BID) vs vehicle in 241 adults with mod. AD who had an inadequate response, intolerance, or contraindication to topical corticosteroids (TCSs) & calcineurin inhibitors (TCIs); data presented at EADV’26 As previously reported, the study met its co-1EPs, with 83.5% pts achieving EASI75 & 74.4% reaching IGA-TS, while 74.3% pts…

ByRidhi Rastogi23 hours ago

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Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

Shots: Bayer has reported topline P-III (REVEAL) trial data assessing PET/CT radiotracerI 124 evuzamitide (IV) vs clinical SoC diagnosis in 170 adults with suspected cardiac amyloidosis Trial met its 1EPs of sensitivity & specificity for the diagnosis of cardiac amyloidosis based on visual scan; data will be discussed with regulators, presented in future & submitted…

ByRidhi Rastogi2 days ago

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Waiv Partners with Daiichi Sankyo to Advance AI-Driven Biomarker Discovery for ADC Program

Shots: Waiv has collaborated with Daiichi Sankyo to lead digital pathology biomarker discovery for an ADC program, leveraging its end-to-end computational pathology platform Waiv will use its platform to analyze early-phase trial data, incl. tumor microenvironment profiling across H&E & IHC slides, biomarker discovery, & outcome prediction, aimed at identifying biomarkers of treatment response The…

ByRidhi Rastogi2 days ago

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Roche to Acquire PathAI for ~$1.05B

Shots: Roche has entered into a definitive merger agreement to acquire PathAI, building on their 2021 partnership, which scaled up in 2024 to incl. the development of AI-enabled companion diagnostic algorithms As per the deal, Roche will acquire PathAI for $750M upfront & ~$300M in additional milestone payments; closing is expected in H2’26 The acquisition…

ByRidhi Rastogi2 days ago

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Angelini Pharma to Acquire Catalyst Pharmaceuticals for ~$4.1B

Shots: Angelini Pharma has entered into a definitive agreement to acquire all outstanding shares of Catalyst, marking Angelini’s entry into the US market As per the deal, Angelini will acquire Catalyst for $31.5 per share in cash, for a total equity value of ~$4.1B; closing is expected in Q3’26 The acquisition will strengthen Angelini’s Brain Health…

ByRidhi Rastogi2 days ago

Ridhi Rastogi

The US FDA Grants IND Clearance to Harbour BioMed’s HBM7004 to Initiate P-I Trial in Advanced Solid Tumors

GSK Partners with Halozyme to Develop SC Formulation of Multiple Oncology Drugs

Bausch + Lomb Launches Bi-Blade+ Vitrectomy Cutter in the EU on Stellaris Elite Platform

ALX Oncology Presents P-I/II Trial Data on Evorpacept Combination in Metastatic Breast Cancer (mBC) at ESMO Breast Cancer’26

Beacon Therapeutics Reports P-II (DAWN) Trial Data on Laru-zova in X-Linked Retinitis Pigmentosa (XLRP)

Incyte Reports 24-week P-III (TRuE-AD4) Trial Data on Opzelura (Ruxolitinib) Cream in Moderate Atopic Dermatitis (AD)

Bayer Reports P-III (REVEAL) Trial Data on Iodine 124 evuzamitide to Diagnose Cardiac Amyloidosis

Waiv Partners with Daiichi Sankyo to Advance AI-Driven Biomarker Discovery for ADC Program

Roche to Acquire PathAI for ~$1.05B

Angelini Pharma to Acquire Catalyst Pharmaceuticals for ~$4.1B

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