Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Imaavy (nipocalimab) as an add-on therapy to treat anti-AChR or anti-MuSK antibody-positive gMG pts (≥12yrs.) Approval was based on the P-III (Vivacity-MG3) trial assessing Imaavy (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC (n=77) vs PBO + SoC (n=76) in gMG pts (N=199; 153 were Ab +ve), which showed…

ByRidhi RastogiDecember 2, 2025

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Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Shots: Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…

ByRidhi RastogiDecember 2, 2025

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Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Shots: Q32 Bio has sold ADX-097, a P-II complement inhibitor, to Akebia Therapeutics As per the deal, Akebia will acquire ADX-097 from Q32 Bio for ~$592M, incl. $12M in upfront & near-term milestones ($7M at signing, $3M after 6mos., $2M payable upon the earlier of a milestone or end-2026), plus development, regulatory & commercial milestones &…

ByRidhi RastogiDecember 2, 2025

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Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

Shots: The US FDA has granted a PMA to the IsoPSA in vitro diagnostic (IVD) kit for the diagnosis of high-grade prostate cancer Approval was based on the clinical evidence from a prospective study of the IsoPSA test conducted at 14 sites across the US, as well as data from supporting analytical validation studies IsoPSA, a…

ByRidhi RastogiDecember 1, 2025

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AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Shots: AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura) Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…

ByRidhi RastogiDecember 1, 2025

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Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

Shots: Samsung Bioepis has launched Obodence (60mg PFS) & Xbryk (120mg vial), biosimilar versions of Prolia & Xgeva, for bone health treatments, with commercial availability expected by Dec 2025 & Jan 2026, respectively Obodence treats postmenopausal women & men with osteoporosis at high fracture risk, glucocorticoid-induced osteoporosis in both sexes, & bone loss in men on…

ByRidhi RastogiDecember 1, 2025

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GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Shots: The US FDA has received 510(k) submissions for SIGNA MRI technology, unveiled at RSNA 2025, to enhance diagnostics with advanced imaging innovations SIGNA Bolt focuses on high-performance 3.0T imaging with ultra-high gradients, AI-enabled workflows, & research-grade flexibility, while SIGNA Sprint with Freelium emphasizes accessibility through a helium-minimal (<1% helium usage) ventless 1.5T system designed for installation…

ByRidhi RastogiDecember 1, 2025

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Philips Unveils Verida to Improve Diagnostic Imaging

Shots: Royal Philips has launched Verida, a detector-based spectral CT fully powered by AI, at RSNA 2025, with availability in select markets beginning in 2026 Verida integrates AI across the entire imaging chain to deliver high-quality spectral & high-definition images with minimal noise, while enabling significant dose reductions & reducing energy use by ~45% Verida reconstructs…

ByRidhi RastogiDecember 1, 2025

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Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Shots: Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…

ByRidhi RastogiDecember 1, 2025

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Imugene Collaborates with JW Therapeutics to Advance onCARlytics and Carteyva Combination in Solid Tumours

Shots: Imugene has entered into a co-development collaboration with JW Therapeutics to evaluate Imugene's oncolytic virus CF33-CD19 (onCARlytics) & JW's Carteyva for pts with advanced solid tumors The company will jointly perform preclinical in vitro & in vivo studies & will advance the combination to a P-I investigator-initiated trial conducted exclusively at CAR-T clinical centers…

ByRidhi RastogiNovember 28, 2025

Ridhi Rastogi

Johnson & Johnson Reports the EC Approval of Imaavy (Nipocalimab) for Generalized Myasthenia Gravis (gMG)

Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Akebia Therapeutics Acquires Q32 Bio’s Complement Inhibitor ADX-097 for ~$592M

Cleveland Diagnostics’ IsoPSA Test Receives the US FDA Premarket Authorization for Prostate Cancer Diagnosis

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Samsung Bioepis Reports EU Launch of Obodence & Xbryk (Biosimilar, Prolia & Xgeva)

GE HealthCare Seeks the US FDA 510(k) Clearance for SIGNA MRI technology to Advance Precision Diagnostics

Philips Unveils Verida to Improve Diagnostic Imaging

Ascletis Advances ASC37 as an Oral Triple Agonist for Metabolic Disease

Imugene Collaborates with JW Therapeutics to Advance onCARlytics and Carteyva Combination in Solid Tumours

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