Shots:
The US FDA has granted 510(k) clearance to CARA System for non-invasive, patient-specific 3D visualization of the cardiac conduction system, with commercialization to begin in the coming mos.
The CARA System combines the CARA MetisTM Simulator, a preprocedural CTA-based simulator to create a personalized 3D map of the cardiac conduction system, with the CARA…
NEWS
GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus
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The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada
NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…
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The US FDA has approved Numelvi (Atinvicitinib) for the control of pruritus associated with allergic dermatitis in dogs (≥6mos.), with availability expected in spring 2026
Numelvi is a second-generation JAK inhibitor supplied in easy-to-dispense bottles and designed for convenient storage under standard conditions.
Numelvi is ≥10-fold more selective for JAK1 over JAK2, JAK3 &…
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ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV
lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…
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argenx has reported P-III (ADAPT OCULUS) trial data on Vyvgart (efgartigimod alfa & hyaluronidase-qvfc; SC PFS) in adults with ocular MG, where Part A randomized pts to Vyvgart (QW × 4) or PBO PH20 SC with 4wk. follow-up, & Part B provided 2 cycles of 4 QW injections separated by a 4wk. interval
Trial…
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Novo Nordisk has partnered with Vivtex to develop next-generation oral biologics for obesity, diabetes, & related comorbidities, leveraging Vivtex’s GI screening & formulation platform
Vivtex will license select oral drug-delivery techs to Novo, which will lead global development, regulatory, manufacturing & commercialization, while Vivtex will receive an upfront, research funding, & milestone payments totalling…
Shots:
IDEAYA Biosciences has enrolled the first patient in its P-I dose escalation/expansion trial of IDE034, a B7H3/PTK7 bispecific TOP1 ADC, for solid tumors
The company is planning to assess the safety, tolerability, & PK of IDE034 as monotx. in a P-I trial & explore combinations with DDR-targeting agents, incl. its proprietary PARG inhibitor, IDE161…
Shots:
The US FDA has granted full approval to Braftovi + cetuximab & fluorouracil-based CT for the treatment of adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation
Approval was backed by the P-III (BREAKWATER) study assessing Braftovi (300mg, PO, QD) in pts, randomized to Braftovi + cetuximab (n=158), Braftovi + cetuximab + mFOLFOX6 (n=236),…
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SteinCares has entered into a strategic licensing agreement with Shilpa Medicare to commercialize a biosimilar across Latin America (LATAM)
As per the deal, SteinCares secures exclusive rights to register, commercialize, & distribute the biosimilar across the region, while SBPL will finalize development & undertake commercial manufacturing at its Dharwad, India facility
Partnership combines SBPL’s…
Shots:
GSK has entered into an agreement to acquire 35Pharma, incl. its asset HS235, expanding scalable growth opportunities within its Respiratory, Immunology & Inflammation portfolio
As per the deal, GSK will acquire 100% of 35Pharma’s equity for $950M in cash, payable at closing
HS235, a therapy targeting the activin receptor signalling pathway, has completed P-I…

