Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Shots: 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 &…

ByRidhi RastogiFebruary 26, 2026

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ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Shots: 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%…

ByRidhi RastogiFebruary 26, 2026

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argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

Shots: 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…

ByRidhi RastogiFebruary 26, 2026

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Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

Shots: 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…

ByRidhi RastogiFebruary 26, 2026

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IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034

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…

ByRidhi RastogiFebruary 25, 2026

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Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

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),…

ByRidhi RastogiFebruary 25, 2026

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SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America

Shots: 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…

ByRidhi RastogiFebruary 25, 2026

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GSK to Acquire 35Pharma for $950M

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…

ByRidhi RastogiFebruary 25, 2026

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The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

Shots: FDA approved Dupixent for pts (≥6yrs.) with AFRS & have a history of sino-nasal surgery, based on the P-III (LIBERTY-AFRS-AIMS) trial, assessing age & weight-based Dupixent dosing (200 or 300mg; Q2W or Q4W; n=33) vs PBO (n=29) in 62 pts Trial met its 1EP with improved sinus opacification by 50% vs 10% at Wk. 52,…

ByRidhi RastogiFebruary 25, 2026

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J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

Shots: The US FDA has received an sBLA of Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) sBLA was supported by P-II/III (ENERGY) trial assessing the efficacy & safety of Imaavy vs PBO in adults with wAIHA, followed by an OLE period Trial achieved stringent 1EP of a durable hemoglobin response & showed…

ByRidhi RastogiFebruary 25, 2026

Ridhi Rastogi

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)

Novo Nordisk and Vivtex Partner in ~2.1B Metabolic Deal to Develop Oral Therapies

IDEAYA Biosciences Reports the First Patient Enrolment in P-I Trial of IDE034

Pfizer’s Braftovi Regimen Receives US FDA Full Approval for Metastatic Colorectal Cancer

SteinCares Forges Licensing Agreement with Shilpa Biologicals for Biosimilars Across Latin America

GSK to Acquire 35Pharma for $950M

The US FDA Approves Regeneron and Sanofi’s Dupixent for Allergic Fungal Rhinosinusitis (AFRS)

J&J Reports the FDA’s sBLA Submission for Imaavy to Treat Warm Autoimmune Hemolytic Anemia

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