Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Shots: Part A of P-II (APEX) trial assessed APG777 vs PBO in 123 mod. to sev. AD pts, which met its 1EP with 71% vs 33.8% EASI reduction as well as highest absolute & PBO-adjusted EASI-75 (66.9% vs 24.6%); results were consistent across disease severity, & EASI-75 at Wk. 16 reached 83.3% & 89.5% in…

ByRidhi RastogiJuly 7, 2025

VIEWPOINTS

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

Shots: Backed by positive results from the P-III ARCADIA study, Galderma’s Nemluvio recently received approval from the US FDA for patients with moderate to severe atopic dermatitis Nemluvio (nemolizumab) has previously been approved for the treatment of prurigo nodularis Christophe Piketty, VP, Head of Innovation, Therapeutic Dermatology, Global Clinical Sciences, Galderma, highlighted insights from the…

BySaurabh ChaubeyJune 30, 2025

NEWS

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Shots: Galderma announced the initiation of two P‑II clinical studies evaluating the efficacy and safety of nemolizumab in pts with SSc and CPUO Patient enrollment for both studies is planned to start in H2’25, with expected completion in 2028 for SSc and in 2026 (US) for CPUO Nemolizumab is a mAb targeting the IL‑31 receptor…

ByDipanshu DixitJune 26, 2025

NEWS

The CVMP Adopts Positive Opinion on Elanco’s Zenrelia for Allergic and Atopic Dermatitis in Dogs

Shots: The CVMP has recommended Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs Opinion was based on clinical data demonstrating quality, safety, efficacy, & a favorable benefit-risk profile incl. a non-inferiority study conducted as a part of the EU approval process Elanco plans to…

ByRidhi RastogiJune 13, 2025

NEWS

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Shots : Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg pts Dupixent achieved a ≥75% improvement in overall disease severity…

ByPrince GiriJune 10, 2025

NEWS

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

Shots: The UK’s MHRA & Swissmedic have approved Nemluvio (SC) for mod. to sev. PN & AD, where it is approved in adults for PN & in combination with TCS ± TCI in pts (≥12yrs.; ≥30kg) for AD who are candidates for systemic therapy. Awaits approval in Singapore & Australia Approval is based on P-III…

ByDipanshu DixitFebruary 18, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis PharmaShots has compiled a list of 9 drugs that have been granted positive…

ByDipanshu DixitJanuary 23, 2025

NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

Shots: The US FDA has approved Nemluvio + TCS ± calcineurin inhibitors (TCI) to treat mod. to sev. atopic dermatitis in patients unresponsive to topical therapies Approval was based on the P-III (ARCADIA) study of the combination vs PBO in patients (n=1,728; ≥12yrs.), showing significant skin clearance in both co-1EPs of IGA score (0/1) &…

ByDipanshu DixitDecember 13, 2024

THOUGHTSPOT

The Role of CCL17 in Immune Regulation: Unlocking New Therapeutic Possibilities

The CCL17 gene, a key player in the human immune system, has garnered significant attention for its role in disease regulation. This chemokine gene is pivotal in mediating immune responses, acting as a messenger that guides immune cells to sites of inflammation. Understanding its function and regulation is essential for unraveling the complexities of immune-related…

ByYan LiaoNovember 8, 2024

VIEWPOINTS

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots: Galderma’s Nemluvio (nemolizumab) was recently approved by the US FDA for the treatment of adults with prurigo nodularis, following positive Phase III results from the OLYMPIA study. Today at PharmaShots, we have Baldo Scassellati Sforzolini, Global Head of Research & Development at Galderma, to discuss the study’s design and the potential of Nemluvio in…

BySaurabh ChaubeyOctober 23, 2024

Apogee Therapeutics Reports P-II (APEX) Trial Data on APG777 for Atopic Dermatitis (AD)

Unlocking Approval: Christophe Piketty from Galderma in an Illuminating Conversation with PharmaShots

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

The CVMP Adopts Positive Opinion on Elanco’s Zenrelia for Allergic and Atopic Dermatitis in Dogs

Regeneron Highlights Dupixent (dupilumab) Data From P-IV (DISCOVER) Study at RAD’25

Galderma’ Nemluvio Receives UK’s MHRA & Swissmedic Approval for Atopic Dermatitis and Prurigo Nodularis

EMA Marketing Authorization of New Drugs in December 2024

Galderma’s Nemluvio (Nemolizumab) Secures the US FDA’s Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD)

The Role of CCL17 in Immune Regulation: Unlocking New Therapeutic Possibilities

Unlocking Approval: Baldo Scassellati Sforzolini from Galderma in a Stimulating Dialogue Exchange with PharmaShots

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