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 CPUOPatient enrollment for both studies is planned to start in H2’25, with expected completion in 2028 for SSc and in 2026 (US) for CPUONemolizumab is a mAb targeting the IL‑31 receptor…

ByDipanshu DixitJune 26, 2025

NEWS

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Shots:The OLYMPIA long-term extension study assessed Nemluvio in 508 pts with prurigo nodularis up to 4yrs., which were enrolled from the P-II or P-III (OLYMPIA 1 & 2) trialsInterim analysis at Wk. 100 showed sustained improvement, with over 90% achieving ≥4-point itch reduction & 70% being itch-free or nearly itch-free per Peak-Pruritus Numerical…

ByRidhi RastogiJune 18, 2025

VIEWPOINTS

Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots

Shots: Recently, the groundbreaking results from Galderma’s Phase III OLYMPIA 1 trial were published in JAMA Dermatology. The study evaluated nemolizumab in patients with moderate-to-severe active prurigo nodularis The trial met all primary and secondary endpoints, with results aligning with those from the OLYMPIA 2 trial, reinforcing nemolizumab’s potential in achieving sustained improvements in the…

BySaurabh ChaubeyMay 26, 2025

TOP 20

Top 20 Healthcare IPOs of 2024

Shots:Initial Public Offerings (IPOs) serve as a strategic avenue for private healthcare companies to enhance liquidity, secure capital, and strengthen market presence. Beyond fundraising, going public often paves the way for strategic partnerships and expanded industry influence.Galderma led the IPO landscape in 2024, raising a staggering $2.54B, followed by BrightSpring Health Services and…

ByPrince GiriFebruary 27, 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

NEWS

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

Shots:Based on ARCADIA and OLYMPIA studies EU approved Nemluvio for moderate-to-severe AD and PN and is now approved for SC use in pts. aged 12 and older for AD and in adults for PN who are candidates for systemic therapy ARCADIA 1 & 2 studies assessed Nemluvio (Q4W) + TCS ± TCI vs PBO…

ByRidhi RastogiFebruary 14, 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

VIEWPOINTS

GAIN JPAC 2024: Gerry Muhle from Galderma in a Stimulating Dialogue Exchange with PharmaShots

Shots: GAIN JPAC is an emerging platform where leaders in aesthetics convene to share knowledge and advance patient treatment and safety PharmaShots hosted Gerry Muhle, Head of Global Product Strategy at Galderma, who discussed the ‘Next by Galderma’ report, providing insights into the future of the aesthetics market and helping professionals better understand patient and…

BySaurabh ChaubeyDecember 30, 2024

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

NEWS

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

Shots: The CHMP's recommendation of Nemluvio (SC) for mod. to sev. atopic dermatitis (≥12yrs.) & prurigo nodularis in eligible ones for systemic therapy was based on P-III ARCADIA & OLYMPIA studies, respectively. Reviews are ongoing in Australia, Singapore, Switzerland, Canada, Brazil & South Korea, with more filings underway ARCADIA 1 & 2 studies assessed…

ByDipanshu DixitDecember 13, 2024

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

Galderma to Present OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis at ICD 2025

Chronic Dermatologic Care: Baldo Scassellati Sforzolini from Galderma in Conversation with PharmaShots

Top 20 Healthcare IPOs of 2024

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

Galderma’s Nemluvio (Nemolizumab) Secures the EU Approval to Treat Moderate-To-Severe Atopic Dermatitis (AD) and Prurigo nodularis (PN)

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)

Galderma’s Nemluvio (Nemolizumab) Receives Positive CHMP Opinion to Treat Prurigo Nodularis (PN) and Atopic Dermatitis

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