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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…

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EMA Marketing Authorization of New Drugs in December 2024

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…

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Galderma

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) &…

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Galderma

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…

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Viewpoints_Baldo Scassellati Sforzolini

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…

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