Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

Shots: BMS & Bain Capital have launched a new independent biopharma company focused on autoimmune diseases, which will be backed by $300M funding commitment led by Bain & 5 immunology assets in-licensed from BMS As per the deal, BMS will retain ~20% equity stake in the new company & is entitled to receive royalties & milestone payments for…

ByRidhi RastogiJuly 29, 2025

NEWS

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

Shots: The EC has approved Zenrelia (ilunocitinib) for the treatment of pruritus linked to allergic dermatitis & clinical symptoms of atopic dermatitis in dogs (≥12mos.) As part of the EU approval process, Elanco conducted an H2H non-inferiority study in 338 dogs across 25 sites in 4 countries, which showed that Zenrelia (QD) is at least…

ByRidhi RastogiJuly 25, 2025

NEWS

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

Shots: LEO Pharma has reported 16wk. interim data from P-IIIb (ADHAND) trial assessing Adbry monotx. (tralokinumab; 300mg, Q2W) vs PBO for 16wks. in adults with mod. to sev. atopic dermatitis on hands eligible for systemic therapy, followed by a 16wk. open-label phase, where all pts received Adbry Trial met its 1EP, with higher proportion of…

ByRidhi RastogiJuly 10, 2025

NEWS

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

Bristol Myers Squibb and Bain Capital Launch a New Company Focused on Immunology Therapies

Elanco’s Zenrelia Secures the EC’s Approval to Treat Allergy and Atopic Dermatitis in Dogs

LEO Pharma Reports Interim P-IIIb (ADHAND) Trial Data on Adbry for Atopic Dermatitis

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

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