LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

Shots: The US FDA has approved Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had inadequate response or are unamenable to topical corticosteroids Approval was based on P-III (DELTA 1 & DELTA 2) trials assessing Anzupgo (BID) vs vehicle in 960 adults with mod. to sev. CHE, both of which…

ByRidhi Rastogi2 days ago

News

BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

Shots: LEO Pharma has entered into an exclusive global license & transfer agreement with BI to commercialize & advance the development of Spevigo (spesolimab) As per the deal, LEO Pharma will handle commercialization & further development of Spevigo in exchange for $105.18M (€90M) upfront, along with milestones & tiered royalties; closing expected in H2’25, subject…

ByRidhi RastogiJuly 14, 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

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Shots: Junshi with its subsidiary, TopAlliance, has partnered with LEO to market toripalimab in 32 EU countries incl. EEA, Switzerland & the UK. TopAlliance will remain the authorization holder overseeing development, manufacturing, registration & other activities in the EU LEO Pharma will handle the drug distribution, promotion & sales plus will pay an upfront…

BySenior EditorJanuary 21, 2025

News

Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Shots: Gilead has entered into a strategic collaboration with LEO Pharma to develop the latter’s small molecule oral STAT6 programs targeting various inflammatory disorders As per the terms, Gilead secures worldwide rights to develop, manufacture & commercialize LEO’s preclinical STAT6 inhibitors & degrading proteins, with LEO having the option to co-commercialize them for dermatology…

BySenior EditorJanuary 13, 2025

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in October 2022

The EMA approved 2 Biologic Drugs in October 2022, leading to treatments for patients and advances in the healthcare industry In October 2022, the major highlights drugs were Yescarta approval for diffuse large B-cell lymphoma and high-grade B-cell lymphoma, and Adtralza for atopic dermatitis PharmaShots has compiled a list of a total of 2 new…

BySenior EditorNovember 23, 2022

News

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

Shots: The CHMP has granted positive opinion to Anzupgo cream (topical pan-JAK inhibitor) for treating moderate to severe chronic hand eczema (CHE), inadequately managed by topical corticosteroids Opinion was based on P-III (DELTA 1 & DELTA 2) trials assessing the safety & efficacy of Anzupgo (BID) vs vehicle for moderate to severe CHE. Those…

ByDipanshu DixitJuly 26, 2022

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2022

The first quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Stryker signed a definitive agreement to acquire Vocera Communications for ~$3.09B, Biohaven acquire Channel Biosciences for ~$3B The first quarter of the year also showcases regulatory events…

BySenior EditorMarch 31, 2022

LEO Pharma’s Anzupgo (Delgocitinib) Gains the US FDA’s Approval to Treat Chronic Hand Eczema (CHE)

BI Collaborates with LEO Pharma to Commercialize & Develop Spevigo

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

Junshi Biosciences & LEO Pharma Collaborate to Commercialize Toripalimab in Europe

Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Insights+: EMA Marketing Authorization of New Drugs in October 2022

LEO Pharma’s Anzupgo (Delgocitinib) Gains the CHMP’s Positive Opinion to Treat Moderate to Severe Chronic Hand Eczema (CHE)

PharmaShots’ Key Highlights of First Quarter 2022

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