Shots:China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical corticosteroids; decision expected in 2027NDA was based on P-III (DELTA China) trial assessing Anzupgo (BID) vs vehicle in 362 Chinese pts with mod. to sev.…
Shots:LEO Pharma presented data from the P-III (DELTA TEEN) study, showing delgocitinib cream efficacy vs. cream vehicle in adolescents (12–17yrs.) with moderate to severe CHE; 63.5% achieved IGA-CHE treatment success vs. 29.2% with vehicleDelgocitinib cream also showed an edge across key 2EPs, including a ≥90% improvement (HECSI-90: 71.6% vs. 37.5%; HESD itch: 64.8%…
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 corticosteroidsApproval 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…
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…
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 AdbryTrial met its 1EP, with higher proportion of…
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…
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…
The EMA approved 2 Biologic Drugs in October 2022, leading to treatments for patients and advances in the healthcare industryIn 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 dermatitisPharmaShots has compiled a list of a total of 2 new…
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…
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 ~$3BThe first quarter of the year also showcases regulatory events…

