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llllllllll Stelara (ustekinumab) / J&JU.S. Food and Drug Administration Approves STELARA (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (PRNewswire) - Jul 30, 2020 - "The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for STELARA® (ustekinumab) as a treatment for pediatric patients (6-11 years of age) who struggle with the skin lesions or plaques associated with moderate to severe plaque psoriasis (PsO)....STELARA is administered as an injection given under the skin, dosed four times per year after two starter doses....The FDA approval of STELARA for pediatric use is based on results from the CADMUS Junior study..."llllllllll Cosentyx (secukinumab) / NovartisNovartis Cosentyx receives EU approval for first-line systemic treatment in pediatric psoriasis (GlobeNewswire) - Aug 3, 2020 - "Novartis...today announced the European Commission (EC) has granted the approval for Cosentyx® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in children and adolescents aged 6 tollllllllll bimekizumab (UCB4940) / UCBUCB Half Year Report 2020 (StockHouse) - Jul 27, 2020 - "Operating expenses reached € 1 311 million (+14%; +13% CER) driven by...as well as launch preparations for bimekizumab for the treatment of psoriasis."llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimSkyrizi: Data from P3 KEEPsAKE 1 trial (NCT03675308) for psoriatic arthritis in 2020 (AbbVie) - Aug 1, 2020 - Q2 2020 Results: Data from P3 trial (NCT03105102) for Crohn's disease in Q4 2020/Q1 2021llllllllll EDP1815 / Evelo BiosciEvelo Biosciences Reports Second Quarter 2020 Financial Results and Business Highlights (BioSpace) - Jul 30, 2020 - "Achieved regulatory and ethics authorization for phase 2 dose ranging trial for EDP1815 in moderate psoriasis in the U.S., UK, and EU. The Company is on-track to initiate the trial in 3Q 2020."llllllllll Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimSkyrizi: Regulatory submissions for Crohn’s disease and psoriatic arthritis in 2021 (AbbVie) - Aug 1, 2020 - Q2 2020 Resultsllllllllll bimekizumab (UCB4940) / UCBBimekizumab: Acceptance of regulatory submission for psoriasis at the end of Q3 2020 (UCB) - Jul 28, 2020 - H1 2020 Results [Screenshot]llllllllll Stelara (ustekinumab) / J&J; Skyrizi (risankizumab) / AbbVie, Boehringer IngelheimA Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms (clinicaltrials.gov) - Jul 27, 2020 - P3; N=132; Recruiting; Sponsor: AbbVie; Not yet recruiting --> Recruitingllllllllll Remsima SC (infliximab biosimilar SC) / CelltrionEuropean Commission grants marketing authorisation for world’s first subcutaneous formulation of infliximab, Remsima SC, for an additional five indications including for use in inflammatory bowel disease and ankylosing spondylitis (Businesswire) - Jul 27, 2020 - "Celltrion Healthcare today announced that the European Commission (EC) has granted marketing authorisation for Remsima® (infliximab, CT-P13) subcutaneous (SC) formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis....We will accelerate the launch process on a country-by-country basis...Celltrion anticipates receiving approval of Remsima® SC in 97 countries, including 31 countries in Europe."llllllllll Ilumya (tildrakizumab-asmn) / Sun Pharma, AlmirallAlmirall: Sustained performance of key growth drivers and excellent progress on pipeline in H1 despite negative impact of COVID-19 (PRNewswire) - Jul 27, 2020 - "Key growth drivers continue to show positive results. Ilumetri® performed strongly despite a decrease in new patient initiations during the COVID-19 pandemic...These assets, together with Lebrikizumab, have the potential to deliver an exciting new era of growth for Almirall."
