European Academies' Science Advisory Council

MoonLake Immunotherapeutics announces the full dataset from its 24-week MIRA clinical trial, establishing the Nanobody® sonelokimab as a highly promising and differentiated therapeutic solution for Hidradenitis Suppurativa

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일요일, 10월 15, 2023
III, PPT, Pain, Professor, Hidradenitis, Quality of life, European Academies' Science Advisory Council, Pharmacokinetics, Doctor of Philosophy, MS, Journal of the European Academy of Dermatology and Venereology, Education, DLQI, Data, Venereology, Safety, Psoriasis, Hidradenitis suppurativa, Moonlake, Disease, FDA, Adalimumab, Webcast, Immunology, Maintenance, Abscess, I&I, Master of Education, MIRA, PGI, Pennsylvania State University, Patient, HS, Pharmaceutical industry, Perfume, Birth control, Dermatology, MD, Inflammation

We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.

Key Points: 
  • We have consistently observed best-in-class clinical activity with our Nanobody®sonelokimab for hidradenitis suppurativa and these results demonstrate its effect on a number of clinically meaningful endpoints.
  • In June we elevated the bar for clinical response to HiSCR75 as the primary endpoint.
  • The MIRA trial set a landmark milestone as the first placebo-controlled randomized trial in HS to use Hidradenitis Suppurative Clinical Response 75 (HiSCR75) as the primary endpoint.
  • The 24-week results show that ongoing treatment with sonelokimab 120mg and 240mg dosed Q4W, further increased HiSCR75 response rates compared to week 12.

Samsung Bioepis Presents Two Abstracts at EADV 2023 Congress, Highlighting Continuous Dedication in Dermatology

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수요일, 10월 11, 2023
Congress, Partnership, SB5, Physician, PASI, European Academies' Science Advisory Council, Pharmacokinetics, Ustekinumab, Abstract, Medicine, Novartis, PK, Week, European Commission, Safety, Psoriasis, Biosimilar, Adalimumab, Samsung, UST, EC, SB2, Journal of the European Academy of Dermatology and Venereology, Infliximab, United Kingdom membership of the European Economic Area, Biogen, Civil service commission, Etanercept, Patient, Generic drug, Medical device, Dermatology, Venereology, EEA

The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.

Key Points: 
  • The study demonstrated biosimilarity of SB17 to UST through equivalent efficacy and comparable safety and PK up to Week 28.
  • SB17 is Samsung Bioepis’ fourth candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab) and SB5 (adalimumab).
  • Samsung Bioepis’ and Biogen’s anti-TNF treatment products have helped nearly 256,0003 patients in Europe.
  • Details of the Samsung Bioepis’ abstracts are as follows:

Almirall's Lebrikizumab Improves Signs and Symptoms of Moderate-to-Severe Atopic Dermatitis (AD) in Patients Inadequately Controlled With or Ineligible for Cyclosporine1

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금요일, 10월 13, 2023
Health, Managed Care, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Congress, EudraCT, Eli Lilly and Company, Knowledge, European Academies' Science Advisory Council, Advantage, CHMP, Abstract, Advocate, Ciclosporin, United Kingdom, BME, University, Week, Safety, ALM, Human, Disease, NRS, Psoriasis Area and Severity Index, Journal of the European Academy of Dermatology and Venereology, Almirall, Adolescence, Marketing, IGA, Adherence, AD, TCS, News, Overalls, EASI, Patient, Quality of life, Pharmaceutical industry, Dermatology, Venereology

Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.

Key Points: 
  • Improvements in absolute skin response over 16 weeks for patients with moderate-to-severe AD treated with lebrikizumab or placebo were also shared.
  • Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, in Europe.
  • Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.
  • † More information about the Phase 3 studies: ADvocate 1: EudraCT Number 2019-002932-10; NCT04146363; ADvocate 2: EudraCT Number 2019-002933-12; NCT04178967; ADhere: EudraCT Number 2019-004300-34; NCT04250337

Kyowa Kirin Announces Three Abstracts and A Symposium at the European Academy of Dermatology and Venereology Congress 2023

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수요일, 10월 11, 2023
Congress, Pain, Partnership, European Academies' Science Advisory Council, Amgen, AMG, Atopic dermatitis, Journal of the European Academy of Dermatology and Venereology, Inflammation, Kyowa Kirin, Week, TSE, Skin, Psoriasis Area and Severity Index, SCORAD, Itch, Neck, Score, Head, AD, Patient, Vaccine, Pharmaceutical industry, Dermatology, Venereology, EASI

Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.

Key Points: 
  • Often beginning in childhood, AD affects 15-20% of children and up to 10% of adults, making it the 15th most common nonfatal disease.
  • "We are pleased to share this additional data from the rocatinlimab Phase 2b study," said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin.
  • "It provides further insight into the potential of rocatinlimab in treating patients living with moderate-to-severe atopic dermatitis.
  • EASI lichenification scores were assessed separately for the following body regions: head and neck (H&N), trunk, upper limbs, and lower limbs.

Jaclyn Leibl-Cote named Collette Chief Executive Officer

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금요일, 10월 6, 2023
Rhode, Knowledge, MBA, University, Female, Babson College, Culture, American Heart Association, Senior, European Academies' Science Advisory Council, Growth, Marketing, Executive, Management

PAWTUCKET, R.I., Oct. 6, 2023 /PRNewswire/ -- Collette, the Rhode Island-based global tour operator, announces the succession of Jaclyn Leibl-Cote to Chief Executive Officer of the organization, only the fourth CEO in the company's 106-year history. She is the third generation of the Sullivan family to transition into the role, and the first female leader of the company. In this role, she will lead Collette's Executive and Strategic Leadership Teams, driving both the global company's strategic direction and its day-to-day operations with a laser focus on fulfilling the company's mission of enhancing life's journey by creating extraordinary travel experiences.

Key Points: 
  • PAWTUCKET, R.I., Oct. 6, 2023 /PRNewswire/ -- Collette, the Rhode Island-based global tour operator, announces the succession of Jaclyn Leibl-Cote to Chief Executive Officer of the organization, only the fourth CEO in the company's 106-year history.
  • "This transition is the culmination of a comprehensive succession planning process to ensure leadership continuity and position Collette for continued growth.
  • Jaclyn has served as President and Chief Customer Experience Officer since 2018, bringing a wealth of knowledge to the organization.
  • Leibl-Cote joined Collette in 2005, holding roles as tour guide, client care agent, product designer and strategist, head of marketing, and most recently as President and Chief Customer Experience officer.

Astria Therapeutics Reports Second Quarter Financial Results and Provides a Corporate Update

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월요일, 8월 7, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, PK, PD, Senior, Pharmacy, Hereditary angioedema, Pharmacokinetics, European Academies' Science Advisory Council, HAE, Patient, Investment, Allergy, First Nations Summit, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Angioedema, Food, Safety, D, Pharmaceutical industry, Lithium, Cryptocurrency, Asteria

Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • Astria Therapeutics, Inc. (NASDAQ:ATXS), a biopharmaceutical company developing STAR-0215 for the treatment of hereditary angioedema (HAE) and focused on life-changing therapies for rare and niche allergic and immunological diseases, today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.
  • In the fourth quarter of 2023, the company expects to announce final results from three single dose cohorts in healthy subjects.
  • Initial results from the two additional dose-ranging cohorts in healthy subjects are also expected to be shared in Q4.
  • Pending proof-of-concept results from the ALPHA-STAR trial, Astria expects to progress directly to a pivotal trial.

Teva’s 3rd interim analysis of PEARL real-world study on AJOVY® (fremanezumab) reveals sustained long-term effectiveness in reducing frequency, duration and severity of attacks in patients with chronic and episodic migraine

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금요일, 6월 30, 2023
Research, Neurology, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Real, Abstract, EAN, Migraine, EHF, University of Pavia, University, Teva, Disability, PEARL, Quality of life, CGRP, Month, Behavioural sciences, Female, Congress, European Academies' Science Advisory Council, Patient, Mab, FINESSE, Calcitonin gene-related peptide, Safety, MMD, Pharmaceutical industry, Health insurance, Aroma compound, Cultured pearl, Brain

Not only was fremanezumab effective in preventing migraine attacks in patients with chronic and episodic migraine, but it has also shown to be effective in reducing the severity and duration of remaining migraine attacks.

Key Points: 
  • Not only was fremanezumab effective in preventing migraine attacks in patients with chronic and episodic migraine, but it has also shown to be effective in reducing the severity and duration of remaining migraine attacks.
  • Four abstracts from the third interim analysis of the PEARL study will be presented at the 9th European Academy of Neurology (EAN) Congress in Budapest, Hungary.
  • 968 patients (87.3% female) out of the 1140 study patients had available data to include in the 3rd interim analysis.
  • The mean monthly duration of remaining migraine attacks and monthly mean score for peak headache severity of remaining migraine attacks decreased at 12 months after fremanezumab initiation.