Dermatomyositis

Sage Therapeutics Appoints Laura M. Gault, M.D., Ph.D. as Chief Medical Officer

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星期二, 十一月 1, 2022
Health, Neurology, General Health, Research, Science, Pharmaceutical, Biotechnology, Security (finance), Goal, Neuropsychiatry, Adult, Risk, GMG, Knowledge, Neurodegeneration, Geographic atrophy, U.S. Securities and Exchange Commission, Case Western Reserve University, Ophthalmology, American Academy of Child and Adolescent Psychiatry, Vertex Pharmaceuticals, Child and adolescent psychiatry, Neurology, University, Doctor of Philosophy, NASDAQ, Private Securities Litigation Reform Act, Medicine, Therapy, Adolescence, FDA, NMOSD, AbbVie, Patient, Compte rendu, Solution, Depression, Yale University, Neuromyelitis optica spectrum disorder, Pharmaceutical industry, Medical device, MD, Psychiatry, Neuroscience, Dermatomyositis, Sage, Pediatrics, Child

Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the appointment of Laura Gault, MD, Ph.D. as Chief Medical Officer.

Key Points: 
  • Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced the appointment of Laura Gault, MD, Ph.D. as Chief Medical Officer.
  • In her new role, Dr. Gault will focus on advancing Sages current and emerging product pipeline through all stages of development.
  • Sage is leading the way in addressing brain health with purposeful science and a dedicated focus on what matters most to patients.
  • Sage Therapeutics is a biopharmaceutical company fearlessly leading the way to create a world with better brain health.

ProDERM Study Results of octagam® 10% Treatment in Patients With Dermatomyositis Published in the New England Journal of Medicine

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星期四, 十月 6, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Octapharma, Muscle, Aggarwal, The New England Journal of Medicine, Progress, Muscle weakness, Patient, DM, Mortality, Immunoglobulin therapy, Disease, Safety, Skin, Pharmaceutical industry, Vaccine, Dermatomyositis, Dermatomyositis

Prior to the ProDERM study findings, no therapy had been approved in the US or Europe for the treatment of dermatomyositis based on randomized clinical trials.

Key Points: 
  • Prior to the ProDERM study findings, no therapy had been approved in the US or Europe for the treatment of dermatomyositis based on randomized clinical trials.
  • The Progress in DERMatomyositis (ProDERM) study was the first large randomized clinical trial to investigate an intravenous immunoglobulin (IVIg) (octagam 10%) in dermatomyositis.
  • The results of the study demonstrated that octagam 10% is an efficacious and well-tolerated treatment for adults with dermatomyositis.
  • Significantly more patients receiving octagam 10% achieved a major or at least moderate improvement in the Total Improvement Score.

Kezar Life Sciences Receives FDA Clearance of IND for Zetomipzomib for the Treatment of Autoimmune Hepatitis

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星期一, 十月 3, 2022
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Inflammation, Association, Disease, Lupus nephritis, Conditional sentence, Indiana University, U.S. Securities and Exchange Commission, Mortality, ALT, Assistant, Physician, Nasdaq, IND, Private Securities Litigation Reform Act, Food, AST, Liver, Cataract, Prednisone, Autoimmune hepatitis, Polymyositis, Immune system, Lupus, List of life sciences, Week, Hepatocellular carcinoma, Safety, Immunosuppression, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Quality of life, Program, Cirrhosis, Liver failure, Dermatomyositis, Patient, AIH, Forward-looking statement, Sec61, Degenerative disease, Diabetes, Pharmaceutical industry, Vaccine, Medicine

Standard of care treatment for AIH is immunosuppressive treatment with chronic corticosteroids that can lead to additional morbidity and mortality.

Key Points: 
  • Standard of care treatment for AIH is immunosuppressive treatment with chronic corticosteroids that can lead to additional morbidity and mortality.
  • There is a significant need for treatment regimens that reduce or remove the need for chronic immunosuppression using corticosteroids.
  • Zetomipzomib is a unique small molecule with the potential to be a non-immunosuppressive, anti-inflammatory treatment for multiple autoimmune diseases.
  • Kezar Life Sciences is a clinical-stage biopharmaceutical company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders.

Octapharma USA to Present Clinical Overview of Dermatomyositis During The Myositis Association’s Annual Conference

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星期三, 九月 7, 2022
Health, Managed Care, Clinical Trials, Research, Pharmaceutical, Science, Kidney failure, Inflammation, Patient, Lists of diseases, National Center for Advancing Translational Sciences, Muscle, Safety, Human services, Kidney, Degenerative disease, Hemorheology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Swelling, Risk factor, Disease, Pulmonary fibrosis, Arthralgia, Estrogen, RN, Death, United States Department of Health and Human Services, Critical care, Food, Skin, Immobilization, Myositis, National Institutes of Health, DM, Multimedia, Symbiosis, Microdeletion syndrome, Plasma, National, Conference, FDA, Sucrose, Immunoglobulin therapy, Adult, Thrombosis, Risk, Immune-mediated inflammatory diseases, Hematology, Octapharma, Polymyositis, TMA, BSN, Pharmaceutical industry, Immunotherapy, Dermatomyositis, Health

(Photo: Business Wire)

Key Points: 
  • (Photo: Business Wire)
    We are excited to have Octapharma participate in the 2022 International Annual Patient Conference, said TMA Executive Director Chrissy Thornton.
  • Octapharmas pivotal clinical research on DM has been an important resource for the myositis community.
  • Octapharma is committed to developing life-saving and life-enhancing therapies for patients with rare diseases, including dermatomyositis, said Octapharma USA President Flemming Nielsen.
  • Laurel Cherwin, RN, BSN, Octapharma USA Clinical Nurse Educator, will present a 90-minute clinical overview of dermatomyositis during the conference.

Second Annual ILD Day to Drive Awareness of Interstitial Lung Disease on Sept. 14

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星期三, 八月 24, 2022
Inflammation, CDT, BBB, Scar, Fatigue, Rheumatoid arthritis, Research, Caregiver, CEO, Pulmonary fibrosis, Awareness, Disease, Scleroderma Research Foundation, PFF, Sarcoidosis, Scleroderma, Interstitial lung disease, Organization, Foundation, National Health Council, DM, PF, Patient, Better Business Bureau, Myositis, Certification, Dermatomyositis, IPF, Oxygen, Cystic Fibrosis Foundation, Cough, Polymyositis, Charity Navigator, Idiopathic pulmonary fibrosis, Medical device, Medicine, ILD

CHICAGO, Aug. 24, 2022 /PRNewswire/ -- Nine organizations are joining forces to present the second annual ILD Day on Wednesday, Sept. 14, to drive awareness of interstitial lung disease (ILD).

Key Points: 
  • CHICAGO, Aug. 24, 2022 /PRNewswire/ -- Nine organizations are joining forces to present the second annual ILD Day on Wednesday, Sept. 14, to drive awareness of interstitial lung disease (ILD).
  • PF can be seen in many types of ILD and the damage caused by ILD can be irreversible and worsen over time.
  • "The goal of ILD Day is to expand the understanding of ILD among patients and healthcare providers, and to share resources and support for those who are living with the disease."
  • ILD Day was created to drive awareness of interstitial lung disease (ILD) in 2021 and is recognized annually on the second Wednesday in September.

Roivant Sciences Reports Financial Results for the First Quarter Ended June 30, 2022 and Provides Business Update

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星期一, 八月 15, 2022
MDS, Psoriasis, MG, Transfusion-dependent anemia, Roivant Sciences, Drug discovery, SLE, Industry, GLOBE, Senior, EASI, NEW, R, Dermatomyositis, Merck Serono, Prescription, Tobacco, Achievement, IQVIA, Namilumab, Phase 1, Patient, Vant (band), TED, Calendar, Hidradenitis suppurativa, Company, Alopecia areata, SG, Neurology, IGA, Japan Tobacco, Safety, Atopic dermatitis, Sarcoidosis, Research, JAK1, AD, Ulcerative colitis, TYK2, MAAC, Graves' ophthalmopathy, EDT, Pharmaceutical industry, Animal, Immunology, Pfizer

First Quarter Ended June 30, 2022 Financial Summary

Key Points: 
  • First Quarter Ended June 30, 2022 Financial Summary
    As of June 30, 2022, we had cash, cash equivalents and restricted cash of approximately $2.0 billion.
  • Net loss was $353.8 million for the three months ended June 30, 2022 compared to $101.1 million for the three months ended June 30, 2021.
  • On a per common share basis, net loss was $0.48 for the three months ended June 30, 2022 and $0.13 for the three months ended June 30, 2021.
  • Non-GAAP net loss was $210.7 million for the three months ended June 30, 2022 compared to $133.4 million for the three months ended June 30, 2021.

First key steps in pipeline rebuild and strong commercial progress in H1 2022

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星期四, 八月 4, 2022
Committee for Medicinal Products for Human Use, Q&A, Adoption, Exercise, Drug discovery, FTE automotive, IPF, Committee, European Directive on Traditional Herbal Medicinal Products, Sale, RA, MANTA, Hospital, UC, Income, Baltic, Patient, Mission statement, D, Depreciation, CHMP, Czech Republic, TYK2, Royal commission, European Commission, Saitama (city), Pharmacovigilance, Drug, Tutoring, Pharmaceutical industry, Renewable energy, Aquaculture, Cryptocurrency, Dermatomyositis, Filgotinib, Galápagos Islands, Central Europe

Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to 5.5 million.

Key Points: 
  • Cost of sales related to Jyseleca net sales in the first six months of 2022 amounted to 5.5 million.
  • Collaboration revenues amounted to 238.6 million for the first six months of 2022, compared to 253.2 million for the first six months of 2021.
  • Depreciation and impairment amounted to 32.6 million for the first six months of 2022 (8.1 million for the same period last year).
  • The preliminary accounting of the acquisitions of CellPoint and AboundBio are included in our H1 2022 condensed consolidated financial statements.

Ermium Therapeutics Extends Its Initial €6,3 M Funding to €12,3 M to Further Advance Breakthrough Auto-Immune Disease Therapeutics

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星期四, 六月 30, 2022
Health, Other Health, Other Science, Research, Science, Pharmaceutical, Biotechnology, Science, Patient, CEO, Biotechnology, USD, SLE, Dermatomyositis, GPCR, CXCR4, Intellectual property, CNRS, Health, Venture capital, Degenerative disease, Kurma, Investment, Therapy, EUR, Travancore–Cochin, Program, Pharmaceutical industry, Vaccine

Ermium Therapeutics, a Paris-based biotech company developing innovative health products for auto-immune diseases, announced today the extension of its initial funding of 6.3 M to 12.3 M with Kurma Partners and Fountain Healthcare Partners.

Key Points: 
  • Ermium Therapeutics, a Paris-based biotech company developing innovative health products for auto-immune diseases, announced today the extension of its initial funding of 6.3 M to 12.3 M with Kurma Partners and Fountain Healthcare Partners.
  • Fountain Healthcare Partners, a transatlantic life science investor, is joining and widening the Ermium Therapeutics initial investment syndicate composed of Kurma Partners, Eurazeo, Domain Therapeutics, and Erganeo.
  • We were very impressed by the work accomplished by the team at Ermium Therapeutics.
  • About Ermium Therapeutics: Ermium Therapeutics, a discovery stage company, was founded in June 2019 by Dr Jean-Philippe Herbeuval (CNRS Universit Paris Cit), Kurma Partners, Domain Therapeutics, and Erganeo.

Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus

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星期二, 六月 28, 2022
Science, Patient, Program, Research, Phase 1, GLOBE, COVID-19, Heart failure, YouTube, Interstitial lung disease, Environment, Psoriasis, Autoimmune disease, Vaccine, Therapy, Securities Act of 1933, Securities Exchange Act of 1934, Autoimmune skin diseases in dogs, Alopecia areata, Medicine, Development, MPH, NYSE, JAK, Risk, Lupus, TYK2, Twitter, Muscle, JAK1, LinkedIn, Ulcerative colitis, SLE, Harvard Medical School, Lists of diseases, Degenerative disease, Inflammation, News, PFE, Malignancy, U.S. Securities and Exchange Commission, Mortality, Immune dysregulation, Clinical trial, Hidradenitis suppurativa, Disability, Facebook, Skin, NEW, Disease, Safety, Pharmaceutical industry, Audit, Roivant Sciences, Dermatomyositis, Brigham, Pfizer, MD

Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinibs global development rights and US and Japan commercial rights to Priovant.

Key Points: 
  • Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinibs global development rights and US and Japan commercial rights to Priovant.
  • Priovant recently initiated a single registrational Phase 3 study in dermatomyositis ( VALOR ).
  • Priovant recently initiated a single registrational Phase 3 study evaluating oral brepocitinib in dermatomyositis ( VALOR ).
  • Oral brepocitinib is being evaluated in a large, global Phase 2b study in SLE, designed to serve as one of two registrational studies.

Roivant and Pfizer Unveil Priovant Therapeutics and Ongoing Registrational Studies for Oral Brepocitinib in Dermatomyositis and Lupus

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星期二, 六月 28, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, Science, Patient, Program, Research, Phase 1, COVID-19, Heart failure, YouTube, Interstitial lung disease, Environment, Psoriasis, Autoimmune disease, Vaccine, Therapy, Securities Act of 1933, Securities Exchange Act of 1934, Autoimmune skin diseases in dogs, Alopecia areata, Medicine, Development, MPH, Drug Quality and Security Act, NYSE, JAK, Risk, Lupus, TYK2, Twitter, Muscle, JAK1, LinkedIn, Ulcerative colitis, SLE, Harvard Medical School, Lists of diseases, Degenerative disease, Inflammation, News, Multimedia, PFE, Malignancy, U.S. Securities and Exchange Commission, Mortality, Immune dysregulation, Clinical trial, Hidradenitis suppurativa, Disability, Facebook, Skin, Disease, Safety, Pharmaceutical industry, Audit, Risk management, Roivant Sciences, Dermatomyositis, Brigham, Pfizer, MD

Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinibs global development rights and US and Japan commercial rights to Priovant.

Key Points: 
  • Priovant was established in September 2021 through a transaction between Roivant (Nasdaq: ROIV) and Pfizer (NYSE: PFE), in which Pfizer licensed oral and topical brepocitinibs global development rights and US and Japan commercial rights to Priovant.
  • Oral brepocitinib is being evaluated in two ongoing registrational programs.
  • Priovant recently initiated a single registrational Phase 3 study evaluating oral brepocitinib in dermatomyositis ( VALOR ).
  • Oral brepocitinib is being evaluated in a large, global Phase 2b study in SLE, designed to serve as one of two registrational studies.