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Autoimmune Disorders

Phase 3 Study Showed that Genentech’s Rituxan is Superior to Standard of Care in Achieving Sustained Remission in Pemphigus Vulgaris

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive top line results from the Roche-sponsored Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). …

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Phase 3 Study of Savara’s Molgradex Fails to Meet its Primary Endpoint in Patients with Autoimmune Alveolar Pulmonary Proteinosis

AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced top line data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP. 138 patients were randomized and received treatment for 24 weeks …

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First-of-its-Kind Data Shows Efficacy and Safety of Novartis’ Cosentyx in All Key Manifestations of Psoriatic Arthritis

Basel, June 12, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, today announced new data from the MAXIMISE trial evaluating the efficacy and safety of Cosentyx (secukinumab) in the management of axial manifestations of psoriatic arthritis (PsA). The ongoing 52-week Phase IIIb trial met both its primary and key secondary …

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Genentech’s Gazyva Met Both Primary and Key Secondary Endpoints in Phase 2 Lupus Nephritis Study

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive topline results for NOBILITY, a Phase II clinical trial investigating the safety and efficacy of Gazyva® (obinutuzumab) for adults with proliferative lupus nephritis. The study met its primary endpoint, showing Gazyva, in …

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Merck to Acquire Tilos Pharmaceuticals for up to $773 Million, Gaining Portfolio of Investigational Antibodies Modulating TGFβ

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. “At …

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Parvus Therapeutics and Genentech Partner to Develop Navacim Therapeutics for the Treatment of Autoimmune Diseases

BURLINGAME, Calif. & CALGARY, Alberta–(BUSINESS WIRE)–Parvus Therapeutics, a biopharmaceutical company focused on the development of disease-specific immunoregulatory medicines to treat autoimmune diseases without impairing normal immunity, has entered into a worldwide collaboration and license agreement with Genentech, a member of the Roche Group, to develop, manufacture, and commercialize novel Navacim™ …

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Adaptimmune and Alpine Immune Sciences Partner for Development of Next-Generation SPEAR T-Cell Products Using Alpine’s SIP and TIP Technology

PHILADELPHIA and OXFORDSHIRE, United Kingdom, May 15, 2019 (GLOBE NEWSWIRE) — Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, and Alpine Immune Sciences, Inc., Seattle, WA, (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for autoimmune diseases and cancer, today announced a collaboration and license …

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FDA Approves First Treatment for Children with Lambert-Eaton Myasthenic Syndrome, a Rare Autoimmune Disorder

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for …

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FDA Approves GSK’s Benlysta for Intravenous Use in Children with Lupus Aged Five Years and Above

LONDON and PHILADELPHIA, April 26, 2019 /PRNewswire/ — GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of …

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FDA Approves UCB’s Cimzia as First and Only Treatment for Non-Radiographic Axial Spondyloarthritis

BRUSSELS, March 28, 2019 /PRNewswire/ — UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved extending the label for CIMZIA® (certolizumab pegol) to include a new indication for the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of …

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