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Autoimmune Disorders

FDA Lifts Clinical Hold on Concert Pharma’s Mid-Stage Trial of CTP-543 in Alopecia Areata

LEXINGTON, Mass.–(BUSINESS WIRE)–Concert Pharmaceuticals, Inc. (NASDAQ:CNCE) today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it has lifted the clinical hold on Concert’s CTP-543 Phase 2a clinical trial for alopecia areata. The Company will amend the protocol for the Phase 2a trial to evaluate two …

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Positive Phase 2a Safety and Efficacy Data Supports Further Development of Celgene’s Oral Lupus Drug

BOUDRY, Switzerland–(BUSINESS WIRE)–Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced results from the phase 2a SLE-001 trial evaluating CC-220, the Company’s investigational, oral immunomodulatory compound, at the Annual European Congress of Rheumatology (EULAR) 2017 in Madrid. A trend toward greater improvement with CC-220 treatment compared …

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Research Moves Closer to Unraveling Mystery Cause of Multiple Sclerosis

A new study has made a major new discovery towards finding the cause of multiple sclerosis (MS), potentially paving the way for research to investigate new treatments. Ahead of MS Awareness Week, which starts today (Monday April 24), an international team involving the University of Exeter Medical School and the …

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FDA Approves Genentech’s Ocrevus for Relapsing and Primary Progressive Forms of Multiple Sclerosis

South San Francisco, CA — March 28, 2017 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The …

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FDA Grants Breakthrough Therapy Designation to Genentech’s Rituxan for Treatment of Pemphigus Vulgaris

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Rituxan® (rituximab) for pemphigus vulgaris, a rare, serious and life-threatening condition characterized by progressive painful blistering of …

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Apitope’s Multiple Sclerosis Drug Demonstrates Positive Results in its Phase IIa Study

Hasselt, Belgium and Chepstow, UK: 21 February 2017 − Apitope, the drug discovery and development company focused on treating the underlying cause of autoimmune diseases, announces positive results from the Phase IIa clinical study of its lead product candidate, ATX-MS-1467, for the treatment of patients with multiple sclerosis. The Phase …

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Celgene to Acquire Autoimmune Disease Startup Delinia

SUMMIT, N.J. & CAMBRIDGE, Mass.–(BUSINESS WIRE)– Celgene Corporation (NASDAQ: CELG) and Delinia, Inc. (“Delinia”), a privately held biotechnology company developing novel therapeutics for autoimmune diseases, today announced that they have entered into an agreement for the acquisition of Delinia by Celgene. The transaction expands Celgene’s Inflammation and Immunology pipeline through …

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FDA Grants Priority Review to Genentech’s Actemra for Giant Cell Arteritis

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Supplemental Biologics License Application (sBLA) for Actemra® (tocilizumab) for the treatment of GCA, a chronic, potentially life-threatening autoimmune condition. The …

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Celgene Obtains Option to Acquire Autoimmune Disease Company Anokion

LAUSANNE, Switzerland & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anokion, a privately held biopharmaceutical company developing novel tolerance-inducing therapeutics for autoimmune diseases, today announced the formation of an exclusive global research collaboration with Celgene Switzerland LLC, an affiliate of Celgene Corp. Under the terms of the collaboration agreement, Anokion received a $45 million upfront …

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CSL and Momenta Announce Collaboration and License Agreement to Develop Fc Multimer Programs

CAMBRIDGE, MA — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and CSL Limited (ASX:CSL; USOTC:CSLLY) today announced that they have entered into an exclusive research collaboration and worldwide license agreement to develop and commercialize Fc multimer proteins, including Momenta’s M230, a selective immunomodulator of Fc receptors, which is expected to enter the clinic …

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