Specialty Pharma Journal Specialty, Precision & Technology
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nimbus Therapeutics, a biotechnology company applying deep computational expertise throughout drug discovery and development, announced today the initiation of a long-term strategic alliance with Celgene Corporation (NASDAQ: CELG) in immunology. Under the terms of the agreement, Celgene will receive an option to acquire each program in the alliance …
Tag Archives: autoimmune disorders
October, 2017
September, 2017
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22 September
Unique Gene Therapy Prevents, Reverses Multiple Sclerosis in Animal Model
Multiple sclerosis can be inhibited or reversed using a novel gene therapy technique that stops the disease’s immune response in mouse models, University of Florida Health researchers have found. By combining a brain-protein gene and an existing medication, the researchers were able to prevent the mouse version of multiple sclerosis. …
July, 2017
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10 July
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 …
November, 2016
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30 November
Momenta’s Humira Biosimilar Succeeds in Late-Stage Psoriasis Study
CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) — Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion …
October, 2016
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3 October
Prime Therapeutics Finds Autoimmune Specialty Drug Spend has Doubled
ST. PAUL, MINN. – Sept. 30, 2016 –In the past four years, spending on autoimmune drugs has doubled and utilization has jumped nearly 40 percent in a population of 4.4 million commercially-insured members, according to new research from Prime Therapeutics LLC (Prime), a pharmacy benefit manager serving more than 22 …
March, 2016
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18 March
Vitae Pharmaceuticals Psoriasis Drug Succeeds in Phase 2a Trial
FORT WASHINGTON, Pa., March 16, 2016 (GLOBE NEWSWIRE) — Vitae Pharmaceuticals, Inc.(NASDAQ:VTAE), a clinical-stage biotechnology company, today announced positive top-line results from its Phase 2a proof-of-concept clinical trial of VTP-43742 in psoriatic patients. VTP-43742 is Vitae’s wholly owned, first-in-class, orally active RORγt inhibitor with the potential to transform the treatment …
November, 2015
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20 November
EU Endorses Biogen and Samsung Bioepis’ Biosimilar Version of Enbrel
ZUG, Switzerland–(BUSINESS WIRE)–Biogen (NASDAQ:BIIB) today announced further progress as part of its commitment to biosimilars. Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization …
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9 November
FDA Accepts Immune Pharmaceuticals’ IND Application for its Bullous Pemphigoid Drug
NEW YORK, Nov. 9, 2015 /PRNewswire/ — Immune Pharmaceuticals Inc. (NASDAQ: IMNP) (“Immune” or the “Company”) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application for its first in class, lead product candidate, Bertilimumab, for the treatment of Bullous Pemphigoid (BP). This …
June, 2015
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10 June
FDA Grants Breakthrough Therapy Designation to Actemra for Systemic Sclerosis
US health regulators have granted Breakthrough Therapy designation to Genentech’s Actemra (tocilizumab) for systemic sclerosis. Genentech, a member of the Roche Group, said that the US Food and Drug Administration (FDA) has granted Breakthrough status to Actemra for systemic sclerosis, also known as scleroderma, a rare, chronic disorder characterized by …
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2 June
Brazil Approves Hospira’s Remsima, a Biosimilar Version of Remicade
The National Health Surveillance Agency in Brazil, ANVISA, has approved the first biosimilars monoclonal antibody for use in the country. Leading biosimilars drugmaker Hospira, Inc. announced that its partner Celltrion has received approval for its Remsima (infliximab) for use in Brazil. The drug is the first biological medication approved by …