Specialty Pharma Journal Specialty, Precision & Technology
CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study …
Tag Archives: Sanofi
December, 2017
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15 December
Regeneron and Sanofi Announce Positive Results for PD-1 Antibody Cemiplimab in Advanced Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Dec. 13, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced positive topline results from a pivotal Phase 2 clinical study of cemiplimab in 82 patients with advanced cutaneous squamous cell carcinoma (CSCC), the second deadliest skin cancer after melanoma. Cemiplimab, an investigational human antibody targeting PD-1 (programmed cell death protein 1), …
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13 December
FDA Approves Sanofi’s Admelog, a Biosimilar of Humalog
PARIS, Dec. 11, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. “Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin …
November, 2017
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10 November
Sanofi Signs License Deal with Principia Biopharma for Multiple Sclerosis Drug Candidate
Paris, France and South San Francisco, Calif – November 9, 2017 – Sanofi will develop Principia Biopharma Inc.’s experimental oral treatment that shows promise in multiple sclerosis (MS) and, potentially, other central nervous system (CNS) diseases. Under the license agreement signed this week, Sanofi will develop Principia’s Bruton’s tyrosine kinase (BTK) …
October, 2017
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27 October
Data Suggests Slowing of Cortical Gray Matter Atrophy with Aubagio Delays Conversion to Clinically Definitive Multiple Sclerosis
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today new investigational data that suggest slowing of cortical gray matter volume loss (atrophy) with Aubagio® (teriflunomide) is associated with delayed conversion to clinically definite multiple sclerosis (CDMS). The data, from the Phase III TOPIC study in patients with …
September, 2017
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21 September
Sanofi and NIH Researchers Develop Three-in-One Antibodies to Treat HIV
CAMBRIDGE, Mass., Sept. 20, 2017 /PRNewswire/ — In a landmark study published in the journal Science today, researchers produced genetically engineered antibodies with the highest activity and breadth of coverage yet seen against human immunodeficiency virus (HIV-1). Natural antibodies recognize a single target on a foreign protein. In this study, …
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20 September
Alnylam’s Rare Disease Drug Meets Endpoints in Late-Stage hATTR Amyloidosis Study
CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the APOLLO Phase 3 study of patisiran, an investigational RNAi therapeutic being developed for patients with hereditary ATTR amyloidosis with polyneuropathy, met its primary efficacy endpoint …
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8 September
Regeneron and Sanofi’s Cemiplimab Receives FDA Breakthrough Therapy Designation for Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, Sept. 8, 2017 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation status to cemiplimab (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (CSCC) and adults with locally advanced and unresectable CSCC, the second deadliest skin cancer …
July, 2017
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20 July
Ablynx and Sanofi Partner to Develop Nanobody-Based Therapeutics for Inflammatory Diseases
GHENT, Belgium, 20 July 2017 – Ablynx [Euronext Brussels: ABLX; OTC: ABYLY] today announced that it has entered into a research collaboration and global exclusive licensing agreement with Sanofi initially focused on developing and commercializing Nanobody®-based therapeutics for the treatment of various immune-mediated inflammatory diseases. This collaboration gives Sanofi access …
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7 July
Alnylam and Sanofi Genzyme Initiate Phase 3 Program of Investigational RNAi Therapeutic Fitusiran
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today the initiation of the ATLAS Phase 3 clinical program for fitusiran. The global, multicenter program is designed to evaluate the safety and efficacy of fitusiran in three separate …