Specialty Pharma Journal Specialty, Precision & Technology
PARIS and KENILWORTH, N.J. – December 26, 2018 – The U.S. Food and Drug Administration has approved VAXELIS(TM) (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) for use in children from 6 weeks through 4 years of age (prior to the 5th …
Tag Archives: Sanofi
December, 2018
November, 2018
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20 November
Denali Announces Positive Results with its Lead RIPK1 Inhibitor Molecule and Intention to Initiate Patient Studies in Multiple Indications in with Sanofi
SOUTH SAN FRANCISCO, Calif., Nov. 19, 2018 (GLOBE NEWSWIRE) — Denali Therapeutics Inc. (NASDAQ: DNLI), a biopharmaceutical company developing a broad portfolio of product candidates for neurodegenerative diseases, today announced positive results from its Phase 1 healthy volunteer study of DNL747, a brain penetrant small molecule inhibitor of receptor-interacting serine/threonine-protein …
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7 November
FDA Grants Priority Review for Dupixent as Potential Treatment for Adolescents with Uncontrolled Moderate-to-Severe Atopic Dermatitis
Paris and Tarrytown, NY – November 6, 2018 – The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose disease was inadequately controlled with topical therapies or …
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1 November
Sanofi and Denali Therapeutics Partner to Develop Treatments for Neurological and Inflammatory Diseases
PARIS, France – November 1, 2018 – Sanofi plans to collaborate with Denali Therapeutics Inc. on the development of multiple molecules with the potential to treat a range of neurological and systemic inflammatory diseases. The two lead molecules (DNL747 and DNL758) target a critical signaling protein known as the receptor-interacting serine/threonine-protein …
October, 2018
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1 October
FDA Approves Libtayo as First and Only Treatment for Advanced Cutaneous Squamous Cell Carcinoma
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo® (cemiplimab-rwlc) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint …
July, 2018
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18 July
Sanofi and REVOLUTION Medicines Partner to Develop Targeted Therapies for Multiple Cancers
CAMBRIDGE, Mass. & REDWOOD CITY, Calif.–(BUSINESS WIRE)–Sanofi and REVOLUTION Medicines, Inc. today announced an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations. This collaboration builds on precision oncology discoveries …
May, 2018
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31 May
Adaptive and Sanofi Collaborate to Use Adaptive’s clonoSEQ Assay in Active and Future Isatuximab Multiple Myeloma Trials
SEATTLE–(BUSINESS WIRE)–Adaptive Biotechnologies, the leader in combining Next Generation Sequencing (NGS) and expert bioinformatics to profile T- and B-cell receptors of the adaptive immune system, announced today that it entered into an agreement with Sanofi to utilize Adaptive’s NGS-based clonoSEQ® Assay to assess minimal residual disease (MRD) status in response to …
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1 May
FDA Grants Priority Review to Regeneron’s Cemiplimab for Treatment of Advanced Cutaneous Squamous Cell Carcinoma
TARRYTOWN, N.Y. and PARIS, April 30, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) …
January, 2018
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23 January
Sanofi to Acquire Hemophilia Company Bioverativ for $11.6 Billion
Paris (France) and Waltham, Mass. – January 22, 2018 – Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing …
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8 January
Alnylam and Sanofi Enter Strategic Restructuring of RNAi Therapeutics Rare Disease Alliance
CAMBRIDGE, Mass. & PARIS–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi announced today a strategic restructuring of their RNAi therapeutics alliance to streamline and optimize development and commercialization of certain products for the treatment of rare genetic diseases. Specifically, Alnylam will obtain global development and commercialization rights …