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Nicole Watkins

FDA Grants Priority Review to Merck’s sBLA for Keytruda Monotherapy for Third-Line Treatment of Patients with Advanced SCLC

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with …

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Xencor Announces Partial Clinical Hold on Phase 1 Study of its Bispecific Antibody in Acute Myeloid Leukemia

MONROVIA, Calif., Feb. 20, 2019 /PRNewswire/ — Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 1 study of XmAb14045, a CD123 x …

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Takeda, Microsoft and EURORDIS Release Report with Action Plan to Help Rare Disease Community Shorten the Diagnostic Odyssey

NEW YORK and BRUSSELS, Feb. 20, 2019 /PRNewswire/ — The Global Commission to End the Diagnostic Odyssey for Children (“the Global Commission”), co-chaired by Takeda, Microsoft and EURORDIS-Rare Diseases Europe, an alliance of more than 800 rare disease patient organisations, today announced its actionable recommendations in a report to address …

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Merck’s Keytruda Fails to Meet Primary Endpoints in Phase 3 Study in Patients with Advanced Hepatocellular Carcinoma

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the pivotal Phase 3 KEYNOTE-240 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus best supportive care, for the treatment of patients with advanced hepatocellular carcinoma (HCC) who were previously treated with systemic therapy, did …

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FDA Approves Novo Nordisk’s Esperoct for Treatment of Adults and Children with Hemophilia A

Bagsværd, Denmark, 19 February 2019 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for ESPEROCT® for the treatment of adults and children with hemophilia A. ESPEROCT® is the brand name for turoctocog alfa pegol, N8-GP. ESPEROCT® is indicated for use in adults and …

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Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials

NEW ORLEANS & NEW YORK–(BUSINESS WIRE)–Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner — through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research …

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FDA Grants Priority Review to AbbVie’s Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is …

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Cerecor Receives Fast Track Designation from FDA for CERC-801 for the Treatment of PGM1 Deficiency

ROCKVILLE, Md., Feb. 19, 2019 (GLOBE NEWSWIRE) — Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced today that the U.S. Food and Drug Administration (FDA) has designated Fast Track Designation …

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Gamida Cell and Editas Medicine Partner to Evaluate Use of CRISPR Genome Editing Technology in NAM-NK Cells

BOSTON–(BUSINESS WIRE)–Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, today announced an agreement with Editas Medicine, Inc., a leading genome editing company, to evaluate the potential use of Editas Medicine’s CRISPR technology to edit NAM-NK cells, which are natural killer cells that have been expanded using Gamida …

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Catabasis Presents Data Supporting Edasalonexent as a Potential Foundational Treatment for Duchenne Muscular Dystrophy

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company, today shared additional clinical results from the MoveDMD trial of edasalonexent. In the Phase 2 MoveDMD trial and open-label extension, boys with Duchenne muscular dystrophy (DMD) treated with edasalonexent on average grew in line with the growth of unaffected boys in …

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