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Nicole Watkins

FDA Grants Accelerated Approval to Bristol-Myers Squibb’s Opdivo for Treatment of Small Cell Lung Cancer

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that Opdivo (nivolumab) received approval from the U.S. Food and Drug Administration (FDA) as the first and only Immuno-Oncology treatment option for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy.1 Approval …

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FDA Approves Lenvima Capsules for First-Line Treatment of Unresectable Hepatocellular Carcinoma

TOKYO August 17, 2018 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Merck & Co., Inc., Kenilworth N.J., U.S.A., known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) approved the kinase inhibitor LENVIMA® (lenvatinib mesylate) for the …

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HitGen Enters Innovative Drug Discovery Research Collaboration with LG Chem by Applying DNA-Encoded Technology

CHENGDU, China, Aug. 17, 2018 (GLOBE NEWSWIRE) — HitGen Ltd today announced a multi-year major drug discovery research collaboration with LG Chem to identify novel small molecule leads for targets of interest. In this collaboration, HitGen will apply its advanced technology platform, based on DNA-encoded library design, synthesis, and screening …

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Merck and Healthy Interactions Launch Digital Health Platform Designed to Enhance Patient Engagement in Diabetes Management

KENILWORTH, N.J., Aug. 17, 2018 /PRNewswire/ — Healthy Interactions, a global leader in health education, in collaboration with Merck (NYSE : MRK ), known as MSD outside the United States and Canada, today announced the launch of map4health™ – a digital platform and mobile application in the U.S. that was …

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FDA Approves Regeneron’s Eylea Injection sBLA in Wet Age-Related Macular Degeneration

TARRYTOWN, N.Y., Aug. 17, 2018 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year …

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Novo Nordisk Acquires Ziylo, Gaining Innovative Technology Platform that Could Accelerate Development of New Diabetes Treatment

BRISTOL and COPENHAGEN, 17 August 2018 ­- Ziylo and Novo Nordisk A/S today announced that Novo Nordisk has acquired all of the shares of Ziylo, a University of Bristol spin-out company based at Unit DX science incubator in Bristol, UK. Ziylo has been pioneering the use of its platform technology – …

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Teva and Regeneron Announce Positive Results from Phase 3 Trial of Fasinumab in Patients with Chronic Pain from Osteoarthritis of the Knee or Hip

JERUSALEM & TARRYTOWN, N.Y.–(BUSINESS WIRE)–Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a Phase 3, randomized, double-blind, placebo-controlled study of fasinumab in patients with chronic pain from osteoarthritis (OA) of the knee or hip. At the week 16 primary …

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Wave Life Sciences’ WVE-210201 Granted Orphan Drug and Rare Pediatric Disease Designations from the FDA for Treatment of DMD

CAMBRIDGE, Mass., Aug. 16, 2018 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (NASDAQ: WVE), a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both orphan drug designation and rare pediatric disease designation for …

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BioNTech Enters Agreement with Pfizer to Develop mRNA-based Vaccines for Prevention of Influenza

MAINZ, Germany & NEW YORK–(BUSINESS WIRE)–BioNTech AG, a rapidly growing biotechnology company focused on precise immunotherapies for the treatment of cancer and infectious disease, today announced that it has entered into a multi-year research and development (R&D) collaboration with Pfizer Inc. (NYSE: PFE) to develop mRNA-based vaccines for prevention of …

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FDA Approves Kalydeco for Treatment of Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to KALYDECO …

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