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Nicole Watkins

NANOBIOTIX Announces Positive Phase II/III Topline Data of Investigational NBTXR3 in Soft Tissue Sarcoma

Paris, France and Cambridge, Massachusetts, June 21, 2018 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today positive topline results of the Phase II/III act.in.sarc trial evaluating NBTXR3 in Soft Tissue Sarcoma (STS). “Data are exceptional and show without any …

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FDA Grants Orphan Drug Designation to Processa’s PCS499 in Necrobiosis Lipoidica

HANOVER, Md., June 22, 2018 /PRNewswire/ — Processa Pharmaceuticals, Inc. (OTC: PCSA) a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have a high unmet medical need, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation …

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FDA Accepts sNDA for Opdivo Plus Low-Dose Yervoy for Treatment of First-Line NSCLC in Patients with Tumor Mutational Burden ≥10 mut/Mb

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) plus low-dose Yervoy (ipilimumab) for the treatment of first-line advanced non-small cell lung cancer (NSCLC) in patients with tumor mutational burden (TMB) ≥10 mutations per megabase (mut/Mb). …

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FDA Approves World’s First Long-Term Implantable Continuous Glucose Monitoring System for Patients with Diabetes

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to …

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ASH to Collaborate on Clinical Practice Guidelines on Diagnosis and Management of von Willebrand Disease

WASHINGTON, June 21, 2018 /PRNewswire-USNewswire/ — The American Society of Hematology (ASH) will collaborate with the International Society on Thrombosis and Haemostasis (ISTH), National Hemophilia Foundation (NHF), World Federation of Hemophilia (WFH), and the University of Kansas Medical Center to develop clinical practice guidelines on the diagnosis and management of …

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FDA Grants Breakthrough Therapy Designation to Heron’s HTX-001 for Postoperative Pain Management

SAN DIEGO–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that HTX-011 for postoperative pain management has received Breakthrough Therapy designation from the U.S. Food and …

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Servier and Taiho Announce Lonsurf Demonstrates Significant Overall Survival Benefit in Phase 3 Gastric Cancer Trial

PARIS–(BUSINESS WIRE)–Servier and Taiho Pharmaceutical Co., Ltd. today announced clinical data from the pivotal Phase III trial (TAGS) for LONSURF® (trifluridine and tipiracil, TAS-102) which showed significant improvement in overall survival (OS) for the treatment of patients with refractory metastatic gastric cancer (HR=0.69 [95% IC 0.56-0.85], p=0.0003). The median overall survival …

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Kalytera Provides Update on its Cannabis-Based Therapy for Prevention and Treatment of GVHD

SAN FRANCISCO and TEL AVIV, Israel, June 21, 2018 (GLOBE NEWSWIRE) — Kalytera Therapeutics, Inc. (TSX-V:KALY) and (OTCQB:KALTF) (the “Company” or “Kalytera”) today provided an update on its lead clinical development program evaluating cannabidiol (“CBD”) for the prevention and treatment of acute graft versus host disease (“GVHD”). GVHD is a …

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FDA Approves Expanded Label for Shire’s Cinryze for Prevention of Attacks in Pediatric Hereditary Angioedema

Dublin, Ireland – Thursday, June 21, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading global biotechnology company focused on rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for CINRYZE® (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks …

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TG and Novimmune Collaborate for Development of CD47-CD19 Bispecific Antibody

NEW YORK, June 20, 2018 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ:TGTX) and Novimmune SA, today announced that the companies have entered into an exclusive global agreement to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701). The companies will jointly develop …

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