2019

Pipeline

New Pipeline Updates from Amgen, Ichnos Sciences and GE Healthcare

November 11, 2019

Company Drug/Device Medical Condition Status
BioCryst Pharmaceuticals, Inc. BCX9250 fibrodysplasia ossificans progressive (FOP) Phase 1 trial initiated enrolling healthy subjects
Revolution Medicines, Inc.

Amgen

RMC-4630 in combination with AMG 510 advanced solid tumors Phase 1b trial initiated enrolling subjects with advanced solid tumors harboring the KRASG12C mutation
X4 Pharmaceuticals, Inc. X4P-001 Severe Congenital Neutropenia (SCN) Phase 1b trial initiated enrolling 45 subjects with SCN and other selected congenital neutropenia disorders
CohBar, Inc. CB4211 nonalcoholic steatohepatitis (NASH), NAFLD and obesity Phase 1b trial initiated enrolling 20 obese subjects with NAFLD
Cartesian Therapeutics Descartes-08 generalized myasthenia gravis (GMG) Phase 1/2 trial initiated
Ichnos Sciences ISC 27864 osteoarthritic pain Phase 2b trial initiated enrolling 624 adult subjects with moderate osteoarthritic pain of the knee and/or hip at sites in India.
Ichnos Sciences ISB 830 atopic dermatitis Phase 2b trial initiated enrolling 312 adult subjects with moderate to severe atopic dermatitis at sites in the U.S., Canada and Europe
RhoVac AB RV001 prostate cancer Phase 2b trial initiated enrolling 175 subjects at multiple centers in Denmark, Finland, Sweden, United Kingdom, Belgium, Germany and the U.S.
Biohaven Pharma Holding Company Ltd. troriluzole Alzheimer’s disease Phase 2/3 trial initiated enrolling subjects with mild to moderate Alzheimer’s disease
CymaBay Therapeutics, Inc. seladelpar Primary Biliary Cholangitis (PBC) Phase 3 trial initiated enrolling 240 subjects in over 20 countries
Revance Therapeutics, Inc. DaxibotulinumtoxinA for Injection (DAXI) isolated cervical dystonia (CD) Phase 3 trial initiated enrolling 301 subjects at 60 sites in the U.S., Canada and Europe
EpicentRX, Inc. RRx-001 small cell lung cancer Phase 3 trial initiated enrolling 126 subjects with third-line and beyond small cell lung cancer
Okami Medical Inc. LOBO Vascular Occlusion System occlusion of peripheral blood vessels 510(k) approval granted by the FDA
Autolus Therapeutics plc AUTO1 acute lymphoblastic leukemia (ALL) Orphan drug designation granted by the FDA
Sanofi Fluzone High-Dose Quadrivalent (Influenza Vaccine) prevention of influenza disease caused by influenza A and B strains contained in the vaccine in subjects 65 years of age and older sBLA approval granted by the FDA
RedHill Biopharma Ltd. Talicia (omeprazole magnesium, amoxicillin and rifabutin) delayed-release capsules 10 mg1/250 mg/12.5 mg Helicobacter pylori (H. pylori) infection in adults Approval granted by the FDA
GE Healthcare Clariscan intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity Approval granted by the FDA
Crescita Therapeutics Inc. Pliaglis (enhanced formulation) superficial dermatological procedures Approval granted by the FDA
Sandoz Ziextenzo (pegfilgrastim) infection in cancer patients Approval granted by the FDA

 

Research Center Profiles

November 2019: Research Center Profiles

November 11, 2019

Research Center Spotlight is a monthly selection of clinical research centers who have Research Center Profile pages posted on CenterWatch.com. Included in their annual subscriptions, company profiles are randomly selected to appear in this section, providing added exposure for their expertise and services in conducting and managing clinical studies. To learn more about becoming a Research Center Profile page subscriber, contact Sales at (617) 948-5100.

Up and Coming

Up and Coming from Assembly, EarlySign and Noveome

November 4, 2019

This feature highlights changes in clinical research organizations’ personnel.

Accolade
Shantanu Nundy has been appointed chief medical officer at Accolade. Nundy, a practicing physician, was formerly a senior technology advisor in the World Bank Group’s health, nutrition and population global practice.