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New Pipeline Updates from Bayer, Exelixis and Forbius

May 6, 2019

Company Drug/Device Medical Condition Status
Forbius AVID200 myelofibrosis (MF) Phase I trial initiated
Tetra Discovery Partners BPN14770 early Alzheimer’s disease (AD) Phase II trial initiated enrolling 255 subjects ages 55-85 in 60 sites across the U.S.
Axovant Gene Therapies, Ltd. AXO-Lenti-PD Parkinson’s disease Phase II trial initiated enrolling 60 subjects
3-V Biosciences, Inc. TVB-2640 non-alcoholic steatohepatitis (NASH) Phase II trial initiated enrolling 90 subjects in the U.S. and 25-30 subjects in China
OMEICOS Therapeutics OMT-28 persistent atrial fibrillation (AF) Phase II trial initiated enrolling 120 subjects at sites in four European countries
Exelixis cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab previously untreated advanced renal cell carcinoma (RCC) Phase III trial initiated enrolling 676 subjects at 150 sites globally
I-Mab Biopharma and MorphoSys AG TJ202/MOR202 relapsed or refractory multiple myeloma Phase III trial initiated enrolling 291 subjects at sites in China and Taiwan
ACADIA Pharmaceuticals, Inc. pimavanserin major depressive disorder (MDD) Phase III trial initiated enrolling 280 subjects at sites in the U.S.
CoapTech, LLC PUMA-G System gastrostomy 510(k) clearance granted by the FDA
Purdue Pharma, L.P. nalmefene hydrochloride (HCl) injection emergency treatment of known or suspected opioid overdose Competitive Generic Therapy (CGT) designation granted by the FDA
Belite Bio LBS-008 (BPN-14967) atrophic age-related macular degeneration and Stargardt disease IND approval granted by the FDA
AVROBIO, Inc. AVR-RD-01 Fabry disease IND approval granted by the FDA
Finch Therapeutics Group, Inc. Full-Spectrum Microbiota (FSM) pediatric Autism Spectrum Disorder (ASD) Fast Track designation granted by the FDA
Bayer darolutamide non-metastatic castration-resistant prostate cancer (nmCRPC) Priority Review designation granted by the FDA
GlaxoSmithKline Benlysta (belimumab) intravenous (IV) infusion pediatric systemic lupus erythematosus (SLE) Priority Review designation granted by the FDA
United Therapeutics Corporation and XVIVO Perfusion, Inc. XPS and STEEN Solution ex-vivo lung perfusion (EVLP) PMA approval granted by the FDA
Samsung Bioepis Co., Ltd. ETICOVO (etanercept-ykro) rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis Approval granted by the FDA
Regeneron Pharmaceuticals, Inc. and Sanofi Praluent (alirocumab) reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease Approval granted by the FDA
Bausch Health Companies, Inc. DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% plaque psoriasis in adults Approval granted by the FDA