Pipeline

May 27, 2019
Company Drug/Device Medical Condition Status
Inovio and CEPI INO-4500 Lassa virus Phase I trial initiated enrolling 60 volunteers
Compugen, Ltd. COM701 in combination with Opdivo (nivolumab) advanced solid tumors Phase I trial initiated enrolling 140 subjects at ten sites in the U.S.
Atriva Therapeutics GmbH ATR-002 influenza Phase I trial initiated enrolling 60 healthy volunteers in Belgium
Axovant Gene Therapies, Ltd. AXO-AAV-GM1 (also known as AAV9-GLB1) GM1 gangliosidosis Phase I trial initiated
Dicerna Pharmaceuticals, Inc. DCR-HBVS chronic hepatitis B virus (HBV) infection in adults Phase I trial initiated enrolling healthy volunteers (HVs) and subjects with non-cirrhotic chronic HBV infection
NeuClone Pharmaceuticals, Ltd. Stelara (ustekinumab) moderate to severe plaque psoriasis in adults and children 12 years or older, active psoriatic arthritis and moderate to severe Crohn's disease in adults Phase I trial initiated enrolling subjects in Australia
ImaginAb, Inc. 89Zr-Df-IAB22M2C cancer Phase II trial initiated enrolling metastatic cancer subjects
IO Biotech IO102 in combination with KEYTRUDA (pembrolizumab) metastatic non-small cell lung cancer (NSCLC) Phase II trial initiated enrolling 96 subjects at more than 20 sites across the U.S. and Europe
Respivant Sciences RVT-1601 idiopathic pulmonary fibrosis (IPF) Phase IIb trial initiated enrolling 180 subjects in the U.S., Canada and Europe
Rigel Pharmaceuticals, Inc. fostamatinib disodium hexahydrate (fostamatinib) warm antibody autoimmune hemolytic anemia (AIHA) Phase III trial initiated enrolling 80 subjects in the U.S.
Perrigo, Co. Voltaren Gel, 1% (diclofenac sodium topical gel, 1%) osteoarthritis ANDA approval granted by the FDA
Mayne Pharma Group, Ltd. SORILUX (calcipotriene) Foam, 0.005% plaque psoriasis of the scalp and body in patients aged 12 years and older Approval granted by the FDA
Pfizer, Inc. Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults Approval granted by the FDA
UCB NAYZILAM acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in patients with epilepsy 12 years of age and older Approval granted by the FDA
Takeda GATEX (teduglutide) for injection pediatric patients one year of age and older with Short Bowel Syndrome (SBS) Approval granted by the FDA
Pfizer, Inc. Fragmin (dalteparin sodium) injection symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older Approval granted by the FDA

 

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