New Pipeline Updates from Merck, AbbVie and MGB Biopharma

February 4, 2019

Company Drug/Device Medical Condition Status
Dicerna Pharmaceuticals, Inc. DCR-HBVS chronic hepatitis B virus (HBV) Phase I trial initiated enrolling healthy volunteers and subjects with non-cirrhotic chronic HBV
Navitor Pharmaceuticals, Inc. NV-5138 Treatment-Resistant Depression (TRD) Phase Ib trial initiated enrolling up to 88 subjects, including healthy volunteers and those diagnosed with TRD
Theravance Biopharma, Inc. ampreloxetine (TD-9855) symptomatic neurogenic orthostatic hypotension (nOH) Phase III trial initiated enrolling 188 subjects with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson’s disease (PD) and pure autonomic failure (PAF)
Qualigen, Inc. FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay diagnosis and treatment of men’s health 510(k) clearance granted by the FDA
Merck V114 prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age Breakthrough Therapy Designation granted by the FDA
C2N Diagnostics brain amyloidosis blood test screening for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis Breakthrough Device Designation granted by the FDA
BioInvent International AB BI-1206 mantle cell lymphoma (MCL) Orphan Drug Designation granted by the FDA
Eureka Therapeutics, Inc. ET140202 ARTEMIS T-cell therapy AFP-positive patients with advanced hepatocellular carcinoma (HCC) IND approval granted by the FDA
MGB Biopharma MGB-BP-3 Clostridium difficile-associated diarrhea (CDAD) IND approval granted by the FDA
CorMatrix Cardiovascular, Inc. Cor TRICUSPID ECM cardiac valve adults with endocarditis and for pediatric patients with congenital heart valve disease IDE approval granted by the FDA
Amerigen Pharmaceuticals, Limited generic version of Shire’s Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) attention deficit hyperactivity disorder (ADHD) ANDA approval granted by the FDA
AbbVie and Promius Pharma, LLC TOSYMRA (previously known as DFN-02) acute treatment of migraine with or without aura in adults NDA approval granted by the FDA
Dr. Reddy’s Laboratories Ltd. and Janssen Pharmaceutical Companies of Johnson & Johnson IMBRUVICA (ibrutinib) in combination with Roche’s obinutuzumab (GAZYVA) adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) NDA approval granted by the FDA