Pipeline

January 21, 2019

Company	Drug/Device	Medical Condition	Status
ADC Therapeutics	ADCT-601	advanced or metastatic solid tumors	Phase I trial initiated enrolling 75 subjects
Mirati Therapeutics, Inc.	MRTX849	advanced solid tumors that harbor KRAS G12C mutations	Phase I/II trial initiated
Promentis Pharmaceuticals, Inc.	SXC-2023	moderate to severe trichotillomania in adults	Phase II trial initiated enrolling 100 subjects in the U.S.
Innovent Biologics, Inc.	Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) in combination with capecitabine and oxaliplatin	advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ)	Phase III trial initiated enrolling 650 subjects in China
TransEnterix	Senhance Ultrasonic System	minimally invasive surgery	510(k) clearance granted by the FDA
OSSIO	OSSIOfiber Bone Pin	stability and secure bone fixation during the orthopedic healing process	510(k) clearance granted by the FDA
Mundipharma International	Flutiform pMDI	asthma treatment in children five years of age or older	Approval granted by the EMA
Bristol-Myers Squibb Company	Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg	first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC)	Approval granted by the EMA
iSchemaView	RAPID neuroimaging platform	stroke patients who are likely to benefit from endovascular thrombectomy (clot removal)	510(k) clearance granted by the FDA
Novartis	crizanlizumab (SEG101)	prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD)	Breakthrough Therapy Designation granted by the FDA
Exelixis, Inc.	CABOMETYX (cabozantinib) tablets	hepatocellular carcinoma (HCC)	NDA approval granted by the FDA
AIVITA Biomedical	anti-PD1 monoclonal antibodies in combination with AV-MEL-1	metastatic melanoma	IND approval granted by the FDA
NeoImmuneTech, Inc. and Genexine	Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq)	high-risk skin cancers	IND approval granted by the FDA
Zydus Cadila	Amlodipine in combination with Atorvastatin	high blood pressure and lowering cholesterol	ANDA approval granted by the FDA
Amneal Pharmaceuticals, Inc.	generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours	mild to moderate dementia caused by Alzheimer's or Parkinson's disease	ANDA approval granted by the FDA
Abbott	Amplatzer Piccolo Occluder	patent ductus arteriosus (PDA) in premature babies and newborns	Approval granted by the FDA
Sanofi	Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed)	repeat vaccination to help protect against tetanus, diphtheria and pertussis	Approval granted by the FDA