U.S.A.

2020 Nominees

ProductCompany
Aidoc Medical, Ltd.Aidoc
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Automated Insulin Delivery - iControllerDiabeloop
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BIOMODEX® EVIASBiomodex
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HeadspaceHeadspace
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OwkinStudioOwkin
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SomrystPear Therapeutics
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Univfy AI PlatformUnivfy
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ProductCompanyTherapeutic Area &
Indication
Abbott’s MitraClip™ Transcatheter Mitral Valve Repair System
AbbottMitral valve regurgitation
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Venovo™ Venous Stent System
Becton, Dickinson and CompanyIliofemoral venous occlusive circulation disease
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PK Papyrus Covered Coronary Stent System
BiotronikCoronary artery perforations
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AXIOS™ Stent and Electrocautery Enhanced Delivery System
Boston Scientific CorporationTrans-gastro or trans-duodenal repair of pancreatic
pseudocysts and necrosis
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HeartLogic™
Boston Scientific CorporationCardiovascular
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SENTINEL
Boston Scientific CorporationEndovascular disease debris repair
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Cala Trio™
Cala HealthNeuroscience
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CUSTOMFLEX® ARTIFICIALIRISClinical Research Consultants, Inc. and HumanOptics AGOphthalmology
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Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve System
Edwards LifesciencesAortic stenosis
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INSPIRIS RESILIA™ Aortic Valve
Edwards LifesciencesAortic valve replacement
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Magtrace® and Sentimag® Magnetic Localization System
EndomagOncology
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iStent inject® WGlaukos CorporationOphthalmology/open-angle glaucoma
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CCM® Therapy for Heart FailureImpulse DynamicsCongestive heart failure
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Implantable System for Remodulin®MedtronicPulmonary arterial hypertension
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reSET® and reSET-O®Pear TherapeuticsSubstance use disorder
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Zephyr Endobronchial Valve System®
Pulmonx CorporationEmphysema
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The GentleWave® SystemSonendo®Root canal treatment
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ProAir® Digihaler™Teva Pharmaceutical IndustriesPulmonary respiratory disease
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ProductCompanyTherapeutic Area &
Indication
Tegsedi®
Akcea Therapeutics and Ionis PharmaceuticalsPolyneuropathy caused by hereditary transthyretin-amyloidosis (hATTR) in adults.
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ULTOMIRIS® (ravulizumab-cwvz)
Alexion Pharmaceuticals, IncParoxysmal nocturnal hemoglobinuria (PNH) that destroys red blood
cells in adults
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GIVLAARI®Alnylam PharmaceuticalsAcute hepatic porphyria (AHP) linked to production of toxic porphyrin
molecules in the bloodstream in adults
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ONPATTRO®Alnylam PharmaceuticalsPolyneuropathy caused by hATTR amyloidosis leading to loss of nerve
and organ function
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Aimovig®AmgenCGRP receptor blocker to treat chronic migraine
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EVENITY®AmgenOsteoporosis in post-menopausal women at high risk of bone fracture
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GALAFOLD®Amicus Therapeutics, Inc.Oral drug for treatment of Fabry Disease through repair of gene-induced enzyme
deficiencies that lead to organ failures, stroke and early death in adults
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Palynziq® (pegvaliase-pqpz) injectionBioMarin Pharmaceutical, Inc.Lowers blood levels of phenylalanine, an amino acid that causes PKU
(phenylketoneuria) leading to brain damage and seizures beginning in infancy
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ENHERTU®Daiichi Sankyo & AstraZenecaTreatment of unresectable or metastatic HER2 positive breast cancer
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OXERVATE®Dompé U.S. Inc.Recombinant human growth factor to treat neurotrophic keratitis,
a rare condition affecting the eye cornea
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Emgality®Eli Lilly and CompanyOnce a month CGRP antibody preventive treatment for adult migraine
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Hemlibra®Genentech Inc.Reduce or prevent bleeding episodes in adults and children with
hemophilia A, with or without factor-VIII inhibitors
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Polivy™ Genentech, a member of the Roche GroupAntibody drug conjugate for treatment of diffuse large B-cell lymphoma
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Oxbryta®
Global Blood Therapeutics, Inc. Prevents inherited propensity for the hemoglobin polymerization that
causes sickle cell disease
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TREMFYA® (guselkumab)Janssen Biotech, Inc.Medium to severe plaque psoriasis in adults
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LILETTA®Medicines360IUD to prevent pregnancy through timed release of hormone levonorgestrel
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ERVEBO®Merck & Co., IncFirst preventive vaccine against the disease caused
by the Zaire ebolavirus in adults
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Zolgensma® (onasemnogene abeparvovec-xioi)
Novartis Gene Therapies One-time gene replacement therapy for children under age 2 with spinal muscular atrophy
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Rybelsus®Novo Nordisk GLP-1 agonist treatment to control blood sugar in adults with Type-II diabetes
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VYNDAQEL® (tafamidis meglumine)Pfizer Inc.For cardiomyopathy associated with transthyretin-mediated amyloidosis (ATTR-CM) to reduce cardiovascular mortality and related hospitalizations
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Andexxa®Portola Pharmaceuticals, Inc.Reversal of medicine-specific, anticoagulant-based,
and life-threatening bleeding events
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Dupixent® (dupilumab)
Regeneron and SanofiSingle dose pre-filled pen technology to treat adults and adolescents with
atopic dermatitis (eczema), asthma and rhinosinusitis with nasal polyposis
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Cablivi®SanofiNanobody to treat adult acquired thrombotic thrombocytopenic
purpura (aTTP), a rare blood disorder
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TAKHZYRO®Takeda Pharmaceutical Company LimitedTreatment for hereditary angioedema (HAE) in adults
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ProductCompanyTherapeutic Area &
Indication
RINVOQ®AbbVie Inc.JAK (janus kinase) inhibitor that blocks inflammation of moderate to severe
rheumatoid arthritis (RA) in patients who don’t benefit from existing treatments
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Adhansia XR®
Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P.
Central nervous system stimulant to treat attention deficit hyperactivity
disorder (ADHD) in people age six and older
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LutatheraAdvanced Accelerator ApplicatiRadioactive isotope treatment for cancerous neuroendocrine
tumors affecting the pancreas or gastrointestinal tract
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XOSPATA®Astellas PharmaTyrosine kinase inhibitor for adults with relapsed or refractory acute
myeloid leukemia (AML) with the tyrosine kinase-3 gene mutation
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NUBEQA®
Bayer U.S., LLCFor patients with non-metastatic castration-resistant prostate cancer
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VITRAKVI®
Bayer U.S., LLCLarotrectinib (trade name: VITRAKVI®) is a first-in-class tropomyosin receptor kinase (TRK) inhibitor to treat tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.
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REYVOW (lasmiditan)Eli Lilly and CompanyA serotonin (5-HT) 1F receptor agonist indicated for the acute treatment of migraine with or without aura in adults
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Olumiant®Eli Lilly and CompanyJAK inhibitor for treatment of Rheumatoid Arthritis in patients
who fail to benefit from existing TNF alpha inhibitor therapies
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Rozlytrek™Genentech, a member of the Roche Group
First “tumor agnostic” treatment with biomarkers to specifically
target ROS-1 positive metastatic non-small cell lung cancer
(NSCLC) as well as other NTRK gene fusion positive solid tumors
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Epidiolex®GW Pharmaceuticals plc & Greenwich Biosciences Inc.Reduction of seizures associated with Leno-Gastaut Syndrome (LGS), Dravet
Syndrome and Tuberous Sclerosis Complex (TSC) in adults and infant children
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ERLEADA®Janssen Biotech, Inc.
Non‑steroidal selective antagonist of the androgen receptor to treat adults with metastatic castration-sensitive prostate cancer and patients with non-metastatic castration-resistant prostate cancer who are at high risk for developing metastasis
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BALVERSA®
Janssen Biotech, Inc.
Kinase inhibitor to treat adults with advanced or metastatic
urothelial cancers that are susceptible to FGFR2 or FGFR3
mutations or have proven resistant to chemotherapy
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XPOVIO®
Karyopharm Therapeutics Inc.
Treatment of relapsed/refractory (RR) multiple myeloma and
RR diffuse large B-cell lymphoma
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MoxidectinMedicines Development for Global Health & TDR
New treatment for onchocerciasis (river blindness) demonstrating superiority over ivermectin, the current standard of care against this major neglected infectious disease prevalent in developing countries.
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RECARBRIO™Merck & Co., IncCombination anti-bacterial for adults with complicated urinary tract infections and complicated intra-abdominal infections
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Piqray® (alpelisib)
Novartis Pharmaceuticals Corporation
Treatment of advanced or metastatic breast cancer with PIK3CA gene mutation
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Adakveo® (crizanlizumab-tmca)
Novartis Pharmaceuticals CorporationTreatment to lower frequency of recurrent vaso-occlusive crises associated
with severe vascular system pain for conditions like sickle cell anemia
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Entresto® (sacubitril/valsartan)
Novartis Pharmaceuticals CorporationReduce hospitalizations and deaths in adults with chronic heart failure
through improvement in the heart’s ability to pump blood to the body
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LORBRENA®
Pfizer Inc.
For patients with anaplastic lymphoma kinase (ALK) positive
metastatic non-small cell lung cancer (NSCLC) in cases where
previous ALK inhibitors have failed
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Annovera™
Population Council and TherapeuticsMD
Novel hormonal contraceptive vaginal ring that prevents ovulation and pregnancy over a full-year cycle of use
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ASPARLAS
Servier Pharmaceuticals
Component therapy of a multi-agent chemotherapy regimen for
treatment of acute lymphoblastic leukemia (ALL) in patients 21
years of age or younger
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TPOXX®
SIGA Technologies, Inc.First drug with an indication for treatment of smallpox in humans in the event of its use as a bioweapon and public health emergency
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Gamifant®Sobi, Inc.First treatment for infants/adults with primary haemophagocytic
lymphohistiocytosis (HLH), an ultra-rare immune disorder that leads to severe
inflammation, infections, bleeding, organ failures and early death.
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Pretomanid
TB AllianceA nitroimidazole drug, one of a class of novel anti-bacterials and approved as a combination with two other drugs for use in patients with highly
drug-resistant pulmonary tuberculosis (TB).
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YUPELRI® (revefenacin) Inhalation Solution
Theravance Biopharma, Inc.
Anticholinergic to treat chronic obstructive pulmonary disease (COPD),
including emphysema and chronic bronchitis
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