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Entyvio
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Entyvio (vedolizumab; Takeda) is a humanized monoclonal antibody approved for the treatment of Crohn’s disease and ulcerative colitis.
August 2, 2018
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Etrolizumab
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Etrolizumab (Roche) is a humanized anti-beta 7 integrin subunit monoclonal antibody in Phase III development for the treatment of ulcerative colitis.
August 2, 2018
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Jevtana
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Jevtana (cabazitaxel; Sanofi) is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with a docetaxel-containing treatment regimen.
January 18, 2018
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TAK-003
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TAK-003 (Takeda) is a needle-free, tetravalent live-attenuated vaccine currently in Phase II/III development in the US and dengue-endemic countries in Asia and Latin America, including Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Peru, the Philippines, Sri Lanka, Thailand, and Vietnam.
January 4, 2018
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TetraVax-DV
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TetraVax-DV is a lyophilized, tetravalent, live-attenuated chimeric vaccine currently in Phase II/III development.
January 4, 2018
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Tivicay
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Tivicay (dolutegravir; ViiV Healthcare) is a once-daily, unboosted integrase inhibitor (INI) for the treatment of HIV-1 infection.
June 28, 2019
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Neupro
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Neupro (UCB/Otsuka) is a transdermal formulation of the non-ergoline dopamine receptor agonist rotigotine. Applied once daily, the patch allows continuous drug administration over 24 hours and avoids the fluctuation in dopaminergic stimulation resulting from numerous oral doses
June 21, 2018
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Tracleer
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Actelion’s Tracleer (bosentan) was the first oral therapy to be developed specifically for the treatment of pulmonary arterial hypertension (PAH).
October 29, 2018
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Nouriast
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Nouriast (istradefylline; Kyowa Hakko Kirin) is the first, and so far, the only adenosine A2a receptor antagonist to be approved for the treatment of Parkinson’s disease. It acts to decrease overactivity of the indirect pathway of the motor circuit that is present in Parkinson’s disease patients with low dopamine levels.
June 21, 2018
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Triumeq
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Triumeq ([dolutegravir + abacavir + lamivudine]; ViiV Healthcare) is a single-tablet regimen (STR) for the treatment of HIV-1 infection. It is a co-formulation of the marketed HIV drugs Tivicay (dolutegravir; ViiV Healthcare) and Epzicom ([abacavir + lamivudine]; ViiV Healthcare), which is known as Kivexa outside the US. Tivicay is an integrase inhibitor that blocks the insertion of the viral genome into the host genome, and Epzicom is a fixed-dose combination nucleoside reverse transcriptase inhibitor that prevents viral RNA replication.
June 28, 2019
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Ublituximab
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Ublituximab (TG Therapeutics) is an anti-CD20 monoclonal antibody, currently in late-stage trials across a range of hematological and neurological indications.
January 31, 2019
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Prezista franchise
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The Prezista franchise comprises the standalone protease inhibitor (PI) Prezista (darunavir; Johnson & Johnson) and the fixed-dose combination of Prezista and Tybost (cobicistat; Gilead), which is branded as Prezcobix in the US and Rezolsta in the EU.
June 28, 2019
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Uptravi
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Uptravi (selexipag; Nippon Shinyaku/Actelion) is the first-in-class oral selective non-prostanoid prostaglandin I2 (PGI2) receptor agonist.
October 29, 2018
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V180
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Merck & Co’s adjuvanted, tetravalent subunit vaccine V180 comprises truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes (DEN-1 strain 258848, DEN-2 strain PR159 S1, DEN-3 strain CH53489, and DEN-4 strain H241).
January 4, 2018
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Vigil
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Vigil (Gradalis) is an autologous tumor-based vaccine incorporating a plasmid encoding granulocyte-macrophage colony-stimulating factor (GM-CSF) and a novel.
October 30, 2015
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Provenge
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Provenge (sipuleucel-T; Sanpower Group) is a cellular immunotherapy composed of autologous dendritic cells loaded with the recombinant antigen prostatic acid phosphatase (PAP), which is expressed on approximately 95% of prostate tumor cells.
January 18, 2018
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Stalevo
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Stalevo (Novartis/Orion), indicated for the treatment of Parkinson’s disease patients with end-of-dose wearing-off symptoms, contains a combination of the catechol-O-methyltransferase (COMT) inhibitor entacapone, levodopa, and an AADC inhibitor (carbidopa).
June 21, 2018
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Stribild
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Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate [TDF]; Gilead/Japan Tobacco) is a single-tablet regimen for the treatment of HIV-1 infection. It is a co-formulation of marketed fixed-dose combination (FDC) Truvada, Vitekta, and Tybost.
June 28, 2019
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Xadago
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Xadago (safinamide; Newron Pharmaceuticals/US WorldMeds/Zambon/Meiji Seika Pharma) has a novel dual mechanism of action, based on the enhancement of the dopaminergic function through the reversible inhibition of monoamine oxidase B (MAO-B) and inhibition of excessive glutamate release by blocking the activity of the voltage-dependent sodium channels.
June 21, 2018
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Xofigo
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Xofigo (radium-223; Bayer) is a radioisotope that kills tumor cells with highly localized short-range alpha irradiation. The drug acts as a calcium mimic and is taken up in the areas of increased bone metabolism, which are associated with bone metastases.
January 18, 2018
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Xtandi
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Xtandi (enzalutamide; Pfizer/Astellas) is an androgen receptor (AR) signaling inhibitor that inhibits the AR at three distinct points in the signaling pathway. Xtandi competitively inhibits binding of the androgens to the AR, inhibits AR nuclear translocation, and inhibits association of the AR with DNA.
January 18, 2018
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Zytiga
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Zytiga (abiraterone acetate; Johnson & Johnson/AstraZeneca) is a small molecule oral irreversible inhibitor of the 17 alpha-hydroxylase enzyme which catalyzes the hydroxylation of intermediates involved in testosterone synthesis.
January 18, 2018
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Ad26.RSV.preF
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Ad26.RSV.preF, in development by Johnson & Johnson, is a replication-deficient vector vaccine that encodes a prefusion form of the RSV F protein.
October 5, 2018
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Advate
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The recombinant factor VIII (rfVIII) therapy Advate was initially developed by Baxter and then marketed by the pharmaceutical spin-off Baxalta, which is now part of Shire. Advate is the first third-generation rfVIII, and is a follow-on product to Shire’s Recombinate.
May 4, 2018
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Adynovate
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Adynovate is a long-acting PEGylated recombinant factor VIII (rfVIII) therapy developed by Baxalta and Nektar Therapeutics as a follow-on to Advate (rfVIII; Shire).
May 4, 2018
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Banzel
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Eisai’s Banzel is an oral sodium channel modulator which is structurally different from currently approved anticonvulsants on account of its triazole derivative structure. The drug’s sole approved indication is the adjunctive treatment of seizures…
May 23, 2017
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baricitinib
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Baricitinib is an oral reversible inhibitor of Janus kinase-1 (JAK1) and JAK2 – that is JAK3-sparing – under co-development by Incyte and Eli Lilly. It is currently in development for the treatment of inflammatory conditions including…
October 4, 2016
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Bay 94-9027
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BAY 94-9027 (Bayer) is a long-acting recombinant factor VIII (rfVIII) product under development for the treatment of hemophilia A.
May 4, 2018
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BeneFix
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BeneFIX (Pfizer) is an recombinant factor IX (rfIX) therapy indicated for the control and prevention of bleeding in hemophilia B.
May 4, 2018
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Betaseron
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Betaseron was the first drug to reach the market that modifies the course of multiple sclerosis (MS), after launching in the US in 1994 and the EU in 1996 (where it is marketed as Betaferon).
November 24, 2017
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Bevespi Aerosphere
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Bevespi Aerosphere ([formoterol + glycopyrrolate]; AstraZeneca) is a twice-daily fixed-dose combination of the long-acting beta 2 agonist (LABA) formoterol and the long-acting muscarinic antagonist (LAMA) glycopyrrolate, delivered via a pressurized metered dose inhaler.
July 31, 2018
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Bexsero
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Bexsero (multicomponent meningococcal serogroup B vaccine; GlaxoSmithKline) is a multicomponent meningococcal serogroup B vaccine. It is approved for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in adolescents and young adults from 10 years through to 25 years of age in the US, and in individuals two months of age and older in the EU. Bexsero contains three surface-exposed recombinant proteins: factor H binding protein, Neisseria adhesin A, and Neisseria heparin-binding antigen. It also includes New Zealand strain outer membrane vesicles. The antibodies generated after immunization with Bexsero target the aforementioned surface proteins present on the outer membrane vesicles.
September 3, 2019
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Binimetinibi
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Binimetinib (Array BioPharma/Pierre Fabre/Ono Pharmaceutical) is an orally available inhibitor of mitogen-activated protein kinase kinase (MEK)1/2, which are components of the RAS/RAF/MEK/ERK pathway.
May 23, 2018
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Blincyto
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Blincyto, produced in Chinese hamster ovary cells, is a bispecific T-cell engager that directs T-cells to target CD19-positive benign and malignant B-cells. It activates endogenous T-cells by connecting…
October 9, 2018
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Bosulif
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Bosulif is a kinase inhibitor that targets the BCR-ABL kinase and also inhibits the Src-family kinases that include Src, Lyn, and Hck. The BCR-ABL kinase is upregulated in the presence of an abnormal BCR-ABL fusion protein…
December 7, 2017
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Breo Ellipta
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Breo Ellipta (GlaxoSmithKline/Innoviva) is a combination of fluticasone furoate and vilanterol indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
July 31, 2018
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Bronchitol
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Bronchitol is an inhaled dry powder formulation of mannitol, a naturally occurring monosaccharide that also acts as a mucolytic agent.
September 3, 2018
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Bydureon
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Bydureon (exenatide long-acting release; AstraZeneca) is a member of the glucagon-like peptide-1 (GLP-1) agonist class.
November 7, 2017
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Byetta
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Byetta (exenatide; AstraZeneca) is a member of the glucagon-like peptide-1 (GLP-1) agonist class.
November 7, 2017
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Dacomitinib
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Dacomitinib is a small-molecule, irreversible inhibitor of HER1, HER2, and HER4, under development by Pfizer. Mutation or amplification of the HER gene is seen in several malignancies including…
August 30, 2018
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Daklinza
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Daklinza (daclatasvir; Bristol-Myers Squibb) is a first-generation NS5A inhibitor approved for use for the treatment of genotype 1/2/3/4 (GT-1/2/3/4) chronic hepatitis C virus patients. Within the US and five major EU markets (France, Germany, Italy, Spain, and the UK), Daklinza is also approved for use in combination with Sovaldi (sofosbuvir; Gilead) for the treatment of GT-1/3 patients.
November 6, 2017
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Daliresp
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Daliresp (roflumilast; AstraZeneca/Allergan/Takeda) is an oral phosphodiesterase 4 (PDE4) inhibitor indicated for the treatment of patients with severe chronic obstructive pulmonary disease (COPD), who suffer from chronic bronchitis and frequent exacerbations.
July 31, 2018
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Darzalex
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Darzalex (daratumumab; Johnson & Johnson) is a human monoclonal antibody against the cluster of differentiation (CD)38 antigen, which is produced in a mammalian cell line…
August 9, 2018
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Duaklir Pressair
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Duaklir Pressair ([aclidinium + formoterol]; AstraZeneca/Circassia/Kyorin Pharmaceutical) is a twice-daily fixed-dose combination of the long-acting beta 2 agonist formoterol and the long-acting muscarinic antagonist aclidinium.
July 31, 2018
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Dulera
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Dulera (mometasone/formoterol; Merck & Co) is an oral inhalation drug that contains a combination of mometasone (an inhaled corticosteroid) and formoterol (a long-acting beta 2 agonist)…
February 16, 2018
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