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Descovy
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Descovy ([emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Japan Tobacco) is a fixed-dose combination of two of Gilead’s nucleos(t)ide reverse transcriptase inhibitors, Emtriva (emtricitabine) and Vemlidy (tenofovir alafenamide [TAF]). The combination is currently approved in the US, Japan, and EU.
July 28, 2019
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Biktarvy
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Biktarvy ([bictegravir + emtricitabine + tenofovir alafenamide (TAF)]; Gilead) is an single-tablet regimen (STR) approved for the treatment of HIV-1 infection. It is a co-formulation of Gilead’s novel integrase strand transfer inhibitor (INSTI) bictegravir, and the marketed drug Descovy, which is a fixed-dose combination (FDC) of the nucleoside reverse transcriptase inhibitors (NRTIs) emtricitabine and TAF.
June 28, 2019
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Delstrigo
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Delstrigo ([doravirine + lamivudine + tenofovir disoproxil fumarate (TDF)]; Merck & Co) is a single-tablet regimen being developed for the treatment of HIV-1 infection. The drug is a co-formulation of the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine and the two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), lamivudine and TDF.
July 28, 2019
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Dovato
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Dovato ([dolutegravir + lamivudine]; ViiV Healthcare) is a single-tablet regimen approved in the US for the treatment of HIV-1 infection in patients who are treatment-naïve. It is also being developed in the EU for the treatment of HIV-1 infection in patients who are treatment-naïve (with an approval decision expected by Q3 2019), as well as for patients who are virologically suppressed (US/Japan/EU).
June 28, 2019
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tislelizumab
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Tislelizumab (BeiGene) is a humanized monoclonal antibody that was designed to bind to the PD-1 receptor and prevent binding of PD-L1. In addition, tislelizumab was designed to minimize binding to Fc-gamma-receptors (FcyR) on macrophages.
September 9, 2019
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Tymlos transdermal patch
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Tymlos (abaloparatide; Radius Health) is a synthetic peptide analog of human parathyroid hormone-related protein (PTHrP), which binds to the same receptor as parathyroid hormone (PTH).
October 8, 2019
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Onzeald
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Onzeald (etirinotecan pegol; Nektar Therapeutics) is a polyethylene glycol (PEG) conjugate of irinotecan, a prodrug that is metabolized via enzymatic cleavage into the biologically active metabolite 10-hydroxy-7-ethyl camptothecin, also known as SN-38. SN-38 inhibits DNA topoisomerase 1 during the S-phase of the mitotic cycle.
February 26, 2020
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Enhertu
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Enhertu (trastuzumab deruxtecan; Daiichi Sankyo/AstraZeneca) is an antibody-drug conjugate composed of a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2), an enzymatically cleavable peptide-linker, and a topoisomerase 1 inhibitor derived from exatecan. The drug-to-antibody ratio of Enhertu is 8:1.
February 26, 2020
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capivasertib
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Capivasertib (AstraZeneca) is an orally active, highly selective Akt inhibitor that preferentially targets Akt isoforms 1–3. Akt is a key enzyme in the PI3K/Akt/mTOR tumor cell survival pathway and is dysregulated in a number of malignancies through loss of tumor suppressor phosphatase and tensin homolog (PTEN), acquisition of activating mutations in phosphatidylinositol-4,5-bisphosphate 3- kinase catalytic subunit alpha (PIK3CA) or AKT1, as well as amplification of PI3K.
February 26, 2020
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balixafortide
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Balixafortide (Polyphor) is a synthetic cyclopeptide derived from polyphemusin that inhibits C-X-C motif chemokine receptor 4 (CXCR4), a G-protein coupled receptor that exclusively binds to its ligand, stromal cell-derived factor-1 (SDF-1).
February 26, 2020
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adagloxad simolenin
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Adagloxad simolenin (OBI Pharma) is a carbohydrate-based vaccine comprised of Globo-H conjugated to keyhole limpet hemocyanin. Upon exposure to the synthetic Globo-H vaccine and an immunological adjuvant, the immune system mounts IgM and IgG responses against Globo-H hexasaccharide.
February 26, 2020
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Company Analysis: AbbVie
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PharmaVitae explores AbbVie’s prescription pharmaceutical performance and outlook over 2019–29.
January 25, 2021
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Disease Analysis: Asthma
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Since its launch as the first fixed-dose combination (FDC) of an inhaled corticosteroid (ICS) and a long-acting beta 2 agonist (LABA), GlaxoSmithKline’s Advair has become a well-established gold-standard therapy in asthma. However, generic competition in Europe, and more recently in the US, marks the end of this successful history.
July 8, 2022
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Disease Analysis: Chronic Obstructive Pulmonary Disease (COPD)
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The “ABCD” GOLD treatment guidelines focus on exacerbation risk and patient-reported outcomes to determine pharmacological treatment strategies, independent of spirometric value. Dual bronchodilator combinations are being considered as the new gold standard over long-acting muscarinic antagonist Spiriva in the treatment of more severe COPD.
June 15, 2022
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Disease Analysis: Cystic Fibrosis
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Cystic fibrosis, caused by mutations in cystic fibrosis transmembrane conductance regulator (CFTR) protein, is a rare and life-limiting genetic disorder that is characterized by thick, sticky mucus and pulmonary complications.
October 10, 2022
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