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.
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.
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).
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.
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).
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.
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.
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.
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).
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.
PharmaVitae explores AbbVie’s prescription pharmaceutical performance and outlook over 2019–29.
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.
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.
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.
Chronic heart failure (CHF) is a progressive condition in which the heart muscle is unable to pump enough blood to meet the needs of the body. CHF can result from functional abnormalities such as ventricular dysfunction or arrhythmias, or structural disorders of the myocardium or valves.
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