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Stivarga
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Stivarga (regorafenib; Bayer/Amgen) is an orally available small molecule inhibitor that is currently in development for the treatment of hepatocellular carcinoma (HCC).
September 9, 2019
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Nexavar
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Nexavar (sorafenib; Bayer/Amgen) is a small molecule inhibitor that is currently the only targeted treatment available for first-line hepatocellular carcinoma patients.
September 9, 2019
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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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Menveo
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Menveo (quadrivalent oligosaccharide diphtheria CRM-197 conjugate vaccine; GlaxoSmithKline) is a quadrivalent meningococcal glycoconjugate vaccine that uses CRM-197, a natural mutant of the diphtheria toxin, as well as an aluminum phosphate adjuvant. It is approved for the prevention of meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals aged two months to 55 years in both the US and EU.
September 3, 2019
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MenABCW-135Y
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GlaxoSmithKline’s MenABCW-135Y is a pentavalent meningococcal conjugate vaccine for the A, B, C, W-135, and Y meningococcal strains. With all of the vaccine’s announced Phase II trials now complete, Datamonitor Healthcare expects that Phase III trials could start by the end of 2019, and forecasts US and EU approvals in adolescents and adults to occur as early as 2022.
September 3, 2019
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Menactra
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Menactra (quadrivalent polysaccharide diphtheria toxoid conjugate vaccine; Sanofi) is a quadrivalent polysaccharide diphtheria toxoid conjugate vaccine indicated for active immunization to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis (N. meningitidis) serogroups A, C, Y, and W-135 in individuals aged nine months through to 55 years in the US.
September 3, 2019
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MenQuadfi
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Sanofi’s MenQuadfi (quadrivalent polysaccharide tetanus toxoid conjugate vaccine) is a second-generation active polyvalent conjugate vaccine against group A, C, Y, and W meningococcal infection. It is presented as a sterile solution for injection containing Neisseria meningitidis capsular polysaccharide antigens individually conjugated to tetanus toxoid protein.
September 3, 2019
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Trumenba
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Trumenba (Pfizer) is a bivalent recombinant meningococcal serogroup B vaccine indicated for immunization to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals aged 10−25 years in the US. Trumenba is a sterile suspension composed of two recombinant lapidated factor H binding protein variants. Factor H binding protein is found on the surface of meningococci and enhances the bacterium’s ability to avoid host defense.
September 3, 2019
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Nimenrix
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Nimenrix (quadrivalent polysaccharide tetanus toxoid conjugate vaccine; Pfizer) is a conjugated polysaccharide vaccine indicated for active immunization to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis (N. meningitidis) serogroups A, C, Y, and W-135 in individuals from the age of six weeks. It induces the production of bactericidal antibodies against capsular polysaccharides of N. meningitidis group A, C, W-135, and Y.
September 3, 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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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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Trogarzo
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Trogarzo (ibalizumab; Theratechnologies/TaiMed Biologics) is a recombinant humanized monoclonal antibody approved for the treatment of HIV-1 infection. It targets the HIV-1 post-attachment process by binding one of the domains of the CD-4 protein, which inhibits a conformational change in CD-4 that is necessary to allow entry of HIV into T-cells.
July 28, 2019
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Cilofexor
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Cilofexor (Gilead), a nonsteroidal FXR agonist, is a ligand-activated nuclear hormone receptor that is a key regulator of bile acid synthesis, conjugation, and excretion. It is abundant in the liver, gallbladder, intestines, and kidney. Stimulation of FXR in the intestine by bile acids or an FXR agonist results in the release of fibroblast growth factor 19 (FGF19).
July 22, 2019
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Cenicriviroc
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Cenicriviroc (Allergan/Takeda) is a potent immunomodulator that blocks the chemokine receptors-2/5 (CCR-2/5). CCR-2/5 have been linked to the inflammatory and fibrogenic pathways in non-alcoholic steatohepatitis (NASH), and by inhibiting CCR-2/5 it is anticipated that cenicriviroc will reduce inflammation and fibrosis.
July 22, 2019
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VK2809
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VK2809 (Viking Therapeutics) is a thyroid hormone receptor (THR) β-selective agonist which is selective to liver tissue. It is delivered as a prodrug. VK2809 selectively activates the cytochrome P450 isozyme 3A4 (CYP3A4), which is predominantly found in the liver. This allows increased hepatic exposure, which simultaneously reduces systemic exposure to other tissues such as skeletal muscle and the heart.
July 22, 2019
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Aramchol
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Aramchol (arachidyl amido cholanoic acid; Galmed) is a conjugate of cholic acid and arachidic acid, and belongs to the synthetic fatty acid bile acid conjugates (FABACs) family. Aramchol inhibits the liver enzyme stearoyl-CoA desaturase 1 inhibitor (SCD1), and as a result fatty acid synthesis is reduced while fatty acid oxidation is increased. Additionally, Aramchol has hypocholesterolemic effects due to the upregulation of ATP-binding cassette transporter 1 (ABCA1). Ultimately, Aramchol causes incomplete SCD inhibition while also being anti-atherogenic.
July 22, 2019
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Ocaliva
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Ocaliva (obeticholic acid; Intercept Pharmaceuticals) is a selective farnesoid X receptor (FXR) agonist. FXR is a nuclear bile acid receptor involved in the regulation of bile acids, lipids, and possibly glucose. Ocaliva is a derivative of chenodeoxycholic acid, the endogenous FXR agonist found naturally in human bile acid. By activating FXR, Ocaliva improves insulin sensitivity and inhibits lipogenesis, which reduces fat buildup in the liver and results in decreased inflammation. Ocaliva has also been linked to weight loss. Ocaliva is currently approved in the US and EU for primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
July 22, 2019
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Elafibranor
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Elafibranor (Genfit) is an oral peroxisome proliferator-activated receptor (PPAR) alpha-delta dual agonist. The medication activates PPAR-alpha and PPAR-delta, which control gene expression. Stimulating these receptors increases insulin sensitivity and fatty acid oxidation, which results in a reduction of fat buildup in the liver and leads to a decrease in fibrosis and inflammation.
July 22, 2019
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Tropifexor
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FXR is a nuclear receptor that regulates bile acid metabolism and signaling. Activation of the receptor inhibits bile acid synthesis from cholesterol via cytochrome P450 7A1 and increases bile acid conjugation, transport, and excretion. This protects the liver from the potentially harmful effects caused during bile acid accumulation. Tropifexor (Novartis/Pfizer) is a novel, highly potent, non-bile acid FXR agonist. It has demonstrated potent activity in rodent Parkinson’s disease models by measuring the induction of FXR target genes in tissues.
July 22, 2019
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Selonsertib
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Selonsertib (Gilead) is a small molecule that inhibits apoptosis signal-regulating kinase 1 (ASK1). ASK1 has been shown to promote inflammation, apoptosis, and fibrosis in settings of oxidative stress. Non-alcoholic steatohepatitis (NASH) increases oxidative stress and ASK1 activation, so by inhibiting ASK1, selonsertib has been shown to decrease inflammation and fibrosis in patients with NASH.
July 22, 2019
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Resmetirom
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Resmetirom (Madrigal Pharmaceuticals) is a thyroid hormone receptor (THR) β-selective agonist which selectively targets receptors in the liver. The THR is involved in the regulation of metabolism, cholesterol, and triglycerides, as well as the pathological buildup of fat in the liver. The high liver specificity of resmetirom aims to avoid adverse events associated with THR activation outside the liver.
July 22, 2019
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Firsocostat
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Firsocostat (Gilead) is an acetyl-CoA carboxylase (ACC) allosteric inhibitor which binds to the biotin carboxylase domain of ACC with high potency and selectivity. Firsocostat inhibits both isoforms (ACC1 and ACC2) of ACC, which results in the reduction of the production of malonyl-CoA carboxylase, therefore reducing a key substrate for fatty acid synthesis. This also reduces the inhibitory effect of malonyl-CoA on the carnitine palmitoyltransferase 1 (CPT-1), which is the rate-limiting step in β-oxidation and leads to an increase in the breakdown of free fatty acids.
July 22, 2019
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Emricasan
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Emricasan (Conatus/Novartis) is a small molecule which inhibits pan-caspases. These enzymes are key modulators of apoptosis and inflammation, and chronically elevated apoptosis is often present in liver disease, which leads to the accumulation of apoptotic cells and the release of apoptotic bodies. These end products of apoptosis are engulfed by surrounding tissues which promote disease pathology and inflammation.
July 22, 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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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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Juluca
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Juluca ([dolutegravir + rilpivirine]; ViiV Healthcare/Johnson & Johnson) is a single-tablet regimen approved in the US for the treatment of patients infected with HIV-1 who have achieved viral suppression.
June 28, 2019
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Odefsey
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Odefsey ([rilpivirine + emtricitabine + tenofovir alafenamide (TAF)]; Gilead/Johnson & Johnson) is a single-tablet regimen approved in the US and five major EU markets (France, Germany, Italy, Spain, and the UK) for the treatment of HIV-1 infection. Odefsey contains Gilead’s nucleos(t)ide reverse transcriptase inhibitors (NRTIs) TAF and Emtriva (emtricitabine), and Johnson & Johnson’s non-nucleoside reverse transcriptase inhibitor Edurant (rilpivirine; Johnson & Johnson).
June 28, 2019
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Symtuza
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Symtuza ([darunavir + cobicistat + emtricitabine + tenofovir alafenamide (TAF)]; Johnson & Johnson) is a once-daily single-tablet regimen (STR) combination of the protease inhibitor (PI) Prezista, the two nucleos(t)ide reverse transcriptase inhibitors (NRTIs), Emtriva (emtricitabine; Gilead) and TAF (Gilead), and the boosting agent Tybost (cobicistat; Gilead). Symtuza is the first STR containing a PI.
June 28, 2019
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Truvada
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Truvada ([emtricitabine + tenofovir disoproxil fumarate (TDF)]; Gilead/Japan Tobacco) is a once-daily, fixed-dose combination of two of Gilead’s marketed nucleoside reverse transcriptase inhibitors (NRTIs):
June 28, 2019
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cabotegravir/rilpivirine
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Cabotegravir is an integrase strand transfer inhibitor analog of Tivicay (dolutegravir; ViiV Healthcare), and rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI), branded as Edurant (Johnson & Johnson).
June 28, 2019
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