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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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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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Opdivo
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Opdivo is a fully human immunoglobulin G4 PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T cells.
March 6, 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.
March 6, 2019
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MT-2271
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MT-2271 is a plant-based, recombinant virus-like particle (VLP) QIV seasonal influenza vaccine in development by Mitsubishi Tanabe Pharma. It contains a mix of recombinant hemagglutinin proteins expressed as VLPs.
January 14, 2019
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Opsumit
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Actelion’s Opsumit (macitentan) is the follow-on product to the leading pulmonary arterial hypertension (PAH) therapy Tracleer.
October 29, 2018
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Orenitram
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United Therapeutics’ Orenitram (trepostinil) is the first-to-market oral formulation of a prostacyclin analog, and is a reformulation of the company’s intravenous prostacyclin analog Remodulin.
October 19, 2018
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MOR208
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MorphoSys is positioning its cluster of differentiation (CD)19-targeted monoclonal antibody MOR208 in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for high-dose chemotherapy and autologous stem cell transplant.
October 9, 2018
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MVA-BN RSV
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MVA-BN RSV is a vaccine based on a recombinant MVA vector which expresses the RSV F and G glycoproteins, as well as the internal N and M2 proteins.
October 5, 2018
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MEDI8897
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MEDI8897 is a human immunoglobulin G1 MAb derived from human B cells intended to provide protection against RSV infection.
October 5, 2018
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Orkambi
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Orkambi contains the combination of lumacaftor and ivacaftor, which has the dual mechanism of correcting and potentiating the function of CFTR protein, normalizing chloride conductance in patients with cystic fibrosis.
September 3, 2018
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Mekinist
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Mekinist (trametinib; Novartis/Japan Tobacco) is a selective allosteric inhibitor of the MEK1 and MEK2 enzymes in the mitogen-activated protein kinase (MAPK) pathway.
August 30, 2018
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Ninlaro
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Ninlaro (ixazomib; Takeda) reversibly inhibits the 20S proteasome, resulting in the accumulation of proteins and eventually leading to the activation of apoptotic pathways.
August 9, 2018
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Ozanimod
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Ozanimod (Celgene) is a sphingosine 1-phosphate (S1P) receptor agonist, with selectivity for the sphingosine 1-phosphate type 1 receptor (S1P1) and sphingosine 1-phosphate 5 receptor (S1P5).
August 2, 2018
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Nucala
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Nucala (mepolizumab; GlaxoSmithKline) is a humanized monoclonal immunoglobulin G1 antibody that binds to interleukin (IL)-5, which plays a significant role in the activation, proliferation, and differentiation of eosinophils.
July 31, 2018
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M-O

M-O

Ocaliva

Odefsey

Opdivo

Nexavar

MT-2271

Opsumit

Orenitram

MOR208

MVA-BN RSV

MEDI8897

Orkambi

Mekinist

Ninlaro

Ozanimod

Nucala