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.
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.
Nexavar (sorafenib; Bayer/Amgen) is a small molecule inhibitor that is currently the only targeted treatment available for first-line hepatocellular carcinoma patients.
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.
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.
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.
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.
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.
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.
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).
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.
Actelion’s Opsumit (macitentan) is the follow-on product to the leading pulmonary arterial hypertension (PAH) therapy Tracleer.
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.
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.
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.
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