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.
Novavax’s virus-like particle (VLP) quadrivalent influenza vaccine (QIV), currently in Phase II
development, has the potential for significant market success if it is able to demonstrate superior
safety or efficacy data in Phase III studies.
Volasertib is a polo-like kinase (Plk) inhibitor being developed by Boehringer Ingelheim for the treatment of AML.
Vonvendi (Shire) became the first recombinant von Willebrand factor (rVWF) therapy approved in the US in December 2015.
Vosevi ([sofosbuvir + velpatasvir + voxilaprevir]) is Gilead’s third-generation, pan-genotypic, interferon-free regimen. The fixed-dose combination contains the hepatitis C virus nucleotide NS5B inhibitor sofosbuvir, a second-generation NS5A inhibitor (velpatasvir), and the company’s NS3 protease inhibitor (voxilaprevir).
Votrient (pazopanib; Novartis) is an oral angiogenesis inhibitor targeting the vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor (PDGFR), and c-KIT. Preclinical studies have shown the role of PDGF in modulating angiogenesis
Vraylar (cariprazine; Gedeon Richter/Allergan/Mitsubishi Tanabe) is a novel atypical antipsychotic with partial agonistic activity at D2 and D3 receptors, and selectivity for the D3 receptor.
Vyxeos (cytarabine/daunorubicin; Jazz Pharmaceuticals) is a liposomal formulation of a 5:1 molar ratio of cytarabine and daunorubicin – chemotherapy drugs which are currently administered as two separate intravenous injections as part of the 7+3 regimen for the treatment of acute myeloid leukemia.Vyxeos (cytarabine/daunorubicin; Jazz Pharmaceuticals) is a liposomal formulation of a 5:1 molar ratio of cytarabine and daunorubicin – chemotherapy drugs which are currently administered as two separate intravenous injections as part of the 7+3 regimen for the treatment of acute myeloid leukemia.
Waylivra (volanesorsen; Ionis Pharmaceuticals) is an antisense drug that inhibits the translation and production of ApoC-III.
Acquisitions and licensing are core to pharma and big biotech growth as pipelines thin and assets lose patent protection. Yet a look back at prior years’ eye-popping deal sums reveals many billions of dollars of write-offs and lost value. Key assets failed or disappointed in at least half of 2014’s largest acquisitions and licensing deals. Failure is part of the drug discovery landscape, but some lessons can be learned from dud deals.
This report provides analyses of products, markets, and competitors in the global market for osteoporosis diagnostic products. This market, as covered by the scope of this report, includes products that are used to diagnose osteoporosis, including bone densitometry systems and bone remodeling biochemical marker tests.
This report provides analyses of products, markets, and competitors in the United States (U.S.) market for osteoporosis management products.
This report focuses on minimally invasive therapy systems and medications designed for the treatment of female UI, including OAB pharmaceutical or drug treatments, injectable urethral bulking agents, and urethral sling systems, of which the OAB drug treatments market contributes the vast majority of revenues.
This report presents market and competitive analyses for selected leading contraceptive and fertility products as well as an overview of the most common types of contraceptives and fertility drugs/treatments available to women in the United States (U.S.) for reproductive management.
This report focuses on minimally invasive therapy systems designed for the treatment of female urinary incontinence (UI); market segments covered include injectable urethral bulking agents, urethral sling systems, and neuromodulation systems.
In 2019, sales of advanced wound care products in the US, five major European markets (France, Germany, Italy, Spain, and the UK), Japan, and Rest of World markets totaled nearly $8.2bn;
This analysis includes a discussion of products, current/forecast markets, competitors, and opportunities in the US, 5EU, Japan, and RoW markets for tissue-engineered skin replacements (epidermal, dermal, and multilayer equivalents, and amniotic tissue grafts) and active wound repair modulators (growth factors, gene therapy agents, and stem cells).
Xadago (safinamide; Newron Pharmaceuticals/US WorldMeds/Zambon/Meiji Seika Pharma) has a novel dual mechanism of action, based on the enhancement of the dopaminergic function through the reversible inhibition of monoamine oxidase B (MAO-B) and inhibition of excessive glutamate release by blocking the activity of the voltage-dependent sodium channels.
Xalkori (crizotinib; Pfizer/Merck KGaA) is a selective, adenosine triphosphate-competitive small molecule multi-kinase inhibitor of mesenchymal epithelial transition growth factor
Xarelto (rivaroxaban; Bayer/Johnson & Johnson) is an oral anticoagulant indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in the US, EU, and Japan.
While Xeljanz (tofacitinib; Pfizer/Takeda) demonstrated positive efficacy in its Phase III clinical trial
program, its future in psoriasis is uncertain.
Ximency (Bristol-Myers Squibb) is a twice-daily fixed-dose combination of daclatasvir, a first-generation NS5A inhibitor; asunaprevir, an NS3 protease inhibitor; and beclabuvir, a non-nucleoside NS5B inhibitor. The combination is approved in Japan for the treatment of genotype 1 (GT-1) chronic hepatitis C virus infection.
Xofigo (radium-223; Bayer) is a radioisotope that kills tumor cells with highly localized short-range alpha irradiation. The drug acts as a calcium mimic and is taken up in the areas of increased bone metabolism, which are associated with bone metastases.
Xolair (omalizumab; Roche/Novartis) is a recombinant humanized monoclonal antibody for the treatment of moderate to severe persistent allergic asthma.
Xtandi (enzalutamide; Pfizer/Astellas) is an androgen receptor (AR) signaling inhibitor that inhibits the AR at three distinct points in the signaling pathway. Xtandi competitively inhibits binding of the androgens to the AR, inhibits AR nuclear translocation, and inhibits association of the AR with DNA.
Xultophy ([insulin degludec + liraglutide]; Novo Nordisk) is a once-daily, injectable combination product comprising a fixed ratio of Novo Nordisk’s long-lasting basal insulin Tresiba (insulin degludec) and glucagon-like peptide-1 receptor agonist Victoza (liraglutide) for the treatment of type 2 diabetes.
Xyntha is a recombinant factor VIII (rfVIII) therapy approved for the treatment of hemophilia A.
Although Pfizer has taken steps to enhance the product by improving the manufacturing processes
and developing an application device for the therapy, Xyntha’s target patient population will be
reduced by competitor therapies approved for prophylactic use.
Yervoy (ipilimumab; Bristol-Myers Squibb/Ono Pharmaceutical) is an intravenous fully humanized immunoglobulin-G1 monoclonal antibody that targets human cytotoxic T-lymphocyte-associated protein-4 (CTLA-4).
Yescarta (axicabtagene ciloleucel; Gilead) became the first chimeric antigen receptor T-cell (CAR-T) therapy to launch for the treatment of diffuse large B-cell lymphoma (DLBCL) when it gained US approval for relapsed/refractory patients in October 2017.
Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine
Yonsa (Churchill Pharmaceuticals) is an oral, ultramicrosize tablet formulation of abiraterone acetate that inhibits 17 alpha-hydroxylase (CYP17). The CYP17 family of enzymes catalyze the hydroxylation of intermediates involved in testosterone synthesis, a common driver of prostate cancer genesis and recurrence.
Zafatek (trelagliptin; Takeda) is a member of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class.
Zaltrap is a human recombinant fusion protein comprising segments of the human VEGFRs 1 and 2 and the Fc portion of the human immunoglobulin G1 (Tang et al., 2008).
Zanubrutinib (BeiGene) is an oral small molecule inhibitor of Bruton’s tyrosine kinase (BTK), developed to be more selective with less off-target effects than Imbruvica (ibrutinib; AbbVie/Johnson & Johnson). BTK is part of the B-cell receptor signaling pathway, which promotes cell proliferation, adhesion, and survival in many B-cell malignancies.
Zeftera (ceftobiprole medocaril; Basilea Pharmaceutica) is a novel intravenous broad-spectrum fifth-generation cephalosporin.
Zejula (niraprib; Tesaro/Takeda) is a small molecule inhibitor of poly (ADP-ribose) polymerase (PARP). PARP inhibitors block the activity of PARP, an enzyme that plays an essential role in DNA repair mechanisms and homologous recombination events by directly blocking enzymatic activity, or by causing PARP to accumulate on DNA (PARP trapping), which results in DNA replication inhibition and cell death.
Zelapar (selegiline; Valeant) is a novel rapidly disintegrating tablet formulation of the monoamine oxidase B (MAO-B) inhibitor selegiline.
Zelboraf (vemurafenib; Roche/Chugai/Daiichi Sankyo) is an orally available agent that selectively targets the BRAF mutation. BRAF is part of the mitogen-activated protein kinase (MAPK) signal transduction pathway, which is critical in tumor cell proliferation.
Zeltherva’s (galinpepimut-S; SELLAS Life Sciences Group) larger target patient population gives it more commercial potential than other drugs being positioned towards the maintenance setting.
Zepatier is a once-daily, fixed-dose combination of Merck & Co’s second-generation protease inhibitor, grazoprevir, and the company’s NS5A inhibitor, elbasvir.
Zepsyre (lurbinectedin; PharmaMar/Chugai) is a novel synthetic agent derived from the marine-derived alkaloid trabectedin that inhibits the transcription process.
Multiple combination products based on the same active compound are known as a drug franchise. Franchises exist to give physicians, as well as patients, different treatment choices and to help with issues such as pill burden and compliance.
Zevalin (ibritumomab tiuxetan; Acrotech Biopharma/Mundipharma) is an intravenous radioactive agent consisting of the murine monoclonal antibody (MAb) ibritumomab, which is covalently linked to the chelator tiuxetan.
Zinbryta is a humanized monoclonal antibody that selectively binds to the alpha chain (cluster of differentiation [CD]25) of the interleukin-2 receptor on activated T cells to prevent the immunoactivation of MS.
Zoladex (goserelin; AstraZeneca/TerSera Therapeutics) is a gonadotropin-releasing hormone (GnRH) receptor agonist which acts on the pituitary gland to stimulate luteinizing hormone (LH) release, resulting in a temporary surge in serum testosterone levels known as “flare.”
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