Pfizer developed Zyvox (linezolid) as the first oxazolidinone antimicrobial agent. The drug gained its first regulatory approval for the treatment of complicated skin and skin structure infections (cSSSI) in the US market in 2000.
Zytiga (abiraterone acetate; Johnson & Johnson/AstraZeneca) is a small molecule oral irreversible inhibitor of the 17 alpha-hydroxylase enzyme which catalyzes the hydroxylation of intermediates involved in testosterone synthesis.
Zyprexa (Eli Lilly) contains the atypical antipsychotic olanzapine, which acts as an antagonist at the D2 and 5-HT2A receptors.
Zykadia (ceritinib; Novartis) is a tyrosine kinase inhibitor that targets anaplastic lymphoma kinase (ALK).
Zydelig (idelalisib; Gilead) is an oral, highly selective inhibitor of the phosphoinositide 3-kinase (PI3K) isoform p110-delta. In vitro studies have demonstrated that Zydelig results in decreased phosphorylation Akt and other downstream effectors, an increase in poly (ADP-ribose) polymerase and caspase cleavage, and an induction of apoptosis.
Zybrestat (fosbretabulin tromethamine; Mateon Therapeutics) is a water-soluble prodrug of cis-combretastatin A4, originally isolated from the African bush willow (Combretum caffrum).
Zulresso is SAGE Therapeutics’ proprietary intravenous formulation of brexanolone, which is an allosteric modulator of both synaptic and extra-synaptic GABA-A receptors.
Zontivity was approved (May 8, 2014) for use with clopidogrel/aspirin, its label was relatively benign, not reporting bleeding in the overall trial, which included stroke/TIA patients who had excessive bleeding with the drug, or in ACS trial, where there was also excessive bleeding.
Zontivity (vorapaxar; Merck & Co) gained US and EU approval for the reduction of thromboembolic
events in secondary-prevention patients with a history of myocardial infarction (MI).
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.”
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.
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.
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.
Zepsyre (lurbinectedin; PharmaMar/Chugai) is a novel synthetic agent derived from the marine-derived alkaloid trabectedin that inhibits the transcription process.
Zepatier is a once-daily, fixed-dose combination of Merck & Co’s second-generation protease inhibitor, grazoprevir, and the company’s NS5A inhibitor, elbasvir.
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.
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.
Zelapar (selegiline; Valeant) is a novel rapidly disintegrating tablet formulation of the monoamine oxidase B (MAO-B) inhibitor selegiline.
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.
Zeftera (ceftobiprole medocaril; Basilea Pharmaceutica) is a novel intravenous broad-spectrum fifth-generation cephalosporin.
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.
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).
Zafatek (trelagliptin; Takeda) is a member of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class.
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.
Ygalo (melphalan-flufenamide; Oncopeptides) is a cytotoxic alkylating agent that consists of melphalan conjugated to phenylalanine
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.
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).
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.
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.
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.
Xolair (omalizumab; Roche/Novartis) is a recombinant humanized monoclonal antibody for the treatment of moderate to severe persistent allergic asthma.
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.
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.
While Xeljanz (tofacitinib; Pfizer/Takeda) demonstrated positive efficacy in its Phase III clinical trial
program, its future in psoriasis is uncertain.
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.
Xalkori (crizotinib; Pfizer/Merck KGaA) is a selective, adenosine triphosphate-competitive small molecule multi-kinase inhibitor of mesenchymal epithelial transition growth factor
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.
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).
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 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.
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 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 provides analyses of products, markets, and competitors in the United States (U.S.) market for osteoporosis management products.
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.
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.
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