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Drugs of Today

I Serio, F Tovoli
Rheumatoid arthritis (RA) is an immune-mediated condition which primarily affects the joints, but with critical extra-articular manifestations, including a significantly increased cardiovascular risk. Patients suffering from RA can develop deforming and disabling alterations of the affected joints. Their quality of life can be substantially affected, and their life expectancy is shorter compared to that of healthy subjects. Fortunately, several pathogenic mechanisms characterizing RA have been identified, leading to the development of targeted drugs...
March 2018: Drugs of Today
J C Cho, L M Childs-Kean, M T Zmarlicka, M P Crotty
Omadacycline is a novel aminomethylcycline antimicrobial agent that is available in both oral and intravenous formulations. The distinguishing structural characteristics of omadacycline from other tetracyclines allow for its continued antimicrobial activity in the presence of traditional tetracycline resistance mechanisms (efflux pumps and ribosomal protection proteins). Omadacycline has been found to have potent activity against antibiotic-resistant pathogens including methicillin-resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, extended spectrum beta-lactamase-producing Escherichia coli and multidrug-resistant Streptococcus pneumoniae...
March 2018: Drugs of Today
D M Paton
Guselkumab is an antibody designed to bind to the p19 subunit of interleukin-23 (IL-23). Detailed studies of affected skin in patients with psoriasis demonstrated that guselkumab induced significant changes in the cellular, cytokine and gene expression profiles of psoriatic lesions accompanied by significant changes in clinical measures of disease activity. The significant clinical response in psoriasis was demonstrated in these studies by significant improvement as reflected in the percentage of patients achieving a Physicians Global Assessment score of 0 or 1, and a 90% or 100% improvement in the Psoriasis Area and Severity Index (PASI 90, PASI 100), as well as changes in quality of life measures...
March 2018: Drugs of Today
P Sharma, G T King, S S Shinde, E Purev, A Jimeno
B-cell non-Hodgkin's lymphomas are the most common hematological malignancies, which despite improvements in chemo-immunotherapy, carry a uniformly poor prognosis in the relapsed/refractory setting. CD19 is an antigen expressed on the surface of most malignancies arising from the B cells, and adoptive transfer of anti-CD19 chimeric antigen receptor (CAR)-expressing T cells has been shown to be effective in treating these B-cell malignancies. Axicabtagene ciloleucel (axi-cel, KTE-C19) is an autologous anti-CD19 CAR T-cell therapy which has shown high overall response rates and a manageable safety profile in patients with relapsed or refractory B-cell malignancies who lack effective and curative treatment options...
March 2018: Drugs of Today
P D'Souza
During the fourth quarter of 2017, Cortellis Competitive Intelligence registered 1,107 new deals (excluding mergers & acquisitions) as part of its ongoing coverage of licensing activity in the life sciences sector compared to 1,043 in the third quarter and 1,035 in the fourth quarter of 2016.
February 2018: Drugs of Today
A I Graul, C Dulsat, P Pina, M Tracy, P D'Souza
This eagle's-eye overview of the drug industry in 2017 provides insight into some of last year's top stories, including the growing opioid crisis affecting the U.S. and other developed countries and the 2017-2018 influenza epidemic, with a spotlight on the need for a universal flu vaccine. As in previous years, we also review orphan drug development, new agency-supported programs such as PRIME and RMAT, pipeline attrition and drug pricing, as well as pharma/biotech mergers and acquisitions of note. Finally, we take a glimpse into the crystal ball to anticipate the new drugs that will be approved in 2018...
February 2018: Drugs of Today
G Holleran, F Scaldaferri, G Ianiro, L Lopetuso, D Mc Namara, M C Mele, A Gasbarrini, G Cammarota
Fecal microbiota transplantation (FMT) is the transplantation of microbial gut contents from a healthy individual into the gastrointestinal tract of a person with a disease, with a view to increasing the recipient's gut microbial diversity and bacterial richness and restoring microbial homeostasis. FMT has been proven to be a safe and effective treatment for Clostridium difficile infection (CDI) and it is now a recommended treatment for recurrent or refractory infection. FMT is not currently recommended for use outside of CDI due to concerns regarding outcome and safety; however, several case series and randomized controlled trials have described its use in a research environment for a few gastrointestinal conditions related to intestinal dysbiosis including ulcerative colitis (UC), Crohn's disease (CD) and irritable bowel syndrome (IBS)...
February 2018: Drugs of Today
G T King, P Sharma, S L Davis, A Jimeno
The recent development of monoclonal antibodies that disinhibit the immune system from recognizing and attacking tumor cells has revolutionized the treatment of cancer. Among these agents are drugs that specifically block cytotoxic T-lymphocyte protein 4 (CTLA-4), programmed cell death protein 1 (PD-1) and programmed cell death 1 ligand 1 (PD-L1) signaling, called immune checkpoint inhibitors (ICIs). While these agents are generally well tolerated, ICI therapy can lead to loss of self-tolerance and the development of autoimmunity, manifesting as immune-related adverse events (IRAEs)...
February 2018: Drugs of Today
C N McBrien, A Menzies-Gow
Eosinophilic granulomatosis with polyangiitis (EGPA) is a rare but potentially life-threatening antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis which affects, to varying degrees, the lungs, paranasal sinuses, heart, kidneys, skin and peripheral nervous system. It is strongly associated with asthma. Peripheral eosinophilia is a defining feature of EGPA and eosinophilic inflammation is often observed in biopsies of affected tissues. Acute and chronic management focuses on the control of inflammation with systemic corticosteroids and other immunosuppressants, all of which carry a significant burden of adverse effects...
February 2018: Drugs of Today
A I Graul, P Pina, M Stringer
This review presents the 113 new drugs and biologics that were approved or launched for the first time globally in 2017. Fifty-two new drugs and biologics reached their first markets worldwide in 2017. Seven of the new launches were first-in-class agents, meaning the first drug with a novel mechanism of action to be approved and launched anywhere in the world. In addition, 36 notable line extensions (i.e., new indications, new combinations and new formulations of previously marketed products) were introduced last year...
January 2018: Drugs of Today
S G Chrysant
Testosterone (T) levels decline with the advancement of age and have been associated with increased incidence of cardiovascular disease (CVD). Indeed, several epidemiologic and prospective cohort studies have suggested that low T levels (lower tertile or quartile) are associated with increased incidence of CVD, type 2 diabetes mellitus (T2DM), obesity and dyslipidemia. In contrast, correction of low T levels with testosterone replacement therapy (TRT) is associated with a decrease in the incidence of CVD, T2DM and dyslipidemia as has been demonstrated by several randomized, controlled trials as well as prospective cohort studies...
January 2018: Drugs of Today
R Thakare, A Dasgupta, S Chopra
Chagas disease is a vector-borne, systemic and chronic parasitic infection caused by Trypanosoma cruzi with approximately 8 million cases worldwide. The treatment for acute phase of Chagas disease consists of benznidazole and nifurtimox, although this treatment combination falls short in terms of efficacy against chronic phases of infection. This review provides an update on benznidazole progress and approval by the U.S. Food and Drug Administration in 2017 for the treatment of Chagas disease along with its lacunae...
January 2018: Drugs of Today
F Tovoli, A Granito, S De Lorenzo, L Bolondi
Hepatocellular carcinoma (HCC) is a worldwide problem, with a high prevalence in nonindustrialized countries and a rising incidence in industrialized countries as well. Its close association with chronic liver diseases and liver cirrhosis represents a significant challenge in its treatment. A front-line systemic treatment for unresectable cases of HCC (sorafenib) was identified only in 2007. Following a decade of failed clinical trials with a wide range of drugs for second-line treatment, regorafenib proved its efficacy as a second-line treatment in 2016, when the randomized, placebo-controlled, phase III RESORCE trial demonstrated a meaningful increase in overall survival in the regorafenib treatment arm compared with the placebo arm (10...
January 2018: Drugs of Today
S Klischies
The annual congress of the European Society of Cardiology (ESC) is the largest medical congress in Europe for this area of research and took place this year in Barcelona, Spain. The ESC Congress 2017 gathered more than 30,000 registered participants from over 140 countries together to share their knowledge in all cardiovascular fields, from basic science to management and prevention of cardiovascular diseases. The congress comprised 5 days of science and education with over 11,000 abstracts submitted, 500 expert sessions and over 200 exhibiting companies, making it the prime meeting platform for the profession...
December 2017: Drugs of Today
A Choudhry, S M O'Brien
Inotuzumab ozogamicin is an antibody-drug conjugate comprised of a humanized anti-CD22 monoclonal antibody conjugated to calicheamicin, a cytotoxic antibiotic agent. Inotuzumab ozogamicin binds to CD22-expressing tumor cells, resulting in apoptotic cell death. Based on the results of the pivotal, phase III INO-VATE trial in acute lymphoblastic leukemia (ALL), approval of inotuzumab ozogamicin was recently granted for the treatment of patients with relapsed or refractory ALL, a group that otherwise has a poor prognosis with standard chemotherapy...
December 2017: Drugs of Today
M Alsharedi, R Srivastava, N Elmsherghi
Immunotherapy has revolutionized cancer care in the modern era of oncology. Research in immunotherapy has led to important advances in the treatment of melanoma, non-small cell lung cancer and other malignancies using checkpoint inhibition. Multiple systemic immunotherapies have been approved or are currently being investigated for the management of urothelial malignancies (1). Five antibodies targeting the programmed cell death protein 1--programmed cell death 1 ligand 1 (PD-1--PD-L1) pathway have been approved by the U...
December 2017: Drugs of Today
M G Matera, P Rogliani, L Calzetta, G W Canonica, M Cazzola
Benralizumab is a humanized monoclonal antibody directed at the a subunit of the interleukin-5 receptor (IL-5R) that is under clinical development. The binding of benralizumab with the alpha chain of IL-5R results in inhibition of hetero-oligomerization of alpha and beta subunits and thus no signal transduction occurs. Consequently, this inhibition prevents proliferation of eosinophils and basophils and the cascade of events following it. Several pivotal trials have documented that benralizumab reduces asthma exacerbation rates with a significant increase in time to the next exacerbation, statistically improves prebronchodilator forced expiratory volume in 1 second (FEV1) and disease-specific health-related quality of life, and is well tolerated in patients with severe asthma and blood eosinophil counts greater than or equal to 150 cells/mcL...
December 2017: Drugs of Today
E Torramadé
The 25th United European Gastroenterology Week (UEGW), the largest European conference centered on diseases of the stomach, bowel, esophagus, liver, pancreas and gallbladder, was held in Barcelona, Spain. This 5-day meeting attracted over 13,000 delegates to share recent research in the treatment of gastrointestinal and liver diseases. The conference provided teaching material, workshops and live sessions to all the attendants. The reports will cover the latest research into treatments for these diseases.
November 2017: Drugs of Today
L Saes, F A L M Eskens
Tivozanib is a tyrosine kinase inhibitor that targets all vascular endothelial growth factor receptors (VEGFRs), causing inhibition of angiogenesis. It has recently been approved by the European Medicines Agency (EMA) for first-line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mammalian target of rapamycin (mTOR) pathway inhibitor-naive, following disease progression after one prior treatment with cytokine therapy for advanced RCC. This review will focus on mechanisms of action, early drug development and results of published and ongoing clinical trials of tivozanib...
November 2017: Drugs of Today
Y Liu, X Chen, W Han, Y Zhang
On August 30, 2017, the U.S. Food and Drug Administration (FDA) approved Novartis' tisagenlecleucel (CTL-019, Kymriah), which is a synthetic bioimmune product of anti-CD19 chimeric antigen receptor (CAR) T cells, for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). This was a milestone in tumor immunology on account of the significant antitumor effect of tisagenlecleucel for the treatment of relapsed/refractory B-ALL patients. Conventional standard therapies for B-ALL have high failure rates, thus developing new therapies is crucial for patients with B-ALL...
November 2017: Drugs of Today
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