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Drugs of Today

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https://www.readbyqxmd.com/read/28387389/the-year-s-new-drugs-biologics-2016-part-ii-trends-and-highlights-of-an-unforgettable-year
#1
A I Graul, C Dulsat, M Tracy, E Cruces
This eagle's-eye overview of the drug industry in 2016 provides insight into some of last year's top stories, including disease outbreaks that drove R&D, orphan drug development, pipeline attrition, drug pricing, and the ongoing movement in M&A. We also consider recent political events in the U.S. and U.K. and their potential impact on the industry in the years to come, and take a glimpse into the crystal ball to anticipate the new drugs that may be approved in 2017.
February 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387388/new-frontiers-in-oncology-immune-checkpoint-inhibitors-in-combination-therapy
#2
G Romano, A Gawlinski
Substantial progress has been achieved in recent years in the field of cancer immunotherapy, with various strategies employed to elicit a host immune response against the tumor. Monoclonal antibodies have been successfully utilized in clinical trials to block key mediators of immune checkpoint pathways, including cytotoxic T-lymphocyte antigen 4, programmed cell death protein 1 and programmed cell death 1 ligand 1. Patients with a range of malignancies have been treated in these clinical trials, and significant benefits were reported among the majority of participants...
February 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387387/deutetrabenazine-treatment-of-hyperkinetic-aspects-of-huntington-s-disease-tardive-dyskinesia-and-tourette-syndrome
#3
D M Paton
Deutetrabenazine is a derivative of tetrabenazine in which two trideuteromethoxy groups substitute two methoxy groups. The active metabolites of deutetrabenazine have a longer half-life than those of tetrabenazine, together with a greater overall absorption. However, the peak plasma concentrations are lower. Because of these pharmacokinetic differences, deutetrabenazine can be given twice daily, thus improving compliance. The lower peak concentrations may account for a lower incidence of some unwanted adverse effects...
February 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387386/notable-deals-in-the-pharmaceutical-industry-in-the-fourth-quarter-of-2016
#4
P D'Souza
During the fourth quarter of 2016, Cortellis Competitive Intelligence had 889 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This was an increase on both the last quarter (865) but a decrease from the same quarter for the previous year (915). This article will focus on highlighting a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers. An update on milestones, options and terminated deals of significance will also be presented, along with an early outlook on the next quarter's pharmaceutical licensing activity...
January 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387385/the-year-s-new-drugs-biologics-2016-part-i
#5
A I Graul, P Pina, E Cruces, M Stringer
Nearly 90 new drugs and biologics, including important new line extensions, were approved or launched for the first time globally in 2016, a comparatively lower number with respect to previous years. Forty-four new drugs and biologics reached their first markets worldwide in 2016, nearly 10% fewer than the previous year. 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, 23 novel line extensions (i...
January 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387384/nebivolol-valsartan-fixed-dose-combination-for-treatment-of-hypertension
#6
D M Paton
Clinical trials demonstrated that a fixed-dose combination (FDC) of the beta-blocker nebivolol (5 mg) and the angiotensin II antagonist valsartan (80 mg) produced a significant reduction of both diastolic and systolic blood pressure in patients with hypertension. Both nebivolol and valsartan contributed to this effect, partial additivity of 86.6% and 82.2% being observed for diastolic and systolic blood pressure, respectively. These values are very similar to the additivity ratios of other recently approved FDCs for hypertension...
January 2017: Drugs of Today
https://www.readbyqxmd.com/read/28387383/daclizumab-and-its-use-in-multiple-sclerosis-treatment
#7
R Milo, M Osherov
Daclizumab is a humanized monoclonal antibody that binds to the a-subunit (CD25) of the interleukin-2 receptor (IL-2R), thus blocking the formation of the high-affinity IL-2R which is expressed mainly on activated and regulatory T cells. IL-2R modulation by daclizumab results primarily in the expansion of regulatory CD56(bright) natural killer cells that are capable of killing activated T cells, rather than direct suppression of activated T cells. The pharmacokinetic profile of its currently available form, daclizumab high-yield process (DAC-HYP, Zinbryta), suggests high subcutaneous bioavailability, linear pharmacokinetics and an effective half-life suitable for monthly administration...
January 2017: Drugs of Today
https://www.readbyqxmd.com/read/28276539/the-liver-meeting-2016-american-association-for-the-study-of-liver-diseases-67th-annual-meeting-november-11-15-2016-boston-massachusetts-usa
#8
K Künnemann
This year, The Liver Meeting, organized by the American Association for the Study of Liver Diseases, was held at the Hynes Convention Center in Boston, Massachusetts (USA). During the 4-day conference, scientists and researchers from all over the world discussed recent results and advances in the field of hepatology. New research with experimental, as well as investigational, therapeutic candidates was presented in several poster sessions as well as oral presentations. The reports from this meeting provide an overview of some of the most important presentations...
December 2016: Drugs of Today
https://www.readbyqxmd.com/read/28276538/valbenazine-for-the-treatment-of-tardive-dyskinesia
#9
N Barquero
Valbenazine (NBI-98854, Ingrezza) is a highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor that modulates dopamine release during nerve communication. The pharmacological target VMAT2 may play an important role in the treatment of tardive dyskinesia (TD), an iatrogenic condition associated with the administration of antipsychotic medication for long periods and characterized by rapid, repetitive, stereotypic, involuntary movements of the face and extremities. There are currently no Food and Drug Administration (FDA)-approved drugs for the treatment of TD...
December 2016: Drugs of Today
https://www.readbyqxmd.com/read/28276537/recombinant-von-willebrand-factor-a-first-of-its-kind-product-for-von-willebrand-disease
#10
M Singal, P A Kouides
von Willebrand disease (VWD) is caused by quantitative or qualitative defects in von Willebrand factor (VWF). The mainstay of therapy is desmopressin, which is, however, not useful in certain forms of VWD notwithstanding adverse events. For these patients, plasma-derived factor VIII (pdFVIII)/VWF concentrates have been available for close to three decades but have a theoretical risk of disease transmission, hypersensitivity/allergic reactions, inhibitors and thrombosis. A recombinant VWF (vonicog alfa, Vonvendi™; manufactured by Baxalta, now part of Shire) was approved by the U...
December 2016: Drugs of Today
https://www.readbyqxmd.com/read/28276536/obinutuzumab-in-follicular-lymphoma
#11
N Martinez-Calle, R Figueroa-Mora, S Villar-Fernandez, M Marcos-Jubilar, C Panizo
The CD20 marker continues to be exploited as a therapeutic target for non-Hodgkin's lymphoma. Obinutuzumab is part of a new generation of anti-CD20 monoclonal antibodies, which are synthesized using molecular engineering technology, resulting in novel target epitopes and unprecedented optimization of antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Rituximab is the current gold standard for anti-CD20 therapy, yet despite outstanding results published over the past decade, many patients continue to relapse after anti-CD20 regimens...
December 2016: Drugs of Today
https://www.readbyqxmd.com/read/28112281/a-measure-of-productivity-and-innovation-in-the-pharmaceutical-industry-2011-2015
#12
R Harrison
The pharmaceutical industry has faced enormous pressures over the last few decades. Declining revenues, increasing payer pressures, and a constantly changing regulatory landscape have forced all companies to identify processes to increase productivity and innovation. However, to date, no one agrees on precisely how to measure these attributes or how to interpret these results to understand the state of the industry. We propose new quantitative measures of productivity and innovation and use these to illustrate an industry that has in recent years become more innovative and productive after years of decline...
November 2016: Drugs of Today
https://www.readbyqxmd.com/read/28112280/tenofovir-alafenamide-fumarate-for-the-treatment-of-hiv-infection
#13
REVIEW
R Sampath, J Zeuli, S Rizza, Z Temesgen
Tenofovir alafenamide fumarate is a recently developed prodrug of tenofovir, a nucleotide analogue reverse transcriptase inhibitor with potent inhibitory activity against HIV. The utility of a previously developed tenofovir prodrug, tenofovir disoproxil fumarate, had been hampered by renal and bone mineral adverse events. Tenofovir alafenamide fumarate overcomes the shortcomings of tenofovir disoproxil fumarate by delivering high intracellular concentrations of the parent drug, tenofovir, while substantially reducing systemic exposure...
November 2016: Drugs of Today
https://www.readbyqxmd.com/read/28112279/secukinumab-il-17a-inhibition-to-treat-psoriatic-arthritis
#14
REVIEW
R Speeckaert, N van Geel, J Lambert, L Claeys, J R Delanghe, M M Speeckaert
Interleukin-17A is an important cytokine in the pathogenesis of psoriatic arthritis. Secukinumab is a recombinant, high-affinity, fully human immunoglobulin G1kappa monoclonal antibody with a selective binding and neutralization of interleukin-17A. By providing an alternative mechanism of action to current treatments, secukinumab has shown efficacy in the key clinical domains of psoriatic arthritis. In the present paper, we discuss the role of interleukin-17A as a clinically relevant target in the treatment of psoriatic arthritis, based on preclinical findings, dose-ranging and regimen-finding, randomized, placebo-controlled clinical trials...
November 2016: Drugs of Today
https://www.readbyqxmd.com/read/28112278/cobimetinib-inhibiting-mek1-2-in-braf-v600-mutant-melanoma
#15
REVIEW
A Jimeno, J R Eagles
Historically, metastatic melanoma has had extremely poor survival outcomes. The outlook, however, is rapidly changing as new molecularly targeted therapies have vastly improved patient outcomes. One such therapy is the potent mitogen-activated protein kinase kinase (MEK) 1/2 inhibitor cobimetinib. Recently, cobimetinib was approved for the treatment of metastatic or unresectable melanoma with serine/threonine-protein kinase B-raf (BRAF) V600E or V600K mutations when used in combination with the BRAF inhibitor vemurafenib...
November 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910966/stem-cell-and-regenerative-medicine-global-conference-scrgc-2016-august-23-24-2016-gyeonggi-do-korea
#16
A Vertès
In its third edition, the Stem Cell and Regenerative Medicine Global Conference (SCRGC) organized by the Global Stem Cell & Regenerative Medicine Acceleration Center (GSRAC) was focused on breaking barriers to accelerate the pace of innovation and development of the regenerative medicine industry. GSRAC is both a think tank and a global network of key opinion leaders from the public and the private sectors. GSRAC was commissioned in 2011 by the Ministry of Health and Welfare (MOHW) of Korea. GSRAC's primary mission is to enable and accelerate the delivery of innovative technologies to patients who are affected by currently untreatable diseases...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910965/notable-deals-in-the-pharmaceutical-industry-in-the-third-quarter-of-2016
#17
E Cruces
During the third quarter of 2016, Cortellis Competitive Intelligence had 865 new deals added as part of its ongoing coverage of pharmaceutical licensing activity. This figure shows similar deal activity compared with the same quarter of 2015 (934), and 21% less than the previous quarter, although they had similar disclosed financial sizes in comparison with the first half of 2016. This article will focus on a number of the most valuable and notable deals forged during the quarter, as well as a selection of deals from some of the most prolific deal makers...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910964/osimertinib-a-third-generation-tyrosine-kinase-inhibitor-targeting-non-small-cell-lung-cancer-with-egfr-t790m-mutations
#18
REVIEW
C E McCoach, A Jimeno
Oncogenic driver mutations in the epidermal growth factor receptor (EGFR) gene have provided a focus for effective targeted therapy. Unfortunately, all patients eventually develop resistance to frontline therapy with EGFR tyrosine kinase inhibitors (TKIs). The majority of patients develop a large subclonal population of tumor cells with a T790M mutation that renders these cells resistant to first-generation TKIs. Osimertinib is a third-generation EGFR TKI that was designed to overcome resistance from T790M mutations...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910963/daratumumab-monoclonal-antibody-therapy-to-treat-multiple-myeloma
#19
REVIEW
C Xia, M Ribeiro, S Scott, S Lonial
Daratumumab (Darzalex[TM]) is a human monoclonal antibody (MAb) that targets CD38; a surface protein highly expressed across multiple myeloma (MM) cells. Preclinical studies have shown daratumumab induces MM cell death through several mechanisms, including complement-dependent cytotoxicity (CDC) antibody-dependent cell-mediated cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP), apoptosis upon secondary crosslinking and immunomodulatory effects via a decrease in immune suppressive cells. Daratumumab has a favorable toxicity profile and encouraging clinical activity as a single agent and in combination with lenalidomide in heavily pretreated, relapsed patients in whom other novel agents (such as bortezomib, thalidomide and lenalidomide) and stem cell transplant have already failed...
October 2016: Drugs of Today
https://www.readbyqxmd.com/read/27910962/baricitinib-jak-inhibition-for-rheumatoid-arthritis
#20
REVIEW
J Gras
Rheumatoid arthritis (RA), a chronic autoimmune inflammatory disease characterized by inflammation and joint destruction, is associated with pain, progressive disability, systemic comorbidities and early death. Conventional disease-modifying antirheumatic drugs (DMARDs) and biological DMARDs (bDMARDs) have been able to achieve remission or a very low disease activity status for RA. Nevertheless, since many patients do not reach a sufficient response with DMARDs or present with unacceptable side effects, new therapies are needed...
October 2016: Drugs of Today
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