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Drugs of Today

G Cross
The joint 24th Medicines for Europe and 21st International Generic and Biosimilars Association (IGBA) Annual Conference brought together key industry leaders and more than 200 participants in Budapest, Hungary, to discuss both challenges and opportunities for the global generic, biosimilar and value added medicines industries. Challenges relating to sustainability were debated with key experts, who shared perspectives on topics such as medicines shortages, use of data, Brexit, international regulatory cooperation, the E...
August 2018: Drugs of Today
M S Salahudeen
In the aging population, the process of medication prescribing and management is likely to be complex and challenging. Polypharmacy and inappropriate medication use are more prevalent among older people and are associated with geriatric syndromes, reduced cognitive and functional outcomes, and increased mortality. Deprescribing is the process of planned and supervised tapering or safe withdrawal of potentially inappropriate medication that can cause harm, or is no longer indicated or beneficial to the current therapy...
August 2018: Drugs of Today
Roma Srivastava, Y Lebowicz, M O Jamil
Lung cancer is the leading cause of cancer-related mortality worldwide and is the second most common cancer in both sexes. The small cell lung cancer (SCLC) subtype constitutes about 13% to 15% of all diagnosed lung cancers with an expected 5-year mortality of about 90%. In the past decades, various strategies used to treat newly diagnosed, relapsed or refractory SCLC have shown no significant improvement in clinical outcomes. In the genomic era of oncology, with a better understanding of tumor biology and pathway specific investigations, multiple investigational agents have been studied with the aim to improve clinical outcomes...
August 2018: Drugs of Today
C C Kopczynski, T Heah
Once-daily (p.m.) netarsudil ophthalmic solution 0.02% (Rhopressa) is approved in the United States for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil, a Rho kinase (ROCK) inhibitor that lowers IOP primarily by increasing trabecular outflow, produces statistically and clinically significant reductions in mean IOP from baseline, with comparable effects on nocturnal and diurnal IOP. In three phase III trials of patients with elevated IOP, the ocular hypotensive efficacy of once-daily netarsudil 0...
August 2018: Drugs of Today
E Guadelupe, H A Deshpande, S M Stein
Carcinoid tumors are rare and usually slow-growing. Some patients with advanced metastatic disease however can develop symptoms of carcinoid syndrome, which results in debilitating diarrhea and flushing. Many treatments including chemotherapy were tried unsuccessfully in the past to treat this syndrome. The symptoms of carcinoid syndrome are thought to be related to the ability of the tumors to produce serotonin. The discovery that the production of this hormone can be inhibited by somatostatin led to the development of somatostatin analogues octreotide and lanreotide, which differ from native somatostatin in that they have a longer half-life...
August 2018: Drugs of Today
L Chu
The 9th Annual Biosimilar Asia, an event hosted by ICB Asia, was held at the Hilton Shanghai Hongqiao from May 16 to 17. It was held simultaneously with Biomanufacturing Asia, and Cell Line Development and Engineering Asia. These three events formed Biopharma Development and Production (BDP) 2018. The BDP 2018 event had more than 60 sessions, over 70 speakers and more than 300 companies from around the world.
July 2018: Drugs of Today
D M Paton
Tildrakizumab is a monoclonal antibody that binds to the p19 subunit of interleukin (IL)-23. Studies examining affected skin in psoriatic patients showed significant changes in the cellular, cytokine and gene expression profiles of psoriatic lesions as a result of treatment with tildrakizumab, as well as significant changes in clinical measures of disease activity. These studies demonstrated significant clinical responses in psoriasis with significant improvements found in the percentage of patients achieving a Physician Global Assessment score of 0 or 1, and a 75%, 90% or 100% improvement in the Psoriasis Area and Severity Index (PASI 75, PASI 90, PASI 100)...
July 2018: Drugs of Today
P M Kasi
Telotristat ethyl (Xermelo), developed by Lexicon Pharmaceuticals, is an oral tryptophan hydroxylase inhibitor blocking peripheral conversion of tryptophan to serotonin (5-hydroxytryptamine [5-HT]). It was approved by the U.S. Food and Drug Administration (FDA) in February 2017 and by the European Commission in September 2017 for patients with carcinoid syndrome in whom diarrhea is not adequately controlled by somatostatin analogues (SSAs). Diarrhea, secondary to the release of serotonin, is the predominant gastrointestinal symptom in patients with carcinoid syndrome and has a significant impact on patients' quality of life...
July 2018: Drugs of Today
V Nehra, S A Rizza, Z Temesgen
The fixed-dose combination of glecaprevir (GLE), a nonstructural protein 3/4A (NS3/4A) protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor, was recently approved for the treatment of adult patients with chronic hepatitis C virus (HCV) genotypes 1-6 (GT-1-6) without cirrhosis or with compensated cirrhosis, and for the treatment of HCV GT-1 patients who have failed treatment with either NS5A inhibitors or NS3/4A protease inhibitors, but not both. This combination, administered over 8 or 12 weeks, has resulted in high cure rates in all six HCV genotypes, including patients with HIV coinfection...
July 2018: Drugs of Today
L M Splawn, C A Bailey, J P Medina, J C Cho
The prevalence of hepatitis B virus (HBV) infections is a worldwide issue that can lead to both acute and chronic complications with increased morbidity and mortality in affected individuals. Current methods of preventing HBV infections primarily include building patient immunity through administration of hepatitis B vaccinations starting at birth. Certain at-risk individuals, including those with occupational exposure to pathogenic bodily fluids, those who are sexually active or intravenous drug users, are recommended to receive some form of hepatitis B vaccination...
July 2018: Drugs of Today
E Cruces
During the first quarter of 2018, Cortellis Competitive Intelligence registered 879 new deals (excluding mergers and acquisitions) with a total disclosed deal value of approximately USD 35.2 billion as part of its ongoing coverage of licensing activity in the life sciences sector. This compares to 1,203 and USD 26.2 bil-lion in the fourth quarter of 2017, and 1,158 and USD 31.8 billion in the first quarter of 2017. This meant a significant increase in the total disclosed deal value compared to these two previous periods (+34% and +10...
June 2018: Drugs of Today
M Alsharedi, H Bukamur, A Elhamdani
Epidermal growth factor receptor (EGFR) mutations, mostly seen in exon 19 or exon 21, are present in roughly 50% of patients with advanced non-small cell lung cancer (NSCLC) of Asian ethnicity compared with 12% in Caucasians. EGFR-mutated NSCLC patients have an increased sensitivity to EGFR tyrosine kinase inhibitors (TKIs), such as erlotinib, gefitinib or afatinib, showing superior response, progression-free survival and overall survival rates with EGFR-TKIs than with platinum doublet chemotherapy, which makes EGFR-TKIs the standard of care in this subgroup of NSCLC patients...
June 2018: Drugs of Today
J C Cho, A D Le, S C Locke
Letermovir is a new antiviral agent with activity against human cytomegalovirus (CMV). Letermovir works as an inhibitor of the CMV DNA terminase complex which further inhibits viral DNA processing and packaging. Letermovir is available both orally and intravenously in 480-mg and 240-mg dosage forms, and is approved for use in the prophylaxis of CMV infection and disease in CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT) over the age of 18. The recommended dose is 480 mg p...
June 2018: Drugs of Today
R Bhandari, A Kuhad, A Kuhad
Amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease, is a fatal motor neuron degenerative disorder leading to paralysis and eventual death. At present, we do not have any specific cure for this deadly disorder. Current drug therapy can only reduce morbidity in ALS patients. In 1995, riluzole was the first drug approved by the U.S. Food and Drug Administration (FDA) for ALS. After a long gap of 22 years, Mitsubishi Tanabe Pharma America got U.S. FDA approval for edaravone (Radicava) in May 2017 for the management of ALS...
June 2018: Drugs of Today
S Hamaui Cuadrado, M Guinart Vidal
The Drug Information Association (DIA) Europe held its annual meeting from April 17-19, 2018, in Basel, Switzerland. The key topics discussed in the 3-day meeting were related to pharmacovigilance, clinical development, patient engagement, data and data standards, preclinical development and early-phase clinical research, regulatory science, translational medicine and science, and value and access. The program was principally focused on the current opportunities and future landscape of the healthcare system as a result of the increasingly innovative technologies and effective utilization of big data...
May 2018: Drugs of Today
F Ghaffarifar
DNA vaccines are considered as third-generation vaccines. The recombinant DNA technology plays an important role in the production of DNA vaccines. These vaccines are intended to increase DNA insertion and translation in the cell, activate CD4+ T cells, and enhance cytotoxic T-lymphocyte induction and antibody production. DNA vaccines are safe with few side effects in humans and animals. Their immunogenicity can be improved by the use of suitable adjuvants and proper delivery systems. In recent years, strategies have been developed to increase the efficacy of DNA vaccines through electroporation, as well as the use of cytokines, genetically engineered vectors, liposomes, and micro- or nanoparticles...
May 2018: Drugs of Today
L T Rahmat, A C Logan
Chronic graft-versus-host disease (cGvHD) is a grave complication of allogeneic hematopoietic cell transplantation (alloHCT). Despite the use of prophylactic regimens for cGvHD, a significant proportion of patients develop cGvHD following alloHCT. The standard first-line therapy for cGvHD is high-dose corticosteroids. However, roughly 50% of patients will exhibit steroid-refractory or steroid-dependent cGvHD, which increases the risk of non-relapse mortality. Ibrutinib was approved by the U.S. Food and Drug Administration (FDA) in August 2017 for the treatment of cGvHD after failure of one or more lines of systemic therapy...
May 2018: Drugs of Today
L Pietrogrande, E Raimondo
Abaloparatide is a synthetic 34-amino acid peptide analogue of the 1-34 portion of the human parathyroid hormone-related protein (PTHrP). It has been approved in the U.S. for the treatment of postmenopausal women with osteoporosis at a high risk for fracture. Abaloparatide is an anabolic agent and it seems to have a potent anabolic activity with reduced effects on bone resorption. It reduces the risk of vertebral and nonvertebral fractures, major osteoporotic fractures and clinical fractures, with a significant improvement in bone mineral density at femoral neck, total hip and lumbar spine...
May 2018: Drugs of Today
G Walker
The opioid pain market is a lucrative one, but is experiencing significant challenges in the U.S. as the country grapples with prescription opioid addiction, overdose and fatalities. The situation has been declared a national Public Health Emergency and the Food and Drug Administration (FDA) has introduced several measures intended to reduce opioid abuse. The development of abuse-deterrent prescription opioids is one such measure, but although abuse-deterrent formulations of opioids reduce drug liking and abuse, concerns have been highlighted by an Institute of Clinical and Economic Review (ICER) report regarding the insufficiency of currently available data to determine the effects of these formulations at the population level...
April 2018: Drugs of Today
S Raso, C Hermans
The development of recombinant factor VIII (rFVIII) was initially driven by the necessity to treat hemophilia A (HA) patients with FVIII concentrates without the risk of transmitting infectious agents. Over the last three decades the safety of rFVIII has been further improved by completely removing animal or human proteins from the manufacturing process, so that patients would not be exposed to known or emerging pathogens. Recent efforts have concentrated on improving the expression of rFVIII, reducing its immunogenicity and enhancing its pharmacokinetic (PK) behavior...
April 2018: Drugs of Today
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