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Drugs of Today

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https://www.readbyqxmd.com/read/29998229/life-sciences-licensing-deals-in-the-first-quarter-of-2018-updates-and-trends
#1
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
https://www.readbyqxmd.com/read/29998228/osimertinib-for-the-treatment-of-patients-with-egfr-mutation-positive-non-small-cell-lung-cancer
#2
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
https://www.readbyqxmd.com/read/29998227/letermovir-for-prophylaxis-of-cytomegalovirus-in-allogeneic-hematopoietic-stem-cell-recipients
#3
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
https://www.readbyqxmd.com/read/29998226/edaravone-a-new-hope-for-deadly-amyotrophic-lateral-sclerosis
#4
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
https://www.readbyqxmd.com/read/29911697/30th-annual-drug-information-association-dia-europe-2018-april-17-19-2018-basel-switzerland
#5
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
https://www.readbyqxmd.com/read/29911696/plasmid-dna-vaccines-where-are-we-now
#6
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
https://www.readbyqxmd.com/read/29911695/ibrutinib-for-the-treatment-of-patients-with-chronic-graft-versus-host-disease-after-failure-of-one-or-more-lines-of-systemic-therapy
#7
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
https://www.readbyqxmd.com/read/29911694/abaloparatide-for-the-treatment-of-postmenopausal-osteoporosis
#8
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
https://www.readbyqxmd.com/read/29869649/the-opioid-crisis-a-21st-century-pain
#9
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
https://www.readbyqxmd.com/read/29869648/recombinant-factor-viii-past-present-and-future-of-treatment-of-hemophilia-a
#10
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
https://www.readbyqxmd.com/read/29869647/sofosbuvir-velpatasvir-and-voxilaprevir-combination-therapy-for-treating-patients-with-hepatitis-c-virus-infection
#11
B B Summers
Hepatitis C virus (HCV) is a significant public health burden worldwide, owing in large part to ineffective and poorly tolerated treatments. The antivirals have evolved over time to become more effective and better tolerated with cure rates increasing from an average of 50% to a complete virologic response. This article summarizes the latest Food and Drug Administration (FDA)-approved addition to combination treatment for patients with HCV, voxilaprevir plus sofosbuvir/velpatasvir.
April 2018: Drugs of Today
https://www.readbyqxmd.com/read/29869646/eravacycline-for-the-treatment-of-patients-with-bacterial-infections
#12
R Thakare, A Dasgupta, S Chopra
Eravacycline is a novel, broad-spectrum, synthetic fluorocycline antibiotic for the treatment of complicated urinary tract infection (cUTI) and complicated intra-abdominal infection (cIAI) due to multidrug-resistant Gram-positive, Gram-negative and anaerobic bacteria that has demonstrated superior potency to that of currently marketed antibiotics. Tetraphase Pharmaceuticals has submitted a new drug application for eravacycline for the treatment of cIAI due to drug-resistant bacteria. In 2013, the U.S. Food and Drug Administration (FDA) granted eravacycline qualified infectious disease product designation for the treatment of cUTI and cIAI...
April 2018: Drugs of Today
https://www.readbyqxmd.com/read/29869645/daclatasvir-asunaprevir-and-beclabuvir-fixed-dose-combination-for-patients-with-genotype-1-chronic-hepatitis-c
#13
A Thiam, B Conway
Hepatitis C is killing 350,000 persons per year worldwide, 60% of the cases being patients with genotype 1 (GT-1). The fixed-dose tablet combination of daclatasvir (30 mg)/asunaprevir (200 mg)/beclabuvir (75 mg), DCV-TRIO, is one of the latest drugs in the pipeline of interferon-free direct-acting antiviral hepatitis C virus (HCV) therapies. DCV-TRIO increases the genetic barrier to resistance by acting at the same time against three hepatitis C key viral proteins. Results from the UNITY 1, 2, 3 and 4 phase III clinical trials showed that DCV-TRIO exhibited high sustained virologic responses at 12 weeks (between 92% and 100% for HCV GT-1 treatment-naive patients)...
April 2018: Drugs of Today
https://www.readbyqxmd.com/read/29771256/rheumatoid-arthritis-new-monoclonal-antibodies
#14
REVIEW
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
https://www.readbyqxmd.com/read/29771255/return-of-the-tetracyclines-omadacycline-a-novel-aminomethylcycline-antimicrobial
#15
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
https://www.readbyqxmd.com/read/29771254/guselkumab-human-monoclonal-antibody-against-interleukin-23-for-moderate-to-severe-psoriasis
#16
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
https://www.readbyqxmd.com/read/29771253/axicabtagene-ciloleucel-for-the-treatment-of-relapsed-refractory-b-cell-non-hodgkin-s-lymphomas
#17
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
https://www.readbyqxmd.com/read/29637940/life-sciences-licensing-deals-in-the-fourth-quarter-of-2017-updates-and-trends
#18
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
https://www.readbyqxmd.com/read/29637939/the-year-s-new-drugs-biologics-2017-part-ii-news-that-shaped-the-industry-in-2017
#19
REVIEW
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
https://www.readbyqxmd.com/read/29637938/fecal-microbiota-transplantation-for-the-treatment-of-patients-with-ulcerative-colitis-and-other-gastrointestinal-conditions-beyond-clostridium-difficile-infection-an-update
#20
REVIEW
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
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