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03:45 EDT 24th May 2018 | BioPortfolio

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Showing "Dermira Grabs Pharma Castoff" PubMed Articles, all 24

Moving pharma contracting into the era of accountability.


A guide to manufacturing CAR T cell therapies.

In recent years, chimeric antigen receptor (CAR) modified T cells have been used as a treatment for haematological malignancies in several phase I and II trials and with Kymriah of Novartis and Yescarta of KITE Pharma, the first CAR T cell therapy products have been approved. Promising clinical outcomes have yet been tempered by the fact that many therapies may be prohibitively expensive to manufacture. The process is not yet defined, far from being standardised and often requires extensive manual handling ...

Unexpected results when assessing underlying aggressiveness in Japanese quail using photocastrated stimulus birds.

Aggressive behaviors can affect both animal welfare and productivity. Because the expression of aggressive behaviors is dependent on the quality of the opponent, they reflect relative rather than absolute levels of underlying aggressiveness. This study was aimed to characterize the aggressive responsiveness of photostimulated (14:10 h light:dark photoperiod) adult Japanese quail when interacting with a photocastrated (6:18 h light:dark photoperiod) counterpart in a novel test environment and to assesses i...


Rejuvenating the Face: An Analysis of 100 Absorbable Suture Suspension Patients.

Absorbable suture suspension (Silhouette InstaLift, Sinclair Pharma, Irvine, CA) is a novel, minimally invasive system that utilizes a specially manufactured synthetic suture to help address the issues of facial aging, while minimizing the risks associated with historic thread lifting modalities.

Cost-effectiveness analysis of blue light cystoscopy with hexylaminolevulinate in transurethral resection of the bladder.

Photodynamic diagnosis using the optical imaging agent hexaminolevulinate (HAL, Hexvix®, Ipsen Pharma GmbH, Ettlingen, Germany) as an adjunct to white light cystoscopy (WLC) during the initial transurethral resection of bladder tumours (TURB) improves the detection rate of bladder cancer and leads to fewer recurrences.

A totally new system is needed for drug research and development.

In response to my paper, where I call for abolishment of patents and for drug research and development as a public enterprise, Raj asserts that there is an increase in novel drug discoveries. The fact is that even the drug industry laments that drug innovation has dried out, which is why they buy start-up companies. Big pharma doesn't invest in innovative research, as it is far more profitable to have creative marketing and legal departments than creative research divisions, and to develop an endless array ...

How Well Are We Applying Quantitative Methods to Reverse Translation to Inform Early Clinical Development?

If we are to improve our low success rate and rising costs in the pharmaceutical industry, we need to use every tool available. Reverse translation can particularly inform discovery and early clinical development via appropriate quantitative integration of relevant data. This commentary reports on a crowd-sourced survey (2017) that sought to evaluate the integration of reverse translation in pharma. The results indicate that these methods are being applied, to varying degrees, across most respondents.

Pharmacogenomics and the Placebo Response.

There is perhaps no more important time in the history of placebos to consider their role in clinical trials and in medicine. Increasingly well-designed pharmaceutical and academic clinical trials testing promising and established drug and surgical interventions have failed to "beat" the placebo response. The collateral damage resulting from these failures is staggering; novel treatments, many with compelling mechanisms of action and promising Phase 2 trial results, never reach the patient, adversely affect...

Pachychoroid Pigment Epitheliopathy Associated With Tamoxifen.

Pachychoroid pigment epitheliopathy (PPE) is considered to be a forme fruste of central serous chorioretinopathy. Tamoxifen (Soltamax; Midatech Pharma, Raleigh, NC) has an anti-estrogenic effect on cytoplasmic estrogen receptors. Serum total testosterone, cortisol, and cortisone levels increase during tamoxifen therapy. Tamoxifen may cause hormone disturbance leading to the development of disorders in the pachychoroid spectrum. The authors present two cases of PPE associated with tamoxifen therapy. A 65-yea...

Current state of the union of epilepsy care in the United States: Antiepileptic drugs - An introduction to the Connectors Project.

How antiepileptic drugs (AEDs) are used in the United States (US) is one proxy public health indicator for the current state of epilepsy management. The use of phenytoin, other older AEDs, and newer AEDs may act as an indicator for the quality of epilepsy practice in addition to the current American Academy of Neurology quality measures. Data on AED used by states and populations can help identify which public health interventions are necessary to improve the status of epilepsy care. The Connectors Project,...

Ion mobility in the pharmaceutical industry: an established biophysical technique or still niche?

Over the past decade ion mobility (IM) coupled with mass spectrometry (MS) has emerged as a wide spread analytical technique, utilized in research areas ranging from small molecule to proteins analyzed under native-MS and solution conditions. The ion-neutral collision cross section (Ω) derived from an IM experiment can be used to make inferences about the ion's size, shape and charge distribution, when compared to molecular dynamic (MD) or quantum mechanically (QM) derived candidate structures. IM can also...

Pharma Opportunities and Risks Multiply as Regulatory Reform Remakes APAC: Expanded Accelerated Pathways Challenge Developer Value Story, Evidence Collection, and Market Access Strategies.

Sweeping reforms in the largest markets of the Asia-Pacific region are transforming the regulatory and commercial landscape for foreign pharmaceutical companies. Japan, South Korea, and China are leading the charge, establishing mechanisms and infrastructure that both reflect and help drive international regulatory convergence and accelerate delivery of needed, innovative products to patients. In this rapidly evolving regulatory and commercial environment, drug developers can benefit from reforms and prolif...

Breast milk microRNAs harsh journey towards potential effects in infant development and maturation. Lipid encapsulation can help.

The possibility that diet-derived miRNAs survive the gastrointestinal tract and exert biological effects in target cells is triggering considerable research in the potential abilities of alimentary preventive and therapeutic approaches. Many validation attempts have been carried out and investigators disagree on several issues. The barriers exogenous RNAs must surpass are harsh and adequate copies must reach target cells for biological actions to be carried out. This prospect opened a window for previously ...

Real world big data for clinical research and drug development.

The objective of this paper is to identify the extent to which real world data (RWD) is being utilized, or could be utilized, at scale in drug development. Through screening peer-reviewed literature, we have cited specific examples where RWD can be used for biomarker discovery or validation, gaining a new understanding of a disease or disease associations, discovering new markers for patient stratification and targeted therapies, new markers for identifying persons with a disease, and pharmacovigilance. Non...

Formulation and composition effects in phase transitions of emulsions co-stabilized by cellulose nanofibrils and an ionic surfactant.

Cellulose nanofibrils (CNF) offer great prospects as a natural stabilizer of colloidal dispersions and complex fluids for application in food, pharma, and cosmetics. In this study, an ionic surfactant (sodium dodecyl sulfate, SDS) was used as emulsifier of oil-in-water and water-in-oil emulsions that were further co-stabilized by addition of CNF. The adsorption properties of SDS in both, CNF dispersions and emulsions, as well as the influence of composition (CNF and SDS concentration) and formulation (ionic...

Early Probe and Drug Discovery in Academia: A Minireview.

Drug discovery encompasses processes ranging from target selection and validation to the selection of a development candidate. While comprehensive drug discovery work flows are implemented predominantly in the big pharma domain, early discovery focus in academia serves to identify probe molecules that can serve as tools to study targets or pathways. Despite differences in the ultimate goals of the private and academic sectors, the same basic principles define the best practices in early discovery research. ...

Customized Titanium Lattice Structure in Three-Dimensional Alveolar Defect: An Initial Case Letter.

The aim of this initial case report was to provide a new protocol for the clinical application of a patient-specific titanium lattice structure (Yxoss CBR®, ReOSS, Filderstadt, Germany) for customized bone regeneration. To obtain a 3-dimensional reconstruction of a posterior mandible segment in a 61-year-old woman, a patient-specific titanium customized lattice structure was used. As graft material autogenous bone tissue mixed with xenogenic alloplastic material (Bio Oss®, Geistlich Pharma, Wolhusen, Swit...

Next Generation Biopharmaceuticals: Product Development.

Therapeutic proteins show a rapid market growth. The relatively young biotech industry already represents 20 % of the total global pharma market. The biotech industry environment has traditionally been fast-pasted and intellectually stimulated. Nowadays the top ten best selling drugs are dominated by monoclonal antibodies (mABs).Despite mABs being the biggest medical breakthrough in the last 25 years, technical innovation does not stand still.The goal remains to preserve the benefits of a conventional mAB (...

Rapid Identification of Intact Staphylococcal Bacteriophages Using Matrix-Assisted Laser Desorption Ionization-Time-of-Flight Mass Spectrometry.

is a major causative agent of infections associated with hospital environments, where antibiotic-resistant strains have emerged as a significant threat. Phage therapy could offer a safe and effective alternative to antibiotics. Phage preparations should comply with quality and safety requirements; therefore, it is important to develop efficient production control technologies. This study was conducted to develop and evaluate a rapid and reliable method for identifying staphylococcal bacteriophages, based on...

An inventory of supranational antimicrobial resistance surveillance networks involving low- and middle-income countries since 2000.

Low- and middle-income countries (LMICs) shoulder the bulk of the global burden of infectious diseases and drug resistance. We searched for supranational networks performing antimicrobial resistance (AMR) surveillance in LMICs and assessed their organization, methodology, impacts and challenges. Since 2000, 72 supranational networks for AMR surveillance in bacteria, fungi, HIV, TB and malaria have been created that have involved LMICs, of which 34 are ongoing. The median (range) duration of the networks was...

Recent advances in theranostics and challenges for the future.

Theranostic nuclear oncology is on the cusp of adoption into routine clinical management of neuroendocrine tumours (NETs) following publication of the Phase 3 randomized controlled trial, NETTER-1. For the first time, level 1b evidence of efficacy and safety of 68-gallium/177 lutetium-DOTA-octreotatepeptide receptor radionuclide therapy (PRRT), of midgut NETs was established. Multicentre Phase 2 studies of 68-gallium/177 lutetium-PSMA theranostic approaches to management of end-stage metastatic castrat...

Enhancing patient-level clinical data access to improve trial outcomes, promote evidence-based practice and incentivize therapeutic innovation.

Clinical trials are crucial to determining the human safety and efficacy of new therapeutic interventions and innovations. Extraordinary amounts of human experiential data are generated over the course of any clinical drug or therapeutics trial. However, much of these data is never made publicly accessible, either archived openly in accessible formats or venues, published in peer-reviewed journals, or provided to researchers for analysis and scrutiny. Improved, reliable data sharing is essential to inform c...

Biocatalytic Synthesis of Nitriles through Dehydration of Aldoximes: The Substrate Scope of Aldoxime Dehydratases.

Nitriles belong to the product classes, which are mostly needed and produced by the chemical industry, playing a major role in various industry segments ranging from high-volume low-price sectors such as polymers to low-volume high-price sectors such as the chiral pharma drugs. A common industrial technology for nitrile production is ammonoxidation as a gas phase reaction at high temperature. A further popular approach are substitution or addition reactions with hydrogen cyanide or derivatives thereof. A ma...

Quantitating ADCC against adherent cells: Impedance-based detection is superior to release, membrane permeability, or caspase activation assays in resolving antibody dose response.

Monoclonal antibody-based immunotherapeutics will dominate Pharma's next generation of blockbuster drugs, and Fc-associated functions, including antibody dependent cellular cytotoxicity (ADCC) are among the highly desired activities mediated by these antibodies. Therefore, quantitative evaluation of ADCC is required during drug development. Our objective was to find the most suitable and reliable nonradioactive method for quantitative analysis of in vitro ADCC against adherent cells, which often serve as mo...


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