Recommended publications
  • Stanford Chem-H Presentation (PDF)
    KiNativ® In situ kinase profiling Stanford University ChEM-H confidential @KiNativPlatform Principle of the KiNativ platform • ATP (or ADP) acyl phosphate binds to, and covalently modifies Lysine residues in the active site • Thus, ATP acyl phosphate with a desthiobiotin tag can be used capture and quantitate kinases in a complex lysate Acyl phosphate Desthiobiotin tag ATP 2 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 3 ATP acyl phosphate probe covalently modifies kinase in the active site Lysine 2 Lysine 1 4 Samples trypsinized, probe-labeled peptides captured with streptavidin, and analyzed by targeted LC-MS2 Identification Quantitation Explicit determination of peptide Integration of signal from MS2 sequence and probe modification site fragment ions from MS2 spectrum 5 Comprehensive Coverage of Protein and Lipid Kinases Protein kinases Atypical kinases Green: Kinases detected on KiNativ Red: Kinases not detected on KiNativ ~80% of known protein and atypical kinases identified on the platform http://www.kinativ.com/coverage/protein-lipid.html 6 Profiling compound(s) on the KiNativ platform Control sample – add probe Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor followed by probe Inhibited kinase Green: Kinases Blue: Probe Gray: Non-kinases Red: Inhibitor 7 Profiling compound(s) on the KiNativ platform Control sample – add probe MS signalMS Sample: Lysate derived from any cell line or tissue from ANY species Treated sample – add inhibitor
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  • NG198 Evidence Review E1
    1 2 Research recommendations for review question: For people with mild to 3 moderate acne vulgaris what are the most effective treatment options? 4 Research question - physical modalities 5 What is the effectiveness of physical modalities (such as light devices) in the treatment of 6 acne vulgaris or persistent acne vulgaris-related scarring? 7 Why this is important 8 Physical treatments for acne are popular with people because they have the benefit of 9 treating a local area without systemic effects. They can be used in people with co-morbidities 10 or side effects where other treatments are unsuitable. They are currently available in the 11 private sector but there is no standardisation of treatment modalities or duration. Many 12 different physical therapies have been described for acne including: 13 • Comedone extraction 14 • Phototherapy – including UVB, intense pulsed light, blue and red light 15 • Photochemical therapy (e.g. photodynamic therapy) 16 • Laser 17 • Photopneumatic therapy (e.g. intense pulsed light + vacuum) 18 • Photothermal therapy (eg gold nanoparticles +light or laser) 19 Physical treatments are also used for acne scarring. These include: 20 • Punch excision 21 • CO2 laser 22 • Dermabrasion 23 • Radiofrequency (e.g. fractional microneedling, bipolar) 24 Further research is required to determine the most effective physical treatments for acne and 25 acne scarring. This could open the way to wider availability in the NHS. 26 Table 26: Research recommendation rationale Research question What is the effectiveness of physical modalities (such as light devices) in the treatment of acne vulgaris or persistent acne vulgaris-related scarring? Why is this needed Importance to ‘patients’ or the Physical treatments for acne are popular with people because population they have the benefit of treating a local area without systemic effects.
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  • Abstract Book – Oral Sessions
    Sunday, June 21, 2015 12:00 p.m. - 1:15 p.m. Latin American Psychopharmacology Update: INNOVATIVE TREATMENTS IN PSYCHIATRY INNOVATIVE TREATMENTS IN PSYCHIATRY Flavio Kapczinski, The University of Texas Health Science Center at Houston Overall Abstract In this panel, we will propose innovative treatments in psychiatry and recent literature findings will be summarized. The effective pharmacological treatment of psychiatric diseases and development of new therapeutic entities has been a long-standing challenge. Despite the complexity and heterogeneity of psychiatric disorders, basic and clinical research studies and technological advancements in genomics, biomarkers, and imaging have begun to elucidate the pathophysiology of etiological complexity of psychiatric diseases and to identify efficacious new agents (Tcheremissine et al. 2014). Many psychiatric illnesses are associated with neuronal atrophy, characterized by loss of synaptic connections, increase of inflammatory markers like TNF-α and DAMPS (damage-associate molecular patterns,- cell free (ccf) DNA, heat shock proteins HSP70, HSP90, and HSP60, and cytochrome C), decrease of neurotrophic factors, increase of oxidative stress, mitochondrial dysfunction and apoptosis (Fries et al., 2012; Pfaffenseller et al., 2014). Also, neurocognitive impairment and poor psychosocial functioning has been related to a psychiatric disease. Therefore, trying to discover new therapeutic targets that act in these pathways can help to develop new treatment or improve the treatment of these serious diseases.
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  • Parkinson Disease-Associated Cognitive Impairment
    PRIMER Parkinson disease-associated cognitive impairment Dag Aarsland 1,2 ✉ , Lucia Batzu 3, Glenda M. Halliday 4, Gert J. Geurtsen 5, Clive Ballard 6, K. Ray Chaudhuri 3 and Daniel Weintraub7,8 Abstract | Parkinson disease (PD) is the second most common neurodegenerative disorder, affecting >1% of the population ≥65 years of age and with a prevalence set to double by 2030. In addition to the defining motor symptoms of PD, multiple non-motor symptoms occur; among them, cognitive impairment is common and can potentially occur at any disease stage. Cognitive decline is usually slow and insidious, but rapid in some cases. Recently, the focus has been on the early cognitive changes, where executive and visuospatial impairments are typical and can be accompanied by memory impairment, increasing the risk for early progression to dementia. Other risk factors for early progression to dementia include visual hallucinations, older age and biomarker changes such as cortical atrophy, as well as Alzheimer-type changes on functional imaging and in cerebrospinal fluid, and slowing and frequency variation on EEG. However, the mechanisms underlying cognitive decline in PD remain largely unclear. Cortical involvement of Lewy body and Alzheimer-type pathologies are key features, but multiple mechanisms are likely involved. Cholinesterase inhibition is the only high-level evidence-based treatment available, but other pharmacological and non-pharmacological strategies are being tested. Challenges include the identification of disease-modifying therapies as well as finding biomarkers to better predict cognitive decline and identify patients at high risk for early and rapid cognitive impairment. Parkinson disease (PD) is the most common movement The full spectrum of cognitive impairment occurs in disorder and the second most common neurodegenera­ individuals with PD, from subjective cognitive decline tive disorder after Alzheimer disease (AD).
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  • June 2021 Therapeutic Research Center (TRC) Is the Leading Advisory Service on Drug Therapy and Medication Management
    June 2021 Therapeutic Research Center (TRC) is the leading advisory service on drug therapy and medication management. Every month over 400,000 prescribers, pharmacists, and pharmacy technicians rely on our unbiased, evidence-based clinical recommendations to help them improve medication use, prevent medication errors, and improve patient care and outcomes. We also have one of the most extensive CE/CME course offerings in the industry. Our accredited continuing education and continuing medical education courses are trusted and relied on by hundreds of thousands of pharmacists, technicians, and prescribers every month. Therapeutic Research Center does not receive commercial support and does not accept any advertising. It is completely independent and is supported entirely by subscriptions. Credit is reported to CPE Monitor, AAFP, and CE Broker as appropriate. Accreditation Information: Therapeutic Research Center is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education for physicians. Pharmacist’s Letter / Therapeutic Research Center is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Therapeutic Research Center / Prescriber’s Letter is accredited by the American Association of Nurse Practitioners as an approved provider of nurse practitioner continuing education. Provider number:080517. Select Therapeutic Research Center courses are also acceptable for American Academy of Family Physicians (AAFP) Prescribed credit, American Osteopathic Association (AOA) credit, and American College of Emergency Physicians (ACEP) Category I Credit. Please refer to the detailed accreditation statements available online for each course. Get started at TherapeuticResearchCenter.com. Log in to access your course list or purchase a course or subscription. For additional assistance, please call 209-472-2240 and we’ll be happy to help you.
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  • Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
    Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models.
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  • These Highlights Do Not Include All the Information Needed to Use BENZHYDROCODONE and ACETAMINOPHEN TABLETS Safely and Effectively
    BENZHYDROCODONE AND ACETAMINOPHEN- benzhydrocodone and acetaminophen tablet KVK-Tech, Inc. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS See full prescribing information for complete boxed warning. Benzhydrocodone and Acetaminophen tablets exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions. (5.1) To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products. (5.2) Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. (5.3) Accidental ingestion of Benzhydrocodone and Acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone. (5.3) Prolonged use of Benzhydrocodone and Acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
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  • United States Atopic Dermatitis (AD) Market Report 2021
    Source: Research and Markets July 28, 2021 04:08 ET United States Atopic Dermatitis (AD) Market Report 2021 Dublin, July 28, 2021 (GLOBE NEWSWIRE) -- The "Atopic Dermatitis (AD) - US Market Insight, Epidemiology and Market Forecast - 2030" report has been added to ResearchAndMarkets.com's offering. This 'Atopic Dermatitis (AD) - Market Insights, Epidemiology and Market Forecast- 2030' report delivers an in- depth understanding of the Atopic Dermatitis (AD), historical and forecasted epidemiology as well as the Atopic Dermatitis (AD) market trends in the United States. Key Findings The total prevalent population of AD in the United States was estimated to be 32,197,083 in 2020. The total diagnosed prevalent population of AD in the United States was estimated to be 25,091,967 in 2020. The prevalent population of AD in the United States is expected to increase at a CAGR of 0.58% during the study period 2018-2030. In the United States, the total number of adult cases of AD comprised of 5,684,566 males and 9,421,907 females in 2020. The total number of cases of mild AD were 9,065,394 in the United States, in 2020, as compared to the cases of moderate and severe AD with 4,365,771 and 1,661,712 cases respectively, in adults. In children, the total number of cases of mild AD were 6,690,281, in 2020, as compared to the cases of moderate and severe AD with 2,596,228 and 698,985 cases respectively, in the United States. Report Highlights In the coming years, Atopic Dermatitis (AD) market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
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  • Summary Analgesics Dec2019
    Status as of December 31, 2019 UPDATE STATUS: N = New, A = Advanced, C = Changed, S = Same (No Change), D = Discontinued Update Emerging treatments for acute and chronic pain Development Status, Route, Contact information Status Agent Description / Mechanism of Opioid Function / Target Indication / Other Comments Sponsor / Originator Status Route URL Action (Y/No) 2019 UPDATES / CONTINUING PRODUCTS FROM 2018 Small molecule, inhibition of 1% diacerein TWi Biotechnology / caspase-1, block activation of 1 (AC-203 / caspase-1 inhibitor Inherited Epidermolysis Bullosa Castle Creek Phase 2 No Topical www.twibiotech.com NLRP3 inflamasomes; reduced CCP-020) Pharmaceuticals IL-1beta and IL-18 Small molecule; topical NSAID Frontier 2 AB001 NSAID formulation (nondisclosed active Chronic low back pain Phase 2 No Topical www.frontierbiotech.com/en/products/1.html Biotechnologies ingredient) Small molecule; oral uricosuric / anti-inflammatory agent + febuxostat (xanthine oxidase Gout in patients taking urate- Uricosuric + 3 AC-201 CR inhibitor); inhibition of NLRP3 lowering therapy; Gout; TWi Biotechnology Phase 2 No Oral www.twibiotech.com/rAndD_11 xanthine oxidase inflammasome assembly, reduced Epidermolysis Bullosa Simplex (EBS) production of caspase-1 and cytokine IL-1Beta www.arraybiopharma.com/our-science/our-pipeline AK-1830 Small molecule; tropomyosin Array BioPharma / 4 TrkA Pain, inflammation Phase 1 No Oral www.asahi- A (ARRY-954) receptor kinase A (TrkA) inhibitor Asahi Kasei Pharma kasei.co.jp/asahi/en/news/2016/e160401_2.html www.neurosmedical.com/clinical-research;
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  • JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors
    Drugs https://doi.org/10.1007/s40265-020-01261-8 CURRENT OPINION JAK Inhibitors for Treatment of Psoriasis: Focus on Selective TYK2 Inhibitors Miguel Nogueira1 · Luis Puig2 · Tiago Torres1,3 © Springer Nature Switzerland AG 2020 Abstract Despite advances in the treatment of psoriasis, there is an unmet need for efective and safe oral treatments. The Janus Kinase– Signal Transducer and Activator of Transcription (JAK–STAT) pathway plays a signifcant role in intracellular signalling of cytokines of numerous cellular processes, important in both normal and pathological states of immune-mediated infamma- tory diseases. Particularly in psoriasis, where the interleukin (IL)-23/IL-17 axis is currently considered the crucial pathogenic pathway, blocking the JAK–STAT pathway with small molecules would be expected to be clinically efective. However, relative non-specifcity and low therapeutic index of the available JAK inhibitors have delayed their integration into the therapeutic armamentarium of psoriasis. Current research appears to be focused on Tyrosine kinase 2 (TYK2), the frst described member of the JAK family. Data from the Phase II trial of BMS-986165—a selective TYK2 inhibitor—in psoriasis have been published and clinical results are encouraging, with a large Phase III programme ongoing. Further, the selective TYK2 inhibitor PF-06826647 is being tested in moderate-to-severe psoriasis in a Phase II clinical trial. Brepocitinib, a potent TYK2/JAK1 inhibitor, is also being evaluated, as both oral and topical treatment. Results of studies with TYK2 inhibitors will be important in assessing the clinical efcacy and safety of these drugs and their place in the therapeutic armamentarium of psoriasis.
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  • Anetumab Ravtansine
    June 2016 Company Update Safe Harbor This presentation includes forward-looking statements. Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations and the availability of financing. These and other risks and uncertainties are detailed in the Company’s Annual Report. © MorphoSys AG, Company Update - June 2016 2 MorphoSys at a Glance MorphoSys is developing a pipeline of truly differentiated therapeutic antibodies built using proprietary technologies Munich, Germany-based biopharmaceutical company The industry’s largest antibody therapeutic pipeline assembled using proprietary technologies: 104 active therapeutic programs 26 antibodies in clinical trials Growing portfolio of attractive proprietary assets Strong balance sheet with recurring cash-flows supports growing investment in R&D Successful track-record of partnering world-wide Listed on the German TecDAX © MorphoSys AG, Company Update - June 2016 3 The MorphoSys Pipeline 26 Clinical Product Candidates, 104 Total Most advanced development stage Program Partner Target Disease Area Discovery Preclinic Phase 1 Phase 2 Phase 3 Bimagrumab (BYM338) Novartis ActRIIB Musculoskeletal diseases Guselkumab (CNTO1959) Janssen IL23p19 Psoriasis Gantenerumab Roche Amyloid-ß Alzheimer’s disease MOR208 - CD19 ALL, CLL, NHL MOR202 - CD38 Multiple myeloma MOR103/GSK3196165 GSK GM-CSF Inflammation
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  • Refreshing the Biologic Pipeline 2020
    news feature Credit: Science Lab / Alamy Stock Photo Refreshing the biologic pipeline 2020 In the absence of face-to-face meetings, FDA and industry implemented regulatory workarounds to maintain drug and biologics approvals. These could be here to stay. John Hodgson OVID-19 might have been expected since 1996) — a small miracle in itself “COVID-19 confronted us with the need to severely impair drug approvals (Fig. 1 and Table 1). to better triage sponsors’ questions,” says Cin 2020. In the event, however, To the usual crop of rare disease and Peter Marks, the director of the Center for industry and regulators delivered a small genetic-niche cancer treatments, 2020 Biologics Evaluation and Research (CBER) miracle. They found workarounds and also added a chimeric antigen receptor at the FDA. “That was perhaps the single surrogate methods of engagement. Starting (CAR)-T cell therapy with a cleaner biggest takeaway from the pandemic related in January 2020, when the outbreak veered manufacturing process and the first to product applications.” Marks says that it westward, the number of face-to face approved blockbuster indication for a became very apparent with some COVID- meetings declined rapidly; by March, small-interfering RNA (siRNA) — the 19-related files that resolving a single they were replaced by Webex and Teams. European Medicines Agency’s (EMA) issue can help a sponsor enormously and (Secure Zoom meeting are to be added registration of the RNA interference accelerate the development cycle. Before this year.) And remarkably, by 31 December, (RNAi) therapy Leqvio (inclisiran) for COVID-19, it was conceivable that a small the US Food and Drug Administration cardiovascular disease.
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