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https://www.readbyqxmd.com/read/30465228/dinutuximab-beta-for-treating-neuroblastoma-an-evidence-review-group-and-decision-support-unit-perspective-of-a-nice-single-technology-appraisal
#1
REVIEW
Becky Pennington, Shije Ren, Samantha Barton, Mariana Bacelar, Steven J Edwards
As part of its Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer (EUSA Pharma) of dinutuximab beta (Qarziba® ) to submit evidence of its clinical and cost effectiveness for treating neuroblastoma. The BMJ Technology Assessment Group (BMJ-TAG) was commissioned to act as the Evidence Review Group (ERG), reviewing the submission from the company. The Decision Support Unit (DSU) was commissioned to review additional evidence submitted by the company and to undertake further analyses...
November 22, 2018: PharmacoEconomics
https://www.readbyqxmd.com/read/30450224/predictive-factors-for-hyperglycaemic-progression-in-patients-with-schizophrenia-or-bipolar-disorder
#2
Ichiro Kusumi, Yuki Arai, Ryo Okubo, Minoru Honda, Yasuhiro Matsuda, Yukihiko Matsuda, Akihiko Tochigi, Yoshiteru Takekita, Hiroyoshi Yamanaka, Keiichi Uemura, Koichi Ito, Kiyoshi Tsuchiya, Jun Yamada, Bunta Yoshimura, Nobuyuki Mitsui, Sigehiro Matsubara, Takayuki Segawa, Nobuyuki Nishi, Yasufumi Sugawara, Yuki Kako, Ikuta Shinkawa, Kaoru Shinohara, Akiko Konishi, Junichi Iga, Naoki Hashimoto, Shinsaku Inomata, Noriko Tsukamoto, Hiroto Ito, Yoichi M Ito, Norihiro Sato
Background: Patients with schizophrenia or bipolar disorder have a high risk of developing type 2 diabetes. Aims: To identify predictive factors for hyperglycaemic progression in individuals with schizophrenia or bipolar disorder and to determine whether hyperglycaemic progression rates differ among antipsychotics in regular clinical practice. Method: We recruited 1166 patients who initially had normal or prediabetic glucose levels for a nationwide, multisite, l-year prospective cohort study to determine predictive factors for hyperglycaemic progression...
November 2018: BJPsych Open
https://www.readbyqxmd.com/read/30442029/costs-of-quality-in-clinical-development
#3
Bolennart Eriksson
BACKGROUND: The basis for this article is an individual project during a Master of Science program at Cranfield University, UK. Research and development (R&D) costs in the pharmaceutical industry have increased at a rate where costs have doubled compared to previous decades since the 1980s. In parallel, during recent years, there has been an increased focus on quality management within clinical development. Furthermore, pharma companies are talking about quality as a competitive advantage with an increased focus on quality metrics...
November 15, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/30362915/using-previous-medication-adherence-to-predict-future-adherence
#4
Hiraku Kumamaru, Moa P Lee, Niteesh K Choudhry, Yaa-Hui Dong, Alexis A Krumme, Nazleen Khan, Gregory Brill, Shun Kohsaka, Hiroaki Miyata, Sebastian Schneeweiss, Joshua J Gagne
BACKGROUND: Medication nonadherence is a major public health problem. Identification of patients who are likely to be and not be adherent can guide targeted interventions and improve the design of comparative-effectiveness studies. OBJECTIVE: To evaluate multiple measures of patient previous medication adherence in light of predicting future statin adherence in a large U.S. administrative claims database. METHODS: We identified a cohort of patients newly initiating statins and measured their previous adherence to other chronic preventive medications during a 365-day baseline period, using metrics such as proportion of days covered (PDC), lack of second fills, and number of dispensations...
November 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/30321128/disease-awareness-advertising-daa-in-emerging-economy-a-comparison-between-views-of-consumers-and-pharmaceutical-professionals
#5
Saikat Banerjee, Sampada Kumar Dash
Research on effectiveness of DAA is limited. Existing researches explore impact of DAA only on relationship between drug manufacturers and consumers. However, in reality, pharma marketing revolves around three major stakeholders: the pharmaceutical companies, physicians and consumers. Pharmaceutical professionals on behalf of drug manufacturers have last mile connectivity with end users and they are an important stakeholder in this entire marketing relationship network. So, it is important for marketers to capture views of pharma professionals in addition to physicians and consumers...
October 15, 2018: Health Marketing Quarterly
https://www.readbyqxmd.com/read/30309442/rumble-over-drug-rebates-as-pharma-payers-duke-it-out
#6
Thomas Reinke
Pharma says rebates are a primary driver of high drug prices because drug companies raise prices in response to payers' demands for rebates in exchange for preferred placement on their formularies. PBMs and payers object. They say the rebates they get from drugmakers are largely passed on to health plans and patients and save consumers billions of dollars in the form of lower premiums and copays.
October 2018: Managed Care
https://www.readbyqxmd.com/read/30149734/european-pharma-oligonucleotide-consortium-a-move-to-consolidate-oligonucleotide-knowledge-and-share-experience-within-the-community
#7
Anna Tivesten, Nadim Akhtar, Jessica Stolee, Yannick Fillon, Rachel Orr, Malcolm L Hill, Leo Van den Bergh, Tom Huybrechts, Jale Muslehiddinoglu, Paul McCormac, John Amery, Andrea Brecht, Achim Geiser, Tobias Metzenthin, Thomas Eichinger
A consortium of seven pharma companies has been formed with the aim of sharing knowledge on and harmonizing approaches to oligonucleotide development. This letter aims to raise awareness of this new group and to set expectations for future publications.
November 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/30124346/5-ht1a-receptor-ligands-and-their-therapeutic-applications-review-of-new-patents
#8
REVIEW
Jakub Staroń, Ryszard Bugno, Adam S Hogendorf, Andrzej J Bojarski
5-HT1A R was one of the first discovered serotonin receptors and is one of the most thoroughly studied. Dysfunctions associated with 5-HT1A R neurotransmission are linked to several psychiatric disorders, including anxiety, depression, and movement disorders. Areas covered: The current review covers patent literature published between January 2012 and May 2018. Queries were performed on Espacenet, SciFinder, clinicaltrials.gov, pharmacodia.com, and the websites of pharmaceutical companies. Expert opinion: Several novel therapeutic applications have been proposed for 5-HT1A R ligands, i...
September 2018: Expert Opinion on Therapeutic Patents
https://www.readbyqxmd.com/read/30076203/emerging-kidney-models-to-investigate-metabolism-transport-and-toxicity-of-drugs-and-xenobiotics
#9
Piyush Bajaj, Swapan K Chowdhury, Robert Yucha, Edward J Kelly, Guangqing Xiao
The kidney is a major clearance organ of the body and is responsible for the elimination of many xenobiotics and prescription drugs. With its multitude of uptake and efflux transporters and metabolizing enzymes, the proximal tubule cell (PTC) in the nephron plays a key role in the disposition of xenobiotics and is also a primary site for toxicity. In this minireview, we first provide an overview of the major transporters and metabolizing enzymes in the PTCs responsible for biotransformation and disposition of drugs...
November 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/29954991/-tax-pharma-companies-if-they-fail-to-act-on-amr-says-review-chief-lord-o-neill
#10
(no author information available yet)
No abstract text is available yet for this article.
June 30, 2018: Veterinary Record
https://www.readbyqxmd.com/read/29954923/delamination-propensity-of-glass-containers-for-pharmaceutical-use-a-round-robin-activity-looking-for-a-predictive-test
#11
Juan Cerdan-Diaz, Ken Choju, Carol R Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, Massimo Guglielmi
Delamination, which is the formation of flakes in drug products due to specific and localized corrosion of glass vials, is a rare but very serious problems, and the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011. Technical Committee TC12 of the International Commission on Glass (ICG) was created in 2012, with the aim to study the problems related to pharma packaging. The first task of TC12 was to address the problem of predicting the propensity of glass vials to delamination, leaving the study of the mechanism(s) of flake formation as a possible future activity...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/29946798/patterns-of-bicalutamide-use-in-prostate-cancer-treatment-a-u-s-real-world-analysis-using-the-seer-medicare-database
#12
Jennifer L Beebe-Dimmer, Julie J Ruterbusch, Lauren C Bylsma, Christina Gillezeau, Jon Fryzek, Neil M Schultz, Scott C Flanders, Arie Barlev, Elisabeth Heath, Ruben G W Quek
INTRODUCTION: Bicalutamide (BIC), a non-steroidal anti-androgen, is FDA-indicated for use in combination with a luteinizing hormone-releasing hormone (LHRH) analog for treatment of Stage D2 metastatic carcinoma of the prostate. Lack of consensus exists regarding the clinical benefit of BIC use, either alone or combined use of BIC with an LHRH analog or antagonist (combined androgen blockade or CAB), versus treatment with androgen deprivation therapy (ADT) alone. METHODS: The SEER-Medicare database was used to identify prostate cancer patients aged ≥ 66 years diagnosed between 2007 and 2011 and who filled at least one prescription for BIC...
September 2018: Advances in Therapy
https://www.readbyqxmd.com/read/29916261/pharma-collaboration-for-transparent-medical-information-phactmi-benchmark-study-trends-drivers-success-factors-and-value-of-globalization-in-medical-information
#13
Suzana A Giffin, Richa Shah, Allison Soloff, Anna Markel Vaysman, Jane Oreper, Andrew Gažo, Pooja Gandhi, Ina Shah, Thomas Malieckal, Daniel Boulos, Teresa Flowers, Carolle A Stevens, Michael S Rocco, Aarti S Patel, Dominick Albano
BACKGROUND: Over the past decade, biopharmaceutical companies have been progressively establishing global frameworks across their capabilities. It is well recognized that the Medical Information (MI) department is a key externally facing function that needs to maintain a consistent focus on optimizing its capabilities of addressing product medical inquiries worldwide. METHODS: In the United States, a consortium named Pharma Collaboration for Transparent Medical Information, phactMI, a collaboration of pharmaceutical company MI departments dedicated to supporting health care professionals in their commitment to provide quality patient care, has provided a forum to benchmark and share best practices across the companies...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29862187/ophthalmic-community-perception-of-new-medication-needs
#14
William C Stewart, Jeanette A Stewart, Lindsay A Nelson
AIM: To survey ophthalmologists (who have participated previously in clinical research) and ophthalmic industry professionals (who have been involved in ocular research and development) to indicate perceived needs for new pharmaceuticals in various ophthalmic subspecialties. METHODS: A prospective, industry-based survey was sent to ophthalmologists and ophthalmic industry professionals about the perceived needs for new pharmaceutical products. RESULTS: This survey was sent to 559 ophthalmic pharma professionals and ophthalmologists...
2018: International Journal of Ophthalmology
https://www.readbyqxmd.com/read/29848987/aids-clinical-research-in-spain-large-hiv-population-geniality-of-doctors-and-missing-opportunities
#15
REVIEW
Vicente Soriano, José M Ramos, Pablo Barreiro, Jose V Fernandez-Montero
The first cases of AIDS in Spain were reported in 1982. Since then over 85,000 persons with AIDS have been cumulated, with 60,000 deaths. Current estimates for people living with HIV are of 145,000, of whom 20% are unaware of it. This explains the still high rate of late HIV presenters. Although the HIV epidemic in Spain was originally driven mostly by injection drug users, since the year 2000 men having sex with men (MSM) account for most new incident HIV cases. Currently, MSM represent over 80% of new yearly HIV diagnoses...
May 30, 2018: Viruses
https://www.readbyqxmd.com/read/29808952/miracle-of-haemophilia-drugs-personal-views-about-a-few-main-players
#16
REVIEW
P M Mannucci
INTRODUCTION: In the second decade of the third millennium there have been dramatic developments pertaining to the availability of highly innovative drugs for hemophilia care, notwithstanding a satisfactory previous scenario. AIM: I am going to emphasize the role of 2 main categories of players: scientist physicians who produced important translational research and the pharmaceutical industry, who developed, produced and made commercially available so many improved treatment weapons stemming from the translational research of the forementioned scientist physicians...
July 2018: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/29803936/understanding-drug-targets-no-such-thing-as-bad-news
#17
Ruth A Roberts
How can small-to-medium pharma and biotech companies enhance the chances of running a successful drug project and maximise the return on a limited number of assets? Having a full appreciation of the safety risks associated with proposed drug targets is a crucial element in understanding the unwanted side-effects that might stop a project in its tracks. Having this information is necessary to complement knowledge about the probable efficacy of a future drug. However, the lack of data-rich insight into drug-target safety is one of the major causes of drug-project failure today...
May 24, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29777001/fda-names-and-shames-branded-pharma-companies-that-obstruct-generics-development
#18
Owen Dyer
No abstract text is available yet for this article.
May 18, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29717691/probability-of-major-depression-diagnostic-classification-using-semi-structured-versus-fully-structured-diagnostic-interviews
#19
Brooke Levis, Andrea Benedetti, Kira E Riehm, Nazanin Saadat, Alexander W Levis, Marleine Azar, Danielle B Rice, Matthew J Chiovitti, Tatiana A Sanchez, Pim Cuijpers, Simon Gilbody, John P A Ioannidis, Lorie A Kloda, Dean McMillan, Scott B Patten, Ian Shrier, Russell J Steele, Roy C Ziegelstein, Dickens H Akena, Bruce Arroll, Liat Ayalon, Hamid R Baradaran, Murray Baron, Anna Beraldi, Charles H Bombardier, Peter Butterworth, Gregory Carter, Marcos H Chagas, Juliana C N Chan, Rushina Cholera, Neerja Chowdhary, Kerrie Clover, Yeates Conwell, Janneke M de Man-van Ginkel, Jaime Delgadillo, Jesse R Fann, Felix H Fischer, Benjamin Fischler, Daniel Fung, Bizu Gelaye, Felicity Goodyear-Smith, Catherine G Greeno, Brian J Hall, John Hambridge, Patricia A Harrison, Ulrich Hegerl, Leanne Hides, Stevan E Hobfoll, Marie Hudson, Thomas Hyphantis, Masatoshi Inagaki, Khalida Ismail, Nathalie Jetté, Mohammad E Khamseh, Kim M Kiely, Femke Lamers, Shen-Ing Liu, Manote Lotrakul, Sonia R Loureiro, Bernd Löwe, Laura Marsh, Anthony McGuire, Sherina Mohd Sidik, Tiago N Munhoz, Kumiko Muramatsu, Flávia L Osório, Vikram Patel, Brian W Pence, Philippe Persoons, Angelo Picardi, Alasdair G Rooney, Iná S Santos, Juwita Shaaban, Abbey Sidebottom, Adam Simning, Lesley Stafford, Sharon Sung, Pei Lin Lynnette Tan, Alyna Turner, Christina M van der Feltz-Cornelis, Henk C van Weert, Paul A Vöhringer, Jennifer White, Mary A Whooley, Kirsty Winkley, Mitsuhiko Yamada, Yuying Zhang, Brett D Thombs
BACKGROUND: Different diagnostic interviews are used as reference standards for major depression classification in research. Semi-structured interviews involve clinical judgement, whereas fully structured interviews are completely scripted. The Mini International Neuropsychiatric Interview (MINI), a brief fully structured interview, is also sometimes used. It is not known whether interview method is associated with probability of major depression classification.AimsTo evaluate the association between interview method and odds of major depression classification, controlling for depressive symptom scores and participant characteristics...
June 2018: British Journal of Psychiatry: the Journal of Mental Science
https://www.readbyqxmd.com/read/29714595/pharma-opportunities-and-risks-multiply-as-regulatory-reform-remakes-apac-expanded-accelerated-pathways-challenge-developer-value-story-evidence-collection-and-market-access-strategies
#20
Alberto Grignolo, Zhang Mingping
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 proliferating accelerated pathway (AP) frameworks, but only with regulatory and evidence-generation strategies tailored to the region...
July 2018: Therapeutic Innovation & Regulatory Science
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