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Recent trends in specialty pharma business model.

The recent rise of specialty pharma is attributed to its flexible, versatile, and open business model while the traditional big pharma is facing a challenging time with patent cliff, generic threat, and low research and development (R&D) productivity. These multinational pharmaceutical companies, facing a difficult time, have been systematically externalizing R&D and some even establish their own corporate venture capital so as to diversify with more shots on goal, with the hope of achieving a higher success rate in their compound pipeline. Biologics and clinical Phase II proof-of-concept (POC

Predicting survival in cancer patients: the role of cachexia and hormonal, nutritional and inflammatory markers.

BACKGROUND: Cancer can lead to weight loss, anorexia, and poor nutritional status, which are associated with decreased survival in cancer patients. METHODS: Male cancer patients (n = 136) were followed for a mean time of 4.5 years. Variables were obtained at baseline: cancer stage, albumin, hemoglobin, tumor necrosis factor alpha (TNF-α), interleukin (IL)-6, bioavailable testosterone, appetite questionnaire, and weight change from baseline to 18 months. Primary statistical tests included Kaplan-Meier survival analysis and Cox proportional hazard regression (PHREG). RESULTS: Univariate PHREG

Clinical value and cost-effectiveness analysis of conditionally approved anticancer drugs in China from 2015 to 2023.

BackgroundThe conditional approval (CA) process in China was established in 2015 to expedite access to urgently-needed drugs, however, the clinical benefits of CA drugs and potential gaps between pre-approval and confirmatory trials remain uncertain. Herein, we aim to compare the clinical values between CA and non-CA anticancer drugs from 2015 to 2023, and to explore the relationship between clinical benefit and average daily cost of treatment of drugs.MethodsThis retrospective study analyzed anticancer drugs first approved in China [2015-2023] using data from National Medical Products Adminis

Taste and smell disturbances in patients with chronic oral graft vs. host disease: An observational study.

BackgroundA common complication of allogeneic hematopoietic stem cell transplantation (alloHSCT) is chronic oral graft vs. host disease (cGvHD). Oral cGvHD may present as mucosal lesions, salivary gland dysfunction, and trismus. Moreover, taste and smell ability may be affected, but the prevalence, nature and severity of altered taste and smell function, and their impact on quality of life (QoL) are understudied.AimTo identify the prevalence, nature, and severity of taste and smell disturbances, their impact on QoL and to assess whether altered taste/smell ability is associated with oral mucos

Advances in nanomaterial-mediated CRISPR/Cas delivery: from lipid nanoparticles to vesicle-derived systems.

Gene and genome editing therapies are increasingly connected with nanomaterials, which protect and transport fragile nucleic acids and CRISPR/Cas systems through biological barriers safely and accurately. This review discusses how different nanocarriers, including lipid-based, polymeric, inorganic, and vesicle-derived systems, can improve delivery efficiency, cell targeting, endosomal escape, and intracellular movement for gene and genome editing. It summarizes findings from early clinical and preclinical studies, comparing several carrier types such as ionizable lipid nanoparticles, polymeric

On CAR-Ts, decentralized in-house models, and the hospital exception. Routes for sustainable access to innovative therapies.

Chimeric Antigen Receptor T cells, or CAR-Ts, are a novel class of gene and cell 'one-shot' therapies based upon collecting, reprogramming, and using patients' own immune cells to treat their cancer. The article discusses the status, prospects, and some relevant legal issues of this frontier of personalized medicine. In particular, it explores the legitimacy of 'in-house' CAR-Ts, ie treatments manufactured and delivered to patients within the same clinical center by relying upon automated cell processing systems, a decentralized model which is very different from the one currently adopted for

Computational identification of salient cancer care topics and themes in oncology social work notes.

BackgroundSocial work notes provide a multifaceted narrative of a patient's cancer journey. Topic modeling is a computational technique that can be used to organize notes into thematic clusters and study topics in oncological social work at scale. In this study, we used the BERTopic framework to perform topic modeling of cancer social work notes and identify roles and themes frequently documented in oncological social work.MethodsWe collected 106 676 social work notes from 25 341 patients diagnosed with cancer at the University of California San Francisco. Notes were split at the sentence leve

The Burden of Cancer, Government Strategic Policies, and Challenges in Pakistan: A Comprehensive Review.

Cancer is a severe condition characterized by uncontrolled cell division and increasing reported mortality and diagnostic cases. In 2040, an estimated 28.4 million cancer cases are expected to happen globally. In 2020, an estimated 19.3 million new cancer cases (18.1 million excluding non-melanoma skin cancer) had been diagnosed worldwide, with around 10.0 million cancer deaths. Breast cancer cases have increased by 2.26 million, lung cancer by 2.21 million, stomach by 1.089 million, liver by 0.96 million, and colon cancer by 1.93 million. Cancer is becoming more prevalent in Pakistan, with 19

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… Past successes and future challenges to the role played by wheat in global food security . Food Secur. ( 2013 ) 5 : 291 – 317 . 10.1007/s12571-013-0263-y 50. Holmboe-Ottesen G Wandel M . Changes in dietary habits after migration and consequences for health: a focus on South Asians in Europe . …

Фенотипический отбор высокоурожайной, водопродуктивной пшеницы (Triticum aestivum L.) с предполагаемыми мутантами при хорошо орошаемых и ограниченных условиях орошения.

Для устойчивого выращивания пшеницы в условиях ограниченных водных ресурсов в Египте жизненно важное значение имеет разработка высокоурожайных и водонепроницаемых сортов хлебной пшеницы с высокой производительностью воды. В этом исследовании в условиях как хорошо орошенной, так и ограниченной ирригации оценивались линии мутантов хлебной пшеницы из поколений М3, М4, М5 и их материнских сортов. three вегетационное время года2022-2024). Eight Согласно оценкам, агрономические характеристики и продуктивность водных ресурсов позволяют обнаружить высокоурожайные, устойчиво питающиеся водой пшеницы с

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… El-Sayed MA Abdel-Haleem M Nutritional significance of bread wheat in Egypt: A food security perspective J. Food Compos. Anal. 2023 115 105002 10.1016/j.jfca.2023.105002 El-Sayed, M. A. & Abdel-Haleem, M. Nutritional significance of bread wheat in Egypt: A food security perspective. J. Food Compos. … Food Secur. 2021 10 71 Ayele, B. & Alemu, D. Genetic variability and trait association in bread wheat under drought stress. Agric. Food Secur. 10 , 71 (2021). 22. Mousa RM El-Badawy ME Zein EMA Evaluation of wheat genotypes for drought tolerance Egypt. J. Agron. 2022 44 1 17 29 Mousa, R. …

Decoding the Role of Companions in Supporting the Health Communication of Older African-American Men With Cancer.

The objective of this study was to systematically characterize the content and patterning of companion's communicative behavior during oncology consultations for older African-American male patients. Companions and family members often play an important role in patient-centered communication for patients with cancer. Despite their disproportionate cancer burden, little is known about how companions facilitate patient-provider communication for older African-American men with cancer. This study represents a secondary qualitative analysis of 14 video-recorded doctor patient-companion medical vis

Rice bran arabinoxylan compound and quality of life of cancer patients (RBAC-QoL): Study protocol for a randomized pilot feasibility trial.

IntroductionRice bran arabinoxylan compound (RBAC) is a nutraceutical for enhancing a depleted immune system during and after cancer treatment. This pilot feasibility trial aims to evaluate the effects of RBAC on cancer patients' quality of life during active treatment, compared to placebo, using a validated questionnaire. Other outcome measures include changes in inflammatory and nutritional status, cytokine profile, and gut microbiota.Methods/designThe study will recruit 50 participants from a regional cancer center in Australia. Patients aged 18-70, diagnosed with solid organ cancers stage

Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.

BackgroundMost cancer drugs enter the US market first. US Food and Drug Administration (FDA) approvals of new cancer drugs may influence regulatory decisions in other settings. The study examined whether characteristics of available evidence at FDA approval influenced time-to-marketing authorisation (MA) in Brazil, and price differences between the two countries.MethodsAll new FDA-approved cancer drugs from 2010 to 2019 were matched to drugs with MA and prices approved in Brazil by December 2020. Characteristics of main studies, availability of randomised controlled trials (RCTs), overall surv

Берберин защищает от поведенческого дефицита, дисфункции памяти и каллозаального обезвоживания в мышах C57BL/6.

ЦЕЛИ: Множественный склероз (MS) — неврологическое расстройство, характеризующееся постепенным обезвоживанием и нейроинфламмацией. Берберин, производный растительным изоквинолоидным алкалоидом, обнаруженным в берберских породах, обладает заметными антивоспалительными и антиоксидантами. Цель этого исследования состояла в том, чтобы оценить защитный эффект берберина от интоксикации чайников в мышах C57BL/6. МАТЕРИАЛЫ И МЕТОДЫ: C57BL/6 Мыши получали пищевые продукты, содержащие чашечник (0,2% по весу) в течение пяти недель и проходили одновременно курс лечения берберина (5 или 10 мг/кг). Была про

Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation: Study protocol.

Hematopoietic stem cell transplantation is a common life-saving treatment for hematologic malignancies, though can lead to long-term functional impairment, fatigue, muscle atrophy, with decreased quality of life. Although traditional exercise has helped reduce these effects, it is inconsistently recommended and infrequently maintained, and most patients remain sedentary during and after treatment. There is need for alternative rehabilitation strategies, like neuromuscular electrical stimulation, that may be more amenable to the capabilities of hematopoietic stem cell transplant recipients. Pat

The ASH Research Collaborative Sickle Cell Disease Research Network: past, present, and future.

AbstractHistorically, sickle cell disease (SCD) has been overshadowed by progress in other hematologic disorders, but recent advances are reshaping its clinical and research landscape. Despite SCD reducing life expectancy by >20 years even with optimal care, transformative initiatives are fostering hope for improved outcomes. The American Society of Hematology (ASH) established the ASH Research Collaborative Sickle Cell Disease Research Network as a comprehensive program to revolutionize SCD research in the United States. This Network comprises a collection of innovative, research-focused coop

A cross-national review of novel oncology approvals in the United States and China (2020-2025).

INTRODUCTION: The United States and China are among the largest hubs for oncology drug development and commercialization. We conducted a comprehensive characterization of how the 2 largest oncology drug markets are evolving relative to one another, with implications for regulators, sponsors, clinicians, and patients. METHODS: Using publicly available drug databases from the US Food and Drug Administration (FDA) and the National Medical Products Administration (NMPA), we collected information on novel oncology approvals in the United States and China from 2020 to 2025. RESULTS: From 2020 to 2

Экологические и семейные факторы риска, связанные с множественным склерозом.

Предыстория и цели: Множественный склероз (MS) является хроническим аутоиммунным заболеванием, которое оказывает воздействие на центральную нервную систему и вызывает рост заболеваемости во всем мире, особенно в Саудовской Аравии. Материалы и методы: В рамках данного исследования изучаются экологические, жизненные и семейные факторы риска, связанные с MS в регионе Алжуф, на основе перекрестного анализа 155 пациентов, диагностированных по клиническим диагнозам MS. Данные собирались с помощью структурированных вопросников и медицинских обследований для оценки социально-демографических характерис

Person-centred care in oncological home services: a scoping review of patients' and caregivers' experience and needs.

BackgroundCancer became a chronic disease that could be managed at home. Homecare supported person-centred care, which was guided by the Picker Principles defining key elements for care delivery. The study aimed to explore and appraise the dimensions underlying cancer patients' and caregivers' experience and expectations with Home Cancer Care, adopting a person-centerd care framework.MethodsWe carried out a scoping review of the literature using three databases, PubMed, Scopus, and WoS for a total of 703 articles. PRISMA guidelines were followed. 57 articles were included in the review. The ex

Chimeric antigen receptor T-cell therapy: Challenges and framework of outpatient administration.

Adoptive cellular therapy has made a landmark change within the treatment paradigm of several hematologic malignancies, and novel cellular therapy products, such as chimeric antigen receptor T-cell therapy (CART), have demonstrated impressive efficacy and produced durable responses. However, the CART treatment process is associated with significant toxicities, healthcare resource utilization, and financial burden. Most of these therapies have been administered in the inpatient setting due to their toxicity profile. Improved toxicity management strategies and a better understanding of cellular

Understanding the symptom experience and self-management strategies of adult hematopoietic stem cell transplantation patients during hospitalization: findings from a qualitative longitudinal study.

PurposeThe aim of this study was to explore the symptom experience and self-management strategies of adult hematopoietic stem cell transplantation patients during hospitalization.MethodsThis was a qualitative descriptive study. A heterogeneous sample of 19 patients who underwent hematopoietic stem cell transplantation from May to October 2021 were enrolled in the study. Semi-structured interviews were conducted at four time points during hospitalization, providing a total of 64 interview datasets.ResultsFour themes and 11 subthemes reflecting the symptom experience and self-management strategi