ABSTRACT
Remote healthcare is a well-accepted telemedicine service that renders efficient and reliable healthcare to patients suffering from chronic diseases, neurological disorders, diabetes, osteoporosis, sensory organs, and other ailments. Artificial intelligence, wireless communication, sensors, organic polymers, and wearables enable affordable, non-invasive healthcare to patients in all age groups. Telehealth services and telemedicine are beneficial to people residing in remote locations or patients with limited mobility, rehabilitation treatment, and post-operative recovery. Remote healthcare applications and services proved to be significant during the COVID-19 pandemic for both patients and doctors. This study presents a detailed study of the use of artificial intelligence and the internet of things in applications of remote healthcare in many domains of health, along with recent patents. This research also presents network diagrams of documents from the Scopus database using the tool VOSViewer. The paper highlights gap which can be undertaken by future researchers. © 2023 IEEE.
ABSTRACT
Research on natural products has investigated and employed many (bio)technologies to find out plant active fractions and optimize extraction and isolation of molecules looking for innovative clinical therapies for several clinical conditions, as well as immune-related diseases. Indeed, the world incidence and prevalence of autoimmune diseases have increased over the last years, while immune therapy has arisen as a new promising tool for cancer treatment. Also, in the emergence of COVID-19 pandemic, immunomodulation has been proved effective to reduce the "cytokine storm” and avoid worsening the clinical condition of patients in the acute stage of respiratory syndrome. These health issues have also driven the search for new immunomodulatory compounds. In this context, prospective analysis is an important tool to identify the most relevant opportunities and demands in research and development (R&D) of pharmaceutical medicines, including substances able to modulate immune and inflammatory responses. In addition, prospection allows understanding the landscape of immunomodulatory plant-derived drugs and the associated technologies described in patents. This chapter employed the descriptors "Immunomodulator*” and "drug” and "plant” in search strategy to map the technological potential of immunomodulatory herbal drugs, using the software VantagePoint, Cortellis Competitive Intelligence, and Orbit Intelligence, respectively. The results provided quantitative data and technological indicators to drive future strategies for the development of these drugs. In conclusion, the most cited plant species in patents expressing molecules with immunomodulatory properties were Curcuma longa, Moringa oleifera, Remirea maritima, Maytenus ssp., Angelica sp., Fagopyrum esculentum, as well as plants from the families Leguminosae, Rosaceae, Iridaceae, Moraceae, and Amaranthaceae, among others. The main chemical classes implicated in immunomodulation were xanthones, coumarins, flavonoids, and (tri)terpenes. The technological mapping also showed that in the year 2002, there was an increased deposit of patents, reaching the highest peak in 2009 with 56 patents. Nowadays, the United States is the country with the biggest number of patents, followed by Canada, Australia, and Korea. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Singapore Pte Ltd. 2022.
ABSTRACT
This article uses data from several publicly available databases to show that the distribution of intellectual property for frontier technologies, including those useful for sustainable development, is very highly skewed in favor of a handful of developed countries. The intellectual property rights (IPR) regime as it exists does not optimize the global flow of technology and know-how for the attainment of the sustainable development goals and is in need of updating. Some features of the Fourth Industrial Revolution imply that the current system of patents is even more in need of reform than before. COVID-19 vaccines and therapies and the vast inequality in access to these has highlighted the costs of inaction. We recommend several policy changes for the international IPR regime. Broadly, these fall into three categories: allowing greater flexibility for developing countries, reassessing the appropriateness of patents for technologies that may be considered public goods, and closing loopholes that allow for unreasonable intellectual property protections.
ABSTRACT
Anaplastic large-cell lymphoma (ALCL) is an aggressive subtype of non-Hodgkin lymphoma. There are two forms of ALCL: primary and secondary. Primary can be systemic, affecting multiple organs, or cutaneous, affecting mainly the skin. A secondary form occurs when another lymphoma undergoes an anaplastic transformation. ALCL rarely presents as initial symptoms of respiratory failure. In most of these situations, the trachea or bronchial involved with an obstruction was present. We present an unusual case of ALCL where the patient rapidly progressed to acute hypoxic respiratory failure with a patent bronchus and trachea. Unfortunately, the patient rapidly deteriorated and died before diagnosis. Only upon at autopsy, it was found that his lung parenchyma was diffusely involved with ALCL. The autopsy report showed that the patient had CD-30 anaplastic lymphoma kinase (ALK)-negative ALCL diffusely involving all lung fields.
ABSTRACT
Introduction: Ivermectin is an antiparasitic medication that is primarily metabolized by the liver. During the COVID-19 pandemic, researchers demonstrated that Ivermectin successfully inhibited the replication of SARS-COV-2 in vivo, but current research has failed to demonstrate clinical benefit for treatment of COVID-19. Despite this, misinformation campaigns have misled patients to ingest Ivermectin at concentrations meant for domestic animals. Here, we present a case of acute liver failure secondary to the use of Ivermectin. Case Description/Methods: A 61-year-old man with medical history of ischemic cardiomyopathy with last echocardiogram showing ejection fraction at 21%, atrial fibrillation on warfarin for oral anticoagulation, and previously treated Hepatitis C presented with generalized weakness and yellowish discoloration of the skin worsening over the last two weeks. The patient denied significant alcohol use, acetaminophen use, or illicit drugs. He admitted to injecting himself with two doses of weight-based horse ivermectin, for COVID prophylaxis, two weeks prior to his presentation. Physical exam was pertinent for scleral icterus and hepatomegaly with no abdominal tenderness. Initial labs revealed elevated liver chemistries in a mixed pattern (Figure 1). Acute hepatitis panel, HSV, and CMV were negative. Hepatitis C antibodies were positive, but the patient was in sustained virologic response. Full workup for chronic liver disease was unremarkable. Ultrasound revealed hepatosplenomegaly with patent portal and hepatic vasculature. Subsequently, the patient developed hepatic encephalopathy along with his coagulopathy, raising concern for acute hepatic failure. The patient was transferred to the ICU and started on NAcetylcysteine, rifaximin, and supportive care. The patient recovered well and fortunately did not require liver transplant. Discussion(s): While the FDA recommends against the use of Ivermectin for COVID-19, many continue to inappropriately consume it. Ivermectin-induced liver failure is a rare but deadly side effect. Given our patient's rapid onset of symptoms post-self injection of Ivermectin, his liver injury was presumed to be related to Ivermectin. The drug interaction between Ivermectin and warfarin had worsened the patients coagulopathy. Physicians should be aware of the ways Ivermectin overdose may clinically present to avoid delayed treatment. This case demonstrates the detriments of perpetuation of medical misinformation to care.
ABSTRACT
Introduction: Although Gastrointestinal fistula is a well-recognized complication of acute pancreatitis, it has been rarely reported. Here we present a rare case of spontaneous gastro-pancreatic fistula following acute pancreatitis. Case Description/Methods: 42 y/o female with PMH of SLE with a recent prolonged hospitalization for acute drug-induced pancreatitis with pseudocyst came to ED with fever, abdominal pain, nausea, and vomiting. She was tachycardic, had leukocytosis, and was positive for COVID-19. CT Scan A/P showed multiple infected peripancreatic collections with communication of the left upper quadrant collection with the gastric lumen (Figure). The patient was hospitalized, Kept NPO, and started on fluids and antibiotics. IR evaluated and put 2 pigtail catheters for drainage of peripancreatic collections. The tip of the pigtail catheter in the left peripancreatic/retroperitoneal collection was in the gastric lumen. The surgery team recommended continuing with conservative treatment with parenteral nutrition, and IV antibiotics as the patient were nontoxic with no signs of free perforation, and pancreatitis would more likely erode a staple or suture line and would put the patient at further risk of free perforation if repair attempted. IR was successful in pulling the drain out of the gastric lumen on the second attempt to allow gastric perforation to heal. Antibiotics were upgraded as per the culture and sensitivity results of the drain fluid. Repeated multiple bedside leak tests and CT scans with oral contrast continue to be positive for patent gastro-pancreatic fistula. Pigtails catheter continues to drain significant necrotic collection. The patient continues to be hospitalized and is being managed conservatively with Parenteral nutrition, and IV antibiotics. Discussion(s): Fistula of the GI tract following acute pancreatitis can be caused by multiple reasons. Necrosis of the bowel may occur concomitantly with the pancreatic or peripancreatic tissue. Furthermore, enzyme-rich fluid and necrosis can lead to vascular thrombosis, which compromises the blood supply of the segmental GI tract, eventually leading to bowel necrosis. GI fistulas are more common in patients with necrotizing pancreatitis with infected pancreatic necrosis. Despite pharmacologic suppression of pancreatic exocrine secretion and advances in endoscopic and percutaneous therapeutic techniques, pancreatic fistula continues to be a source of morbidity and mortality following pancreatitis and requires multidisciplinary treatment.
ABSTRACT
Introduction: The SARS-CoV-2 pandemic has affected medical decision-making in all practice areas, including the pediatric cardiac intensive care unit (CICU), sometimes necessitating the use of innovative management strategies. Venovenous extracorporeal membrane oxygenation (VV-ECMO) and, particularly, late ductal stenting are infrequently applied interventions in the CICU. Here we present a critically ill infant with d-transposition of the great arteries (d-TGA), ventricular septal defect (VSD), pulmonary stenosis (PS), and patent ductus arteriosus (PDA), in which VV-ECMO and late ductal stenting were utilized successfully in the setting of active SARS-CoV-2 infection to treat worsening PS and pulmonary venous desaturation, thereby delaying surgical intervention and its associated risks during active infection. Case Description: A 3 month old male with d-TGA, VSD, and PS, initially managed with a balloon atrial septostomy at birth, was admitted to the CICU after presenting with respiratory distress and hypoxemia. He was found to be SARS-CoV-2 positive, requiring only nasal cannula initially. Admission echocardiogram demonstrated known d-TGA, VSD, severe pulmonary stenosis (peak gradient 95-110mmHg), unrestrictive atrial communication, and preserved systolic function. A tiny, hemodynamically insignificant PDA was also noted. While admitted, the patient exhibited intermittent, severe desaturations requiring escalating respiratory support. He was started on a prostaglandin infusion with aim to promote additional pulmonary blood flow through the PDA, thereby limiting the severity and frequency of desaturations. However, the patient ultimately became severely hypoxemic, despite multiple interventions to improve oxygenation. Echocardiogram at this time demonstrated preserved ventricular function, so the decision was made to escalate to VVECMO therapy. Following ECMO cannulation, the patient's hypoxemia quickly resolved, and he remained hemodynamically stable. Given the persistence of his PDA and the desire to avoid the risks of cardiac surgery in the setting of acute COVID infection, percutaneous intervention to augment pulmonary blood flow was attempted. Despite its diminutive size, his PDA was able to be successfully cannulated and stented the day after ECMO initiation. He was able to be quickly weaned from ECMO support and was decannulated the following day. He was subsequently extubated and ultimately discharged home with planning for definitive surgical intervention underway. Discussion(s): Here we present an interesting case of an infant with d-TGA, VSD, PS, and PDA in which VV-ECMO and PDA stenting were successfully applied to treat acute hypoxemia in the setting of SARS-CoV-2 infection and severe pulmonary stenosis. These therapies may be considered in appropriate patients for whom the risks of cardiac surgery are significant.
ABSTRACT
Introduction: Long-term prognosis, especially for post-intensive care syndrome (PICS) is an emerging problem in critically ill patients. Prevalence and risk factors are unclear in patients with severe coronavirus disease 2019 (COVID-19). We aimed to investigate the prevalence and risks of mortality and PICS in ventilated patients with COVID-19. Method(s): A multicenter prospective study was conducted on ventilated patients with COVID-19 infection. The questionnaire for PICS evaluation was mailed within a median of 6 mo after hospital discharge, concerning Barthel Index, Short-Memory Questionnaire, and Hospital Anxiety and Depression Scale scores. Result(s): 251 patients completed the PICS questionnaires with a prevalence of PICS of 58.6%, along with the highest percentages of cognitive impairment. Delirium (OR 2.34, p = 0.03) and the duration of mechanical ventilation (OR 1.29, p = 0.02) were identified as independent risks for PICS. In 297 patients who received mechanicalventilation for 7 day or longer, protein and energy delivery in day 4-7, especially for protein delivery, were independently and monotonically associated with in-hospital mortality, but not with PICS occurence. Conclusion(s): 60% of the ventilated patients with COVID-19 suffered from PICS. Delirium and longer mechanical ventilation were identified as risks for PICS. In the patents requiring longer mechanical ventilation, nutrition delivery in the late period of the acute phase might be imprtant to survive COVID-19.
ABSTRACT
3CL protease inhibitors has become the focus of the current research on anti-coronavirus drugs. The analysis of the patent information will help the research and innovation of such anti-coronavirus drugs. This paper analyzes the application trends of anti-coronavirus 3CL protease inhibitor-related patents, the distribution of regional status of patents, important applicants, patented technology themes, progress of key drug development and other factors. We also analyze the development of related patent technologies and aim to help domestic pharmaceutical enterprises carry out innovation and complete the strategic layout.Copyright © 2023 Chinese Journal of New Drugs Co. Ltd.. All rights reserved.
ABSTRACT
Background: The phase III EMERALD trial (NCT03778931) reported significantly prolonged progression-free survival (PFS) and a manageable safety profile with elacestrant vs SoC endocrine therapy (ET) in patients (N=478) with ER+/HER2- advanced or mBC following progression on prior CDK4/6i plus ET. PROs measuring quality of life (QoL) are reported here. Method(s): EMERALD patients (pts) completed 3 PRO tools at prespecified time points: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30), the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), and the EuroQoL 5 Dimension 5 Level (EQ-5D-5L). Result(s): The ratio of PROs tools completed vs. PROs tools expected was 80-90% through cycle 4 and approximately 70% at cycle 6;likely due to clinical study period overlapping with COVID-19 period. Overall, the EORTC QLQ-C30 scores were similar for elacestrant and SoC, with no differences across all time points for both functional and symptom scales. However, PRO-CTCAE results showed that fewer pts who received elacestrant reported very severe nausea (4.0% vs 14.3% by cycle 6) or very severe vomiting (9.1% vs 50% by cycle 6) compared with SoC. There were no clinically meaningful differences across all time points in adverse events typically observed with pts with cancer on ET, such as fatigue, nausea, vomiting, joint and muscle pain and hot flashes. EQ-5D-5L scores were generally comparable throughout treatment for both study arms, with elacestrant showing numerically better outcomes vs SoC for mobility, self-care and usual activities. Similar trends were observed for the full intent-to-treat population and in pts with detectable estrogen receptor 1 mutations (ESR1m). Conclusion(s): This analysis confirmed that QoL was maintained between treatment groups in the EMERALD trial. Together with the previously described statistically significant prolonged PFS and manageable safety profile, these PRO results provide additional evidence that oral elacestrant is clinically meaningful in this patient population with limited therapeutic options. Clinical trial identification: NCT03778931. Editorial acknowledgement: Jeffrey Walter, IQVIA. Legal entity responsible for the study: Stemline Therapeutics/Menarini Group. Funding(s): Stemline Therapeutics/Menarini Group. Disclosure: J. Cortes: Financial Interests, Personal, Advisory Board: Roche, Celgene, Cellestia, AstraZeneca, Seattle Genetics, Daiichi Sankyo, Erytech, Athenex, Polyphor, Lilly, MERCK SHARP& DOHME, GSK, LEUKO, Bioasis, Clovis oncology, Boehringer Ingelheim, Ellipses, Hibercell, BioInvent, Gemoab, Gilead, Menarini, Zymeworks, Reveal Genomics;Financial Interests, Personal, Invited Speaker: Roche, Novartis, Celgene, Eisai, Pfizer, Samsung Bioepis, Lilly, MERCK SHARP& DOHME, Daiichi Sankyo;Financial Interests, Personal, Other, Consulting/advisor: Expres2ion Biotechnologies;Financial Interests, Personal, Stocks/Shares: MedSIR, Nektar Therapeutics;Financial Interests, Institutional, Research Grant: Roche, Ariad Pharmaceuticals, AstraZeneca, Baxalta GMBH/Servier Affaires, Bayer healthcare, Eisai, Guardant Health, Merck Sharp & Dohme, Pfizer, Piqur Therapeutics, Puma B, Queen Mary University of London;Other, Travel cost and expenses: Roche, Novartis, Eisai, Daiichi Sankyo, Pfizer, Gilead, AstraZeneca. F.C. Bidard: Financial Interests, Personal, Advisory Role: Pfizer, AstraZeneca, Lilly, Novartis, Radius Health, Menarini;Financial Interests, Institutional, Advisory Role: Menarini;Financial Interests, Personal, Speaker's Bureau: Pfizer, Novartis, AstraZeneca, Roche, Lilly, Rain Therapeutics;Financial Interests, Institutional, Research Grant: Novartis, Pfizer, Menarini Silicon Biosystems, Prolynx;Financial Interests, Institutional, Other, patents: ESR1 & MSI detection techniques;Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Roche, Pfizer, AstraZeneca, Novartis. A. Bardia: Financial Interests, Personal, Advisory Board: Pfizer, Novartis, Genentech, Merck, Sanofi, Eisa , Lilly, Mersana, AstraZeneca/Daiichi, Menarini, Gilead;Financial Interests, Personal, Royalties: UpToDate;Financial Interests, Institutional, Invited Speaker: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics/Gilead, Daiichi Pharma/AstraZeneca, Eli Lilly.;Non-Financial Interests, Principal Investigator: Gilead, Mersana, AstraZeneca/Daiichi, Novartis, Pfizer, Genentech, Lilly, Merck, Sanofi. V.G. Kaklamani: Financial Interests, Personal, Other, Honoraria: Genentech, Novartis, Pfizer, Genomic Health, Puma Biotechnology, AstraZeneca, Seattle Genetics, Daichi, Gilead Sciences;Financial Interests, Personal, Advisory Role: Amgen, Eisai, Puma Biotechnology, Celldex, AstraZeneca, Athenex, bioTheranostics;Financial Interests, Personal, Speaker's Bureau: Genentech, Novartis, Genomic Health, Puma Biotechnology, Pfizer, AstraZeneca/Daiichi Sankyo;Financial Interests, Personal, Research Grant: Eisai. I. Vlachaki: Financial Interests, Personal, Full or part-time Employment: Menarini Hellas A.E. G. Tonini: Financial Interests, Personal, Full or part-time Employment: Menarini Ricerche S.p.A. N. Habboubi: Financial Interests, Personal, Full or part-time Employment: Stemline Therapeutics;Financial Interests, Personal, Leadership Role: Stemline Therapeutics. P.G. Aftimos: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Macrogenics, Roche, Novartis, Amcure, Servier, G1 Therapeutics, Radius, Deloitte, Menarini, Gilead, Novartis, Eisai, Lilly;Financial Interests, Personal, Invited Speaker: Synthon, Amgen;Financial Interests, Institutional, Research Grant: Roche.Copyright © 2023
ABSTRACT
This paper addresses the spatial pattern of urban biomedicine innovation networks by separately using four scales, i.e., the national scale, interregional scale, urban agglomeration scale, and provincial scale, on the basis of Chinese biomedicine patent data from the incoPat global patent database (GPD) (2001-2020) and using the method of social network analysis (SNA). Through the research, it is found that (1) on the national scale, the Chinese biomedicine innovation network becomes denser from west to the east as its complexity continuously increases. Its spatial structure takes the form of a radial network pattern with Beijing and Shanghai as its centers. The COVID-19 pandemic has not had an obvious negative impact on this network at present. (2) On the interregional scale, the strength of interregional network ties is greater than that of intraregional network ties. The eastern, central and western biomedicine innovation networks appear to be heterogeneous networks with regional central cities as the cores. (3) At the urban agglomeration scale, the strength of intraurban-agglomeration network ties is greater than that of interurban-agglomeration network ties. The three major urban agglomerations have formed radial spatial patterns with central cities as the hubs. (4) At the provincial scale, the intraprovincial networks have poor connectivity and low internal ties strength, which manifest as core-periphery structures with the provincial capitals as centers. Our research conclusion helps to clarify the current accumulation of technology and offer guidance for the development of China's biomedicine industry.
Subject(s)
COVID-19 , Pandemics , Humans , COVID-19/epidemiology , China , Health Occupations , Asian PeopleABSTRACT
Patent protection emerged as one of the most challenging barriers to the access to medicines, medical equipment, and vaccines as well for the treatment and containment of Covid-19 when it became a pandemic. The severe scarcity of vaccines and pharmaceutical products were weakening the fight against Covid-19, and endeavor to contain the recurrence of pandemic waves while mutation of the SARS-CoV-2 was also on the full swing. Therefore, India and South Africa jointly proposed for patent waiver at WTO in October 2020 to effectively deal with the short-supply of medicines, medical equipment, vaccines and high price concern related to these products. After 20 months of consultation and negotiations with major stakeholders, the WTO came up with decision on patent waiver in 12th Ministerial Conference (12th MC). The time taken to reach to the decision in the pandemic situation and the narrow scope of the decision is a serious concern for the entire world to deal effectively with Covid-19 and its variants. This paper attempts to analyse the patent waiver in the context of the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). It discusses patent barriers, alternative measures and needs for equitable access to vaccines and pharmaceuticals amidst the pandemic. Paper applies the qualitative methodology of research mainly content analysis method in the framework of contextualisation, decontextualisation, and recontextualisation. Results show that suspending certain provisions of the TRIPS required for the production of vaccines and medicines would prove a crucial tool for economies to return to its pre-Covid-19 era. Paper concludes that, patent waiver can be one of the most important tool to fight the Covid-19 (as WHO has not yet declared the end of pandemic) and will pave the way to deal with any such unknown future pandemic effectively. © 2023 John Wiley & Sons Ltd.
ABSTRACT
Introduction: A nosocomial outbreak of coronavirus disease (COVID-19) occurred in the Toda Chuo General Hospital in Toda City, Saitama Prefecture, Japan in December 2020. The purpose of this study was to compare the accuracy of three prognostic indices for predicting the outcome of COVID-19 in patents with COVID-19 pneumonia. Patients and Methods: Patients in the Department of Urology and Transplant Surgery at Toda Chuo General Hospital with nosocomially acquired COVID-19 confirmed by a positive polymerase chain reaction test were included in the study. We used the COVID-GRAM, International Severe Acute Respiratory and Emerging Infections Consortium's World Health Organization 4C Mortality Score, and COVID-19 Registry Japan to independently predict the prognoses of 10 patients and identify common prognostic factors. All three indices include age, dyspnea, and comorbidities as prognostic factors. Result(s): Ten patients were included in the study, of which two patients died. According to the COVID-GRAM both patients were "high risk," whereas the 4C Mortality Score predicted "high risk" and "very high risk." Conclusion(s): The prognostic scores of all three indices were useful for predicting illness severity.Copyright © 2023 The Authors
ABSTRACT
3CL protease inhibitors has become the focus of the current research on anti-coronavirus drugs. The analysis of the patent information will help the research and innovation of such anti-coronavirus drugs. This paper analyzes the application trends of anti-coronavirus 3CL protease inhibitor-related patents, the distribution of regional status of patents, important applicants, patented technology themes, progress of key drug development and other factors. We also analyze the development of related patent technologies and aim to help domestic pharmaceutical enterprises carry out innovation and complete the strategic layout.Copyright © 2023 Chinese Journal of New Drugs Co. Ltd.. All rights reserved.
ABSTRACT
Background: Pharmaceutical businesses had enormous difficulties in product distribution during COVID-19, and the solution to this perpetual issue is a resilient supply chain. Aim(s): The study aims to understand the vulnerabilities to which it subjected the pharmaceutical product distribution supply chains during the COVID-19 pandemic and further develop an adaptive model through which the pharmaceutical product supply chain can enhance its resilience capabilities. Material(s) and Method(s): The conceptual model is developed for the supply chain of pharmaceutical companies based on the literature survey, and then the conceptual model is explored through factor analysis. Researchers have developed a validated model after a statistical analysis using Cronbach's alpha. Subjective analysis has concluded that the pharmaceutical supply chain's resilience is driven by factors such as "trade cost," which comprises transport cost, business practices, and raw material sourcing cost;"shock propagation," which comprises country-specific shocks, production shocks, and policy changes;and "technological infrastructure bottleneck," which relates to the availability of cold chain storage warehouses and refrigerated transport vehicle facilities. Result(s): An empirical model pertaining to supply chain resilience may be further studied with different geographies, like Pune, Hyderabad, and Delhi NCR, for the purpose of generalizing the study. Conclusion(s): The identified major factors were trade cost, shock propagation, and technological infrastructure bottlenecks. The sensitivity of the issue under investigation required a personal touch to the survey, as the COVID-19 pandemic had left these respondents emotionally vulnerable. As COVID-19 is the recent catastrophe that has hit humanity, it has made the pharmaceutical product distribution channel vulnerable during the pandemic. This difficult time of pandemic has really tested the pharmaceutical products' supply chain capabilities as well.Copyright © 2023, Association of Pharmaceutical Teachers of India. All rights reserved.
ABSTRACT
Background The phase III CheckMate 816 study demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and pathologic complete response (pCR) with neoadjuvant N + C vs C in patients (pts) with resectable NSCLC. Here, we report 3-y efficacy, safety, and exploratory biomarker analyses from CheckMate 816. Methods Adults with stage IB (tumors >=4 cm)-IIIA (per AJCC 7th ed) resectable NSCLC, ECOG PS <= 1, and no known EGFR/ALK alterations were randomized to N 360 mg + C Q3W or C alone Q3W for 3 cycles followed by surgery. Primary endpoints were EFS and pCR, both per blinded independent review. Exploratory analyses included EFS by surgical approach and extent/completeness of resection, and EFS and pCR by a 4-gene (CD8A, CD274, STAT-1, LAG-3) inflammatory signature score derived from RNA sequencing of baseline (BL) tumor samples. Results At a median follow-up of 41.4 mo (database lock, Oct 14, 2022), continued EFS benefit was observed with N + C vs C (HR, 0.68;95% CI, 0.49-0.93);3-y EFS rates were 57% and 43%, respectively. N + C improved EFS vs C in pts who had surgery, regardless of surgical approach or extent of resection, and in pts with R0 resection (table). Recurrence occurred in 28% and 42% of pts who had surgery in the N + C (n = 149) and C arms (n = 135), respectively. In the N + C arm, BL 4-gene inflammatory signature scores were numerically higher in pts with pCR vs pts without, and EFS was improved in pts with high vs low scores (data to be presented). Grade 3-4 treatment-related and surgery-related adverse events occurred in 36% and 11% of pts in the N + C arm, respectively, vs 38% and 15% in the C arm. Conclusions Neoadjuvant N + C continues to provide long-term clinical benefit vs C in pts with resectable NSCLC, regardless of surgical approach or extent of resection. Exploratory analyses in pts treated with N + C suggested that high BL tumor inflammation may be associated with improved EFS and pCR. Clinical trial identification NCT02998528. Editorial acknowledgement Medical writing and editorial support for the development of this , under the direction of the authors, was provided by Adel Chowdhury, PharmD, Samantha Dwyer, PhD, and Michele Salernitano of Ashfield MedComms, an Inizio company, and funded by Bristol Myers Squibb. Legal entity responsible for the study Bristol Myers Squibb. Funding Bristol Myers Squibb. Disclosure P.M. Forde: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi Sankyo, F-Star, G1 Therapeutics, Genentech, Iteos, Janssen, Merck, Novartis, Sanofi, Surface;Financial Interests, Institutional, Research Grant: AstraZeneca, BioNTech, Bristol Myers Squibb, Corvus, Kyowa, Novartis, Regeneron;Financial Interests, Personal, Other, Trial steering committee member: AstraZeneca, BioNTech, Bristol Myers Squibb, Corvus;Non-Financial Interests, Personal, Member of the Board of Directors: Mesothelioma Applied Research Foundation;Non-Financial Interests, Personal, Advisory Role, Scientific advisory board member: LUNGevity Foundation. J. Spicer: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, CLS Therapeutics, Merck, Protalix Biotherapeutics, Roche;Financial Interests, Personal, Other, Consulting fees: Amgen, AstraZeneca, Bristol Myers Squibb, Merck, Novartis, Protalix Biotherapeutics, Regeneron, Roche, Xenetic Biosciences;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Bristol Myers Squibb, PeerView;Non-Financial Interests, Personal, Other, Data safety monitoring board member: Deutsche Forschungsgemeinschaft;Non-Financial Interests, Personal, Leadership Role, Industry chair: Canadian Association of Thoracic Surgeons. [Formula presented] N. Girard: Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, MSD, Roche, Pfizer, Mirati, Amgen, Novartis, Sanofi;Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Boehringer Ingelheim, Novartis, Sanofi, AbbVie, Amgen, Eli Lilly, Grunenthal, Tak da, Owkin;Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen;Financial Interests, Institutional, Funding: BMS;Non-Financial Interests, Personal, Officer, International Thymic malignancy interest group, president: ITMIG;Other, Personal, Other, Family member is an employee: AstraZeneca. M. Provencio: Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Janssen, Pfizer, Roche, Takeda;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Bristol Myers Squibb, MSD, Pfizer, Roche, Takeda. S. Lu: Financial Interests, Personal, Advisory Role: AstraZeneca, Boehringer Ingelheim, GenomiCare, Hutchison MediPharma, Roche, Simcere, ZaiLab;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Hanosh, Roche. M. Awad: Financial Interests, Personal, Other, Consulting fees: ArcherDX, Ariad, AstraZeneca, Blueprint Medicine, Bristol Myers Squibb, EMD Serono, Genentech, Maverick, Merck, Mirati, Nektar, NextCure, Novartis, Syndax;Financial Interests, Institutional, Research Grant: AstraZeneca, Bristol Myers Squibb, Genentech, Eli Lilly. T. Mitsudomi: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, BridgeBio Pharma;Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, MSD, Novartis, Ono, Pfizer;Financial Interests, Personal, Speaker's Bureau: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Daiichi Sankyo, Eli Lilly, Guardant, Invitae, Merck, MSD, Novartis, Ono, Pfizer, Taiho;Financial Interests, Personal, Advisory Board: AstraZeneca;Non-Financial Interests, Personal, Leadership Role, Former president: IASLC. E. Felip: Financial Interests, Institutional, Research Grant: Fundacion Merck Salud, Merck KGAa;Financial Interests, Personal, Other, Consulting fees: Amgen, AstraZeneca, Bayer, BerGenBio, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, F. Hoffmann-La Roche, GlaxoSmithKline, Janssen, Merck, MSD, Novartis, Peptomyc, Pfizer, Sanofi, Takeda;Financial Interests, Personal, Speaker's Bureau: Amgen, AstraZeneca, Bristol Myers Squibb, Eli Lilly, F. Hoffmann-La Roche, Janssen, Medical Trends, Medscape, Merck, MSD, PeerVoice, Pfizer, Sanofi, Takeda, touchONCOLOGY;Non-Financial Interests, Personal, Member of the Board of Directors: Grifols. S.J. Swanson: Financial Interests, Personal, Speaker's Bureau: Ethicon. F. Tanaka: Financial Interests, Institutional, Research Grant: Boehringer Ingelheim, Chugai, Eli Lilly, Ono, Taiho;Financial Interests, Personal, Other, Consulting fees: AstraZeneca, Chugai, Ono;Financial Interests, Personal, Speaker's Bureau: AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Chugai, Covidien, Eli Lilly, Intuitive, Johnson & Johnson, Kyowa Kirin, MSD, Olympus, Ono, Pfizer, Stryker, Taiho, Takeda. P. Tran: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb;Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. N. Hu: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. J. Cai: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb;Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb;Financial Interests, Personal, Other, Travel support for attending meetings and travel: Bristol Myers Squibb. J. Bushong: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb;Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. J. Neely: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb;Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. D. Balli: Financial Interests, Personal, Other, patents planned, issued, or pending: Bristol Myers Squibb;Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. S.R. Broderick: Financial Interests, Personal, Advisory Board: AstraZeneca. All other authors have declared no conflicts of interest.Copyright © 2023 International Association for the Study of Lung Cancer. Published by E sevier Inc.
ABSTRACT
Vaccination patent is associated with exclusive rights that restrict the production, use, and sale of inventions by third parties for a specific period. This factor contributes to the high cost of vaccines, making it challenging to access vaccines in many underdeveloped nations such as Indonesia. The urgency for faster vaccine distribution during the COVID-19 pandemic further highlights this issue. However, the patent provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) may exacerbate the unequal distribution of vaccines worldwide. This study analyzes the implementation of the flexibility feature of the TRIPs Agreement, and Doha Declaration contained in Law Number 13 of 2016 respecting Patent to achieve a pandemic-free era. It is also necessary to examine the Indonesian patent rules and regulations, the TRIPs Agreement, the Doha Declaration, and other legal documents to examine these issues. The results showed that the patent rules and regulations have adopted flexibility under the TRIPs Agreement and the Doha Declaration. However, the effect on the country's sluggish pharmaceutical supply chain has not been improved. A patent suspension system on a global scale is required to hasten the transition to a pandemic-free period since the feature of flexibility cannot handle the slow pace of vaccine procurement. The patent suspension system can be implemented through international agreements, such as the Patent Suspension Proposal filed by South Africa and India in October 2020. The suspension is crucial to accelerate the equitable distribution of vaccines and reduce their price. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.
ABSTRACT
Background: COVID-19 infection has been associated with paradoxical thromboembolism through a patent foramen ovale (PFO) and ischaemic stroke. Such events have not been reported after COVID-19 vaccination. The aim of the present study was to investigate PFO-associated stroke during the mass COVID-19 vaccination in Slovenia. Methods: This prospective study, conducted between 26 December 2020 and 31 March 2022, enrolled consecutive patients (≥18 years) with PFO-associated stroke referred for a percutaneous closure to a single interventional facility in Slovenia. Results: A total of 953,546 people aged between 18 and 70 years received at least one dose of a COVID-19 vaccine approved by the European Medicines Agency. Of the 28 patients presenting with PFO-associated stroke, 12 patients (42.9%) were vaccinated prior to the event, of whom nine were women and three were men, aged between 21 and 70 years. Stroke occurred within 35 days after vaccination in six patients (50%). Clinical presentation included motor dysphasia, paresis, vertigo, ataxia, paraesthesia, headache, diplopia and hemianopia. At hospital discharge, 11 patients (91.6%) had at least one residual ischaemic lesion. Conclusion: A temporal coincidence of COVID-19 vaccination and PFO-associated stroke has been described. A potential cause-effect relationship may only be hypothesised.
ABSTRACT
BACKGROUND: Pulmonary microbial infection is mainly caused by microbes like atypical bacteria, viruses, and fungi, on both the upper and lower respiratory tracts. The nanotechnology-based treatment approach is one of the contemporary needs to combat different pulmonary infections. AIM: The main aim of the study is to explore all pulmonary infectious diseases and to compare the advanced and novel treatment approaches with the conventional methods which are available to treat the infections. MATERIAL AND METHOD: This work sheds light on pulmonary infectious diseases with their conventional and present treatment approaches along with a focus on the advantageous roles of nano-based formulations. In the literature, it has been reported that the respiratory system is a key target for various infectious diseases and various challenges are arising in the treatment of pulmonary infections. RESULT: The present review article describes the global situation of pulmonary infections and different strategies which are being available for their management, along with their limitations. The article also highlights the advantages and different examples of nanoformulations currently combating the limitations of conventional therapies. CONCLUSION: The content of the present article further reflects a summary of recently published research and review works on pulmonary infections, conventional methods of treatment with their limitations, and the role of nano-based approaches to combat the existing infectious diseases which will jointly help the researchers to produce effective drug formulations with desired pharmacological activities.
ABSTRACT
Introduction: During armed conflicts dialysis patients may experience limitations or interruptions of therapy leading to severe life-threatening complications due to medical and logistical challenges. Before the Russian-Ukrainian war, there were approximately 10,000 adults requiring dialysis in Ukraine. Some patients decided to flee their place of residence and look for opportunities to continue dialysis in another location in Ukraine or abroad. To better understand the needs of conflict-affected kidney failure patients and to provide data which could support equitable and evidence-based prioritization of resources, the Renal Disaster Relief Task Force of the European Renal Association conducted a survey on distribution, preparedness and management of adults requiring dialysis displaced due to the war in Ukraine. Method(s): Cross-sectional online survey was conducted to assess the status of dialysis patients who were displaced across European countries since the beginning of the conflict in February 2022. The survey was sent to all national nephrology societies across Europe with a request to disseminate it to all dialysis centers in their countries. Data were collected between May and August 2022. Fresenius Medical Care (FMC) shared a limited set of aggregated data without direct center participation. Result(s): We received data on 602 patients (290 collected through the survey and 312 from FMC), who were dialyzed in 24 countries. Most patients were dialyzed in Poland (45.0%), followed by Slovakia (18.1%), Czech Republic (7.8%), Romania (6.3%), Germany (4.7%) and Hungary (3.5%). Most patients were originally dialyzed in Kyiv (north-central), Kharkiv (northeast), Odesa (southwest) and Zaporizhzhia (southeast). Before reaching the current reporting center, 34.6% of patients were treated in at least one other center since leaving their regular unit. Mean age was 48.1+/-13.4 years, 43.5% were females. Before patients left Ukraine, 95.7% had been on hemodialysis (HD), 2.5% on continuous ambulatory peritoneal dialysis (PD) and 1.8% on automated PD. HD session frequency was reduced under war conditions in 23.5% of patients. Eighty-eight percent of HD patients had a patent arteriovenous fistula, 7.3% were HBs antigen positive, 16.1% had anti-HCV antibodies, 0.6% anti-HIV antibodies and 27.3% anti-HBc antibodies. In terms of patient preparedness for displacement, 63.9% carried medical records with them, 63.3% had a list of medications, 60.4% had medications themselves and 44.0% had a dialysis prescription. Overall, 26.1% of patients were admitted to the dialysis unit in the possession of all these factors while 16.1% presented with none. After leaving Ukraine, 33.9% of patients were hospitalized. Of the 88.5% of patients tested in the reporting center for COVID-19 1.9% was positive. Communication and language problems were reported by 43.8% of responding physicians. Conclusion(s): Up to the end of August 2022, less than 10% of Ukrainian dialysis patients decided to flee their country since the start of the Russian-Ukrainian conflict and the majority of them chose as their place for dialysis a country neighboring Ukraine. Preparedness for displacement varied and was incomplete in most patients. Results from our survey may inform evidence-based policies and interventions to prepare for and respond to special needs of vulnerable kidney failure populations during armed conflicts and other emergencies. No conflict of interestCopyright © 2023