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he COVID-19 pandemic caused by SARS-CoV-2 has shown a rapid increase in the number of infected patients with a remarkable mortality rate, making it a global public health concern. Because there is currently no specific anti-viral drug for the treatment of COVID-19, repurposing of already approved drugs for other diseases may be explored. Drug repurposing has become a promising approach due to the opportunity to reduce development timelines and overall costs. In this chapter, we will discuss various computational drug repositioning strategies, the current COVID-19 treatment scenario, and challenges to the correct interpretation of existing preclinical/clinical evidence, as well as the generation of new evidence related to drug repurposing. © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.
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Paediatric population is the high-risk segment for the infection of COVID-19 due to weak immune status and low compliance to COVID-19 prevention protocols. The first dose of vaccination for the paediatric population is started in the fifth phase of vaccination, after the vaccination was administered to health workers, elderly individuals, and young adults. Present article aims to analyse the status, trends, and challenges in the implementation of the paediatric vaccination for COVID-19 and provide recommendations that could be taken under consideration by healthcare authorities while designing the second and third vaccination protocols for the paediatric population. Relevant articles published by various journals related to paediatric COVID-19 vaccination were searched from the different databases and analysed for the current status of vaccination, trends, challenges, compliance level, implementation hurdles, and other relevant information. Limited research is available in the paediatric domain for the COVID-19 vaccination. Few vaccines are approved for the paediatric population in India, including the Covaxin, ZyCoV-D, Corbevax and Covovax. It is recommended that the vaccination trials should be accelerated by the government agencies to make COVID vaccines available from other indigenous manufacturers. It is also recommended that the COVID-19 prevention protocol should be made in such a manner that children find that interesting and like to follow them.Copyright © The Author(s) 2023.
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The coronavirus disease (COVID-19) was first detected in Wuhan, China, in the month of December 2019. Further, in March 2020, the COVID-19 epidemic was described by the World Health Organisation (WHO) as a global pandemic. COVID-19 quickly spread around the world in the following months, affecting about 2.5 million individuals by April 2020. World markets, including the pharmaceutical industry, were devastated by this pandemic. Although no specific solution for this emerging infectious disease is currently available, the pharmaceutical industry is helping policymakers meet unmet COVID-19 desires, ranging from research and advancement initiatives on possible prevention methods to the management of the supply chain of drugs in times of crisis. Changes in demand, commodity shortages, contact adjustments, etc., are hindering developments in the mechanism of technology, research and development and are putting an impact on the health market of COVID-19. Other implications of COVID-19 on the physical condition and pharmaceutical market may include acceptance delays, heading to self-sufficiency in the delivery chain, etc. In addition, the pharmaceutical markets are battling to sustain natural consumer flows, as the latest pandemic has had an effect on access to essential drugs at reasonable rates, which is the key priori-ty of all pharmaceutical systems.Copyright © 2022 Bentham Science Publishers.
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COVID-19 is a disease caused by SARS-CoV-2 that can trigger respiratory tract infection. Due to its tendency to affect the upper respiratory tract (sinuses, nose and throat) or lower respiratory tract (windpipe and lungs), this disease is life-threatening and affects a large number of populations. This virus's unique and complex nature enhances the scope to look into the direction of herbal plants and their constituents for its prevention and treatment. The herbal remedies can have preventive as well as therapeutic actions. This review focuses on various aspects of using herbal medicines for COVID-19, as herbal constituents may also have adverse effects. Various studies revealed that some medicinal plants show life-threatening adverse effects, so selecting plants, and their related studies should be appropriate and strategic. This article includes various factors that should be considered before herbal drug use in COVID-19 patients. These are clinical trials, safety, molecular mechanism, and self-medication, which have been elaborated. This article also discusses the targets of covid-19 and different coronavirus strains. As before, treatment diagnosis of the disease is very important. Various patents have been filed and granted for its proper diagnosis so that its treatment can be easy.Copyright © 2022 Society of Pharmaceutical Sciences and Research. All rights reserved.
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Background: The pattern of new drug approval is changing across the world as shown by the study using Center for Drug Evaluation and Research and European Medicines Agency data in US and UK with more drug approval for anti-cancer and immunomodulator drugs. There is a need to generate similar database for developed South East Asian countries too. Aims and Objectives: This study was conducted for one such country-Singapore for the new drug approval pattern of last 5 years (2017-2021). Material(s) and Method(s): This was a pharmacoepidemiological study, in which government drug regulatory website data available in public domain was searched. The new drug approval data were classified according to active ingredient, drug approval date, new drug application category, indication of drugs, and World Health Organization Anatomic Thoracic Classification. Result(s): In this study, 418 new drug approvals were found in last 5 years in Singapore. From this maximum, drug approvals were given to anti-neoplastic and immunomodulator category drugs. In anti-neoplastic category new drugs approval few examples were Trastuzumab deruxtecan and Tucatinib for breast cancer therapy and Tepotinib and Capmatinib for non-small cell lung cancer therapy. Conclusion(s): This study shows that drug development in anti-cancer drug and immunomodulator is significant in Singapore. This trend is quite matching with other country such as US and UK.Copyright © 2023 Priti Solanky, et al.
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RNA therapeutics have taken a center stage during the pandemic, due to the successful development and launch of two mRNA COVID-19 vaccines (by Moderna and Pfizer/BioNTech). Although there are already multiple commercially successful RNA drugs for the treatment of orphan indications, this is the first time that RNA therapies unlock their commercial value in mass population. With the backdrop of massive capital and interest flooding into the field of RNA therapeutics, many companies began to expand their orphan-indication-centered RNA therapeutic portfolio into common diseases. In this article, we calculated the success rate of publicly available RNA therapeutic pipelines at each development stage as well as their likelihood of approval (LOA). We found those targeting common diseases have a much lower LOA rate when compared with pipelines targeting rare diseases (5.8% vs. 23.8%). Consequently, we discussed the underlying challenges and potential opportunities for RNA therapeutics moving from rare to common diseases.Copyright © 2022 Authors. All rights reserved.
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New HIV drug for experienced patients... New MS drug reduces relapse and brain lesions... Malaria vaccine shows promise... Antibiotic resistance in Western Pacific and South-East Asia... Leukemia pharmacotyping precision medicine blueprint... MIS-C not associated with serious adverse reactions from mRNA vaccines
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BACKGROUND: In the past decade, the Chinese drug regulatory system has undergone many changes. A major reform starting in 2015 has significantly reshaped the regulatory processes. It was important to assess the impact of the reform on new drug approvals in China. METHOD: We analyzed the temporal trends of regulatory characteristics of the new drugs approved by the Chinese regulatory agency from 2011 to 2021, using data collected in the Pharmcube database. RESULTS: A total of 353 new drugs were approved, including 220 small molecule drugs, 86 biological products and 47 vaccines. The annual number of new drug approvals increased dramatically since 2017, reaching a record high of 70 in 2021. The median NDA approval time was 15.4 months in 2017-2021, the shortest in the decade, and was significantly shorter than that in the pre-reform period. The newly instituted expedited pathways such as priority review (PR) and accelerated approval for urgently needed overseas drugs (UNOD) significantly reduced new drug application (NDA) approval times compared with standard review. For imported drugs, in 2017-2021, the median time difference between the first approval in the world and the approval in China was 5 years, representing significant "drug lag". However, the proportion of the imported drugs approved in China within 3 years of its first foreign approval has increased to 24.4% in 2017-2021. CONCLUSION: The regulatory reform has produced significant, positive immediate outcomes in several metrics of drug regulatory approval. China's regulatory system will continue to evolve as there still are many areas requiring further reform and improvement.
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Public heath emergencies such as the outbreak of novel infectious diseases represent a major challenge for drug regulatory bodies, practitioners, and scientific communities. In such critical situations drug regulators and public health practitioners base their decisions on evidence generated and synthesised by scientists. The urgency and novelty of the situation create high levels of uncertainty concerning the safety and effectiveness of drugs. One key tool to mitigate such emergencies is pandemic preparedness. There seems to be, however, a lack of scholarly work on methodology for assessments of new or existing drugs during a pandemic. Issues related to risk attitudes, evidence production and evidence synthesis for drug approval require closer attention. This manuscript, therefore, engages in a conceptual analysis of relevant issues of drug assessment during a pandemic. To this end, we rely in our analysis on recent discussions in the philosophy of science and the philosophy of medicine. Important unanswered foundational questions are identified and possible ways to answer them are considered. Similar problems often have similar solutions, hence studying similar situations can provide important clues. We consider drug assessments of orphan drugs and drug assessments during endemics as similar to drug assessment during a pandemic. Furthermore, other scientific fields which cannot carry out controlled experiments may guide the methodology to draw defeasible causal inferences from imperfect data. Future contributions on methodologies for addressing the issues raised here will indeed have great potential to improve pandemic preparedness.
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Emergências , Pandemias , Humanos , Pandemias/prevenção & controle , Aprovação de Drogas , Saúde Pública , Surtos de DoençasRESUMO
Published studies from the year 2021, whose data collection took place at the end of 2020 and before the approval of the first COVID-19 vaccine Comirnaty, received a great deal of media attention because they concluded, among other things, that homeopathy users in particular were sceptical about COVID-19 vaccination. The studies considered are based on a data collection that took place at a point in time that, from today's perspective, does not provide a basis for deriving statements about the COVID-19 vaccination readiness of individuals in Germany. The state of knowledge in the population regarding the novel vaccine, its efficacy and potential side effects or vaccine damage has changed drastically since then. In addition to the unsuitable survey period, the study has significant methodological shortcomings. For example, vaguely defined selection criteria for some questionnaire items cause potential bias in the results. In the questioning of a potential correlation between homeopathy use and vaccination skepticism, a scientifically demanded analysis for possible third-party variables leading to a spurious correlation was not performed. To then present the correlation as a causal relationship is scientifically inadmissible. Current methodologically valid studies also show that there is no correlation between attitudes toward alternative medicine and vaccination skepticism. Copyright © 2022 Georg Thieme Verlag. All rights reserved.
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New drug approved for rare enzyme deficiency genetic disorder... New treatment for generalized pustular psoriasis... Nitric oxide may help patients who are pregnant and have COVID-19 pneumonia... Opioid prescriptions decreased between 2012 and 2019... Two-drug strategy confers benefits and risks for patients undergoing coronary artery bypass graft surgery