htb supplement: 2018 Vol 19:(1)
New drugs in development
July 2018
www.i-Base.info
Drugs, Diagnostics, Vaccines, Preventive Technologies, Research toward a cure, and immune-based and gene therapies in development
Many in-house and commercial assays that detect the COVID-19 virus have been developed or are currently under development. Many of these molecular assays are currently being validated in partner laboratories. An overview of assays that have applied to FIND for participation in their assay assessment... work can be found here
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This tracker, developed by the Vaccine Centre at the London School of Hygiene & Tropical Medicine, will follow COVID-19 vaccine candidates as they progress through the development pipeline. We will update it weekly. An overview of the different vaccine types as well as the phases of clinical develo...pment is provided in the Summary tab.
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
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29 April 2022
What are the new vaccines in the pipeline? What are the challenges to turning vaccines into vaccination ? What timelines can we expect for future vaccines? WHO’s Dr Katherine O’Brien explains in Science in 5.
This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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How do vaccines work to protect us? What are the vaccine technologies in the pipeline and how do we ensure safe vaccines? Dr Katherine O’ Brien explains in Science in 5 !
Antimicrobial resistance (AMR) as a serious public health threat was globally acknowledged by WHO in 2015, through the launch of the Global Action Plan (GAP). With a limited number of new antibiotics in the developmental pipeline, many countries are in the process of establishing strategies for anti...microbial stewardship (AMS). Within each country, different healthcare challenges have
contributed to AMR. This has also shaped individual AMS strategies and policies. In South Africa (SA), there is a high burden of infectious diseases, mainly of bacterial origin. In addition, SA also has the highest number of people living with
human immunodeficiency virus (HIV) globally. According to the 2019 statistics, there are approximately 7.97 million people living with HIV in SA. Together with this, SA has the fourth largest tuberculosis population globally.
Other important challenges include poverty, malnutrition, a high burden of non-communicable diseases, and a dire shortage of trained healthcare professionals (e.g. clinicians, pharmacists, and nurses).
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The COVID-19 vaccine tracker and landscape compiles detailed information of each COVID-19 vaccine candidate in development by closely monitoring their progress through the pipeline.
The COVID-19 vaccine tracker:
Provides summary tables of COVID-19 vaccine candidates in both clinical and pre-...clinical development;
Provides analysis and visualization for several COVID-19 vaccine candidate categories;
Tracks the progress of each vaccine from pre-clinical, Phase 1, Phase 2 through to Phase 3 efficacy studies and including Phase 4 registered as interventional studies;
Provides links to published reports on safety, immunogenicity and efficacy data of the vaccine candidates;
Includes information on key attributes of each vaccine candidate and
Allows users to search for COVID-19 vaccines through various criteria such as vaccine platform, schedule of vaccination, route of administration, developer, trial phase and clinical endpoints.
The database is updated regularly - twice a week (Tuesday and Friday, 17:00 CET).
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Accessed on 22.04.2023
To target helminth elimination, a new consortium of research institutes, universities, not-for-profit organizations, and pharmaceutical companies have joined forces and expertise to establish a research and development pipeline for the development of anthelminthics targeti...ng nematodes. The focus is on STH as well as onchocerciasis.
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Overuse and misuse of antibiotics in animals and humans is contributing to the rising threat of antibiotic resistance. Some types of bacteria that cause serious infections in humans have already developed resistance to most or all of the available treatments, and there are very... few promising options in the research pipeline
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The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was form...ed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi...nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera...ble challenges to securing long-term polio vaccine security.
This framework is designed to enhance the efforts of existing structures and workstreams within the Global Polio Eradication Initiative (GPEI) and other stakeholders by improving communication and coordination on vaccine security. Ensuring vaccine security is crucial for maintaining a timely, sustained, and uninterrupted supply of affordable, quality-assured polio vaccines in the global fight to achieve and sustain a polio-free world. However, challenges such as fragmented approaches, short-term planning, a dynamic policy environment, and a diverse product pipeline present significant risks to long-term vaccine security. This framework emphasizes the need for alignment and coordination across key polio operational domains, including Poliovirus Containment, Research and Development, and Vaccine Manufacturing and Supply. It also underscores the critical role of normative frameworks and policies in shaping long-term vaccine strategies that guide these operational areas. Additionally, it highlights the importance of cross-cutting elements such as financing and access to resources, along with the integration of communication, coordination, and advocacy efforts, as essential enablers for achieving vaccine security. To secure long-term vaccine supply, it is imperative to enhance alignment and strengthen coordinated efforts across workstreams and with stakeholders, including vaccine manufacturers.
Recognizing that vaccine security is an ongoing endeavor, requiring continuous monitoring and adaptation, this framework will undergo regular updates and revisions. Initially, the management of the framework will be carried out by the GPEI Vaccine Supply Group (VSG).
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August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and efficac...y of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
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Chagas disease is a neglected tropical disease caused by the protozoan parasite Trypanosoma cruzi. It is a significant public health problem, affecting millions of people worldwide. And although it was described 110 years ago, only two old nitroheterocyclic drugs, benznidazole and nifurtimox, are cu...rrently available for the treatment of Chagas disease and both have several limitations. Besides the clear unmet medical need, many challenges preclude the development of new treatments, some of them related to a lack of understanding of the pathophysiology of the disease and parasite-host interactions. New knowledge and tools are becoming available, but the number of new chemical entities progressing through the preclinical pipeline is inadequate. Therefore, it is still uncertain whether safe, effective and accessible new drugs will be available in the near future. The Chagas disease research community must commit to even greater collaboration to ensure that patients eventually benefit from better treatments.
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