Spikevax is a vaccine for preventing COVID, currently authorised for use in people aged 12 years and older. It contains. Health 8 days ago List of substances. If you do not find the substance you need, please register it. Health 5 days ago EMA and National level. National medicine shortages tracking. Find first generic registrations for originator drugs across all markets. First approval date and marketing authorizations for all molecules from USA and Europe. Monthly updates. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics ….
If a particular excipient was approved in a certain dosage form at a certain level, a sponsor could consider it safe for use for a similar type of product. Health Just Now The Orphanet database also includes drugs without an orphan designation as long as they have been granted a marketing authorisation with a specific indication for a rare disease.
Some drugs are included in the database because they are tested in a clinical trial performed on a rare disease, but they do not have a regulatory status. Health 1 days ago the www. Health 5 days ago The EU Veterinary Medicinal Product Database is intended to be a source of information on all medicinal products for veterinary use that have been authorised in the European Union and the European Economic Area.
The database is hosted by the European Medicines Agency. The Molsoft ICM 3. Health 1 days ago In a study, Leyens and colleagues concluded that between the years and , 25 medicinal products had received accelerated approval from the FDA and 17 had received EMA conditional approval In both jurisdictions, most such approvals were in the oncology area, and most of the products were designated as orphan drugs.
Clinical data publication for all other centrally authorised products remains suspended until further notice. The database displays links to PILs in Felleskatalogen, which is a private-own webiste. Each MA Holder must send Felleskatalogen an updated. It consists of all ADRs listed in section 4. Category: Cancer Detail Drugs. Health 2 days ago Description: Database of Information Sharing tracking with the European Medicines Agency EMA - Track interactions meetings, conference calls, exchange of confidential material between FDA and EMA to better analyze the type of information exchanged and the frequency by several parameters e.
For Immediate Release: September 17, Health 2 days ago a-methapred. The benefits of the domain-specific training on different biomedical applications have been discussed elsewhere Beltagy et al.
The domain-specific word embedding-based BiLSTM yielded better prediction performance than those built from general domain corpora. Furthermore, the explainability of domain-specific word embedding was superior as demonstrated by t-SNE analysis.
We did not observe any significant improvement of domain-specific transformers i. Furthermore, further training of domain-specific transformers e. Advances in AI in NLP and increased computational power have allowed various transformer-based language models to be developed and successfully used in different downstream tasks Devlin et al. However, the balance between performance, computational cost, and data size must be considered. Further evaluation of other languages will be a great addition to expand the utility of the developed DICE corpus.
First, the proposed data curation process of the DICE corpus is reproducible and could be migrated to the documents in other languages. Accordingly, the associated AI-based language models could be developed for drug indication information extraction in other languages.
Second, tremendous efforts have been made to language translation powered by AI in the biomedical domain Liu et al.
For example, Liu et al. By combining the developed biomedical entity linking model, the proposed indication extraction models could be utilized in other languages. However, further investigation and evaluation are strongly recommended. It is worthwhile to consider some additional studies to further investigate the utility of DICE in different medical applications.
First, the model performance of different models was only evaluated based on one test set. Considering the lack of annotated data i. Some extra verifications are strongly recommended for expanding the utility of the developed DICE and accompanying models.
Second, the developed DICE and classification models could serve as the first step to extract indication information. The other biomedical entity recognition approaches e. Third, in the current study, the AI-based indication extraction models are binary-based. Considering the unbalanced distribution of the five defined categories 4, indication, 1, clinical observations, contraindication, usage instructions, and 68 side effects , we suggest further investigations on the performance of the multi-class models.
Lastly, while the developed DICE is a five-tier indication classification scheme, we only investigated its utility for automatic indication information extraction through its usage as a binary classifier. Evaluation for potential utility for testing multiple-class model performance is suggested. Automatic drug indication extraction is of great importance for different biomedical applications. We hope our developed DICE will be considered as a standard drug indication classification corpus, providing the opportunity for other biomedical NLP researchers to promote AI-powered indication extraction in different real-world applications.
ZL conceived and designed the study. AB and ZL performed data analysis. ZL wrote the manuscript. All authors read and approved the final manuscript. The views presented in this article do not necessarily reflect those of the U. Food and Drug Administration. Any mention of commercial products is for clarification and is not intended as an endorsement.
RR is co-founder and co-director of ApconiX, an integrated toxicology and ion channel company that provides expert advice on non-clinical aspects of drug discovery and drug development to academia, industry, and not-for-profit organizations. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
Aronson, A. AMIA Symp. PubMed Abstract Google Scholar. Beltagy, I. Brown, T. Chen, Z. BMC Med. Mak 18, Delavan, B. Drug Discov. Today 23, — Devlin, J. Fang, H. Fung, K. Gers, F. Hinton, G. Stochastic Neighbor Embedding. Citeseer: NIPS , — Hochreiter, S. Google Scholar. Long Short-Term Memory. Neural Comput. Huang, K. Jang, B. Khare, R. Scaling Drug Indication Curation through Crowdsourcing. Database Oxford , AMIA Symposium.
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