The COVID-19 pandemic: European regulators respond
The COVID-19 pandemic is spreading around the world with, as of this writing, more than one million cases globally and more than 500,000 cases in Europe alone. Here we summarize how The European...
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Clarivate Enhances Cortellis Clinical Trials Intelligence with New Site...
Clinical trial planning platform enables researchers to pinpoint best sites to support trial protocols and patient recruitment needs LONDON, UK AND PHILADELPHIA,PA, April 20, 2020, Clarivate Analytics...
View ArticleTreating a pandemic: Drug repurposing, expanded access and emergency use...
As the COVID-19 global pandemic rages on, clinicians and politicians alike have responded enthusiastically to the potential for using known, already-approved drugs as treatments for SARS-CoV-2...
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Healthcare Business Insights, Part of Clarivate, Announces 2019 Revenue Cycle...
Winners include Liberty Hospital, Nebraska Medicine, Novant Health and The Valley Hospital London, UK and Philadelphia, US, April 28, 2020 – Healthcare Business Insights (HBI), a part of Clarivate...
View ArticleCOVID-19 testing: FDA guidance update
As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings, and...
View ArticleHow can we improve and accelerate patients’ access to medicines in low and...
As the World Health Organization (WHO) reports that one third of the world’s population does not have timely access to the healthcare products they require, the efficient, predictable and speedy...
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COVID-19: Scientific innovation will help us beat this virus
“Nothing in life is to be feared, it is only to be understood. Now is the time to understand more, so that we may fear less.” Marie Curie The Coronavirus (COVID-19) pandemic has taken the world by...
View ArticleDo EMA and FDA review outcomes for new active substances (NASs) align?
In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities...
View ArticleApplying regulatory flexibility in the age of COVID-19
A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency...
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2019 trends in regulatory approvals of new medicines
A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as...
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Celebrating 30 years of BioWorld
BioWorld has built an enduring relationship with everyone in the drug development and medical technology sectors. As we celebrate our 30th anniversary, we reflect on how the publication has changed...
View ArticleIdentifying risks in drug discovery
It is estimated that for every eight active substances entering Phase I clinical trials, only one product is approved and marketed.[1] The low success rate for clinical trials is largely driven by poor...
View ArticleOrgan-specific Toxicity and Personalized Approaches
In part two of this blog series about best practices in toxicology, we continue the discussion from the previous post, which described the aspects of drug discovery that could impact safety. Because...
View ArticleGaining insight with artificial intelligence
In part three of this blog series about best practices in toxicology, we continue the discussion from previous articles that outlined elements in the discovery stage that could impact safety, and...
View ArticleUnderstanding disruptions to the antibiotic supply resulting from COVID-19
The COVID-19 pandemic has highlighted vulnerabilities within the generic drug supply chain. To minimize the effects of antibiotic API supply disruptions, it is important to understand the underlying...
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Patient enrollment continues to be a limiting factor for trial durations
To prepare for our recent webinar “Trends in Clinical Trial Planning,” we dug into proprietary data from The Centre for Medicines Research (CMR) International, a wholly owned subsidiary of Clarivate...
View ArticleThe future of continuous manufacturing in pharma
Batch processing has been the standard manufacturing method used by the pharma industry for the last 50 years. But recent advances in manufacturing technology have resulted in a faster, more efficient...
View ArticleResilient supply chain requires geographic diversity
Manufacturing location is vital to securing the biopharma supply chain – for the finished product, APIs and the raw materials. How vulnerable are we? “There’s a difference in knowing something and...
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Making data driven decisions with reliable intelligence
Johnson & Johnson (J&J) experienced difficulties keeping up to date on the global drug pipeline and spent considerable time and expense gathering and analyzing data from multiple sources, so it...
View ArticleSecuring the best price for an out-licensed asset
Biotech Ensysce seeks out-licensing or partnering opportunities around the world for its proprietary abuse and overdose resistant prodrug technologies. Learn how the company has made successful deals...
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