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EMA releases its regulatory strategy for next five years
The EMA has published its regulatory strategy until 2025, highlighting that it will use the COVID-19 pandemic to adapt its processes as needed.
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Influenza antiviral Avigan® (favipiravir) to enter Phase III trials in COVID-19 patients
The developers of Avigan have increased production and announced a Phase III clinical trial testing its efficacy against COVID-19.
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How to take care of your mental health during the COVID-19 pandemic
During the COVID-19 pandemic, when many are in lockdown or self-isolating, mental health could suffer. This article suggests some ways to stay healthy over this period.
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J&J says clinical trials for COVID-19 vaccine candidate will begin by September
Following the selection of a COVID-19 vaccine lead, Johnson & Johnson (J&J) aims to begin clinical trials in humans later this year while also scaling up its manufacturing facilities.
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Study suggests Zolgensma will generate $2.5bn of global sales by 2025
According to researchers, Zolgensma, made by Novartis, will lead the global spinal muscular atrophy market and generate billions in sales.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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Mylan and Upjohn transaction closure delayed by COVID-19
Mylan and Upjohn (a Pfizer company) revealed they have delayed the transaction due to meeting restrictions and concerns over staff health and safety during the COVID-19 pandemic.
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95 percent of pharma industry concerned about COVID-19 impact, finds survey
The survey indicates that almost all respondents were concerned about the COVID-19 pandemic’s effects on company performance, including supply and demand failures.
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FDA hands Boehringer and Lilly complete response letter for insulin adjunct
Boehringer Ingelheim and Eli Lilly have received a complete response letter from the US FDA for their sNDA of empagliflozin 2.5mg, an insulin adjunct.
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India to set up $1.3bn pharma manufacturing fund, says report
Due to the COVID-19 outbreak, India has decided to invest $1.3 billion into its internal drug manufacturing capabilities, says a new report.
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COVID-19 update: Eli Lilly assures security of insulin supply
Having become aware of insulin shortages in pharmacies, the company has stated that its products are not backordered and should be available for delivery by wholesalers.
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Regulatory responses to the COVID-19 coronavirus
European Pharmaceutical Review brings you the latest updates from regulatory bodies across the globe in response to the COVID-19 coronavirus.
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CMA launches COVID-19 taskforce to combat drug price hikes
In the UK, the CMA has announced it will establish a taskforce to handle businesses that exploit the COVID-19 outbreak and inflate drug prices.
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MEDICRIME – tackling falsified medicines in Europe
In 2014, medicines were stolen from Italian hospitals and resold across Europe. The authors of a new report highlight the flaws in regulations that handed the perpetrators insufficient sanctions and explain why MEDICRIME provides a better regulatory framework.
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EMA issues statement on ibuprofen reports relating to COVID-19
The EMA has announced that reports of NSAIDs like ibuprofen making the COVID-19 coronavirus worse have no scientific basis.
