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FDA approves first generic albuterol sulfate metered dose inhaler
The generic Proventil HFA (albuterol sulfate) metered dose inhaler has been approved for the prevention of bronchospasm in patients four years of age and older.
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Open letter calls for UK government to stop pharma profiting from COVID-19
An open letter from aid organisations and academics has called on the UK government to stipulate conditions for pharmaceutical companies using public funding for COVID-19 vaccines.
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Production of Avigan® Tablet (favipiravir) accelerated for use against COVID-19
FUJIFILM intends to accelerate production of Avigan to 100,000 treatment courses per month by July and up to 300,000 by September 2020 to meet demand for possible use treating COVID-19.
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Cutting the financial and time costs of regulatory affairs with automation
An exploration of how automation tools and AI could revolutionise the regulatory affairs sector with Ronan Brown, Senior Vice President and Head of Integrated Global Compliance at IQVIA.
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FDA grants emergency use authorisation to blood purification system for COVID-19
A blood purification system to reduce cytokine storms in COVID-19 patients has been given emergency use authorisation by the FDA.
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EMA task force established to co-ordinate rapid regulatory action for COVID-19 medicines
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
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EC approves Nilemdo™ (bempedoic acid) for lowering cholesterol
The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
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FDA warns company selling fraudulent COVID-19 products containing chlorine dioxide
The US Food and Drug Administration (FDA) issued the letter after finding the products contain chlorine dioxide, a powerful bleaching agent with potentially fatal side effects.
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EU authorities agree new measures to support the pharma supply chain during COVID-19 pandemic
The European Medicines Agency (EMA) and other authorities have created a new shortage reporting system and are looking into how regulations can be applied more flexibly during the COVID-19 pandemic.
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75 percent of nanopharmaceuticals are being developed for oncology
A report states that three quarters of the roughly 230 nanopharmaceuticals in clinical development are for use as targeted cancer therapeutics.
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UK and Europe tackle false COVID-19 medicinal products
The MHRA and Council of Europe have both announced measures to prevent the spread of falsified or unlicensed COVID-19 medical products.
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Limiting shortages: steps for the UK to strengthen drug supply
Dr Sam Roscoe explains his recommendations for pharmaceutical companies and supermarkets in the UK to limit reliance on deliveries from overseas, to ease the impact of the COVID-19 coronavirus on drug supply chains.
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Pharma sales to increasingly rely on virtual platforms due to COVID-19, says report
Virtual tools are being increasingly utilised by pharma companies to replace in-person meetings following the outbreak of the COVID-19 pandemic.
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COVID-19 update: running clinical trials during the coronavirus pandemic
In the face of the coronavirus pandemic, restrictions and extreme situations may require changes to ongoing or upcoming clinical trials. These are the key recommendations from the EC, MHRA and FDA.
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Limited supply of antimalarial drugs may prevent use against COVID-19, say doctors
An open letter from doctors highlights that although chloroquine and hydroxychloroquine are strong candidates to fight COVID-19, there is a limited supply.
