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Gilead's complaint alleges five contract breaches by the US Centers for Disease Control and Prevention (CDC) and seeks a declaration of contract breach and damages.
While medical professionals fight COVID-19 on the front line, small biotech businesses face a new uphill battle – maintaining research continuity for non-COVID-19 life-changing therapeutics.
The US FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer in adult patients.
The UK MHRA granted expedited acceptance for the Phase II trial of MRx-4DP0004, a live biotherapy product and targeted immunomodulatory therapy.
Dr Abhishek Dadhich rounds up how the Indian pharmaceutical market has been impacted by the coronavirus pandemic and the steps the country’s government could take to overcome these setbacks.
Larotrectinib has been given a positive opinion by NICE, following the submission of a revised price after it was previously rejected.
Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.
Novo Nordisk has set up a programme to allow patients in the US experiencing financial hardship because of COVID-19 to receive free insulin for 90 days.
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.
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.
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.
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.
A blood purification system to reduce cytokine storms in COVID-19 patients has been given emergency use authorisation by the FDA.
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.
The European Commission has granted Esperion approval for Nilemdo, the company has sold commercialisation rights to Daiichi Sankyo.
