Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at the second regulatory workshop on COVID-19 vaccines. The meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on 22 June […]
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EIB to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing
The European Investment Bank (EIB) and BioNTech (Nasdaq: BNTX, BioNTech) have concluded a €100 million debt financing agreement to support the development of BNT162, the company’s COVID-19 vaccine programme. The deal will also allow the company to expand its manufacturing capacity in order to supply the vaccine fast worldwide in response to the pandemic. This […]
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Regulatory flexibility to ensure availability of veterinary medicines during COVID-19
The European Commission, EMA and the Coordination Group for Mutual Recognition and Decentralised Procedure – Veterinary (CMDv) have issued guidance on adaptations to the regulatory framework to companies that develop, manufacture and distribute veterinary medicines in order to address some of the constraints posed by the COVID-19 pandemic. According to the jointly developed question-and-answer (Q&A) document, regulatory rules […]
Read MoreCoronavirus Global Response: €7.4 billion raised for universal access to vaccines
The Commission has registered €7.4 billion, equivalent to $8 billion, in pledges from donors worldwide during the Coronavirus Global Response pledging event. This includes a pledge of €1.4 billion by the Commission. This almost reaches the initial target of €7.5 billion and is a solid starting point for the worldwide pledging marathon, which begins today. The […]
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