LONDON – Initial results from the U.K. randomized trial assessing mixed COVID-19 vaccine schedules show there is a significant increase in systemic side effects with one dose of Astrazeneca plc’s and one of Pfizer Inc./Biontech SE’s vaccines (in either order), compared to receiving two doses of the same vaccine.
Building on existing guidance and nearly eight years’ experience with biosimilar monoclonal antibodies and fusion proteins, the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) issued a final guidance detailing a streamlined approach to licensing biosimilars.
LONDON – The SARS-CoV-2 variant first detected in India last year has joined those from the U.K., South Africa and Brazil as a “variant of global concern,” the World Health Organization said on May 10.
LONDON – Abingworth announced the final closing of its latest fund at $582 million, bringing the amount committed to the London-based venture capital firm in 2021 to more than $1 billion. The clinical co-development fund 2 will finance and manage late-stage development of phase III programs sourced from pharma and biotech companies, receiving a pre-negotiated fee when a drug is approved. The model obviously has appeal, with the new fund being significantly oversubscribed and exceeding its target of $350 million.
The European Commission posted a draft legislative framework for regulation of artificial intelligence, a document that spans all potential uses of such algorithms rather than just medical ones.
LONDON – A single dose of Pfizer Inc./Biontech SE’s COVID-19 vaccine does not promote a strong enough immune response to provide protection against variants of SARS-CoV-2, including the Kent variant B.1.1.7, which as of April 29 had caused 226,635 confirmed infections in the U.K.
In a first for the biotech industry, the European Commission (EC) has imposed a €7.5 million (US$9.05 million) fine on Sigma-Aldrich, under the EU’s 2004 Merger Regulation, for providing incorrect or misleading information during a merger investigation.
LONDON – The latest tranche of data from an array of large-scale COVID-19 studies running in the U.K. provides real-world evidence that vaccines have a dramatic effect in preventing hospitalization and death, but that there are a very small number of vaccine failures. The data cover 3,842 people who received a vaccine and subsequently were admitted to the hospital between Dec. 8, 2020, when the national vaccination rollout began, and the data cutoff of April 10, 2021.
Astrazeneca plc’s saga of its COVID-19 vaccine continued this week with the European Commission (EC) deciding to begin legal action against the Cambridge, U.K.-based company, claiming it has failed to deliver doses in line with its contract.
DUBLIN – The European Medicines Agency (EMA) has reiterated its support for Astrazeneca plc’s Vaxzervia COVID-19 vaccine, following an interim analysis of a data review, which the agency’s Committee on Human Medicinal Products (CHMP) has conducted over the past two weeks.
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