The discovery of synthetic lethality between BRCA mutations and PARP inhibitors ranks has led to major advances in the treatment of BRCA-mutated cancers. Mutations in BRCA1 and BRCA2 can leave cells with a deficiency in homologous repair (HR). And that deficiency can make them vulnerable to PARP inhibitors, which block alternate DNA repair pathways, as well as platinum-based treatment, which induces DNA mutations that BRCA-deficient cells are unable to cope with.
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.
LONDON – Cumulus Neuroscience Ltd. has raised £6 million (US$8.3 million) to advance development of its home use wearable headset for tracking response to treatment in clinical trials in psychiatric disorders and neurodegenerative diseases, including Alzheimer’s.
The European Commission posted a draft legislative framework for regulation of artificial intelligence (AI), a document that spans all potential uses of such algorithms rather than just medical ones. The text seems to suggest that all medical uses of AI will be deemed high-risk uses, but this draft is just the opening salvo in a process that will span a year, perhaps longer, before the legislation will be drafted and finalized.
PARIS – Archos SA reported setting up a center of excellence in med-tech. They are working in close partnership with various SATTs – technology transfer acceleration offices, who finance innovative research lab projects in France. Their new division, Medical Devices Venture, is designed to help develop startups targeting the health care disciplines of the future that combine technology, machine learning and a platform for collaboration.
HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd. “Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.
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.