To help better utilize real-world data in drug development, the EMA published its final guideline Oct. 26 on the use of registry-based studies to support regulatory decision-making.

LONDON – A U.K. study following up 32.5 million people for 28 days after their first dose of a COVID-19 vaccine has shown an increased risk of hemorrhagic stroke after receiving the Pfizer Inc./Biontech SE product, and confirmed case reports of an increased risk of developing Guillain-Barré syndrome after the Astrazeneca plc vaccine.

LONDON – The U.K. Health Security Agency (UKHSA) has designated an offspring of the Delta variant of SARS-CoV-2 as a “variant under investigation” after uncovering some early evidence it may have an increased growth rate.

Iceni Diagnostics Ltd. is accelerating efforts to commercialize a diagnostic for detecting COVID-19 using sugars rather than antibodies. Lateral flow diagnostics (LFDs) have been widely used during the COVID-19 pandemic to diagnose people with an active infection. The tests use antibodies, which attach to the SARS-COV-2 virus but Iceni’s Host-Pathogen Glycan Recognition technology has been touted as a potential alternative due to its polymer approach.

PARIS – Quantum Surgical SAS has closed $48 million in funding to finance the commercial launch of its integrated robotics platform for percutaneous treatment in liver cancer. The round was led by Hong Kong-based Ally Bridge Group who invested $24 million, or half the total amount raised. Three banks also participated in this funding round: The European Investment Bank, Bpifrance and Caisse d’Epargne Languedoc Roussillon.

PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.

DUBLIN – Sofinnova Partners closed out its flagship Capital X fund at €472 million (US$550 million), providing further evidence that private equity investing in European biotechnology and medical technology remains in rude health. It represents, managing partner Graziano Seghezzi told BioWorld, one of the most successful fundraising campaigns in its 30-year history. “We went out and raised this fund in six months.”

LONDON – Valneva SA’s COVID-19 vaccine, VLA-2001, prompted a stronger immune response with fewer side effects than Astrazeneca plc’s product, according to headline data from the phase III trial. Shares in Valneva (NASDAQ:VALN) shot up by nearly 40% to close Oct. 18 at $39.21 when the data were announced, partly repairing the damage on Sept. 13 when the U.K. government cancelled a $1.65 billion contract with the French vaccines specialist for 100 million doses.

PARIS – Teams from the Pitié-Salpêtrière hospital, the Institute for Research in Development, Sorbonne University and the National Institute of Health and Medical Research are proposing a new technique that uses artificial intelligence (AI) to identify the risk of developing a type of cardiac arrhythmia called Torsades de pointes (TdP) associated with taking certain drugs.