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.
LONDON – A new National Security Act coming into force on Jan. 4, 2022, will extend the U.K. government’s power to scrutinize and intervene in foreign acquisitions and bring a swathe of domestic life sciences companies within the ambit of national security legislation for the first time.
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.
LONDON – The EMA recommended approval of Apellis Pharmaceuticals Inc.’s C3 complement inhibitor, Aspaveli (pegcetacoplan), to treat paroxysmal nocturnal hemoglobinuria, but has diverged from the FDA, excluding treatment-naïve patients adding its use should be restricted to those who have failed to respond to C5 inhibitor drugs.
LONDON – After the hard, solitary slog through months of pandemic, U.K. biotech finally convened in person, buoyed by the contribution the sector has made to dealing with COVID-19, and evidently pleased to be face-to-face once more.
Curevac AG, once a forerunner in COVID-19 vaccine development but later surpassed, said it would terminate its first effort in the field, CVnCoV, withdrawing it from a rolling review at the EMA to focus instead on development of second-generation mRNA vaccine candidates with Glaxosmithkline plc.
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