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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.
Cambridge, U.K.-based Astrazeneca plc has new data from its long-acting COVID-19 antibody combination, AZD-7442, which aims to provide longer protection, potentially for up to a year. Latest data show the intramuscularly injected drug achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalized patients with mild to moderate symptomatic disease.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) joined the JAK inhibitor pile-on Oct. 6 with new measures to reduce the risk of major heart problems and malignancies in people taking Pfizer Inc.’s Xeljanz (tofacitinib).
Exscientia plc has raised $510.4 million in an upsized Nasdaq IPO and private funding round as it pushes forward with its artificial intelligence-based drug discovery mission. The Oxford, U.K.-based company aims to out-license some of its candidates to other companies, while saving others for its own pipeline.
DUBLIN – Iomx Therapeutics AG raised €65 million (US$75.4 million) in a series B round, which will enable it to move its lead immuno-oncology program into the clinic. The funding will also allow it to take a second program into IND-enabling studies and to back-fill its pipeline with additional programs.
LONDON – The EMA set out the reasons for why it is diverging from the FDA on booster doses of Pfizer Inc.’s/Biontech SE’s COVID-19 vaccine, despite having reviewed the same data.
LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
DUBLIN – After a COVID-19-fueled funding bonanza, European biotechnology appears to have reverted to the mean in the second half of this year. Firms engaged in drug development raised a total of $1.886 billion in disclosed transactions during the third quarter (Q3) of 2021. That represents a 44% fall on the total raised in Q2, which was itself down 46% on the Q1 total. The sector has raised a total of $11.44 billion so far this year, meaning that last year’s highwater mark of $12.682 billion is still within reach – but only just. The funding momentum appears to have stalled for now.