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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.
LONDON – It is both safe and effective for people to receive an influenza vaccine at the same time as a COVID-19 vaccine, with no negative impacts on the strength of the immune response produced by either vaccine and reported side effects mainly mild to moderate. Only nine of 679 participants in a U.K. study testing combinations of different flu and COVID-19 vaccines said they would not want to have two different vaccines at the same time in the future. Six of those were in the control arm of the trial, in which saline was injected as a placebo.
LONDON – Industry-sponsored clinical research in the U.K. took a big hit in the pandemic and is still struggling to catch up – and to capitalize on innovative trial designs and delivery approaches that were so successful in speeding up COVID-19 studies.
A second activist investor has questioned the leadership of Glaxosmithkline plc’s CEO Emma Walmsley, after Bluebell Capital Partners Ltd. took a reported £10 million (US$13.7 million) stake in the embattled U.K. pharma.
LONDON – There were well-deserved celebrations in Paris on Sept. 20, as Jeito Capital toasted the oversubscribed close of its first fund at €534 million (US$625.5 million). This is claimed as the largest European venture fund dedicated to life sciences, exceeding the original target of €500 million, and with €340 million of the total raised under the constraints of the pandemic from January 2020 onward.
LONDON – Researchers in the U.K. have applied the heft of national population-level databases to devise a new algorithm that predicts those people who are most at risk of hospitalization and death from COVID-19, despite having received two doses of vaccine.
European regulators have rejected Pfizer Inc.’s tanezumab, casting further doubts on whether the FDA will okay the troubled drug that is intended as a non-opioid alternative for osteoarthritis pain.
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