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BioWorld - Thursday, March 30, 2023
Home » Topics » Europe, BioWorld

Europe, BioWorld
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Apellis chalks up positive opinion in Europe for rare blood disorder drug

Oct. 15, 2021
By Nuala Moran
No Comments
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.
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Hands holding gears

BIA Autumn Forum: Keep collaboration, innovation momentum post-pandemic, new UK science minister urges

Oct. 14, 2021
By Nuala Moran
No Comments
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.
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Curevac vial

Curevac quits early COVID-19 vaccine program to work on next-gen candidate, scrubbing EC purchase agreement

Oct. 12, 2021
By Michael Fitzhugh
No Comments
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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B cells release antibodies to bind to the COVID-19 virus

AZ preps filings for long-lasting COVID-19 antibody cocktail, as EMA reviews Regeneron rival

Oct. 11, 2021
By Richard Staines
No Comments
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.
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MHRA cautions on Xeljanz use

Oct. 6, 2021
By Mari Serebrov
No Comments
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).
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IPO stock market ticker

UK drug discoverer Exscientia hits the big time with oversized Nasdaq IPO

Oct. 6, 2021
By Richard Staines
No Comments
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.
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3D Euro symbol

Strüngmann family, MIG Capital lead $75M series B round at Iomx Therapeutics

Oct. 5, 2021
By Cormac Sheridan
No Comments
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.
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EMA opts for broad view in decision on COVID-19 vaccine boosters

Oct. 5, 2021
By Nuala Moran
No Comments
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.
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EMA icons

EMA reverses course on COVID-19 boosters

Oct. 4, 2021
By Nuala Moran
No Comments
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.
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European investing illustration

Funding momentum stalls as European firms raise $1.9B in Q3

Oct. 1, 2021
By Cormac Sheridan
No Comments
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.
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