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Two novel biosimilars approved in EU and US
The first omalizumab biosimilar in allergic diseases is approved by the European Commission and the US Food and Drug Administration (FDA) has authorised the fifty third biosimilar in the US.
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Alexion Pharmaceuticals
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Why patient-centricity is essential to accelerate rare disease clinical research
There is an urgent need for novel treatment options for people living with rare diseases, but carrying out clinical research in this field is notoriously difficult. As Clinical Trials Day approaches, Cezary Statuch, Head of Medical Affairs International and Japan at Alexion Pharmaceuticals, highlights how adopting patient-centric approaches can help…
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AstraZeneca appoints new EVP of BioPharmaceuticals R&D
Former Senior Vice President, Head of Research and Product Development of Alexion, will succeed Mene Pangalos as Executive Vice President, BioPharmaceuticals R&D at AstraZeneca.
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Approval expanded for generalised myasthenia gravis medicine
Extended EU approval of Soliris to paediatric generalised myasthenia gravis (gMG) patients is based on Phase III data which demonstrated improvement in disease severity through 26 weeks.
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Bioavailability enhancement services market to exhibit 11 percent CAGR
Between 2022 and 2035, the bioavailability enhancement services market will see an 11 percent compound annual growth rate, a report has predicted.
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Alexion to expand biologics manufacturing with €65m investment
The investment in new drug substance production equipment and warehousing facilities to enhance Alexion’s biologics manufacturing in Ireland.
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AstraZeneca announces new site plans at innovation hub
AstraZeneca has announced plans to invest in a new facility, uniting its R&D activities with commercial and corporate functions in Boston, US.
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Competition and Markets Authority investigating AstraZeneca’s Alexion acquisition
The UK’s competition authority will assess whether AstraZeneca’s acquisition of Alexion will result in a “substantial lessening of competition”.
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UK patients with rare blood disorders receive new treatment option
NICE has recommended that Ultomiris (ravulizumab) be available on the NHS for patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome.
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Vtesse appoints Jason Meyenburg as Chief Commercial Officer
4 January 2017 | By Niamh Louise Marriott, Digital Editor
Meyenburg joins the company from Alexion Pharmaceuticals, where he most recently served as Senior Vice President of Commercial Operations.
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NICE recommends new rare inherited bone disorder drug for children
28 September 2016 | By Niamh Louise Marriott, Digital Content Producer
The drug is the first treatment to target hypophosphatasia, a condition affecting the development of bone, and could allow children to lead a normal life...
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NICE calls for more research into Alexion’s sebelipase alfa
18 February 2016 | By Victoria White
NICE has published draft guidance that recommends further clinical trials are carried out to demonstrate the benefits sebelipase alfa for treating LAL deficiency...
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FDA approves Alexion’s Kanuma for LAL deficiency
9 December 2015 | By Victoria White
Kanuma (sebelipase alfa) has been approved for the treatment of patients with a diagnosis of lysosomal acid lipase deficiency (LAL-D)...
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NICE says ‘no’ to asfotase alfa in draft guidance
3 December 2015 | By Victoria White
NICE has published draft guidance as part of its highly specialised technologies programme that does not recommend Alexion’s asfotase alfa for treating paediatric-onset hypophosphatasia...
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Pivotal Phase 3 data on Kanuma in LAL-D published
10 September 2015 | By Victoria White
In the Phase 3 study, Kanuma met the primary endpoint of alanine aminotransferase (ALT) normalisation compared with placebo as well as six secondary endpoints...
