news
EC approve Zeposia® to treat ulcerative colitis
The European Commission (EC) has granted Zeposia® (ozanimod) a marketing authorisation to treat people with ulcerative colitis.
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Drug Safety
news
AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
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NICE recommends risdiplam for spinal muscular atrophy
The new draft guidance recommends Evrysdi (risdiplam) to treat spinal muscular atrophy as part of a managed access agreement (MAA).
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EMA issues advice on use of Lagevrio for the treatment of COVID-19
The Europe Medicines Agency (EMA)'s human medicine committee advise (CHMP) that Lagevrio can be used for COVID-19 patients who do not require oxygen and are at increased risk.
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FDA approves first drug to treat common form of dwarfism in children
The US Food and Drug Administration (FDA) approves vosoritide injection to improve growth in children at least five years of age with achondroplasia and open epiphyses.
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Oral milvexian reduces risk of postoperative venous thromboembolism
Milvexian showed a 12 percent rate of postoperative venous thromboembolism compared to the benchmark rate of 30 percent in a Phase II study.
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NICE approves first long-acting injectable HIV-1 treatment
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
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Crohn’s patients achieve 65 percent clinical remission with Tremfya®
At week 48 of the Phase II trial, 65 percent of patients with Crohn's disease receiving Tremfya® achieved clinical remission.
whitepaper
Future of QA/QC for Complex Biologics Whitepaper
Download this whitepaper to discover the latest developments and research in QA/QC for biologic therapies via exclusive articles, interviews and application notes.
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European Commission grants marketing authorisation for Vumerity®
The European Commission (EC) has granted marketing authorisation for Vumerity® to treat adults with relapsing-remitting multiple sclerosis.
article
Social media is transforming our understanding of drug safety
Here, Daniel Ghinn of CREATION.co discusses the growing role social media analysis is playing in helping to provide pharmaceutical companies and health regulators with real-world evidence on drug safety.
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NICE does not recommend elosulfase alfa for Morquio A syndrome
The new draft guidance does not recommend Vimizin (elosulfase alfa) for the treatment of Morquio A syndrome following new evidence.
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FDA approves Besremi to treat rare blood disease
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera.
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Drug combination an alternative leukaemia treatment to chemotherapy
A clinical trial found that all-trans retinoic acid and arsenic trioxide is an effective treatment for acute promyelocytic leukaemia.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
