All monoclonal antibodies (mAbs) articles
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NewsAmgen wins new European approval for Uplizna in generalised myasthenia gravis
The EC decision clears a new first-in-class approach to manage the rare autoimmune condition.
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NewsGSK’s Nucala green lit for COPD in expanded EU approval
The EC's decision opens up the monthly biologic for use by COPD patients with an eosinophils phenotype.
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NewsTeva’s migraine biologic Ajovy marks phase III progress for paediatric patients
The monoclonal antibody could provide a new preventative treatment option for episodic migraines, new late-stage data suggests.
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NewsNovartis chromatography study shows downstream purification benefits
The impurities research illustrates an approach that could offer a simpler and more flexible downstream purification process.
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NewsAstraZeneca and Daiichi’s Enhertu wins first-in-decade US oncology approval
FDA approval of the drug in combination with Perjeta initiates a $150 million milestone payment to Daiichi Sankyo from AstraZeneca under their joint collaboration.
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NewsEuropean Pharmacopoeia updates monoclonal antibody standards
The Ph. Eur. Commission also adopted seven new monographs and two new general chapters at its recent 183rd session.
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NewsDupixent receives first-in-decade EU approval in chronic spontaneous urticaria
European approval of Sanofi and Regeneron’s monoclonal antibody provides eligible urticaria patients with a new first-line targeted treatment option.
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NewsIpsen strikes €1bn deal to acquire French biotech ImCheck Therapeutics
The move will boost its oncology pipeline, adding a potential first-in-class anti-BTN3A monoclonal antibody for acute myeloid leukaemia.
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NewsFDA waives trial requirement for Stelera biosimilar, easing the copycat’s path
First-of-its-kind case continues EMA and MHRA harmonisation, streamlining the global biosimilar approval pathway.
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News
Boehringer partnership to advance biologic for rare skin condition
The new partnership between Boehringer Ingelheim and LEO Pharma aims to expand treatment access for more patients with generalised pustular psoriasis.
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NewsInvestigational plaque psoriasis treatments show promise in late-stage trials
With the Phase III trials demonstrating sustained skin clearance in plaque psoriasis, this could lead to patients accessing more treatment options to manage the autoimmune inflammatory disease.
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NewsNovartis nets potential first-in-class medicine in new cardiovascular acquisition
The potentially multi-billion-dollar deal strengths Novartis’ late-stage pipeline for cardiovascular therapies, signalling advancement of novel treatments for heart disease.
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NewsAntibody drug has promise as “next frontier” in inflammatory bowel disease
With its best-in-class potential, the biologic could provide a new treatment option for patients with inflammatory bowel disease (IBD), say Teva Pharmaceuticals and Sanofi.
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NewsTrial highlights potential next-gen biologic for lung cancer
Preliminary results from an ongoing trial of a novel monoclonal antibody have confirmed favourable efficacy and safety in recurrent extensive-stage small cell lung cancer (SCLC).
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NewsFirst-in-class therapy approved for chronic skin disease
The biologic treatment targets a key driver of prurigo nodularis, with trial data demonstrating improved itch as well as skin nodules for patients with the condition.
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ArticleAlzheimer’s drug development roundup – July 2024
From exciting data on cell therapy and monoclonal antibodies, through to new regulatory developments, this article summarises some of the key developments within the Alzheimer’s therapeutic landscape over July.
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NewsUtilising naturally occurring endotoxins in recovery studies
The research aimed to address concerns from regulatory agencies about accepting low endotoxin recovery studies that use a naturally occurring endotoxin analyte.
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NewsLBP-immunotherapy could benefit oncology patients
New data for a microbiome-based therapeutic together with an immune checkpoint inhibitor has shown “encouraging clinical benefits” in advanced cancers.
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NewsTwo 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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NewsNew Phase III data for hidradenitis suppurativa biologic released
The IL-17A and IL–17F inhibitor demonstrated positive efficacy and safety in adults with moderate-to-severe hidradenitis suppurativa, new data shows.