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Eculizumab biosimilar gets positive CHMP opinion
Samsung Bioepis’ first haematology biosimilar, which references Soliris (eculizumab), has been recommended for approval by the CHMP.
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Clinical Trials
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Monoclonal antibodies can lower COVID-19 hospitalisation risk
Over a third of COVID-19 patients reduced their risk of serious outcomes when treated early with monoclonal antibodies, a study shows.
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Treatment shows strong potential for ALK-driven neuroblastoma
A Phase I study has shown significant promise in treating newly diagnosed ALK-driven high-risk neuroblastoma in paediatric patients.
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Novel delivery approach demonstrates efficacy of immunotherapy
A first-in-human study showed a novel approach for delivering intrathecal and intravenous immunotherapy improved survival of melanoma patients with leptomeningeal disease (LMD).
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First immunotherapy recommended for advanced cervical cancer
Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
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First-in-class plaque psoriasis oral therapy approved in EU
Bristol Myers Squibb’s Sotyktu is the only TYK2 inhibitor approved for the treatment of any disease in the European Union.
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Nasal spray for depression shows long-term efficacy
SPRAVATO® achieved significant long-term response rates in treatment-resistant depression, compared to quetiapine extended release, Janssen’s Phase IIIb study has shown.
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First mild asthma combination reliever approved in UK
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first dual-combination, inhaled corticosteroid and long-acting beta2-agonist reliever therapy for mild asthma.
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Developing novel therapies for NASH
In this exclusive interview, Dr Hank Mansbach, Chief Medical Officer of 89bio discusses clinical development of FGF21 therapy to treat fatty liver disease.
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First gene therapy recommended for AADC
NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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Could Dupixent be the first biologic to treat COPD?
Dupixent® is the first biologic to demonstrate significant improvement in lung function compared to placebo, a pivotal Phase III trial has shown.
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BioNTech to jointly develop novel antibody for cancers
ONC-392, an anti-CTLA-4 monoclonal antibody for solid tumours will be jointly developed by BioNTech and biopharma OncoC4.
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Novartis releases long-term data for SMA gene therapy
Long-term follow-up study data for Zolgensma®, Novartis’ one-time gene therapy for spinal muscular atrophy (SMA), has shown promising overall milestone achievements.
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First FcRn blocker approved in UK for myasthenia gravis
VYVGART (efgartigimod alfa-fcab) has been approved for adults with generalised myasthenia gravis by UK Medicines and Healthcare products Regulatory Agency (MHRA).
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Dual cystic fibrosis modulator therapy shows efficacy in four-year study
Cystic fibrosis patients can safely take a dual combination of cystic fibrosis modulator drugs for four years, a study has shown.
