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Generic manufacturers sign sublicences to produce long-acting HIV medicine
Sublicence agreements signed by the Medicines Patent Pool (MPP) and three generic manufacturers could enable millions to access a long-acting HIV medicine.
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Therapeutics
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Biopharma could reap benefits from SVB UK acquisition
One of the largest banking collapses in US history could provide the biotech sector unseen opportunities, say GlobalData.
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GSK to exclusively license novel oral antifungal
The only US Food and Drug Administration (FDA)-approved oral antifungal for vulvovaginal candidiasis will be exclusively licensed by GSK.
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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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£277m investment to advance UK life sciences manufacturing
Four UK life sciences companies are set to benefit from a £277m investment in the first tranche of Life Sciences Innovative Manufacturing Fund (LSIMF) grants.
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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Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.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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New biologics manufacturing facility gets $1b investment
Eli Lilly’s new biologics manufacturing facility in Ireland will utilise technologies such as automation and support sustainable practises.
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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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EMA publishes mid-point regulatory science strategy report
Progression in supporting development of precision medicine was noted as an achievement in a mid-term report on the EMA’s Regulatory Science Strategy to 2025.
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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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Takeda to build £600m plasma therapy manufacturing site
Takeda’s largest manufacturing capacity expansion investment in Japan will fund the build of a new facility for plasma-derived therapies.
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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.
