All Drug Development articles – Page 51
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NewsFirst 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Final draft guidance published by the National Institute for Health and Care Excellence (NICE) has recommended immunotherapy pembrolizumab drug for advanced cervical cancer.
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NewsFirst-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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NewsNew 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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NewsNasal 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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NewsEMA 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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NewsFirst 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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ArticleDeveloping 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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NewsTakeda 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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NewsFirst 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NICE's final draft guidance has recommended the first and only gene therapy for children with aromatic L-amino acid decarboxylase (AADC) deficiency.
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NewsCould 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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NewsMHRA approves prostate cancer combination therapy
The first PARP inhibitor to show clinical benefit with a new hormonal agent in first-line metastatic castration-resistant prostate cancer has been granted UK approval.
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NewsBioNTech 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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NewsNovartis 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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NewsFirst 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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NewsFirst mixed race woman potentially cured of HIV
A female patient, who had leukaemia and HIV has been potentially cured by a stem cell transplant from cord blood, scientists say.
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NewsDual 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.
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Webinar
Controlling endotoxins contamination during pharmaceutical production
Watch this webinar to learn from Peter Cornelis, how to prevent endotoxins contamination during pharmaceutical production, as well as gain insights into sampling plans, test methods, and method optimisation.
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NewsNovel small molecule drug facilitates leukaemia remission
Leukaemia patients went into remission when given a novel drug containing a small molecule that inhibits menin and MLL1 interaction, a study showed.
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NewsPfizer to acquire Seagen for $43 billion
To advance cancer breakthroughs, antibody-drug conjugates (ADCs) are the central technology in Pfizer’s intended acquisition of Seagen Inc.
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NewsSMC accepts treatment for chronic hepatitis delta virus
Bulevirtide has been accepted by the Scottish Medicines Consortium to treat chronic hepatitis delta virus (HDV) infection in adults.