All Clinical Development articles – Page 33
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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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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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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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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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NewsGOSH and Leucid to manufacture novel CAR T therapy
Great Ormond Street Hospital and Leucid Bio will manufacture a novel lateral CAR targeting NKG2D ligands, under a first-of-its-kind manufacturing agreement.
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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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NewsInjectable peptide rapidly reduces intracranial pressure
A study for idiopathic intercranial hypertension is the first to show rapid and a major reduction in brain pressure and monthly headaches.
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NewsCould default eligibility improve clinical trial enrolment?
The number of potential clinical trial participants increased from over 51,000 to 1.7 million after researchers applied a new approach to improve eligibility.
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NewsNatural allopregnanolone made orally bioavailable
Designed to treat anxiety and postpartum depression, a biotherapeutics company has made natural allopregnanolone orally bioavailable without permanent chemical modification.
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ArticleLearning from lecanemab: a breakthrough treatment
Here, Dr Michael Irizarry, Eisai’s Senior Vice President of Clinical Research and Deputy Chief Clinical Officer for Alzheimer’s Disease and Brain Health discusses its highly anticipated Alzheimer’s drug, lecanemab.
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NewsCombination therapy significantly improves pulmonary hemodynamics
Janssen’s single tablet of macitentan plus tadalafil significantly improved pulmonary hemodynamics in a Phase III trial for pulmonary arterial hypertension (PAH).
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NewsImmunotherapy before surgery benefits melanoma patients
In a Phase II trial, immunotherapy drug pembrolizumab significantly lowered the risk of recurrence for stage III-IV melanoma patients when given before and after surgery.
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NewsCell therapy first for chronic heart failure
In a Phase III trial, a new cell therapy has shown potential for the first time to treat inflammation, a major contributor to heart failure.
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NewsCHMP recommends first pegylated enzyme for Fabry disease
A PEGylated enzyme replacement therapy for Fabry disease has received recommendation for a marketing authorisation from the European Medicines Agency (EMA)'s human medicines committee.
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NewsVitiligo treatment gets positive CHMP opinion
If approved, the cream formulation of the JAK inhibitor ruxolitinib will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union.
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NewsFirst successful CAR-T treatment for muscle inflammation
Researchers in Germany have helped a patient to overcome anti-synthetase syndrome muscle inflammation using CAR-T cells.
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NewsImfinzi plus Imjudo approved in EU for advanced cancers
Hepatocellular carcinoma and non-small cell lung cancer patients are set to benefit from the recent approval of Imfinzi plus Imjudo combinations in the EU.