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Novel LAI antipsychotic approved in EU
The long-acting injectable (LAI) formulation is indicated as a once-every-two-months treatment for adults with schizophrenia.
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Next-gen Moderna COVID-19 vaccine shows promise
Phase III data shows that mRNA-1283 has a similar safety profile to Moderna's approved COVID-19 vaccines, the company states.
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Novel heart failure drug could halt disease progression
Heart failure drug acoramidis could increase survival rates in transthyretin amyloid cardiomyopathy (ATTR-CM), Phase III study data suggests.
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GSK immuno-oncology treatment achieves novel EU approval
The EC’s approval of the immuno-oncology treatment “will define a new standard of care for certain patients with advanced or recurrent endometrial cancer in the EU,” says principal investigator of the RUBY trial.
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ASH 2023: microbiome-based therapy shows potential in graft-versus-host disease
Data presented at the 2023 American Society of Hematology (ASH) Annual Meeting suggest that the off-the-shelf microbiome therapeutic could offer a “potentially life-saving approach” in graft-versus-host disease (GvHD).
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Antibody-immunotherapy combination shows promise in lung cancer
A study evaluating the combination of a PD1 inhibitor with dupilumab enabled one out of six lung cancer patients to achieve a near-complete clinical response two months post-treatment, a paper states.
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First pill for desmoid tumours approved
Approval of the first treatment option for desmoid tumours beyond surgery and radiation has been granted by the US Food and Drug Administration (FDA).
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Could stem cell therapy stabilise MS progression?
Positive findings from a first-in-human trial means that an advanced cell therapy for progressive multiple sclerosis will be evaluated in Phase II.
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First chikungunya vaccine approved
Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
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siRNA therapy shows long-term potential in lowering LDL-C
New data presented at the European Society of Cardiology (ESC) Congress 2023, showed Novartis’ Leqvio® (inclisiran) provided an approximate 49 percent reduction in LDL cholesterol beyond six years of clinical observation.
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First oral medicine for postpartum depression approved
The first approved oral treatment that provides rapid symptomatic improvement in postpartum depression (PPD) is expected to be commercially available in the fourth quarter of 2023.
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Novel pill could aid postpartum depression symptoms
If approved, the treatment could provide the first oral, at-home, neuroactive steroid therapy to treat postpartum depression (PPD).
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Efficacy of novel drug proven in MDD study
Significant results from a Phase II study in major depressive disorder (MDD) for a novel kappa opioid receptor (KOR) antagonist has prompted initiation of a Phase III programme.
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Beyfortus approved for US infants against RSV disease
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).
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Eli Lilly ulcerative colitis antibody drug doubles remission rates
Mirikizumab, the first therapeutic antibody tested for blocking interleukin-23 in ulcerative colitis has demonstrated strong efficacy in two Phase III trials.
