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CHMP to review MAA for geographic atrophy treatment
Iveric Bio's marketing authorisation application (MAA) for avacincaptad pegol (ACP) to treat a leading cause of blindness has been accepted for review by the European Medicines Agency.
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Clinical Trials
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Immunotherapy combo could overcome melanoma anti-PD-1 resistance
A “practice-changing” immunotherapy drug combination demonstrated inhibition of two main immune checkpoints in a trial assessing efficacy in metastatic melanoma.
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CDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
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AbbVie gains EU migraine treatment approval
The first once-per-day oral CGRP receptor antagonist gepant treatment has been approved in the EU as a preventative treatment for both chronic and episodic migraines.
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UK approval for Pompe Disease therapy
16 August 2023 | By
The MHRA has granted marketing authorisation for a two-component therapy for adults with late-onset Pompe Disease, a rare disorder.
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FDA approval for Janssen’s prostate cancer treatment
The US FDA approval of Akeega (niraparib and abiraterone acetate) is based on positive results from the Phase III MAGNITUDE study.
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ATRAG formulations for lung disease
Carl-Johan Dalsgaard, CEO of Vicore Pharma speaks to EPR about clinical trials of C21, an angiotensin II type 2 receptor agonist developed to treat rare lung diseases – and the first ever ATRAG to reach clinical-stage development.
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Multiple myeloma bispecific antibody granted accelerated approval
Accelerated US approval of a first-in-class bispecific antibody (BsAb) therapy offers a new option for a difficult-to-treat blood cancer.
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Novo Nordisk makes $1 billion acquisition agreement
Under a $1 billion acquisition agreement, Novo Nordisk A/S will investigate a potential first-in-class small molecule CB1 receptor blocker as a treatment for obesity.
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Will Novartis provide new oral option for chronic hives?
If approved, Novartis’ remibrutinib has potential to be the first of a new class of chronic spontaneous urticaria (CSU) treatment in a decade.
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Semaglutide demonstrates cardiovascular benefit
In Novo Nordisk’s landmark trial for cardiovascular outcomes, semaglutide 2.4mg has potential to change how obesity is regarded and treated, headline data suggests.
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AstraZeneca’s tezepelumab and dapagliflozin accepted for use in Scotland
The Scottish Medicines Consortium (SMC)’s acceptance means eligible patients across the UK can now benefit from AstraZeneca's Tezspire (tezepelumab) for severe asthma and Forxiga (dapagliflozin) for chronic heart failure.
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New vaccine development centre to strength UK’s capabilities
The UK’s new vaccine development and evaluation centre will target pathogens for which a vaccine does not exist or could be improved, supporting pandemic preparedness.
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Astellas to advance oncology CAR-T therapy
An investment of $50 million by Astellas Pharma in Poseida Therapeutics’ Phase I allogeneic CAR-T product candidate for solid tumour indications is set to advance the cancer immunotherapy field.
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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.
