news
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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Drug Development
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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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European Commission revokes marketing authorisation for Novartis’ crizanlizumab
Novartis will remove its sickle cell medicine crizanlizumab from the EU/EEA market following a European Commission decision.
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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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FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
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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.
news
ADC oncology therapy market to value over $36b by 2029
With antibody-drug conjugates (ADCs) gaining favour as oncology treatments, research shows Daiichi Sankyo, Seagen and Roche are currently three of the market's most important players.
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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.
podcasts
EPR Podcast 20 – RNAi Therapeutics – Paul Nioi, Alnylam Pharmaceuticals
In this podcast, Paul Nioi, Vice President of Discovery and Translational Research at Alnylam Pharmaceuticals discusses the clinical development and manufacturing of RNA interference (RNAi) therapeutics.
news
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.
news
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.
news
Antibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
