All Pharmacovigilance and safety oversight articles – Page 28
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ArticleRealising milestones with gene therapy for SMA
Novartis Gene Therapies' Vice President for Clinical Development & Analytics shares what shaped the success of one of the few commercially-available gene therapies.
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NewsEnzyme replacement therapy approved for Fabry disease
The European Commission (EC) has given approval to the first PEGylated enzyme replacement therapy to treat Fabry disease.
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ArticleTransforming oncology with antibody therapeutics
Martin Vogel, Therapeutic Area Lead for Oncology, Janssen EMEA, discusses the potential of bispecific monoclonal antibodies like amivantamab to address unmet needs in advanced non-small cell lung cancer treatment.
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NewsFirst RSV vaccine approved for older adults
The US Food and Drug Administration (FDA) has approved the first-ever vaccine for respiratory syncytial virus (RSV) in adults over 60 years old.
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NewsEuropean Commission approves CAR T therapy for lymphoma
CD19-directed CAR T-cell therapy Breyanzi has been approved by the European Commission (EC) based on significant results from a lymphoma Phase III trial.
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NewsNovel device opens blood-brain barrier to deliver chemotherapy
A novel ultrasound technique opened the blood-brain barrier to successfully deliver chemotherapy to glioblastoma patients in a first-in-human trial.
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NewsBiologic could be first new hidradenitis suppurativa treatment in a decade
The first and only fully human biologic that directly inhibits interleukin-17A has been granted a positive opinion by the Committee for Medicinal Products for Human Use (CHMP).
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NewsImmunotherapy to become standard treatment for infants with ALL
First-line immunotherapy blinatumomab significantly improved survival in babies with acute lymphoblastic leukaemia in an international trial.
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NewsModerna’s mRNA vaccine manufacturing centre begins construction
Moderna achieves another milestone in its UK government partnership, with the start of construction of its mRNA vaccine manufacturing centre.
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NewsNovartis releases data for potentially “practice-changing" PNH medicine
Iptacopan achieved "improvement of anaemia never seen before with anti-C5s” in paroxysmal nocturnal haemoglobinuria, showed Novartis data presented at 2023 EBMT.
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NewsPioneering malaria vaccine gains regulatory clearance
University of Oxford-developed R21/Matrix-M malaria vaccine has secured approval in two African countries.
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NewsMonoclonal antibody combination treatment given NICE approval
Shown to increase myeloma remission times by more than two years, a combination treatment that uses a monoclonal antibody has been approved by NICE.
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NewsInjectable small molecule inhibitor could improve vision
Long-term Phase II study data of small molecule inhibitor UBX1325 delivered significant vision improvements in diabetic macular edema (DME).
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ArticleGuide To Testing
In this edition, experts from Institute of Biomedical Research Antoine Marxer and Associates of Cape Cod International share insight on endotoxin testing.
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ArticleEuropean Pharmaceutical Review Issue 2 2023
EPR Issue 2 includes articles on the future of cell and gene therapy, the potential of AAV gene therapies, NMR relaxometry and more…
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NewsNICE recommends therapy duo for advanced leukaemia
Janssen states Imbruvica® plus venetoclax will provide "a much-needed new treatment option" for chronic lymphocytic leukaemia.
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ArticlePharma within planetary boundaries
Regulatory changes along a drug’s lifecycle should ensure that the health benefits of pharmaceuticals, which have a large ecological footprint, do not cost the environment. Dorothea Baltruks, Research Associate at the Centre for Planetary Health Policy, outlines how forthcoming EU pharmaceutical legislation could pave the way to solutions.
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NewsOral drug reduces treatment-resistant migraine frequency
Initial data from study results being presented at the 75th American Academy of Neurology Annual Meeting indicate that an oral CGRP inhibitor reduced episodic migraine frequency.
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NewsCould ATR-FT-IR spectroscopy become ‘gold standard’ for heparin analysis?
A paper states ATR-FT-IR spectroscopy plus multivariate analysis for heparin analysis is cost-effective compared to NMR.
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NewsNavigating delivery challenges of nucleic acid therapeutics
A paper has reviewed how novel drug delivery systems could achieve stable formulations of nucleic acid therapeutics.