All Pharmacovigilance and safety oversight articles – Page 17
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NewsThe role of GAMP 5, data integrity and QbD in pharmaceutical quality assurance
By ensuring accurate and reliable data in drug development, data integrity supports regulatory compliance and drug safety, a paper explains.
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NewsEmploying MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
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NewsSandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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NewsMedical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
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NewsNew BeiGene Head of Europe, Global Clinical Operations appointed
Bringing over two decades of experience in oncology clinical development, the biotech’s new hire will work to advocate for innovation and patient-centric clinical development for the company’s European initiatives.
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ArticleAnalytica 2024 in overview
Between 9 - 12 April 2024, the world’s leading trade fair analytica will once again open its doors in Munich to the international laboratory industry. At analytica, industry experts, exhibitors and visitors gather to explore the latest developments in laboratory technology, analysis and biotechnology. The fair, covering the entire spectrum ...
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NewsNew data revealed for Novartis SMA gene therapy
Novartis has revealed new data for its one-time gene therapy for spinal muscular atrophy (SMA) in older children.
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NewsNew antibody drug formulation wins novel MHRA approval
A new formulation of an antibody drug has been authorised via a process from the Medicines and Healthcare products Regulatory Agency (MHRA) that enables “considerably shorter” approval timelines.
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NewsNICE recommends first licenced treatment for AL amyloidosis
Having been available in Scotland and Northern Ireland since 2022, NICE’s positive opinion of the combination treatment means it is now accessible on the NHS.
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ArticleRare disease spotlight: first EU-approved treatment for Friedreich’s ataxia
In this exclusive article, Biogen’s Vice President and Head of the Neuromuscular Development Unit, Dr Toby Ferguson, discusses the current rare disease landscape and recent developments in treating Friedreich’s ataxia (FA).
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NewsBoehringer reveals major data from liver disease trial
Data suggests Boehringer Ingelheim’s novel glucagon/GLP-1 receptor dual agonist could become a best-in-class liver disease treatment for metabolic dysfunction-associated steatohepatitis (MASH).
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NewsCHMP meeting highlights: February 2024
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
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NewsAnalysis reveals “superior efficacy” of long-acting injectable HIV treatment
The Cabenuva (cabotegravir + rilpivirine) injectable regime could benefit individuals with HIV who have challenges adhering to treatment, Phase III interim analysis suggests.
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NewsNICE recommends first medicine for severe alopecia areata
Clinical studies of Pfizer’s oral medicine for alopecia areata have demonstrated response rates continued to improve for up to two years.
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NewsNelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
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ArticleTaming cardiovascular risk: the promise of LDL cholesterol lowering therapeutics
In this exclusive interview, CEO of NewAmsterdam Pharma, Michael Davidson, offers insight into the low-density lipoprotein (LDL) cholesterol lowering therapeutic landscape and shares promising data from the company’s lead candidate, a cholesterol ester transfer protein (CETP) inhibitor.
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ArticleNavigating the unique CMC challenges of oral anaerobic live biotherapeutics
Here, Chief Technical Officer, Mike Frodsham and Ryan Wilson, Head of Microbiome Services at SGS Quay Pharma, explore the chemistry, manufacturing, and control (CMC) challenges of developing drug products containing live anaerobic bacterial strains, used for treatments such as microbiome therapeutics.
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NewsVertex secures European approval for CRISPR cell therapy
Now conditionally approved in Europe for sickle cell disease and transfusion-dependent beta thalassemia, the CRISPR therapy offers eligible patients a functional cure.
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NewsBioNTech agrees collaboration to accelerate autologous CAR-T therapies
The collaboration between BioNTech SE and Autolus Therapeutics utilises manufacturing and commercial infrastructure, supporting a shared goal of advancing autologous CAR-T programmes towards potential market authorisation.
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NewsNext-in-class combination treatment shows potential in cystic fibrosis
Phase III trials have found CFTR modulator vanzacaftor/tezacaftor/deutivacaftor (vanza triple) to be non-inferior to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in improving cystic fibrosis lung function.