All Pharmacovigilance and safety oversight articles – Page 22
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NewsCounterfeit diabetes pens identified in EU and UK
Following shortages of the diabetes medicine Ozempic (semaglutide), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have confirmed cases of falsely labelled pre-filled pens at UK and EU wholesalers.
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NewsEACS 2023: Gilead shares real-world evidence for Biktarvy®
Efficiency of Gilead Science’s long-term HIV treatment option with a high barrier to resistance has been further demonstrated in real-world data based on three-year study follow up.
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NewsRegulatory-first for gene editing therapy
The world’s first investigational in vivo CRISPR-based gene editing therapy cleared for late-stage clinical development is expected to enter Phase III in late 2023.
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NewsFirst-in-class phosphate absorption inhibitor approved by FDA
A first-in-class treatment with a differentiated mechanism of action has been approved to reduce serum phosphorus in chronic kidney disease (CKD) in individuals for which phosphate binders are not suitable.
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NewsSanofi treatment could slow type 1 diabetes progression
New Sanofi Phase III trial data adds to evidence of the treatment potential for the first disease modifying therapy in type 1 diabetes.
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NewsNICE recommends Roche biologic for lymphoma
Glofitamab is the first treatment to be recommended by the National Institute for Health and Care Excellence (NICE) at the same time as it is approved for advanced lymphoma in the UK.
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NewsFollicular lymphoma BTK inhibitor recommended by CHMP
Following the CHMP’s recommendation of a follicular lymphoma combination treatment, if approved, BRUKINSA will be the first BTK inhibitor to be authorised for follicular lymphoma.
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WebinarNavigating challenges in HPAPI development and manufacturing
HPAPIs now account for more than half of clinical small molecule NCE drugs. Learn from our experts how to overcome the most common challenges in HPAPI handling.
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NewsECNP 2023: new esketamine NS safety data for depression
New safety data for a Phase IIIb study in treatment-resistant depression (TRD), revealed at ECNC 2023, showed that esketamine NS significantly increased the proportion of patients achieving remission compared to quetiapine XR.
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NewsNovel anti-epileptic drug demonstrates efficacy
Research reveals that a new, potassium-channel opening drug has shown an ability to reduce seizure frequency by more than half in certain epilepsy patients.
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NewsIndia joins mission to harmonise pharmacopoeial standards
As a “major manufacturer of the world’s medicines”, the Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) to contribute to the harmonisation of quality standards.
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NewsModerna reveals optimistic data for influenza-COVID-19 vaccine
Strong influenza and COVID-19 immunogenicity compared to approved standalone vaccines has been demonstrated in Moderna’s combination vaccine, interim Phase I/II trial data shows.
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NewsWHO recommends second malaria vaccine
Newly recommended by the World Health Organization (WHO), the new “safe, effective and affordable” malaria vaccine has potential to reduce deaths "by up to a third”.
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NewsIncreasing efficacy in extractables and leachable testing
Researchers have proposed a read-across methodology for pharmaceutical extractables and leachable (E&L) testing as a time-saving alternative to toxicity testing.
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NewsWill novel antibiotic become front-line for C. difficile?
Based on positive Phase II data, the first-in-class antibiotic candidate ibezapolstat for C. difficile is expected to advance to Phase III trials more quickly.
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NewsFDA approves first-in-class antidepressant
The first antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor has been approved for major depressive disorder (MDD) by the US Food and Drug Administration (FDA).
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NewsChemo-free regimen demonstrates efficacy in NSCLC
Topline results from a Phase III study in NSCLC suggest that Rybrevant® and lazertinib could advance treatment beyond tyrosine kinase inhibitor (TKI) monotherapy.
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NewsTakeda ulcerative colitis biologic receives FDA approval
A new route of administration for a biologic to treat ulcerative colitis (UC) has been approved in the US.
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NewsDMT-SSRI combination shows potential for depression
A Phase Ib study evaluating selective serotonin reuptake inhibitors (SSRIs) interaction with SPL026, native N, N-dimethyltryptamine (DMT) in major depressive disorder (MDD) has revealed positive data.
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ArticleConsiderations for safety data migration methods
Pharmacovigilance regulation in the EU and beyond has continued to grow and become more stringent over the last decade. In this article, ICON’s Graeme Bones explains how to handle the different types of data migration methods and how companies can select the optimum approach to ensure data integrity is maintained.