All Pharmacovigilance and safety oversight articles – Page 27
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News6.1 percent CAGR expected for pharmaceutical sterility testing market
The rising importance of quality and sterility is expected to drive the pharmaceutical sterility testing market in the next decade, a report says.
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NewsChikungunya vaccine demonstrates 99 percent immune response
If approved, VLA1553 could become the first licensed chikungunya vaccine available to address this unmet medical need.
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NewsCould novel gene therapy treat sickle cell disease?
Researchers have revealed positive preliminary data from a CRISPR gene therapy trial for sickle cell disease.
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NewsEDQM publishes annual report
Included in EDQM’s annual report were reflections on the 11th Edition conference, which highlighted key topics such as the potential of nanomedicines and Big Data.
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NewsSmall molecule treatment reduces risk of death by half in NSCLC
Astrazeneca’s small molecule tyrosine kinase inhibitor reduced the risk of death by 51 percent in non-small cell lung cancer (NSCLC), a major Phase III study has shown.
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NewsStudy identifies key contamination source during ATMP manufacture
Researchers say they are the first to demonstrate contamination of over 40 percent of lipoaspirate samples for adipose tissue-derived stem cell (ADSC)-based advanced therapy medicinal product (ATMP) manufacture.
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NewsAnalysis reports nitrosamine prevalence in small molecule drugs
Data from a paper on small molecule drugs has indicated nitrosamines in pharmaceuticals is likely more prevalent than originally expected.
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NewsNivolumab plus chemo provides one-year PFS in 94 percent lymphoma patients
A PD-1 checkpoint inhibitor plus chemotherapy is expected to become new standard of care for advanced Hodgkin lymphoma, based on Phase III trial data.
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NewsNICE recommends oral migraine treatment for first time
An oral small molecule CGRP antagonist has been recommended for episodic migraines in National Institute for Health and Care Excellence (NICE) final draft guidance.
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NewsCRISPR-based microbial gene therapy delivers promise
A microbial gene therapy can “eliminate antibiotic-resistant E. coli strains in the gut”, according to first-in-human study interim results.
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NewsCHMP meeting highlights – May 2023
The Committee for Medicinal Products for Human Use (CHMP) recommended two new medicines for approval in its May meeting, including a neurosteroid for epileptic seizures.
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NewsNew recognition routes to fast-track UK medicine access
New recognition routes will facilitate faster and safer access to innovative medicines through seven international partners, according to the UK’s MHRA.
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NewsNanoparticle HIV vaccine shows potential in trial
Positive first-in-human trial results have highlighted potential of a nanoparticle vaccine towards broadly neutralising against HIV.
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NewsFirst redosable gene therapy approved
The “landmark approval” of a redosable gene therapy for dystrophic epidermolysis bullosa “ushers in a whole new paradigm to treat genetic diseases".
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NewsSurvey reports untapped potential for UK clinical trials
With the UK Government’s clinical trials landscape independent review expected, a survey has identified “huge untapped potential for trial recruitment”.
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NewsFirst NICE-recommended treatment for chronic heart failure
In final draft guidance, the National Institute for Health and Care Excellence (NICE) has recommended dapagliflozin (Forxiga) for patients with heart failure regardless of ejection fraction.
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NewsNICE recommends Rinvoq® for Crohn’s
AbbVie’s Rinvoq® will be the first JAK inhibitor available for treatment of Crohn’s in England and Wales, following NICE approval.
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NewsFirst treatment conditionally licensed for chronic hepatitis D
Gilead Science’s antiviral medication for chronic hepatitis D has been recommended by the National Institute for Health and Care Excellence (NICE).
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NewsIntratumoural viral delivery improves glioblastoma survival
“Injecting a virus into a patient’s brain tumour” combined with immunotherapy improved glioblastoma survival outcomes in a clinical trial.
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NewsCould personalised mRNA vaccine be first for cancer?
Half of pancreatic ductal adenocarcinoma (PDAC) patients given a personalised mRNA neoantigen vaccine experienced delayed recurrence 18 months post-vaccination.