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PRAC
This page shows the latest PRAC news and features for those working in and with pharma, biotech and healthcare.
bluebird bio to restart marketing of Zynteglo in EU after previous suspension
EMA’s safety committee PRAC has confirmed favourable risk-benefit balance of gene therapy. ... The PRAC also investigated and assessed these safety events as part of its review into Zynteglo.
Latest news
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J&J's single-dose COVID-19 vaccine secures approval from the UK’s MHRA
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of J&J’s COVID-19 vaccine is positive. ... The PRAC concluded, however, that a warning regarding unusual
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J&J resumes US rollout of single-dose COVID-19 vaccine
On 20 April, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) also confirmed that the overall benefit-risk profile of Johnson &Johnson’s (J&J) COVID-19 vaccine ... The PRAC concluded, however, that a warning
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EMA finds overall benefit-risk ‘remains positive’ for J&J COVID-19 vaccine
PRAC noted that the cases reviewed in relation to the J&J vaccine were ‘very similar’ to cases that occurred with AstraZeneca/Oxford University’s COVID-19 vaccine. ... Following its review, PRAC has also concluded that these events should be listed
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J&J delays EU COVID-19 vaccine rollout following pause in the US
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has also started a review into reports of people developing blood clots after receiving the J&J COVID-19 vaccine.
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UPDATE: US pauses rollout of J&J’s COVID-19 vaccine amid reports of rare blood clots
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has also started a review into reports of people developing blood clots after receiving the J&J COVID-19 vaccine.
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Changes to pharmacovigilance legislation in Europe
If the same safety concerns apply to more than one medicinal product, the competent authority may, following consultation with the Pharmacovigilance Risk Assessment Advisory Committee (PRAC), encourage the performance of a ... Among others activities,
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Dr June Raine continues as chair of EMA's pharmacovigilance committee
The PRAC also voted to extend Dr Almath Spooner's tenure asvice-chair. ... Under her leadership Dr Raine said the PRAC would have three key priorities:. •
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EMA’s Pharmacovigilance Risk Assessment Committee gains new members
The European Medicines Agency's (EMA) newest committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has added two new members. ... Its new members Babylon and van der Zeijden will participate in the PRAC from April 2013.
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MHRA's Dr June Raine to chair new EMA pharmacovigilance committee
The PRAC will lead implementation of the wide-ranging pharmacovigilance reforms the EMA brought in over the summer. ... Dr Raine said: “The PRAC is set to play a pivotal role in delivering the public health benefits of the new European
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- NIHR launches new framework to highlight health progress outcomes
- Johns Hopkins and National Cancer Unit develop new genetic risk-scoring method for major diseases
- UKHSA secures UK-based vaccine deal for future influenza pandemics
- Novo Nordisk and Valo Health agree deal worth up to $3.3bn to develop cardiovascular treatments
- Landscape review reveals £1.1bn of UK funding for rare diseases
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Langland, a Publicis Health company, is the only health communications agency that thinks further across Clinical Trial Experience, Medical Strategy...
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