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EMA’s PRAC June meeting highlights
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) finds the benefits of amfepramone medicines do not outweigh their risks and addressed possible links between COVID-19 vaccines and menstruation.
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Results are in for PT027 asthma treatment as MANDALA trial wraps up
The Phase III MANDALA trial has demonstrated that the combination medication PT027 significantly reduces the risk of severe exacerbation in patients with moderate to severe asthma, reports AstraZeneca.
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mRNA-1010 quadrivalent flu vaccine shows promise in Phase I study
Moderna's quadrivalent flu vaccine mRNA-1010 boosted titres against all four strains 29 days after vaccination in young and older adults.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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CHMP issue positive opinion on Comirnaty® for five to 11 year olds
The human medicines committee issue a positive opinion on the COVID-19 vaccine Comirnaty® in children aged five to under 12 years.
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AZD7442 reduces COVID-19 risks by 83 percent in Phase III trial
A separate treatment trial showed 88 percent reduced risk of severe COVID-19 or death when treated within three days of symptom onset.
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EMA endorses two monoclonal antibody medicines for COVID-19
The European Medicines Agency’s human medicines committee (CHMP) has recommended authorising Ronapreve™ and Regkirona for COVID-19.
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Cosentyx®displays a 72 percent reduced arthritis flare risk
Cosentyx® resulted in a 72 percent reduced flare risk for enthesitis-related arthritis and juvenile psoriatic arthritis in a Phase III study.
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Depression drug shows positive results in groundbreaking Phase IIb study
COMP360 25mg versus 1mg comparator dose demonstrated a -6.6 point difference on the Montgomery-Åsberg Depression Rating Scale by week 3.
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Aimovig®displays superiority over topiramate in migraine study
Amgen announces positive results from the first and only randomised, double-blind, head-to-head study comparing Aimovig® to topiramate.
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Rinvoq® shows positive results in rheumatoid arthritis post-hoc analysis
In the analysis, 34 percent of rheumatoid arthritis patients receiving Rinvoq® achieved Clinical Disease Activity Index (CDAI) remission.
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Wegovy™ demonstrates sustained weight loss in two-year obesity study
Novo Nordisk's Wegovy™ reduced body weight by 15.2 percent versus 2.6 percent with placebo in Phase IIIb study.
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Biktarvy® shows high efficacy against HIV in real-world setting
Gilead's Biktarvy demonstrated a consistently high efficacy of over 95 percent in analyses of the ongoing real-world cohort BICSTaR study.
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Aramchol™ reduces fibrosis progression in 24 weeks
Aramchol reduced liver fibrosis progression in 15 out of 16 patients and did not worsen non-alcoholic steatohepatitis in almost half of patients.
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FDA authorises Comirnaty® for emergency use in five to 11 year olds
The US Food and Drug Administration has authorised the emergency use of COVID-19 vaccine Comirnaty in children aged five to 11 years.
