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Positive results in Duchenne muscular dystrophy (DMD) trial
Interim trial results suggest vamorolone may offer a superior alternative to long-term treatment with high-dose glucocorticoids in young Duchenne muscular dystrophy (DMD) patients.
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Older people likely to be underrepresented in COVID-19 trials, says study
Researchers suggest, based on certain exclusions, older people are likely to be underrepresented in 50 percent of COVID-19 trials and all vaccine trials in the US.
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EUA requested for potential COVID-19 respiratory failure treatment
An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.
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Global anti-counterfeit packaging market to grow to $17.47 billion
Growth in the anti-counterfeit technologies market will be particularly large in the pharma industry due to increasing awareness around health and safety, says report.
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US expands COVID-19 convalescent plasma treatment trials
Operation Warp Speed and the NIH are funding the expansion of two trials evaluating the efficacy of convalescent plasma therapy in hospitalised COVID-19 patients.
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EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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Avelumab significantly improves advanced bladder cancer patient survival
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
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Promising interim results from ALS study testing IPL344
The data suggests disease deterioration was halved in the six Amyotrophic Lateral Sclerosis (ALS) patients treated with IPL344 over eight months.
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Phase I trial finds potential COVID-19 antibody treatment safe in healthy volunteers
A first-in-human Phase I clinical trial of potential COVID-19 antibody CT-P59 has shown the treatment is well tolerated in healthy subjects.
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Clinical trial for AstraZeneca Oxford COVID-19 vaccine candidate to resume
After the clinical trial for AZD1222 was halted last week, the studies for AstraZeneca's COVID-19 vaccine candidate will now resume.
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Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
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Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
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Dexamethasone Taw application to treat COVID-19 to be evaluated by EMA
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
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EMA safety committee recommends withdrawal of ulipristal acetate marketing authorisation
The EMA's PRAC has recommended the revocation of the marketing authorisation for ulipristal acetate, after a review confirmed liver injury caused by the medicine.
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Russia’s Sputnik V COVID-19 vaccine safely elicits an antibody response, reports paper
Preliminary data from Phase I/II trails evaluating the vaccine reveal 100 percent of participants had a humoral and cellular response, with no serious adverse events reported.