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FDA approves Phase III trial of synthetic biological COVID-19 treatment
The international Phase III trial will evaluate whether a 14 day course of carrimycin can improve outcomes for COVID-19 patients with severe symptoms.
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Therapeutics
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First COVID-19 patient enrolled in acute kidney injury drug trial
AM-Pharma has announced the enrolment and financing of a COVID-19 cohort in its Phase III acute kidney injury treatment trial.
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Tocilizumab and sarilumab reduce COVID-19 patient mortality by 8.5 percent, data shows
IL-6 receptor antagonists tocilizumab and sarilumab have a significant impact on COVID-19 patient mortality, a study has shown.
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New process for producing synthetic insulin developed
Researchers say that their novel way to produce synthetic insulin could also be used to create at least eight other drugs.
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NICE initiates new Innovative Licensing and Access Pathway for medicines
The new pathway developed by NICE for medicines to go from clinical trials to NHS patients is now in action.
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Trial to evaluate monoclonal antibody therapy for mild-to-moderate COVID-19
The study will determine if the combination of BRII-196 and BRII-198, two investigational antibodies for SARS-CoV-2, can prevent disease progression.
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FDA approves Ebanga (Ansuvimab-zykl) for the treatment of Ebola
Ebanga was approved based on its ability to reduce 28-day mortality in patients with confirmed Ebolavirus infection.
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First long-acting HIV treatment approved in Europe
The European Commission approval of the long-acting injectable HIV treatment could transform the lives of people living with the disease.
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Seven secret ingredients for successfully launching and commercialising a biopharma’s first drug in Europe
After the US, Europe is considered the second most attractive market for serving patient needs while realising commercial value from innovative drugs. However, the 27 EU member states each have their own approaches to pricing and market access – and need tailored commercialisation and go-to-market strategies. Simon-Kucher & Partners analysed…
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First hospitalised COVID-19 patient dosed in FSD201 treatment trial
The study will evaluate whether FSD201 is safe and of benefit to hospitalised patients with COVID-19, in combination with standard of care.
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Pioneering a full-ecosystem microbiota approach to improve survival outcomes in life-threatening diseases
The human gut contains the largest ecosystem of microbial species having complex host-microbiome interactive networks that contribute to our physiology and regulate our immune system. An imbalance in this host-microbiome interaction is associated with disease and the ability to restore or stabilise the network by introducing a rich and diverse…
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AstroRx® shows promise in early phase amyotrophic lateral sclerosis trial
Amyotrophic lateral sclerosis (ALS) patients treated with AstroRx® had a 45 percent reduction in their disease progression rate.
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New opportunities for the global API market
Active pharmaceutical ingredients (APIs) are primary components in the manufacture of drugs, yet this global market experiences numerous challenges. Regulatory pressure, pricing arbitrages, a shift to digital manufacturing and patents for blockbuster drugs are chief among them, but the COVID-19 pandemic added a further hurdle as governments globally decided to…
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COVID-19 challenge trials: is there a compelling ethical argument against?
Ethicist says that, should trials offer the huge benefits and low risks, he finds no compelling ethical objection to challenge trials for COVID-19 vaccines.
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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
