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Voclosporin approved by FDA to treat lupus nephritis
The FDA has approved Aurinia Pharmaceuticals' LupkynisTM(voclosporin) for the treatment of lupus nephritis, alongside standard-of-care.
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FDA approves first extended-release injectable, complete regimen for HIV
The approval of Cabenuva (cabotegravir and rilpivirine, injectable formulation) means HIV infected adults could receive once-monthly injections to manage their condition.
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FDA approves crizotinib for children with certain anaplastic large cell lymphomas
In a Phase I/II trial, 81 percent of paediatric patients with relapsed or refractory, systemic anaplastic large cell lymphoma achieved complete remission with crizotinib (Xalkori).
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US could purchase over 1.5 million doses of Regeneron’s COVID-19 antibody cocktail
The additional doses of casirivimab and imdevimab, two monoclonal antibodies, will be used in non-hospitalised COVID-19 patients.
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Baricitinib and remdesivir reduce time to recovery in COVID-19 patients
A clinical trial in hospitalised COVID-19 patients has demonstrated that baricitinib and remdesivir reduce time to recovery.
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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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FDA monitoring impact of SARS-CoV-2 mutations
The FDA has alerted clinical laboratory staff and healthcare providers that it is monitoring the potential impact of SARS-CoV-2 mutations, including the UK variant.
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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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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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The rise of biosimilars – navigating regulatory complexity in Europe
Gabriela Marton sets out some of the EU-associated regulatory challenges life sciences companies will need to navigate if they want to take advantage of the rise of biosimilars.
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Why cold chain requirements are not holding COVID-19 vaccines back
Despite the stringent storage conditions required for Pfizer and BioNTech’s COVID-19 vaccine, the need for a return to normal life has levelled the playing field for all candidate prophylactics against SARS-CoV-2.
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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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Current innovations in the vaccine pipeline
As the global COVID-19 response continues, so does the rapidly expanding pipeline for a novel COVID-19 vaccine. Here, experts from Avalere Health outline ongoing US and global vaccine development efforts, including the role of public-private partnerships in accelerating vaccine development. They will also focus on the broader context of respiratory…
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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.