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FDA approves Phexxi™ vaginal gel for prevention of pregnancy
The US FDA approved Phexxi™ (lactic acid, citric acid and potassium bitartrate) gel, the first non-hormonal, vaginal pH regulator contraceptive.
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US Food and Drug Administration (FDA)
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FDA approves Lynparza (olaparib) for HRR mutated prostate cancer
Lynparza’s approval was based on results from a Phase III clinical trial in which it improved overall survival and progression-free survival in patients with certain prostate cancers.
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The COVID-19 pandemic and clinical trial disruptions
Research suggests almost 70 percent of global clinical trials have been disrupted by enrolment suspensions caused by the COVID-19 pandemic.
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FDA grants priority review to Biologics License Application for sutimlimab
The FDA has granted priority review of the Biologics License Application for sutimlimab to treat haemolysis in patients with cold agglutinin disease (CAD).
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Stem cells used to replace neurons in patient with Parkinson’s disease
A team has revealed that a patient who received induced pluripotent stem cells to replace lost dopaminergic neurons has reduced symptoms of Parkinson's disease.
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Phase IIb trial to study hydroxychloroquine and azithromycin as COVID-19 treatment launched
A double-blind clinical trial has begun in the US to study hydroxychloroquine and azithromycin treatment in patients with COVID-19.
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FDA grants Fast Track Designation to Moderna’s COVID-19 vaccine
The US FDA has given Fast Track Designation to Moderna's mRNA vaccine candidate, mRNA-1273, designed to protect against COVID-19.
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FDA new drug approvals down 16 percent in 2019, impacting outsourcing
A new report has found that in 2019 the FDA approved 119 new drugs and biologics, but that this is down from 137 in 2018, impacting contract manufacturing organisations.
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ICU Medical recalls one lot of Lactated Ringer’s Injection in US
The US FDA has announced ICU Medical is recalling a lot of Lactated Ringer's Injection due to iron oxide particulates being found by a consumer.
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FDA approves Tabrecta for treatment of metastatic non-small cell lung cancer
The FDA has approved Tabrecta (capmatinib) for patients with metastatic non-small cell lung cancer whose tumours have a mutation that leads to MET exon 14 skipping.
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CDMO pledges increased production of hydroxychloroquine sulfate, potential COVID-19 treatment
The CDMO AMRI has said it will boost its production of the malaria drug hydroxychloroquine sulfate, identified as a potential COVID-19 treatment, following an emergency use authorisation from the FDA.
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FDA grants remdesivir emergency use authorisation to treat COVID-19
The US FDA has given emergency use authorisation to remdesivir for the treatment of patients in hospital with severe COVID-19.
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The quest for efficiency – moving towards continuous processing
There are many challenges faced by the biopharmaceutical industry in order to develop and provide sufficient drugs to treat a growing and ageing population. This article discusses whether continuous processing provides the solution.
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How modern chromatography data systems are improving regulatory compliance in pharmaceutical manufacturing
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
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FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
