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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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US Food and Drug Administration (FDA)
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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.
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Nanoparticle delivery offers a possible alternative to opioid pain relief
An international team of researchers has used nanoparticles to deliver a drug – one that previously failed in clinical trials for pain – into specific compartments of nerve cells, dramatically increasing its ability to treat pain in mice and rats. Nikki Withers spoke to Nigel Bunnett to hear more about…
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The importance of continually evolving solid dosage forms
Solid dosage forms have been one of the foremost choices of drug administration for generations. However, with an ever-growing global population, evolving customer demands and continual updates to regulations comes greater need for advanced medicines and progress in this sector. This article explores the benefits and how the field must…
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Fresenius Kabi recalls 13 lots of ketorolac tromethamine injection
The FDA has announced that Fresenius Kabi is voluntarily recalling 13 lots of ketorolac tromethamine injection due to particulate matter found in reserve sample vials.
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Emerging biotechs tackle medical research continuity concerns amid COVID-19
While medical professionals fight COVID-19 on the front line, small biotech businesses face a new uphill battle – maintaining research continuity for non-COVID-19 life-changing therapeutics.
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FDA accelerates approval of Trodelvy to treat triple-negative breast cancer
The US FDA has granted accelerated approval of Trodelvy (sacituzumab govitecan-hziy), to treat triple-negative breast cancer in adult patients.
