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CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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Therapeutics
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Clinical trial disruptions: is it all down to COVID-19?
This article explores how COVID-19 has impacted clinical investigation sites and what companies could do to mitigate the effect on trials moving forwards.
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NICE recommends new chemo-free chronic lymphocytic leukaemia treatment
More than 1,000 people each year could benefit from treatment with a combination of venetoclax and obinutuzumab, according to NICE.
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Stem cell therapy trial for COVID-19 patients with ARDS advised to continue
The trial’s independent Data Safety Monitoring Board (DSMB) recommended that the Phase III study evaluating remestemcel-L continue based on the second interim analysis.
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FDA grants emergency use authorisation to COVID-19 antibody bamlanivimab
The neutralising antibody therapy bamlanivimab (LY-CoV555) is authorised for emergency use in recently diagnosed patients who are at risk of developing severe COVID-19.
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NICE recommends Liraglutide for treatment of obesity and non-diabetic hyperglycaemia
Liraglutide (Saxenda) will be offered to adults with non-diabetic hyperglycaemia and a high risk of cardiovascular disease.
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FDA publishes list of essential medicines and medical countermeasures
The agency has compiled a list of essential medicines, medical countermeasures and critical inputs, as directed by Trump’s executive order in August.
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Stepping up metformin production: a case study
This article describes how researchers stepped up metformin tablet production from a pilot scale coater to three industrial scale equipment lines.
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Novel non-opioid postsurgical pain implant launched
Innocoll Holdings Limited has announced the commercial launch of the XARACOLL® (bupivacaine HCI) implant, a non-opioid treatment for acute post-surgical pain for up to 24 hours in adults following open inguinal hernia repair.
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US to receive 300,000 vials of experimental COVID-19 antibody therapy
Eli Lilly will provide the US government with vials of its COVID-19 antibody therapy bamlanivimab (LY-CoV555) if the treatment is granted Emergency Use Authorisation.
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Trial to evaluate oral nitric oxide therapy in COVID-19 patients
The study will establish whether NOviricid can improve COVID-19 patient outcomes and survival in 840 recently diagnosed African American patients with comorbidities.
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Availability of critical medicines during pandemics
The impact of COVID-19 is wide-reaching with disruptions to supply chains likely to continue over the coming years. In this article, Dave Elder discusses the effect of the pandemic on the supply and demand of critical medicines and what this means for pharma supply chains.
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FDA approves remdesivir for treatment of COVID-19
The FDA has given marketing authorisation for Veklury (remdesivir) to treat COVID-19 patients requiring hospitalisation.
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Aspirin could protect patients from severe COVID-19 complications
A study has shown that aspirin use was associated with a 47 percent decrease in the risk of dying in the hospital from COVID-19.
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EIB to support COVID-19 therapy with €24.5 million investment
The European Investment Bank (EIB) will provide Immunic with up to €24.5 million to support the ongoing development of IMU-838, a potential COVID-19 therapy.
