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EUA requested for potential COVID-19 respiratory failure treatment
An Emergency Use Authorization (EUA) request for the use of RLF-100™ (aviptadil) in critical COVID-19 patients was submitted to the US FDA.
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US Food and Drug Administration (FDA)
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The future of label management is with intelligent automation
Kiran Chinnalla and Julian Backhouse explain why automation for labelling in pharma can help the industry to remain compliant in the face of regulatory changes.
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IND granted to Ampion as COVID-19 treatment after Phase I study
The FDA has given the green light to an IND and further Phase I clinical trial of Ampio Pharmaceuticals' Ampion as an inhaled COVID-19 therapy.
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Avelumab significantly improves advanced bladder cancer patient survival
A Phase III trial concluded that avelumab is an effective maintenance therapy for patients with advanced or metastatic urothelial carcinoma, whose disease had not progressed after chemotherapy.
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Gilead Sciences to acquire Immunomedics for $21 billion
Gilead is set to acquire Immunomedics for approximately $21 billion, with the transaction anticipated to close in the fourth quarter of 2020.
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Baricitinib and remdesivir reduce time to recovery in COVID-19 patient trial
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
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Oral COVID-19 vaccine candidate to enter Phase I human trials
Vaxart's application for a Phase I clinical trial to evaluate its oral COVID-19 vaccine candidate has been cleared by the FDA.
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Promising interim results from ALS study testing IPL344
The data suggests disease deterioration was halved in the six Amyotrophic Lateral Sclerosis (ALS) patients treated with IPL344 over eight months.
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Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
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Biopharma pledges to uphold scientific integrity in COVID-19 vaccine development
Nine biopharma CEOs pledged to make the integrity of the scientific process and sufficient supply priorities in the development of COVID-19 vaccines.
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FSD Pharma applies to FDA for trial testing FSD201 in COVID-19 patients
The Investigational New Drug Application (IND) is for a Phase II trial evaluating the safety and efficacy of FSD201 (ultramicronized PEA) in hospitalised COVID-19 patients.
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Nestlé Health Science to acquire Aimmune Therapeutics for $2.6 billion
Nestlé Health Science will acquire Aimmune Therapeutics for a total value of $2.6 billion, extending the former's food allergy portfolio.
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FDA expands emergency use authorisation for remdesivir to treat all COVID-19 patients
The FDA has expanded the Emergency Use Authorisation for Veklury (remdesivir) to treat all hospitalised patients with COVID-19.
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Artificial pancreas for type 1 diabetes control given nod by FDA
The all-in-one, Control-IQ system controlled the blood glucose levels of children aged six and over more successfully than standard technologies in a clinical trials.
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Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.