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New potential topical therapy in dermatitis space set to move towards Japan approval submission based on positive new results.
The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.
Akero’s FGF21 analog yields 63%-72% relative hepatic fat reduction in Phase IIa study; the company awaits biopsy data hoping to see a fibrotic benefit. Also, Genfit says COVID-19 pandemic should not significantly delay its Phase III NASH readout.
Approved in February as an on-demand remedy, Nurtec will be filed for migraine prevention after success in Phase III. It could be the first oral preventive therapy and first dual purpose migraine drug.
South Korea’s Qurient achieves proof of concept in a Phase II study with its first-in-class antibiotic telacebec for tuberculosis and aims to file a US NDA for the orphan drug.
Efficacy seen in reducing hospitalization in high-risk heart failure patients, but not in reducing the risk of cardiovascular death. Analysts say this portends a more niche opportunity for vericiguat.
A Phase III trial testing dapagliflozin in chronic kidney disease patients with and without diabetes was stopped early following a recommendation from an independent data monitoring committee.
A coronavirus vaccine is some way off and until then, Vas Narasimhan, head of Novartis, is thinking that of the drugs being repurposed to treat COVID-19, hydroxychloroquine looks best placed to provide the quickest benefit.
Clinical trials in a range of diseases continue to be impacted by concerns about patient safety and health care resources as the COVID-19 pandemic grows.
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