2024-03-01 10:06:00
AstraZeneca abandons its US rights to roxadustat
After roxadustat failed in a phase III trial and failed to reach an agreement with FibroGen for a new trial, required by the FDA for any potential new filings, AstraZeneca has decided to waive its rights to the HIF-PH inhibitor in the United States and certain other countries. The drug was withdrawn by the FDA in 2021 for the treatment of anemia associated with chronic kidney disease. AstraZeneca still retains a stake in China and South Korea, where roxadustat is approved under the brand Evrenzo.
Charcot disease: Biogen’s Qalsody obtains a positive opinion in Europe
The EMA Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the marketing authorization in Europe for Qalsody from Biogen. This treatment, which targets a genetic cause of Charcot disease, aims to slow the inevitable decline in physical abilities of people affected by this pathology. Initially discovered by Ionis Pharmaceuticals, before signing a licensing agreement with Biogen, Qalsody has already been authorized in the United States since April 2023.
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In the EU, only one treatment for Charcot disease is currently authorized, riluzole. The final decision from the European Commission is expected in the second quarter of 2024.
FDA approves antibiotic combination from Allecra Therapeutics
The FDA has just approved the antibiotic combination Exblifep (cefepime/enmatazobactam) fromAllecra Therapeutics as treatment for urinary tract infections, including pyelonephritis, a serious kidney disease. As part of this approval, the American authority extended the commercial exclusivity of the Franco-German start-up in the United States by five years, until 2032.
Allecra Therapeutics now hopes to commercialize its combination of assets in Europe, through a commercial partnership with Advanz Pharma, and in China, through Shanghai Haini Pharmaceutical. In January, the Committee for Medicinal Products for Human Use (CHMP) had already issued a positive opinion on Exblifep.
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