2023-06-16 07:00:00
Valneva moves closer to clearance once morest chikungunya
The Nantes biotech announced the publication, in the journal The Lancetphase III data from its vaccine candidate once morest chikungunya, VLA1553. According to the results, the compound showed a sero-response rate of 98.9%, 28 days following a single injection of the vaccine. In addition, 96% of trial participants maintained an immune response six months following vaccination. A decision from the FDA is expected by the end of August 2023.
Priority review for AstraZeneca’s capivasertib
The FDA has decided to grant priority review to the association capivasertib et Faslodex (fulvestrant) from the British laboratory, following a phase III trial in patients with advanced HER2-positive breast cancer. In the clinic, the combination reduced the risk of disease progression or death by 40%, compared to Faslodex alone. AstraZeneca hopes for a regulatory decision from the health agency by the fourth quarter of 2023.
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FDA to review Onivyde for pancreatic cancer
The US health agency accepted the request for additional indication of theOniview (irinotecan) from the French laboratory, in combination with 5-fluorouracil/leucovorin and oxaliplatin, as a potential first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The FDA’s final decision is expected on February 13, 2024.
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