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11 February, 2026 |
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Want to know more about the FDA’s refusal to review Moderna’s flu shot? Check out our latest Post-Hoc Live, where we unpacked Tuesday’s late-breaking news and discussed how biotech leaders are feeling about the agency. |
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Alexis Kramer |
Editor, Endpoints News
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by Max Bayer
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The FDA may be more willing to look at Moderna’s mRNA-based flu vaccine if the company re-filed it for a narrower group of older adults, a senior agency official told reporters in a call Wednesday defending the regulator’s denial of the application. The official, who spoke to reporters under the condition they not be named, said it was
“entirely feasible” that Moderna could resubmit the application for only 50 to 64 year olds. If the shot shows a clinical benefit in that age group, “then doctors can use it off label if it ends up getting approved on that subgroup,” they said. | |
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by Nicole DeFeudis
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Chinese prosecutors have charged two of AstraZeneca’s former senior employees with illegal trade, unlawful collection of personal information, and medical insurance fraud, the company said this week. AstraZeneca disclosed the charges in its fourth-quarter earnings announcement on Tuesday. The Financial Times reported Wednesday that one of those employees is Leon Wang, former head of AstraZeneca’s China business. Endpoints News is majority-owned by the FT, but operates independently. AstraZeneca didn't respond to
requests for comment in time for publication. AstraZeneca's China subsidiary was also charged with unlawful collection of personal information and illegal trade, the company said. But it added that prosecutors made no allegations that the subsidiary received an illegal gain in connection with the information collection charge. | |
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by Zachary Brennan
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Vinay Prasad, director of the FDA's office of biologics and vaccines, overruled both the vaccine review team and the head of the FDA's vaccine team as part of the regulator's refusal to review Moderna's flu vaccine application, a source with direct knowledge of the
application told Endpoints News. The decision not to review Moderna's mRNA-based flu vaccine came to light on Tuesday, after the biotech issued a contentious news release saying that the agency had shifted the requirements for the vaccine trial. There were earlier hints that Prasad may have acted unilaterally,
signing the refuse-to-file letter that is usually signed by professional staff. A center director stepping in can be a sign of disagreement between FDA leadership and staff below them. Prasad's overrule was confirmed earlier Wednesday by STAT. | |
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by Anna Brown
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One day after bumping out CEO Paul McKenzie, Australia’s CSL revealed what he left behind: declining profit and a $1.1 billion hole due to lower US vaccine demand and increased generic competition. CSL announced McKenzie would retire immediately after the board “recognized he didn’t have the skills that we wanted for the future,” chairman Brian McNamee said Tuesday. The company has faced a tumultuous few years with failed spinoffs, headcount reductions and site closures. Net profit for the last six months of 2025 crashed by 81% and total revenue dropped 4% to $8.3 billion, CSL said Wednesday. The company will take $1.1 billion in impairment charges this year, most of it in the first half. Even with the headwinds, CSL maintained its guidance for fiscal 2026, projecting
revenue growth of 2% to 3%. | |
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