A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application and setting an assigned PDUFA date of Aug. 5, 2026.
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.
The use of DNA scaffolds could mark a turning point in HIV vaccine design. Scientists at Scripps Research and the Massachusetts Institute of Technology (MIT) have created a new vaccine platform based on DNA origami, a material that the immune system does not recognize as a threat, avoiding unwanted responses.
Moderna Inc. blamed a switcheroo by the U.S. FDA for the refusal-to-file (RTF) letter on the seasonal influenza vaccine mRNA-1010. Shares of the firm (NASDAQ:MRNA) closed Feb. 11 at $40.51, down $1.49, having traded as low as $36.66 as investors learned of the RTF letter, which Moderna said is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-BLA-submission talks.
Zhejiang Difference Biological Technology Co. Ltd. (Diff Biotech)’s proprietary nasal spray influenza attenuated live vaccine, DIFF-flu, has received clinical trial approval from China’s National Medical Products Administration (NMPA).
Delonix Bioworks Ltd. has obtained IND clearance from China’s National Medical Products Administration (NMPA) for its group B meningococcal (MenB) vaccine candidate, DX-104. This follows the successful completion last month of clinical trial notification (CTN) procedures and ethics committee approval in Australia.
A recent publication in Cell Reports Medicine from researchers at the Washington University School of Medicine and the La Jolla Institute for Immunology presents a promising new strategy for H5N1 vaccination.
Kahimmune Therapeutics SAS has signed an exclusive licensing agreement with Gustave Roussy and SATT Paris-Saclay. Created at the end of last year as a spin-off of Gustave Roussy and SATT Paris-Saclay, Kahimmune builds on the latest discoveries in immunology relating to the dark genome.
Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.
Shionogi & Co. Ltd. and Fosun Pharmaceutical (Group) Co. Ltd. were involved in separate divestment transactions this week, with Shionogi buying out Pfizer Inc.’s stake in Viiv Healthcare Ltd. to lift its holding to 21.7%.
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