mRNA

FDA
Even after the runaway success of mRNA vaccines against COVID-19, the pathway to approval for upcoming would-be mRNA therapeutics has yet to be laid out.
The COVID-19 pandemic highlighted a need for local production of vaccines. Now, German pharma company BioNTech has said it will start manufacturing vaccines in Africa.
The company plans to launch up to 15 new products and bring up to 50 new candidates to the clinic over the next five years as part of its growth plan, while scaling down COVID-19 manufacturing.
The companies will evaluate Moderna’s investigational Claudin18.2 mRNA cancer vaccine in combination with CARsgen’s Claudin18.2 CAR T cell candidate.
The company has signed a memorandum of understanding and land collaboration agreement to develop medicines exclusively for Chinese use.
ReCode plans to use its SORT LNP genetic medicines delivery technology to treat CF and PCD patients who don’t respond to current treatments.
Moderna claims it can have vaccines ready for multiple cancer types by 2030, but experts say challenges remain.
The lawsuit, brought by Arbutus Biopharma, marks the latest legal action in an ongoing battle for intellectual property underlying mRNA vaccines for COVID-19.
Choose your raw materials wisely
Moderna may seek the FDA’s accelerated approval for its personalized cancer vaccine, president Stephen Hoge said Monday.
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