CymaBay maps out regulatory filing for primary biliary cholangitis drug seladelpar
Regulatory applications in EU and the UK will follow a potential filing in the US in early 2024.
22 September 2023
22 September 2023
Regulatory applications in EU and the UK will follow a potential filing in the US in early 2024.
Following the divestiture, Glenmark Pharma will own a 7.84% stake in GLS.
Kezar is eligible to receive up to $132.5m in initial upfront and milestone payments.
The company is expecting a decision from the regulator in the first half of next year.
The collaboration will use Evaxion’s EDEN platform to bring AI-designed mRNA vaccine to the market.
The licence grants Meitheal marketing rights for insulin aspart, lispro, and glargine following FDA approval.
New ADCs are being developed to target tumour-specific antigens.
The UK-based surgical robotics company has now raised over $1bn in funding, cementing its unicorn status.
Offering the perfect platform for professionals from across a range of clinical trial functions to meet, network, and hear about latest developments.
The success of CAR-Ts in MM has fueled R&D investment into this class of therapy, with more CAR-Ts in development than all other cell and gene therapy classes combined. The approval of the autologous CAR-T cell therapies Abecma and Carvykti sees the CAR-T pipeline mostly constituted of autologous drugs. However, there are also multiple allogeneic CAR-Ts in the pipeline, with these therapies having an “off-the-shelf” advantage over autologous therapies.
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