ARS hits roadblock for neffy approval as FDA requests additional study
The US FDA requested an additional repeat-dose study to be completed before granting approval for the epinephrine nasal spray.
21 September 2023
21 September 2023
The US FDA requested an additional repeat-dose study to be completed before granting approval for the epinephrine nasal spray.
Merck KGaA announced plans to join forces with BenevolentAI and Exscientia to leverage their AI-driven drug discovery platforms.
The approval is based on findings from the Phase III EMERALD clinical trial of Orserdu.
The Denmark-based Cellerator facility will manufacture cell therapies for clinical trials.
Regeneron has the rights for the development and commercialisation of therapeutic antibodies resulting from the alliance.
The biologics manufacturing company’s CEO said robotics and AI adoption in biopharma needs to catch up to other industries.
Fresh Tracks is planning to seek approval for liquidation and dissolution from stakeholders pending a better offer.
The neurotech will receive the investment in Series B equity financing round to invest in Alzheimer’s disease research.
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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