19 September 2023
19 September 2023
The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.
The acquired portfolio is expected to expand Pharmanovia’s CNS presence in Brazil, South Africa, France and Italy.
A Phase I/II clinical trial will enrol 196 healthy participants irrespective of their smallpox immunisation status.
Ligand signed a purchase and sale agreement with Primrose Bio and made an investment of $15m.
Embattled biotech giant Illumina has led series A funding into genomics mapping company Broken String Biosciences.
GSK’s drug is the first treatment approved for intermediate or high-risk myelofibrosis patients who develop anaemia.
The CHMP’s opinion indicates that the therapy could be approved within two months.
The FDA's review is expected to take between ten and 13 months.
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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