06 December 2023
06 December 2023
In a Type C meeting, the FDA requested additional data to support Travere’s Filspari approval as a treatment for focal segmental glomerulosclerosis.
Professor Timothy Mackey talks about the recent reports of fraudulent Ozempic pens and the challenges in chasing drug counterfeiters.
The updated Covid-19 vaccine is also authorised for use in the US and the European Union.
Opdivo plus cisplatin-based chemotherapy followed by Opdivo monotherapy showed improvements in the primary efficacy endpoints.
The FDA has set a PDUFA date of 5 April 2024 for the ADC Elahere, which was part of an acquisition announced by AbbVie last week.
The multi-year research collaboration will involve Aqemia’s AI platform, with the company receiving up to $140m from Sanofi.
The company will use the investment to progress programmes into clinical trials and continue investing in discovery processes.
CRISPR Therapeutics detailed plans to expand the use of its oncology CAR T therapies for autoimmune indications.
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Merging industry-leading business intelligence & award-winning journalism, this is an unrivalled opportunity for engagement with B2B professionals across a network of 40+ leading media websites.
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.
Only a handful of approved therapeutic drugs are currently available for the treatment of ARF, all belonging to the solute carrier family 12 member 1 inhibitor. The clinical trial space in ARF consists of almost an equal mix of commercial as well as academic sponsors, with Iran and the US emerging as the key countries for conducting Phase III trials.
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