18 September 2023
18 September 2023
The FDA pushed lifileucel’s PDUFA date from November 2023 to 24 February 2024, citing resource constraints.
The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.
While orphan drug approvals have hit an all-time high, existing incentives need to continue to further support rare disease research.
The therapy will be available to patients who have insomnia multiple times a week, do not respond to CBTi, and whose wakeful day is severely impacted.
Experts say a wider diverse pool of patients needs to be given a chance to participate in clinical research to get rare disease drugs faster to market.
According to GlobalData’s analyst consensus forecasts, GlobalData anticipates Reblozyl’s projected total annual sales to reach $3.2bn by 2029.
A new report found that the Remote Patient Monitoring (RPM) sector will grow, since the pandemic revealed the benefits of remote healthcare.
Eli Lilly witnessed the largest growth in market capitalisation of 36.1% over Q2 2023, propelling the company to the top of the list.
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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