Janssen Pharmaceutical Cos.
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Eisai and Biogen had double-digit stock price gains based on the positive Phase III readout for lecanemab. The good news also lifted competitors Lilly and Roche as well as earlier-stage Alzheimer’s drug developers.
Unsuccessful attempts to use real-world evidence for approvals highlight the need to demonstrate relationship between real-world data and clinical trial patients. The Pink Sheet examines what went wrong for Bluebird/Bristol’s Abecma, Ultragenyx’s Dojolvi, and Karyopharm’s Xpovio.
The number of approvals under a South Korean fast-track scheme launched around two years ago has increased, led more recently by COVID-19 vaccines and treatments, as well as anticancer drugs. Meanwhile, a new breakthrough therapy program similar to that in the US has been introduced to prioritize and speed up regulatory reviews of innovative medicines.
Of the nine specific appeal points raised against NICE’s rejection of the company’s antidepressant nasal spray, Spravato, just one was upheld.