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.

Shuttle Pharmaceuticals and PaxMedica launch two small initial public offerings in the US as the market awaits a significant IPO. Also, Assertio closed a $70m follow-on offering, Codiak restructures and cuts jobs, and Vilya emerges with $50m in series A venture capital.