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Janssen Pharmaceutical Cos.

www.janssen.com

Latest From Janssen Pharmaceutical Cos.

The Real World Is Not Enough: Comparability Is Common Obstacle For RWE In US FDA Decisions

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.

Real-World Evidence Review Pathway

COVID-19, Oncology Dominate Korea’s Fast-Track Approval Program

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.

South Korea Approvals

Janssen Secures Only Partial Win In Appeal Against English Funding Snub For Spravato

Of the nine specific appeal points raised against NICE’s rejection of the company’s antidepressant nasal spray, Spravato, just one was upheld.

United Kingdom Cost Effectiveness

Finance Watch: Recent Upswing Turns Down, But Two Small IPOs Launch

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. 

Financing Restructuring
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