The European Medicines Agency says it does not have enough data to justify the approval of Olumiant for hospitalized COVID-19 patients. The marketing authorization application for another product, Reata’s Imbarkyd for chronic kidney disease, has also been withdrawn.

With the planned $487m acquisition of sensorineural-focused Akouos, Lilly makes its second gene therapy M&A play in two years, on top of partnering/financing activity in the space.

Real-world evidence provides external controls for bluebird bio’s eli-cel and Ipsen’s palovarotene, while Reata used RWE to address FDA concerns about the pivotal single-arm study of omaveloxolone. In the post-market, Intercept is gearing up to seek full approval of Ocaliva relying in part on claims database.

National Resilience, Parker Institute team to incubate cancer startups. Metropolitan AntiViral Drug Accelerator will focus on eight molecular features of SARS-CoV-2 to create novel oral antivirals.