Approvals

NGM Bio’s aldafermin failed to hit its primary endpoint in its Phase IIB trial because of that, the company decides to shift resources to other programs.
FDA
It’s a busy week for the U.S. Food and Drug Administration, with a number of drug approvals on the calendar and an advisory committee meeting. Read on for more information.
If approved, Takeda said Maribavir would become the first and only treatment indicated for CMV infection in refractory patients.
Janux plans to use the funds raised from the IPO to submit four Investigational New Drug applications to the U.S. FDA in the first half of 2022.
FDA
CARsgen is building a new $157 million CAR-T manufacturing facility in Durham, that is expected to create approximately 200 new jobs.
FDA
Maria Fardis, who has been with the company since 2016, stepped down as CEO following FDA’s delay on its Biologics License Application.
Less than two weeks after Ginkgo Bioworks announced a merger with SPAC Soaring Eagle Acquisition Corp., it announced a collaboration partnership with Biogen.
Two of Merck’s Phase III pediatric trials show 15-valent pneumococcal conjugate vaccine, V114, may be safe and effective in healthy children.
Eli Lilly’s SURPASS-4 trial program shows tirzepatide, significantly reduced blood glucose levels and body weight better than insulin glargine in adult patients with type 2 diabetes.
The House Select Subcommittee on the Coronavirus Crisis questioned executives from Emergent BioSolutions as part of a congressional probe.
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