Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. LianBio, a prominent player in bringing foreign meds to China, will wind down. Plus more.
Takeda has surprisingly won the FDA’s backing for Eohilia, an oral suspension formulation of budesonide, for eosinophilic esophagitis (EoE). The Japanese pharma had previously abandoned the drug after an FDA rejection in late 2021. But the company refiled last fall after receiving “significant grassroots support” from the gastrointestinal and EoE communities, according to Takeda’s R&D chief Andy Plump, M.D., Ph.D.
WuXi AppTec and WuXi Biologics appeared to be in deeper trouble amid unrelenting geopolitical tension between the U.S. and China. A group of bipartisan lawmakers are asking the U.S. federal government to sanction the two Chinese firms out of national security concerns, Reuters reported. The companies have previously refuted claims that they pose a national security threat.
3. LianBio lays off half of workforce as biotech begins to wind down
LianBio, a company built on the business model of in-licensing novel drugs for the Chinese market, will shut down. The decision followed a four-month strategic review that found no alternative to the firm’s future. The company expects to delist from the Nasdaq around March 18. It'll return $528 million in cash to shareholders, and completely dissolve around 2027.
4. Japan's Ono Pharma taps Texas startup Shattuck for $227M bifunctional fusion protein deal
Ono Pharmaceutical has penned a deal to tap into Shattuck Labs’ bifunctional fusion protein capabilities. For an undisclosed upfront payment and up to $227 million in milestones, Ono will select two targets in autoimmune and inflammatory diseases. The company will have an exclusive option to develop and commercialize multiple products.
5. Takeda powers toward pivotal trials after phase 2b narcolepsy win but pauses multi-indication dream
Takeda’s narcolepsy candidate TAK-861 delivered a partial success in a phase 2b program. The oral orexin receptor 2 agonist showed promise in narcolepsy type 1 but didn’t move the needle in type 2 disease, which is a rarer, normally milder form. The company now plans to start phase 3 testing this year in the type 1 group.
China’s Brii Biosciences has decided to fully acquire a hepatitis B vaccine candidate, VBI-2601, from its partner VBI Vaccines. The move gives VBI $33 million and eliminates some $437 million in future milestone payments and additional royalties that Brii agreed to pay VBI under certain circumstances. Brii also gets manufacturing capabilities and certain rights to a VBI glioblastoma candidate.
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9. Piramal API plant in Michigan hit with FDA Form 483 write-up