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Deals:
AbbVie announced it will buy Gilgamesh Pharmaceuticals’ depression drug for up to $1.2 billion.
Royalty Pharma is paying BeOne Medicines $885 million upfront for certain royalty payments from Amgen tied to ex-China sales of its DLL3 T-cell engager Imdelltra.
Fosun Pharma outlicensed a second inflammatory disease candidate to Sitala Bio for up to $670 million.
MannKind is spending up to $360 million to buy scPharmaceuticals and the treatment Furoscix.
Novartis agreed to a $30 million blood-brain barrier partnership with BioArctic, inventor of Leqembi, the Alzheimer’s drug marketed by Eisai and Biogen.
Scenic Biotech agreed to a license and research agreement with Alnylam Pharmaceuticals.
FDA:
A major U.S. drug manufacturing plant once owned by Catalent and now owned by Novo Nordisk did not properly investigate cat hair, pests, and other problems, an FDA report found.
Amgen announced that the FDA broadened the approved use of Repatha (evolocumab) to include adults at increased risk for major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol.
The FDA recommended pausing use of Valneva’s chikungunya vaccine, citing one death “directly attributable” to Ixchiq and hospitalizations
Biohaven Pharmaceuticals said it won’t need to go before an FDA advisory committee to discuss its spinocerebellar ataxia drug.
Funding rounds:
The Fund for Science and Technology, a research foundation backed with funds from the estate of the deceased Microsoft co-founder Paul Allen, will dole out at least $500 million to support “long bets” in science.
St. Louis cell therapy biotech Wugen raised $115 million.
Leal Therapeutics raised a $30 million Series A round.
Immuneering announced a $25 Million Private Placement.
Osivax received a $19.5 million BARDA Award to Advance Next-Generation Influenza Vaccine for Pandemic and Seasonal Preparedness
Trethera was awarded a $2.3 Million Grant by the National Institutes of Health.
LB Pharmaceuticals seeks IPO
Layoffs:
Arena BioWorks is laying off staff for the second time.
Appia Bio is shutting down its operations.
Industry news:
The Department of Health and Human Services moved to strip thousands of federal health agency employees of their collective bargaining rights, according to a union.
HHS is also terminating a National Institutes of Health grant program that supports students from marginalized backgrounds in the biomedical sciences.
Novo Holdings sold KabaFusion.
The National Cancer Institute is phasing out the Pediatric Brain Tumor Consortium.
The U.S. confirmed its first travel-associated human screwworm case connected to Central American outbreak.
The Supreme Court allowed the Trump administration to proceed with cuts to hundreds of millions of dollars worth of NIH grants tied to diversity, equity and inclusion studies.
Regeneron unveiled positive results from a Phase 3 trial in generalized myasthenia gravis.
BioXcel is set to seek a label update for its psychiatric drug Igalmi after a Phase 3 trial success.
Amylyx Pharmaceuticals’ withdrawn ALS drug Relyvrio failed another neurological disease study.
Eli Lilly said Verzenio extended survival in a late-stage breast cancer trial.
Citius Oncology deployed its AI platform.
Brand and marketing agency Meyocks unveiled a new brand.
To read last week’s edition of Rx Rundown, click here.