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Citing insufficient safety evidence for one of the drug’s main ingredients, the regulator in a Complete Response Letter rejected the company’s application for Parkinson’s disease candidate IPX203.
The companies have filed their own suit against the Federal Trade Commission, claiming the FTC’s attempt to legally block their $28 billion merger is unconstitutional.
After initial Phase II data for the oral IL-23 receptor antagonist licensed from Protagonist Therapeutics spooked investors, Janssen provided a fuller readout and advanced the candidate.
Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.
Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.
The verdict, rendered by a California jury on Friday, found that the companies did not engage in an anticompetitive conspiracy to delay generic versions of HIV PreEP medicines.
AbbVie’s Humira will now face competition from new biosimilars, including Boehringer Ingelheim’s Cyltezo, Celltrion’s Yuflyma, Organon and Samsung’s Hadlima, and Sandoz’s Hyrimoz.
The revised guidance comes amid lawsuits filed by drug manufacturers and industry groups, which claim the Inflation Reduction Act is unconstitutional. Prices negotiated will be effective as of 2026.
The acquisition, valued at up to $2.5 billion, marks the first major move by Bausch + Lomb CEO Brent Saunders since he took the company’s helm in March.
The companies Friday reported positive late-stage results for elafibranor as a second-line treatment for primary biliary cholangitis, a rare liver disease.
More than a month after failing its Friedrich’s ataxia trial, PTC Therapeutics’ vatiquinone has again missed its primary endpoint, this time in a mitochondrial disease-associated seizures study.
In its third acquisition this month, Eli Lilly is buying antibody-drug conjugates startup Emergence Therapeutics to bolster its cancer business.