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The FDA has introduced models intended to accelerate rare disease drug development, but recent reversals of guidance from the agency speak to a lack of clarity in its implementation. AI can help focus this process.
European pharma companies splashed billions of dollars into the U.S. biopharma sector in a matter of days, but there are differing views on whether the activity represents the rise of a new buyer class or a quirk of timing.
Three pharma CEOs joined the $30 million compensation club in 2025 but Eli Lilly’s David Ricks exceeded his nearest peer by more than $4 million.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The team comes together to discuss the dominant themes of what was an incredibly busy week of events in San Francisco during JPM 2024.
The U.S. Patent and Trademark Office has sided with Daiichi over Seagen in a years-long patent saga concerning a key linker technology used in its blockbuster Enhertu antibody-drug conjugate for cancer.
FDA
The FDA on Tuesday extended the label for Takeda’s immune globulin infusion as a maintenance therapy for adults with chronic inflammatory demyelinating polyneuropathy.
Delaware Chancery Court Judge Paul Fioravanti on Tuesday ordered activist investor Carl Icahn to remove confidential information from his lawsuit against legacy Illumina board members.
FDA
Vertex Pharmaceuticals and CRISPR Therapeutics have secured another FDA approval for their Casgevy Cas9 gene-edited cell therapy, this time in treating transfusion-dependent beta thalassemia.
Disco Pharmaceuticals is taking to the biotech dance floor with seed funding from major players and pipeline programs in small cell lung cancer and colorectal cancer.
The biotech Tuesday announced a restructuring plan as its humanized IgG1 antibody lirentelimab failed two Phase II studies in atopic dermatitis and chronic spontaneous urticaria.
The snacks and confectionery giant has been seeking to enter the biopharmaceuticals space in recent years.
Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year.
Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.