By Nick Paul Taylor
The follicular lymphoma market is thinning out fast. Days after Gilead pulled an accelerated approval for Zydelig in the indication, Incyte has withdrawn a submission for approval of its rival PI3K inhibitor in response to talks with the FDA about confirmatory studies.
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By Andrea Park
2021 was full of ups and downs, and coronavirus test makers like Abbott bore the brunt of each and every one of them.
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By Kevin Dunleavy
Immunocore's Kimmtrak has been approved by the FDA for uveal melanoma a month ahead of its target date. It is the first therapy for unresectable or metastatic uveal melanoma, and the first drug of its class, as a T-cell receptor therapy, to be approved. It will be priced at $18,760 per vial for a weekly dose, or $400,000 for the average patient duration.
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By Nick Paul Taylor
Gilead’s $4.9 billion oncology bet has hit a late-phase setback. Spooked by an “apparent imbalance” in adverse reactions between study arms, the FDA has imposed a partial clinical hold on a handful of trials of magrolimab—raising questions about the program and the billions biopharma has bet on CD47.
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By Paige Minemyer
Change Healthcare is mulling the sale of its payment integrity business, ClaimsXten, in hopes it will pave the way for federal approval for its merger with UnitedHealth Group, Bloomberg reports.
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By Angus Liu
In a blow to Roche, gene therapy developer bluebird bio can continue to use “spark” in its marketing campaign for sickle cell disease—at least for a while. A federal judge in Delaware has denied a request by Roche’s Spark Therapeutics for a preliminary injunction against a bluebird disease awareness campaign dubbed “Be the Spark.”
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By Conor Hale
The funding round follows a European approval at the end of 2020 and the Dexter system's first gynecologic and general surgery procedures last year.
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By Heather Landi
Four top executives, including former Cerner CEO Brent Shafer, have golden parachutes ranging from $10 million to almost $22 million if they are forced out in the Oracle acquisition, according to a filing with the SEC. The filing also outlines how the deal came together and offers details about another takeover offer that occurred months before.
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By Andrea Park
Less than two years after scoring its first FDA clearance, Akili Interactive is betting big on its digital therapeutic technology.
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By Kyle LaHucik
In the 41-year HIV epidemic, no treatments have been approved to completely clear the virus largely because of its ability to live on in hidden form in the genomes of T cells. Now, researchers say an approved cancer drug might help flush the dormant HIV from immune cells, potentially paving the way for new treatment options.
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By Sharon Klahr Coey
In times of trouble, (hello, global pandemic year two), it’s a common and popular practice to wax poetic about the strength of the human spirit … and that’s just what Pfizer does in the latest of its brand-building “don’t talk too much about the vaccine” spots.
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By Annalee Armstrong
CytoDyn CEO Nader Pourhassan, Ph.D., is out, and CFO Antonio Migliarese is in, at least for the interim, in the latest twist in one of the wildest tales in biotech. The embattled company, which has been trying for the past year to prove its therapy leronlimab can work in diseases from cancer to COVID-19 to HIV, unveiled the leadership change Tuesday morning.
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