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A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”
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With the biopharma industry performing better of late, analysts, executives and other industry watchers are “cautiously optimistic”—a term heard all over the streets of San Francisco at the J.P. Morgan Healthcare Conference earlier this month.
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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The New York-based genetic medicine company, which expects gross proceeds of approximately $100 million, joins a small group of biotechs that have launched initial public offerings this year.
The U.S. government has requested that a Delaware federal judge deny an AstraZeneca motion for summary judgement in its Inflation Reduction Act case, arguing that the company’s core claims are meritless.
In a late-stage study, most Huntington’s disease patients reported that their symptoms of chorea were “much improved” or “very much improved” following treatment with Neurocrine Biosciences’ VMAT2 inhibitor Ingrezza.
While Moderna’s total revenue for the third quarter beat analyst expectations, the company Thursday reported a loss as demand for its COVID vaccines declined.
A recent report by Tufts Medical Center reveals impressive approval rates for durable cell and gene therapies, but experts urge caution over persistent safety and accessibility concerns.
Sales of type 2 diabetes treatment Mounjaro brought in $1.4 billion in the third quarter. However, the company cut its full-year profit guidance due to charges mainly related to recent acquisitions.
Riding a wave of skyrocketing Wegovy and Ozempic sales, the company on Thursday raised its sales and operating profit outlook for the rest of the year as part of its third-quarter earnings announcement.
The company’s blockbuster cancer drug continues to snap up FDA approvals, this time in treating biliary tract cancer in combination with cisplatin and gemcitabine. It’s the sixth indication in gastrointestinal cancers.
The Swiss pharma has set up its challenge to AbbVie’s blockbuster immunosuppressive drug Humira with a label expansion for Cosentyx in hidradenitis suppurativa, a painful long-term skin condition.
Ahead of the Inflation Reduction Act’s drug price negotiations, the regulator has approved Amgen’s biosimilar challenge to Johnson & Johnson’s Stelara—with an interchangeable designation to boot.