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The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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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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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.
The biotech venture capital firm, led by former Andreessen Horowitz senior partner Kouki Harasaki, emerged from stealth on Wednesday focused on investing in companies with first-in-class or best-in-class therapies.
The British biopharma and Arrowhead Pharmaceuticals have reached an agreement with J&J’s Janssen to transfer worldwide rights to develop and commercialize JNJ-3989 to GSK.
The biopharma industry is moving toward using AI to try to determine how well a given person would perform in a role, with applications that go beyond recruiting.
The investment in the French biotech is one of many the pharma giant has made this year to advance cell and gene therapy development. Cellectis shares skyrocketed over 180% in premarket trading Wednesday.
The British biopharma company reported 10% sales growth in the third quarter, driven mainly by robust sales of its respiratory syncytial virus shot Arexvy and shingles vaccine Shingrix.
The regulator has released Mersana Therapeutics’ antibody-drug conjugate XMT-2056 from its clinical hold, allowing the biotech to proceed with Phase I studies of the candidate with a lower starting dose.