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The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
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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.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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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.
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.