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Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
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Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.
Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.
At a J.P. Morgan media event Tuesday, the Gilead C-suite seemed to be walking on air as they highlighted Yeztugo’s capture of the HIV market and its plans for business development.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors.
The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks.
After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.
Lenacapavir, to be marketed as Yeztugo, could “redefine the PReP market,” according to analysts.
In combination with Eli Lilly’s tirzepatide, marketed as Zepbound for obesity, Scholar Rock’s monolonal antibody helped patients lose the same amount of weight as patients on tirzepatide alone while preserving more muscle mass.
On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.
EY’s 2025 Biotech Beyond Borders report provides a sobering snapshot of the industry’s financial health, with more and more companies facing cash runways of less than one year. The analyst firm’s leaders urge a return to basics for biotech.
Industry watchers responded mostly positively to the commissioner’s new voucher program, but worries remain over staffing cuts at the agency.
The U.K.-based biotech is set to enter mid-stage studies for its depression drug this year, while two other GABAA modulators are poised for clinical trials in 2026.
Speaking at BIO2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory landscape.