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After the FDA flagged patient deaths linked to Amgen’s rare disease drug Tavneos and called for its voluntary removal, the pharma recruited an independent data analysis from Duke researchers to help build the case for the drug’s continued market approval.
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As the industry faces policy changes and significant cuts to federal funding, local ecosystems can bolster companies through innovative resources to sustain growth and keep the U.S. at the center of biomedical innovation.
Over the past decade, Eli Lilly has bought out more biotechs than any of the other top 12 pharmas by revenue—with 10 of those acquisitions arriving just this year.
Members of the American Biotech Innovation Alliance (ABIA) want to build a national biotech strategy—just like China did years ago.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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With incoming president Donald Trump threatening a trade war with China, experts told BioSpace that the new administration will likely understand why medicines should be treated differently.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis talks to Dr. Peter Marks, Director, CBER about his thoughts on the future of cell and gene therapies.
After a series of strongly worded letters—one of which was addressed directly to Commissioner Robert Califf—the FDA has publicly laid out its reasoning for rejecting Vanda Pharmaceuticals’ gastroparesis drug candidate tradipitant.
AbbVie and Gilead are going back to their roots and leaning on their established areas of expertise to set themselves up for sustainable success in 2025.
Omvoh’s label expansion is important progress for Eli Lilly as it works to diversify its portfolio beyond obesity, according to analysts from BMO Capital Markets.
Annemarie Hanekamp has overseen some of the most transformative changes in oncology over her years in Big Pharma. Now, she will oversee BioNTech’s transition from a COVID-19 vaccine maker to an “end-to-end organizational oncology powerhouse.”
Along with its gene editing therapy Casgevy, Vertex is offering fertility preservation support for its patients—a program that the HHS claims violates anti-kickback statutes.
While investors and analysts push for a deal, Biogen CEO Chris Viehbacher and Head of Development Priya Singhal refuse to make one out of desperation.
Amidst a “renaissance” of interest in neuropsychiatry, Seaport’s executive team is taking nothing for granted.
Taken together with Keros’ recent pivot away from obesity, the termination of its pulmonary arterial hypertension study could lead to a “difficult path ahead” for Keros, according to Guggenheim analysts.