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The FDA rejected bitopertin in February amid reports of skepticism from former CBER director Vinay Prasad, who has since departed the agency.
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The public biotech universe has shrunk by more than 20% since 2021, yet financial stress remains entrenched across the sector, according to a report from EY Tuesday.
Novo Nordisk and Eli Lilly presented data extolling the benefits of their relative weight loss therapies in obesity-linked indications, while analysts at BMO Capital Markets were “encouraged” by the strategy communicated by Novo management.
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
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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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Biotech R&D job postings live on BioSpace rose for the fourth straight month in April, and a CBRE report shared similar findings for employment. The head of CBRE’s U.S. life sciences practice discusses what’s behind the growth and the current job market.
Opportunities increased by the end of the first quarter, according to BioSpace data.
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.
Sanofi’s investment will support a Canadian site’s efforts to apply AI to drug production, while Amgen has unveiled the second expansion of its Puerto Rico plant in quick succession.
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.
Analysts and investors alike had been eagerly awaiting sales figures for Novo Nordisk’s Wegovy pill. The answer blew past expectations by 86%.
Pfizer-backed cancer company CellCentric will use the cash to support the launch of a pivotal myeloma trial testing its potentially first-in-class oral treatment this year.
For $300 million upfront, Bayer is purchasing Perfuse Therapeutics to advance an eye implant for glaucoma and diabetic retinopathy, marking the company’s first pharma acquisition since 2021.
Viridian Therapeutics’ elegrobart normalized the degree of eye protrusion and improved double vision in a Phase 3 study. The company plans to file for approval in the first quarter of 2027.
Johnson & Johnson plans to advance the co-antibody therapy, which combines its IL-23 blocker Tremfya and the TNF-alpha inhibitor Simponi, into late-stage testing for Crohn’s disease and ulcerative colitis.