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FDA inspectors found that Medline, which raised billions of dollars last year, failed to prevent repeat bacterial contamination of finished drug products.
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From Chinese innovation to AI, biotech CEOs are being hit with challenges at a breakneck pace. Three leaders from BioSpace’s NextGen Class of 2026 told us about the issues keeping them up at night.
Deal dynamics between Chinese biotechs and global pharma companies are changing fast, with the biotechs seeking higher upfront payments and the Big Pharmas seeking more expansive platform deals.
Pfizer showcased multiple late-breakers at the American Society of Clinical Oncology’s annual conference but its biggest data are expected later this year.
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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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Attendance at the Biotech CEO Sisterhood’s annual photo of women leaders and allies in Union Square doubled this year. There’s still more work to do.
After winning a surprise approval for its hereditary angioedema drug Ekterly, KalVista is confident the oral offering will capture the lion’s share of the market for on-demand use.
Novo Nordisk pulled back from cell therapies last October, scrapping development of a type 1 diabetes therapy and laying off most employees working on this modality.
Genentech, a member of the Roche Group, plans to open the facility in 2029 to ramp up capacity to make obesity candidates, including the dual GLP-1/GIP receptor agonist CT-388.
Ahead of GSK are Bristol Myers Squibb and Merck, which have already won FDA approvals for subcutaneous formulations of their respective PD-1 blockers Opdivo and Keytruda.
The obesity market and Most Favored Nation drug pricing were among the topics de jour at the J.P. Morgan Healthcare Conference last week, while smaller biotechs sought to assure investors that their regulatory ducks are in a row; Novo Nordisk’s oral obesity pill got off to a hot start while the FDA delayed a decision on Eli Lilly’s investigational offering; and SpyGlass Pharma and AgomAb Therapeutics join the 2026 IPO club.
At some point in your research career, you may find yourself transitioning from academia to industry or vice versa. To best set yourself up for success, adapt your approach to the specific scientific culture where you work.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.
In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors.