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Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartis’ chief dealmaker Ronny Gal explains why the Swiss pharma hasn’t acquired a GLP-1, and why it probably won’t.
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Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.
Former European Trade Commissioner Phil Hogan and former US Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
Heightened diligence standards and longer decision timelines for early-stage startups slowed venture activity last year, J.P. Morgan found in a report published ahead of the bank’s annual healthcare conference in San Francisco.
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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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The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer.
Last month, the FDA declined to approve Sanofi’s tolebrutinib for a specific form of multiple sclerosis. In a recently published complete response letter, the agency detailed its reasoning behind the rejection.
While Zenas’ obexelimab hit the primary endpoint in the Phase III INDIGO study, it came far below the efficacy threshold set by Amgen’s B cell depleter Uplizna, approved by the FDA for IgG4-related disease last April.
The agreement, which BMO Capital Markets called a “mild positive” for Structure, appears to address Roche’s concerns about the composition of investigational weight loss drug CT-996.
OncoNano’s platform, called ON-BOARD, packages drugs in pH-sensitive micelles that ensure their specific delivery near tumors, while also preventing systemic exposure.
Next-generation automation is closing the gap between curative science and real-world demand, enabling faster development, global consistency and broader patient access to CAR T therapies.
After a strong open to the year, the public markets suffered a six-month drought that led to biotech’s tightest IPO window in years.
Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Industry leaders are focused on the resilience of key starting material supply and the knock-on effects of automation in the new year.
In a year that saw advisory committees placed under a particularly bright microscope at the FDA, the agency held fewer meetings than usual and agreed with its advisors only 57% of the time, Jefferies reported.