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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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Many scientists-turned-CEOs paradoxically abandon scientific principles when it comes to commercializing their innovations. But applying the scientific method to business decisions can help life science entrepreneurs avoid common pitfalls, attract investment and ultimately bring transformative technologies to market.
FDA vouchers are normally a coveted prize for biopharma companies, but a surprise rejection for Disc Medicine’s rare disease drug has biopharma reconsidering.
PitchBook’s 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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Biologics have a major advantage over small molecule drugs under the Inflation Reduction Act’s provisions, according to stakeholders attending this week’s J.P. Morgan conference.
The German biotech is dropping $20 million upfront on two preclinical monoclonal antibodies for undisclosed targets developed by WuXi Biologics.
Analysts in life sciences play a crucial role in analyzing and interpreting data to support research, development and decision-making processes within the field.
Panelists at JPM’s Biotech Showcase gave positive projections as the year begins and offered advice to those in the space.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 3 at JPM2024.
Triumvira Immunologics’ president and chief operating officer Rob Williamson noted that cell therapy companies might still have an uphill battle unless they can differentiate.
The Massachusetts–based startup will use the Series A funds to advance its pipeline of oral GPR17, CSF1R and TYK2 candidates.
Patients treated with AR-15512 showed higher rates of at least a 10-mm improvement in unanesthetized Schirmer’s score, a metric of tear production.
The BioSpace team is recording from San Francisco as they bring you the the latest highlights from Day 2 at JPM2024.