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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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Competition for biotech and pharma employment picked up year over year and remains strong, according to BioSpace data. A survey late last year showed that 64% of employed/contract and 96% of unemployed respondents will actively look for work in 2026.
Reporting Q4 and full year earnings on Wednesday, J&J executives hailed growth across the healthcare giant’s portfolio while standing fast on its talc lawsuit and tariffs.
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.