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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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The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.
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Listen to this in-depth discussion on how AI can help identify end-to-end data weaknesses, as well as broader implications regarding the inevitability of human interaction, with guests from GSK, IQVIA, Exelixis and DataHow.
For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape.
The regulator accepted Karuna Therapeutics’ NDA and set a PDUFA date of September 26, 2024. If approved, it would be the first new mechanism of action to treat schizophrenia in decades, the company contends.
The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
The pharma giant is paying $9 million upfront to Phenomic AI to develop targets for stroma-rich cancers, some of the hardest cancers to treat, utilizing its single-cell RNA computing platform.
BioSpace spoke to analysts and players in the contract manufacturing and development organizations space to assess the challenges this year and what lies ahead in 2024.
This week on The Weekly we talk struggles with GLP-1 drug shortages and what that might mean for Novo and Lilly competitors; Regeneron and Sanofi positive results for Dupixent in COPD. Plus, Merck buys Caraway, Beigene’s deal with Ensem, ups and downs for Flagship.
In a deal with Tokyo-based PRISM BioLab, Eli Lilly will gain access to the Japanese biotech’s proprietary platform to develop small molecule inhibitors of protein-protein interactions.