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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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Patients treated with Longboard Pharmaceuticals’ bexicaserin saw a 32.5% drop in the frequency of countable motor seizures relative to placebo in a Phase 1b/IIa study. The company’s shares soared 316% Tuesday on the news.
The antibody-drug conjugate market remains hot so far in 2024 with Tuesday’s collaboration and license agreement between Roche and MediLink Therapeutics to develop a next-generation ADC in oncology.
The Swiss pharma is looking to leverage Voyager Therapeutics’ capsid technology for gene therapies aimed at treating Huntington’s disease and spinal muscular atrophy.
All three companies closed out the year, which saw significant growth in mergers and acquisitions, with high-value deals that could potentially set the tone for M&A in 2024.
Biopharmas of varying sizes—including larger companies like Amgen, Gilead and Pfizer—cut employees in 2023 to stay afloat.
Eli Lilly has signed a multi-year contract with animal genomics biotech Fauna Bio to use its artificial intelligence platform to discover drug targets for obesity in a deal worth nearly half a billion dollars.
Under the companies’ agreement, a previously disclosed option exercise fee of $75 million has been reduced to $10 million and the remaining pre-option development milestone has been removed.
GSK withdrew three patents related to its asthma inhalers while Impax delisted both of its patents for Adrenaclick and Kaléo delisted eight patents covering Auvi-Q—the companies’ respective epinephrine auto-injectors.
The acquisition announced on Friday will give Bristol Myers Squibb ownership of Karuna Therapeutics’ investigational antipsychotic KarXT, which is being tested for schizophrenia and Alzheimer’s disease psychosis.
In a Phase II study, Jazz Pharmaceuticals’ investigational fatty acid amide hydrolase inhibitor JZP150 did not significantly improve post-traumatic stress disorder symptoms compared to placebo.