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Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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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 U.K. drugmaker also announced plans to drop another $2 billion on expanding its R&D and manufacturing footprint in the “important” U.S. market.
Bayer reported a decline of 37% in earnings per share on Tuesday, which sent its stock down 12%. CEO Bill Anderson urged investors to be patient as the company executes on a performance-boosting strategy outlined in March.
BioSpace takes a look at the headlines across a heavy earnings week for biotechs, checking in on Allogene, Rapport and more.
With $70 million upfront and more than $1.8 billion on the line, Roche will gain access to Flare’s drug discovery engine to bolster its oncology pipeline.
In a small Phase IIa trial, Insilico’s generative AI-designed idiopathic pulmonary fibrosis drug improved lung function and was well-tolerated across all dosing groups.
In line with the restructuring initiative, 23andMe is looking for strategic opportunities for its pipeline assets, including licensing deals or outright sales.
Analysts did not seem very concerned by the treatment-related serious adverse event, noting that NGN-401 was well-tolerated at a lower dose and showed promising efficacy outcomes.
CEO Roberto Iacone admitted in an interview that the market remains tough, even for a biotech in the red-hot ADC world. But Alentis is targeting an IPO as early as 2025.
BioSpace has named 50 biopharma companies to its 2025 Best Places to Work list, including Moderna and Sutro Biopharma, whose executives share what makes their organizations special.
The shocking failure of AbbVie’s emraclidine has investors questioning the Big Pharma’s long-term neuroscience strategy, which put the drug at the center of expectations.