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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 rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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The investigational injection fosgonimeton appeared to have better efficacy in patients with more severe disease, according to post-hoc subgroup analyses, though none resulted in statistically significant effects.
Recursion’s oral drug candidate for cerebral cavernous malformation showed no improvements in patient- or physician-reported outcomes at 12 months. The biotech will engage with the FDA to determine the need for an additional study.
Big Pharma has finally gotten its arms around something advocates have wanted for a long time: direct-to-consumer sales. Eli Lilly and Pfizer are leading the way.
Having difficult conversations with the right mindset can build trust and further develop your relationship with your team.
Getting caught between younger team members and older bosses can be stressful for millennial managers. A leadership expert and millennial manager share tips for bridging the gap between these groups.
Eli Lilly offers weight loss drug Zepbound directly to consumers while Novo Nordisk continues to struggle with supply challenges for its own GLP-1s. Meanwhile, gene therapies for retinal diseases target competitive market, and layoffs persist.
The intellectual property landscape for newer gene-editing technologies, like that for CRISPR-Cas9, remains unclear and hard to navigate.
Analysts expect the companies’ Vabysmo and Eylea HD to generate a combined $13.2 billion by 2030 in the vascular endothelial growth A therapy market, as healthcare providers and patients switch from older products.
Astellas Gene Therapies is closing its San Francisco biomanufacturing facility, shifting gene therapy manufacturing to North Carolina, cutting at least 17 employees and affecting dozens more.
Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.