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Biopharma companies won’t fully capture the benefits of AI unless they reorganize their R&D units, according to McKinsey.
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Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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Three new studies have been released—but not yet peer-reviewed—that support the wet market theory relating to COVID-19.
The company is conducting analyses to understand safety data that had been gathered prior to the pausing of the three studies, NCT04605159, NCT04980391 and NCT05229068.
That’s the advice for emerging growth life sciences companies in 2022, according to attorney Frank Rahmani, partner in the global life science and capital markets practice group at Sidley Austin LLP.
The FDA said that the shared NDA documents did not show ample proof that bardoxolone methyl effectively slows down kidney function loss in patients with Alport syndrome.
The decision was intended to resolve the matter as swiftly as possible so that those who claimed to have been harmed by the product could receive expeditious compensation.
It is unknown whether tightening economic sanctions will limit Russia’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.
With nipocalimab, Janssen is hoping to take one big swing and knock the power right out of these autoantibodies.
The Centers for Disease Control and Prevention (CDC) revised its recommendations on wearing masks indoors to protect against COVID-19.
Chicago-based AbbVie has been making major decisions with company-wide impacts. The therapeutic company appears to be making changes that will benefit its bottom line.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.