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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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Here’s how some biopharmas have managed to gain funding despite a falloff in investment in the sector. Hint: Positive late-stage data is a key factor.
The Japanese pharma is voluntarily withdrawing its lung cancer drug mobocertinib, marketed as Exkivity, from U.S. and global markets after it missed the mark in a Phase III confirmatory trial.
On Monday, Syndax Pharmaceuticals announced that its menin inhibitor revumenib met the goal in a pivotal leukemia study and stopped the trial early. Their stock price still dropped on the news.
Eli Lilly on Tuesday continued its buying spree with a $1.4 billion acquisition of the radiopharma company’s pipeline of clinical and preclinical radioligand therapies.
The Swiss pharma will seek accelerated approval for iptacopan in IgA nephropathy next year after the complement blocker demonstrated promising efficacy in the Phase III APPLAUSE-IgAN study.
Shares of the biotech startup jumped as much as 70% on Friday after the company reported promising early-stage results for a four-week trial that included only 24 patients.
Eli Lilly’s Biologic License Application for its monoclonal antibody lebrikizumab was denied by the regulator after issues were found at a third-party contract manufacturing organization.
Judge Michael Newman of the Southern District of Ohio issued a ruling Friday denying the U.S. Chamber of Commerce’s request for a preliminary injunction against the Inflation Reduction Act provisions.
Despite a sharp downturn in initial public offering activity, New York-based gene therapy company Lexeo Therapeutics and French biotech Abivax are seeking funding for their lead candidate programs.
An FDA advisory committee this week voted overwhelmingly against BrainStorm Cell Therapeutics’ amyotrophic lateral sclerosis treatment. However, other potential therapies offer hope for ALS patients.