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Update: Reversal after 20 deaths allows new Japan patients to take Amgen’s rare disease drug Tavneos
Kissei Pharmaceutical is reversing a recommendation related to Amgen-shared Tavneos that it made just a few days ago, now saying the rare disease drug can be given to new patients.
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While the pathogen appears unlikely to trigger a pandemic, analysts see potential for Moderna to build goodwill amid a period of political pressure on vaccine manufacturers.
Clinical trial setbacks have limited the near-term opportunities for some of Daiichi Sankyo’s ADCs but the drug developer is betting near-term readouts will catapult it into the top tier of oncology companies in the coming years.
BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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While some analysts may regard Vertex Pharmaceuticals’ first quarter results as “unremarkable,” BMO Capital Markets wrote on Monday, the second half of 2026 could be big for the biotech, with the potential approval of IgAN therapy povetacicept.
The selloff in Eli Lilly’s shares was “overdone,” according to RBC Capital Markets, which noted that the overall safety profile of Foundayo remains favorable.
The FDA is reportedly down to a handful of final candidates to lead CBER, with a potential selection expected in the coming month or two. For now, the appointment of acting director Katherine Szarama has not allayed the industry’s concerns.
Novel targets aim to stop lung scarring—where current drugs only slow it—while improving tolerability and unlocking fibrosis in other organs next
A subsidiary of Indian drugmaker Hetero Group mistakenly packaged two types of antidepressants in packs of sertraline, potentially posing risks to patients.
As Q1 earnings arrive, three biotechs have big quarters ahead, with two—Amylyx and Neumora Therapeutics—betting at least partly on novel assets for obesity.
Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include frontotemporal dementia, is exploring strategic alternatives in addition to cutting staff.
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics and Intellia Therapeutics.
Amid disruption to the outsourced fill/finish market, PCI is investing $100 million to more than double the capacity to fill ready-to-use prefilled syringes and cartridges at its San Diego campus.
The advisory committee meeting—the FDA’s first drug-related adcomm in nine months—could have been a “more conceptual discussion” about the design of AstraZeneca’s Phase 3 trial of camizestrant in HER2-negative advanced breast cancer, former cancer regulator Harpreet Singh told BioSpace.