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Vertex, ahead of FDA decision, calms fears surrounding kidney drug
On a conference call, executives expressed conviction in the coming launch of an IgA nephropathy medicine viewed by Wall Street investors as important to Vertex’s future.
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Medicare Part D premiums are spiking 50% on average next year, KFF finds
The health policy think tank urged seniors to shop carefully for prescription drug coverage during Medicare open enrollment, given skyrocketing premiums and wide variance in costs between plans.
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UniQure gets an FDA decision date; Teva scraps brain drug study
The FDA appears likely to hold an advisory committee for UniQure’s closely watched Huntington’s disease gene therapy. Elsewhere, a biotech’s share price was cut in half following a regulatory setback.
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Karyopharm, deep in debt, to sell itself in bankruptcy
The parent of cell therapy maker Gamida Cell will be the lead bidder in a court-supervised auction of Karyopharm, which recently cut a forbearance deal to push off debt payments.
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Keytruda biosimilars are coming — but they face an uphill battle
A patent cliff is fast approaching for Merck’s flagship blockbuster, but the deck might be stacked against its biosimilars gaining widespread traction.
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Earnings roundup: AstraZeneca’s cost cuts, Alnylam’s slump and Regeneron’s resilience
AstraZeneca will “redeploy resources” through a new restructuring program. Meanwhile, Alnylam shares sold off on fears surrounding a top drug and investors rewarded Regeneron for a record quarter.
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Breaking the silos: What effective scenario modeling looks like in 2026 and beyond
Explore how integrated scenario modeling helps pharma leaders navigate pricing uncertainty and the complexity of global launches.
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This week in charts: ESMO’s winners and losers
The latest installment in BioPharma Dive’s visualization-focused series looks at Wall Street’s response to a trio of closely watched presentations at a top meeting for cancer drugs.
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Earnings roundup: Lilly’s unwavering momentum, Novartis’ rebound and GSK’s waiting game
Lilly’s better-than-expected results allayed concerns — for now — over GLP-1 pricing pressure. Elsewhere, Novartis withstood a tumultuous quarter and GSK battled investor angst.
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With Setara, the team behind Actio opens its second act
The fledgling startup has $90 million to develop a pipeline of drugs, led by a Charcot-Marie-Tooth disease medicine, that Actio was working on when Jazz Pharmaeuticals bought its lead epilepsy program.
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Aspen raises a $141M IPO in pursuit of a cell therapy for Parkinson’s
The San Diego biotechnology startup is one of several firms working on a cutting-edge technique with the potential to slow or even halt the neurodegenerative condition.
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Labor Department finalizes sweeping PBM disclosure rule
Starting in 2027, the controversial drug middlemen will have to share a broad swath of fee and compensation data with self-funded employer clients. Employers cheered the rule, while PBMs slammed it as government overreach.
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Genmab soars to record highs after cancer drug succeeds in key trial
The drugmaker’s market value swelled by more than $7 billion on findings suggesting a recently-acquired medicine could become a new treatment standard for a form of head and neck cancer.
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HHS to allow compounders to make 6 unapproved peptides
RFK Jr. has given notice that the agency won’t take enforcement action on six peptides that controversially won a contested recommendation from outside advisers to the FDA in July.
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Flagship blends three biotech startups to form Etcelera
Etiome, Cellarity and Empress Therapeutics are being combined into one new AI-aided drugmaker claiming to possess the ability to better predict the way new medicines will fare in humans.
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Lilly’s ‘triple-G’ drug tops Novo’s Ozempic in diabetes trial
The highest dose of retatrutide beat Ozempic on measures of blood sugar and weight loss, but was also associated with higher side effect rates and treatment discontinuations.
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FDA unveils guidance for ‘plug and play’ gene therapies
The plan builds on recent FDA moves to speed "personalized" treatments by offering an approval framework for therapies benefiting different subsets of patients with the same disease.