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New data from a Phase 3 trial will further support a rolling submission for Compass Pathways’ psilocybin treatment COMP360. Patients who saw a clinically meaningful benefit on depression severity maintained response through week 26.
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Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
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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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Novo Nordisk shares tumbled last year when obesity candidate CagriSema failed to clear a weight loss bar of 25%. Now, executives are taking another look at the data but steering clear of making hard bets.
Alumis held its initial public offering in June last year, while Acelyrin debuted on the Nasdaq in mid-2023.
In a mid-stage study, the candidate itolizumab achieved 23.3% clinical remission rate at 12 weeks, numerically better than Humira’s 20% at the same time point.
According to the lawsuit, Sanofi has failed to provide partner Regeneron adequate information regarding the sales of Dupixent—including agreements with payers and pharmacy benefit managers that determine pricing and rebates for the drug.
As Eli Lilly ends the year with Zepbound in good supply, TD Cowen analyst Steve Scala asked CEO David Ricks if the company has taken the GLP-1 supply chain too far.
Bristol Myers Squibb clocked $10 million in sales for new schizophrenia drug Cobenfy in the fourth quarter of 2024, with the launch proceeding ahead of expectations.
The headcount reduction will save money that the company will use in developing mavorixafor, its CXCR4 antagonist that last year received FDA approval to treat WHIM syndrome, in the larger patient population with chronic neutropenia.
Bristol Myers Squibb will make even deeper cuts to its organization to enhance efficiencies as it faces the 2028 loss of exclusivity for its blockbuster drugs Eliquis and Opdivo.
Viracta’s closure comes on the heels of its delisting from Nasdaq last month and multiple rounds of layoffs last year.
Despite the discontinuations, CEO Pascal Soriot said AstraZeneca’s December 2020 acquisition of Alexion was a “fantastic” deal for the pharma.