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Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
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New mid-stage data from Biogen’s Ionis-partnered therapy diranersen served to both validate the tau hypothesis in Alzheimer’s disease and raise questions that could soon be elucidated by anti-tau candidates from Denali Therapeutics, Eisai and Eli Lilly.
After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
Biopharma is entering its second-quarter earnings season riding high on a wave of massive deals and venture capital flow, plus a clearing of regulatory and policy overhangs. What can industry watchers expect to hear on the upcoming investor calls?
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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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Camlipixant, which GSK picked up in its $2 billion buyout of Bellus Health in April 2023, “is unlikely to transform patient care,” the pharma said.
Insmed’s inhalable candidate showed “impressive” long-term efficacy in pulmonary arterial hypertension, according to analysts at Guggenheim Partners, with functional and biomarker improvements through one year of follow-up.
Journal publications that suggested changes in FDA guidelines do not “communicate FDA policy or interpretation of a regulatory issue,” acting director Kyle Diamantas wrote in a letter to House Energy & Commerce committee ranking member Diana DeGette.
The FDAs enforcement action against Purolea Cosmetics Lab offers an early look at how the agency expects AI-generated work to fit within existing quality systems, with experts saying human oversight and quality controls remain essential.
With the AtaiBeckley acquisition, Eli Lilly is jumping into psychedelics, a drug class that Jefferies analysts say could herald the “biggest change” for the field of psychiatry.
Merck’s once-daily pill is the first oral PCSK9 inhibitor to hit the market for high cholesterol, beating AstraZeneca in the race to develop more accessible treatment options.
Braveheart Bio is looking to take on Bristol Myers Squibb in hypertrophic cardiomyopathy, while Attovia Therapeutics wants to challenge Sanofi and Regeneron’s Dupixent. Vogenx, meanwhile, is looking to establish its name in the cardiometabolic space.
In this episode of Denatured, you’ll hear from Lance Alstodt, chairman and CEO at Biorestorative Therapies, and Paul Mieyal, chief business officer at South Rampart Pharma. We explore why pain has remained such a difficult therapeutic area to tackle and one of the biggest unmet needs today, and how non-opioid mechanisms to regenerative therapies could reshape the future of treatment.
Psychedelics, chiefly Compass Pathways’ COMP360, are unlikely to make an immediate dent in the sales of Johnson & Johnson’s depression drug Spravato, H.C. Wainwright’s Patrick Trucchio told BioSpace.
After committing $55 billion last year to bolster U.S. manufacturing capabilities, Johnson & Johnson is making changes to its pharmaceutical supply chain.