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Amid a season of regulatory and scientific advances, experts reveal a culture of data hoarding among cell and gene therapy developers that is reinforcing fragmentation, stalling innovation and delaying access to treatments.
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Presentations at this year’s American Association for Cancer Research meeting could have a broad impact on the treatment landscape for head and neck and lung cancer, and implications for specific drug modalities like TIGIT and VEGF.
Executives don’t just get paid big bucks to operate a company. Sometimes they get paid millions to walk away.
Biotech was starting to show signs of recovery after years of investor pullback—until new tariffs and economic uncertainty sent fresh shockwaves through an already fragile market.
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Emergent BioSolutions Inc. announced the results of a new national public opinion survey showing that more than 90 percent of Americans surveyed recognize opioid overdoses are a pressing concern for teenagers and college students, and more than 9 in 10 parents in the survey agree schools should do more to educate on the risks of opioids and how to respond to an overdose.
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During the COVID-19 pandemic, Health Secretary Robert F. Kennedy Jr.—along with FDA Commissioner Marty Makary and CBER Director Vinay Prasad—argued against vaccine mandates, partly because they limited medical choice. This week, the FDA under their leadership approved updated COVID-19 vaccines with restrictions that do the same.
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Jacqueline Corrigan-Curay, who stepped into the role as the agency’s top drug regulator in January, is departing in July, according to an email sent to agency staff.
While Eli Lilly brushed off concerns about gastrointestinal side effects for oral weight loss candidate orforglipron, analysts from William Blair worried that adverse events are not tapering off as expected.
In combination with Roche’s PD-L1 blocker Tecentriq, zanzalintinib bested Bayer’s Stivarga. Exelixis is positioning the drug candidate as a successor to cabozantinib, which is set to lose patent exclusivity in 2030.
After consistently failing to meet investor expectations, Novo Nordisk touted a safety profile for CagriSema in line with the GLP1-RA class, while reporting mid-stage data for its GLP1- and amylin-targeting drug amycretin that raised dosing questions.
Although the company withheld detailed findings from the study of treatment-resistant depression, analysts at Stifel called COMP360’s efficacy “more than good enough” for registrational purposes.
While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential.
The Inflation Reduction Act includes an exemption for orphan drugs for a single indication, but experts say this is far from sufficient to maintain momentum in the rare disease space.
In advance of this week’s CDC vaccine advisory meeting, HHS Secretary Robert F. Kennedy Jr. restacked the committee, claiming problematic industry ties within the previous group. Experts say ACIP had long navigated COIs appropriately and that the new appointees risk the apolitical nature of membership.
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Analysts at William Blair say dapiglutide’s 11.6% weight reduction at 28 weeks could still be better, given that Zealand’s study predominantly included men and enrolled patients with lower BMI at baseline.