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Biogen touted an “unprecedented” drop in tau in a Phase 2 trial, backing the company’s decision to take diranersen to Phase 3 despite a missed primary endpoint and seemingly supporting the anti-tau approach.
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As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
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Read our takes on the biggest stories happening in the industry.
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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Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.
The U.K. National Institute for Health and Care Excellence on Thursday recommended against funding Vertex Pharmaceuticals’ CRISPR-based sickle cell disease therapy Casgevy unless uncertainties can be cleared up.
This episode focuses on a healthy discussion regarding the IRA, particularly the unintended consequences to small molecule development within the industry and for patients.
At the center of the deal is Amolyt Pharma’s late-stage candidate eneboparatide for the rare disease hypoparathyroidism. AstraZeneca also gains ownership of AZP-3813, which is being assessed for acromegaly in a Phase I trial.
A lawsuit filed by the Pharmaceutical Research and Manufacturers of America failed to block an Arkansas law that empowers hospitals to use outside pharmacies to dispense discounted drugs.
Wednesday’s FDA approval expands Mirum’s Livmarli into the rare genetic disorder that causes progressive liver disease. The biotech has also filed a supplemental New Drug Application for a higher dose of the drug and allowing its use in younger patients.
In a change of position as congressional scrutiny of WuXi AppTec grows, the Biotechnology Innovation Organization announced it is taking steps to separate from the China-based biotech.
Looking for regulatory jobs in the biopharma industry? Check out the BioSpace list of seven top companies hiring for these critical roles.
Knowing that you want to integrate AI is one thing—but how do you actually do it? For biotech companies kickstarting their generative AI journey, here are four things to consider.
With an advisory committee meeting slated for Friday, the regulator has posted briefing documents in which it has raised concerns about early deaths in patients treated with Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti.