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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.
FEATURED STORIES
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.
FROM OUR EDITORS
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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The company is ending its program evaluating antibody-drug conjugate tusamitamab ravtansine after a non-small cell lung cancer trial did not meet a primary endpoint.
Clene disclosed Thursday the FDA has determined that biomarker Neurofilament Light Chain reduction in its Phase II programs “were insufficient to support accelerated approval at this time.”
The regulator’s Complete Response Letter on Wednesday said Merck’s data package for gefapixant “did not meet substantial evidence of effectiveness.” The FDA also rejected the drug in 2022 due to a lack of efficacy evidence.
The oral formulation of budesonide, marketed as Tarpeyo, is the only FDA-approved therapy that significantly reduces the loss of kidney function in immunoglobulin A nephropathy patients.
The biotech’s investigational COMP360 psilocybin treatment showed positive safety and tolerability with no serious adverse events in a mid-stage study of people with post-traumatic stress disorder.
A study finds that employees are more likely to view pay for performance positively—and rise to the challenge of performing well—when they view their managers as friendly and good at their jobs.
Now designated as a Tech Hub by the White House, Alabama’s nonprofit Southern Research is winnowing its focus and investing in healthcare solutions.
Gene therapy company uniQure announced Tuesday “ongoing evidence” of a clinical benefit for its Huntington’s disease treatment. However, investors were not impressed as the stock dropped nearly 20%.
On this episode of the Weekly: Biden administration puts pressure on the biopharma industry; renewed interest in psychedelics after MindMed announces LSD-based candidate meets primary endpoint; bluebird changes its tune.
The competition between Merck’s pneumococcal vaccine and Pfizer’s Prevnar series of vaccines is intensifying after the regulator granted priority review to the former’s BLA for V116.