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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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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 has several targeted therapeutics in early-stage trials and preclinical development for cancer types with high expression levels of the protein.
The lawsuit, brought by Arbutus Biopharma, marks the latest legal action in an ongoing battle for intellectual property underlying mRNA vaccines for COVID-19.
Liver toxicities triggered a partial clinical hold on Merck KGaA’s trial studying its BTK inhibitor candidate for multiple sclerosis.
Junshi Biosciences announced Tuesday that its ovarian cancer candidate, senaparib, met the primary endpoint in a Phase III interim analysis.
Following mixed Phase I/II data for its homocystinuria hopeful pegtarviliase, Aeglea lays off all but 10 employees and launches a sweeping strategic review.
An interim analysis of the Phase III P302 study showed Moderna’s investigational flu shot, mRNA-1010, fell short of the statistical threshold for early success.
A California judge denied Elizabeth Holmes’ motion for release pending appeal, ruling that the former Theranos CEO must serve her prison sentence while she appeals her guilty verdict.
Data from two mid-stage studies show HI-Bio’s investigational therapy felzartamab lowers pathogenic antibody titers in patients with primary membranous nephropathy (PMN).
Karuna Therapeutics’ KarXT and Acadia Pharmaceuticals’ pimavanserin are sparking hope that a treatment for the negative symptoms of schizophrenia could be on the horizon.
In an open letter published Monday, more than 480 biopharma industry leaders expressed their support for the FDA after a Texas federal judge ruled to hold the approval of the abortion pill mifepristone.