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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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The FDA granted Breakthrough Therapy Designation to Verttex’s candidate inaxaplin (VX-147). for the treatment of APOL1-mediated focal segment glomerulosclerosis.
Calls for a reform of drug prices have become a regular occurrence, particularly in the midst of political campaigns. Yet a new report shows the median price of a new drug launched in 2021 was $180,000.
Moderna announced its Omicron-containing COVID-19 booster candidate, mRNA-1273.214, demonstrated superior antibody response against Omicron in its Phase II/III study.
Annexon released final data from an open-label phase II clinical trial, showing that its drug candidate ANX005 safely stabilized disease progression in patients with Huntington’s disease.
The Tisch MS Research Center of New York has been researching the concept of using cell therapy as a therapeutic strategy to promote repair and regeneration in certain patients with MS.
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 with one abstention to recommend authorization of Novavax’s COVID-19 vaccine.
For the first time in half a decade, the FDA will convene to address two therapies developed by bluebird bio that could have ripple effects across the industry regarding lentiviral vectors.
Aslan partners with Johns Hopkins and Duke, Editas joins forces with Immatics, Yumanity (soon to be Kineta, Inc.) teams with Janssen, Serotiny & Janssen Biotech and Ginkgo and Novo Nordisk.
Amarin and Vincerx Pharma intend to restructure their financial strategies and lessen operational costs by trimming their employee rosters.
Seres Therapeutics, Inc. announced that the company’s Phase III Ecospor IV study demonstrated a strong safety profile in addition to statistically significant positive results against C. difficile infection.