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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 idea is not just a flight of fancy by a brilliant mind with big dreams. It is part of a larger de-extinction strategy aimed at solving climate change.
Henrietta Lacks’ family accuses Thermo Fisher Scientific of profiting off the first cell line that had been shared and replicated in a lab for the development of countless medical innovations.
There is — still — plenty of news about COVID-19 and new drugs, therapies and FDA applications. Here’s a look.
AstraZeneca submitted data for an Emergency Use Authorization for AZD7442, a long-acting antibody combination from B-cells donated by patients who recovered from COVID-19.
After serving three presidential administrations, Dr. Francis S. Collins is stepping down as director of the National Institutes of Health at the end of the year.
The DOL’s Office of Federal Contract Compliance Programs found that AstraZeneca paid a much lower base salary than similar employees to 23 Hispanic female staff and 295 female employees.
The deal has a value of over one billion dollars, with highlights for Xencor including receiving a $100 million upfront payment, a $25 million equity investment, eligibility for plamotamab royalties and potential milestone payments worth up to $1.18 billion.
The FDA granted the latest designation based on the Phase III DESTINY-Breast03 trial on adult patients diagnosed with unresectable or metastatic HER2-positive breast cancer.
Instead of continuing to develop the two different assets, EDP-305 and EDP-297, the company intends to seek an out-licensing deal to focus on infectious respiratory diseases.
Sage Therapeutics and Biogen announced positive results from their ongoing clinical trials on the efficacy and safety of zuranolone in treating major depressive disorder and postpartum depression.