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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 Boston Business Journal reported the layoffs would affect the multiple sclerosis team, but Biogen declined to confirm the details.
AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica in mantle cell lymphoma and marginal zone lymphoma, the companies announced Thursday.
The FDA is set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.
Currently, there are no gene editing–based treatments on the market, but the technology continues its march toward potential FDA approval, with several products in mid- and late-stage trials.
After 12 years on the market, the FDA announced it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena.
Results from two late-stage trials showed the Merck-Eisai combo treatment failed to boost survival in two difficult-to-treat advanced cancers.
At the World Vaccine Congress this week, Novavax presented data suggesting that its protein nanoparticle booster generated immune responses that could protect against severe infection.
Phase IIa data showed AI Therapeutics’ ALS candidate increased expression of a target engagement biomarker and led to a 73% reduction in a toxic protein aggregate.
Farallon Capital Management is waging a proxy battle with Exelixis over R&D spending. The hedge fund issued a letter to the company’s board of directors on Wednesday.
NLRB General Counsel Jennifer Abruzzo issued a memo to all field offices clarifying the board’s recent ruling in a case regarding severance agreements.