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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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Roche’s candidate drug for Alzheimer’s treatment received breakthrough therapy designation which has increased its chance of getting full FDA approval.
According to Fauci, kids can safely go trick-or-treating outdoors this Halloween. He did add that children who are eligible for COVID-19 vaccinations should do so for an “extra degree of protection.”
After guiding BlueRock Therapeutics and its potential Parkinson’s disease stem cell therapy into the clinic and to a $1 billion acquisition by Bayer, Emile Nuwaysir is taking on gene therapy startup Ensoma as CEO.
If authorized, it could be available in the U.S. before the end of the year. It is also working to submit applications to other regulators worldwide.
Biden’s campaign trail promise to cure cancer is hanging in the balance as his plan for a new biomedical research agency is being axed from the Democrats’ social spending package.
This year – 2021 – will be a transformational year, Rosen predicted, citing three important milestones.
Pathogens for antimicrobial resistance may still be a bit off peoples’ radar, but the lessons from unpreparedness of COVID-19 are in the mind of Qpex.
Of these six patients, three had a partial response (PR) with their tumors shrinking by more than 30%.
The FDA approved ChemoCentryx’s Tavneos (avacopan) as an adjunctive treatment for adults with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (ANCA-associated vasculitis or ANCA vasculitis).
Mirati and Sanofi will assess the combination of adagrasib and SAR442720 in a Phase I/II study in patients with previously treated non-small-cell lung cancer who express KRASG12C mutations.