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(Reuters) - Biogen Inc and partner Eisai Co Ltd said on Friday the U.S. Food and Drug Administration has extended the review period for their experimental Alzheimer s disease treatment by three months from March.
Biogen s shares rose about 10% as the FDA extension raised some hopes that the drug may still be approved despite a panel of experts to the FDA voting against it in November. Our key takeaway is that if the FDA would have wanted to reject the drug, we would have heard the decision by now, said Truist analyst Robyn Karnauskas.
An FDA approval would make the drug, aducanumab, the first new treatment for Alzheimer s in decades and the first that appears to be able to slow progression of the fatal, mind-wasting condition that affects millions of people.
The result was based on the Phase 3 ENSEMBLE study involving nearly 44,000 participants, Xinhua news agency quoted the company as saying on Friday. The
As The Day s military/defense reporter, I work to explain complex issues in a way the everyday citizen can understand. On any given day, I can be found poring over defense budgets, writing a feature on a local veteran or documenting the impact of deployments on those left behind. I even spent two nights aboard a submarine.
Julia Bergman
As The Day s military/defense reporter, I work to explain complex issues in a way the everyday citizen can understand. On any given day, I can be found poring over defense budgets, writing a feature on a local veteran or documenting the impact of deployments on those left behind. I even spent two nights aboard a submarine.
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NAIROBI (Thomson Reuters Foundation) - As the world battles the COVID-19 pandemic, resources are being sucked away from the fight against a host of debilitating diseases that affect 1.7 billion of the poorest people on the planet, medical experts have warned.
On Saturday, charities will mark World Neglected Tropical Diseases Day, seeking to draw attention to a diverse group of communicable diseases that still cause immense suffering around the world, even though they can be prevented or cured.
They include leprosy, Chagas disease, intestinal worms, dengue and chikungunya, Guinea worm disease, scabies, trachoma and schistosomiasis, lymphatic filariasis or elephantiasis, yaws, river blindness and sleeping sickness.