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Missed News 595
June 14, 2021
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Missed News 594
June 12, 2021
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Missed News 593
June 11, 2021
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Missed News 592
June 10, 2021
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Missed News 591
June 9, 2021
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FDA’s Decision to Approve New Treatment for Alzheimer’s Disease
June 8, 2021
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Today FDA approved Aduhelm (aducanumab) to treat patients with Alzheimer’s disease using the Accelerated Approval pathway, under which the FDA approves a drug for a serious or life-threatening illness that may provide meaningful therapeutic benefit over existing treatments when the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients and there remains some uncertainty about the drug’s clinical benefit.
This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid-beta plaques in the brain. The clinical trials for Aduhelm were the first to show that a reduction in these plaques—a hallmark finding in the brain of patients with Alzheimer’s—is expected to lead to a reduction in the clinical decline of this devastating form of dementia.
We are well aware of the attention surrounding this approval. We understand that Aduhelm has garnered the attention of the press, the Alzheimer’s patient community, our elected officials, and other interested stakeholders. With treatment for a serious, life-threatening disease in the balance, it makes sense that so many people were following the outcome of this review. Further, the data included in the applicant’s submission were highly complex and left residual uncertainties regarding a clinical benefit. There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives.
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Missed News 590
June 8, 2021
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The World Economy Is Suddenly Running Low on Everything
June 7, 2021
Business, Human Interest, Medical, Science, Technical amazon, business, Business News, current-events, Future, Hotels, human-rights, medicine, mental-health, research, Science, Science News, technology, Technology News, travel, vacation 3 Comments
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A year ago, as the pandemic ravaged country after country and economies shuddered, consumers were the ones panic-buying. Today, on the rebound, it’s companies furiously trying to stock up.
Mattress producers to car manufacturers to aluminum foil makers are buying more material than they need to survive the breakneck speed at which demand for goods is recovering and assuage that primal fear of running out. The frenzy is pushing supply chains to the brink of seizing up. Shortages, transportation bottlenecks, and price spikes are nearing the highest levels in recent memory, raising concern that a supercharged global economy will stoke inflation.
Copper, iron ore, and steel. Corn, coffee, wheat, and soybeans. Lumber, semiconductors, plastic, and cardboard for packaging. The world is seemingly low on all of it. “You name it, and we have a shortage on it,” Tom Linebarger, chairman, and chief executive of engine and generator manufacturer Cummins Inc., said on a call this month. Clients are “trying to get everything they can because they see high demand,” Jennifer Rumsey, the Columbus, Indiana-based company’s president, said. “They think it’s going to extend into next year.”
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Irrigation lines are set up to water almond tree rootstocks in Tulare, California, on April 21.
Photographer: Gary Coronado/Los Angeles Times/Getty Images
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Missed News 589
June 7, 2021
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Missed News 587
June 4, 2021
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James' World 2 