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The FDA this week approved Biogen's Alzheimer's drug, Aduhelm, the first new medicine for the disease in nearly two decades. Members of the agency's advisory panel weren't happy with the decision and now some are resigning in protest. More details below. We also have updates on the Covid vaccines and the latest on the pandemic.
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| | FDA issues controversial decision on Alzheimer's drug | "The straw that broke the camel's back" was a phrase thrown around a lot this week in pondering whether the $56,000 per year list price of Biogen's newly approved Alzheimer's drug, Aduhelm, will be the catalyst for government reforms on drug pricing. Beyond the fact that the price is four to five times higher than most expected, there is serious debate over whether the drug even works. The FDA OK'd it through the accelerated approval pathway based on the fact that it clears amyloid plaque buildup in the brain, expecting this should slow the loss of memory and confusion that Alzheimer's brings. That's a huge scientific debate in itself. Biogen CEO Michel Vounatsos told us the company has up to nine years to produce data confirming that it works.
-Meg Tirrell | | | | Three members of prestigious FDA panel resign over approval of Biogen's drug | At least three members of a key FDA advisory panel resigned over the agency's decision to approve Aduhelm. The FDA's approval was a departure from the advice of its independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School and one of the three who resigned, said the agency's decision "was probably the worst drug approval decision in recent U.S. history."
-Berkeley Lovelace Jr. | | | | CDC to hold emergency meeting on rare heart inflammation following Covid vaccines | A CDC advisory panel will hold an emergency meeting on June 18 to discuss rare, but higher-than-expected, reports of heart inflammation in 16- to 24-year-olds after receiving their second dose of Pfizer's or Moderna's Covid-19 vaccines. The CDC said this week it's received reports of 275 cases of myocarditis or pericarditis in that age group as of May 31, higher than what would be expected. "We clearly have an imbalance there," Dr. Tom Shimabukuro of the CDC's Immunization Safety Office told an FDA advisory committee on Thursday.
-Berkeley Lovelace Jr. | | | | Fauci says more vaccines are needed to prevent Delta spread in U.S. | U.S. health officials are scrambling to get more Americans vaccinated to keep the Delta variant, first identified in India, from proliferating across the United States. The variant has already become the dominant strain in the U.K., causing more new infections than the Alpha strain, first identified in the country. "We cannot let that happen in the United States," Fauci said. In the U.S., the Delta variant accounts for more than 6% of cases scientists have been able to sequence, he said. The actual number is likely higher as the U.S. is running the genetic sequence on a fraction of cases
-Rich Mendez | | | | India reports more than 6,000 daily Covid deaths — highest ever in the world | India's daily reported death toll from the coronavirus crisis reached a record high on Thursday, with more than 6,000 people succumbing to the disease. That surpassed a record number of daily fatalities reported by the United States this year. India is fighting a devastating second wave of outbreak that started in February and accelerated in April and early May. The fatalities rose after one of India's poorest states, Bihar, revised its total Covid-19 related death toll on Wednesday from about 5,400 to more than 9,400, accounting for people who died at home or in private hospitals, according to reports.
-Saheli Roy Choudhury | |
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