 | Fri, Sep 30, 2022 | | | |
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Think a friend or colleague should be getting this newsletter? Share this link with them to sign up. Biogen this week reported positive results for its Alzheimer's drug, lecanemab, which slowed cognitive decline in patients by 27% compared to those who did not receive it. The drug is an antibody that targets buildup of plaque on the brain between neurons. BMO analyst Evan David Seigerman called the results "unambiguously positive," saying the drug will likely receive full approval from the Food and Drug Administration. On Thursday, the FDA approved a new drug for Lou Gehrig's disease or ALS, developed by Amylyx Pharmaceuticals. The drug, Relyvrio, is one of only a handful of treatments for the illness. But its approval is controversial because it's based on a single phase 2 clinical trial. Our partners at NBC News have the full story for us. And the CDC this week released preliminary real-world data on the effectiveness of the monkeypox vaccine, called Jynneos. People at risk who did not receive a single dose were 14 times more likely to get infected than those who had received a shot.
Feel free to send any tips, suggestions, story ideas and data to me at spencer.kimball@nbcuni.com.
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The Alzheimer's drug reduced patient decline by 27% compared with trial participants who took the placebo, Biogen said in a press release Tuesday night As early as six months into treatment with lecanemab, the companies said, patients began to show statistically significant benefits relative to the placebo group. They also said the drug's safety profile was "within expectations." Positive trial results for Biogen's experimental, late-stage Alzheimer's treatment are also good news for Eli Lilly, which is working in its own drug to battle the disease. |
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The drug, from the Massachusetts-based Amylyx Pharmaceuticals, joins only a handful of drugs approved by the agency for the fatal neurodegenerative disease and its symptoms. The FDA's decision was based on a single phase 2 clinical trial of 137 ALS patients that found people who took Amylyx's drug, which will be sold under the name Relyvrio, lived about 10 months longer than those who didn't receive it. Amylyx said it is still figuring out what it will charge for the drug. It's possible that it could be priced similarly to an older ALS drug, edaravone, which costs around $170,000 a year. |
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People at risk for monkeypox who have not received a single dose of vaccine are 14 times more likely to get infected than those who have gotten a shot, according to the Centers for Disease Control and Prevention. The preliminary data, collected from 32 states from the end of July through early September, is the first concrete evidence that the Jynneos vaccine is providing at least some protection against infection from the monkeypox virus circulating in the current outbreak. | |
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Pfizer on Monday asked the Food and Drug Administration to authorize its new Covid booster shots that target the omicron BA.5 subvariant for children ages 5 to 11. Pfizer's application to the FDA comes before clinical trial results of the new vaccines have been published. The company, in a statement, said its request is based on human data from a similar vaccine that targets the omicron BA.1 subvariant and data from animal studies on the BA.5 shots. Pfizer's main competitor on Covid shots, Moderna, asked the FDA to authorize its omicron shots for kids ages 6 through 17 on Friday. |
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Biogen will pay $900 million to settle a lawsuit that alleged the company gave doctors kickbacks to encourage them prescribe its drugs, the Justice Department announced Monday. A former Biogen employee turned whistleblower, Michael Bawduniak, sued the pharmaceutical company in 2012 on behalf of the federal government under the False Claims Act. Bawduniak alleged Biogen paid kickbacks to doctors in the form of speaking fees, consulting fees and meals from 2009 through 2014 to encourage them to prescribe its multiple sclerosis drugs. |
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Covid-19 vaccination is linked to a slight increase in the length of a women's menstrual cycle, delaying the beginning of bleeding by a few hours, according to a large international study funded by the National Institutes of Health. Dr. Diana Bianchi, head of NIH's child health and human development institute, said the changes following vaccination appear small, temporary and within the normal range. However, the longer menstrual cycle, typically about a month long, didn't necessarily increase the number of days of bleeding, according to health agency. |
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