Former FDA adviser calls for wider probe into Biogen Alzheimer's drug approval

FILE PHOTO: Signage is seen outside of the Food and Drug Administration headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File PhotoShare this contentREUTERS: A federal probe of the US Food and Drug Administration's approval of a controversial new Alzheimer's disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said on Tuesday .

Acting FDA Commissioner Janet Woodcock earlier this month asked the Office of the Inspector General at the Department of Health and Human Services to investigate whether FDA representatives' interactions with drugmaker Biogen Inc were inconsistent with agency policies."I happen to think that there's a lot more to investigate than just that," said Dr.

Speaking at a live event sponsored by The Forum at the Harvard T.H. Chan School of Public Health, he said more information is needed on FDA's role in Biogen's evaluation of clinical trial data, as well as why the agency decided to base its approval on a"surrogate" biomarker rather than the drug's impact on cognitive function.

The FDA in early June approved Biogen's Aduhelm, citing evidence that it can reduce brain plaques, a likely contributor to Alzheimer’s disease, rather than proof that it slows progression of the lethal mind-wasting condition. "If the FDA knows about some really clear scientific evidence ... they should share that because I don't think there is a lot of clarity around that in the field right now," Kesselheim said.He was one of three experts who resigned from the FDA advisory panel that recommended late last year that the agency turn down Biogen's application to market Aduhelm, which the company has priced at about US$56,000 a year.

Singapore Latest News, Singapore Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

We discussed ousting Johnson, ex-adviser to UK prime minister saysLONDON: The former top adviser to British Prime Minister Boris Johnson said he discussed the possibility of toppling Johnson shortly after an ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »

Australian adviser's wife pleads Myanmar junta for his releaseYANGON: The wife of a detained Australian adviser to Myanmar's deposed leader pled on Sunday (Jul 18) for her husband's release, citing worries ... SaveMyanmar WhatsHappeningInMyanmar 強盜行為
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »

EU begins real-time review of Sanofi-GSK COVID-19 vaccine:Europe's drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi and ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »

Old Pic Of Kris Wu With Show Luo Goes Viral; Netizens Call Them The “Scumbag Alliance”
Source: TODAYonline - 🏆 1. / 99 Read more »

Australia's Victoria awaits lockdown call as COVID-19 cases easeSYDNEY: Australia's Victoria state reported a slight easing in locally acquired cases of COVID-19 on Tuesday (Jul 20) as the state's almost 7 ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »

Japan government says companies targeted by China-backed cyber hacking groupTOKYO: Japanese companies were targeted by a cyber hacking group called APT40, government spokesperson Katsunobu Kato said on Tuesday (Jul 20), ...
Source: ChannelNewsAsia - 🏆 6. / 66 Read more »