“Unprecedented alliance”: House inquiry faults FDA, Biogen on rapid approval of Alzheimer's drug
The report lays out recommendations that the FDA should follow to “help restore the American people’s trust,” as well as measures that Biogen and other drug companies should take to “fulfill their responsibility to the patients and families.” Since the recommendations leave it to the FDA and company to change their policies, it is unclear whether they will actually prevent future episodes like this from occurring.
Aduhelm, a lab-made protein administered directly into a patient’s vein, was said to work by reducing a sticky substance in the brain called amyloid beta, which clumps between neurons and disrupts their function. Some scientists have theorized that buildup of amyloid beta in the brain causes Alzheimer’s disease.In September 2015, Biogen began enrolling patients in two Phase 3 clinical trials, which test the safety and effectiveness of a drug and compare it with standard treatment.
For example, the FDA issued accelerated approval for Aduhelm despite failing to gain the support of a single member of its own advisory committee, and without putting the idea up for discussion by any internal or external body. Although the report found that the company “appears to have developed financial assistance programs for eligible patients,” investigators wrote that “these programs would leave significant gaps in coverage.”
日本 最新ニュース, 日本 見出し
Similar News:他のニュース ソースから収集した、これに似たニュース記事を読むこともできます。
House committee questions Biogen drug approval processThe FDA's approval process of Biogen's Alzheimer's drug was questioned in a Congressional report released Thursday.
続きを読む »
FDA approval of Alzheimer's drug Aduhelm 'rife with irregularities,' House report saysA report by two House committees found that the Food and Drug Administration's controversial approval of the Alzheimer's drug Aduhelm was 'rife with irregularities.'
続きを読む »
Kala Pharmaceuticals stock up 750% in 3 days after upbeat FDA news on PCED treatmentShares of Kala Pharmaceuticals Inc. have rocketed higher in for three-straight sessions, toward a more-than 8-fold gain, since the biopharmaceutical company...
続きを読む »
FDA adds sesame to the official food allergen listThe change comes as a result of the Food Allergy Safety, Treatment, Education and Research Act, which was signed into law in 2021.
続きを読む »
Genentech wins FDA approval of bispecific blood cancer drug Lunsumio - San Francisco Business TimesAnother bispecific antibody — linking to two key players in the fight against cancer — could be approved by regulators as soon as this spring.
続きを読む »
People Are Sharing Things That Were Actually 'Good' Until They Became Too Popular, And It's Wild'The house flipping trend has NOT helped home affordability. It's good to make a junk house habitable again — it's not good to turn a $220K house into a $350K house.'
続きを読む »