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Aduhelm approval sparks HHS watchdog review of FDA's accelerated approval pathway – TechCrunch

Aduhelm approval sparks HHS watchdog review of FDA's accelerated approval pathway – TechCrunch
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Overnight Health Care: FDA adds new warning to J&J COVID-19 vaccine | WHO chief pushes back on Pfizer booster shot | Fauci defends Biden's support for recommending vaccines 'one on one'

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Today: The FDA is adding a warning to Johnson & Johnson s COVID-19 vaccine, the WHO is pushing back on Pfizer s calls for a booster dose, and a House panel wants information from Biogen about its controversial Alzheimer s drug.
We’ll start with J&J:
FDA adds new warning to J&J COVID-19 vaccine
The Food and Drug Administration (FDA) is adding a label to Johnson & Johnson s COVID-19 vaccine, warning that it has been linked to rare cases of Guillain-Barré syndrome (GBS), a neurological disorder in which the body s immune system mistakenly attacks part of its nervous system.
There have been 100 preliminary reports following vaccination after approximately 12.5 million doses administered, FDA said in a statement. Of these reports, 95 of them were serious and required hospitalization. There was one reported death. ....

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Democrats demand docs about Biogen, FDA coordination on Aduhelm

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Acting FDA Commissioner Janet Woodcock on Friday called for an independent watchdog to investigate whether any interactions between FDA staff and Biogen violated FDA policies.
The committee is also seeking documents related to Biogen’s role in an FDA move last week to narrow prescribing guidelines to patients with the earliest stages of Alzheimer’s, as opposed to any patient with the disease. STAT reported that even some senior FDA officials were surprised by the decision for such a wide initial label, and a source close to Biogen told STAT that the company wanted a narrower label “from the start, but was reluctant to push back on FDA’s desire for a broader label for fear it could derail approval.” ....

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The Health 202: Democrats are pressing forward on allowing the government to fund abortions

The Health 202: Democrats are pressing forward on allowing the government to fund abortions
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Biogen Alzheimer's Drug Spurs Lawmakers' Demand for Documents

Biogen Alzheimer's Drug Spurs Lawmakers' Demand for Documents
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