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FDA advisory committee overwhelmingly votes no on Biogen’s aducanumab

Path to approval looks increasingly difficult for potential Alzheimer’s treatment

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EMA will assess potential COVID-19 vaccine on ‘case by case’ basis

Agency will not specify a minimum level of efficacy, according to Reuters

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FDA briefing documents back Biogen’s Alzheimer’s drug aducanumab

Documents show the efficacy data for the drug as being ‘exceptionally persuasive’

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The Unknown Unknowns

Patient insights are fundamental to ensuring we understand the reality of living with a condition. We need to consciously  challenge our approach and ensure we are unearthing authentic patient insights that...

Bedrock Healthcare Communications

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COVID-19 vaccine developers won’t face pre-approval FDA inspections for EUAs

Companies typically face inspections before gaining approval from the FDA

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Vaccine developers call on FDA to offer clarity on COVID-19 trials

Comments from J&J and Pfizer made before FDA advisory committee meeting yesterday

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Independent consultant will review Lilly’s COVID-19 plant issues

COVID-19 antibody trial was paused last week due to safety issue

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Regeneron scores first FDA approval for Ebola antibody treatment

Treatment cut mortality rate in study based in the Democratic Republic of Congo

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Regeneron seeks US emergency use authorisation for COVID-19 antibody cocktail

If approved, the US government will make initial doses available at no cost

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FDA publishes new guidelines for COVID-19 vaccine approval

New rules mean a COVID-19 shot is unlikely to be approved pre-election in the US

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Lilly seeks US emergency approval after posting new data for COVID-19 antibodies

Combination of two antibodies reduced viral load and symptoms of COVID-19

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Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November

Company will seek emergency use authorisation for experimental vaccine

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