Archives of “Food and Drug Administration” tag

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Solid gains for stocks as investors cheer FDA approval of Pfizer Covid vaccination

  
Analysis, US Market
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S&P and NASDAQ close at record levels

The US major indices had a solid gains today led by the NASDAQ index which increased 1.54%. The Russell 2000 also had a solid gain of near 1.9%.

The gains were help by the FDA’s full approval of the Pfizer Covid vaccination. The hope is that those who have remained unvaccinated will be encouraged to get vaccinated now, and also that businesses and local governments, etc. will start to force workers to get the approved Pfizer vaccination.
Highlights:
  • NASDAQ closed at a record high
  • the S&P and NASDAQ hit new all-time intraday record levels. The S&P could not stay above its previous record closing level.
  • Dow is up for the second straight day
  • NASDAQ and S&P client for the third straight day
the final numbers are showing:
  • Dow up 215 points or 0.61% at 35335.71
  • S&P index up 37.84 points or 0.85% at 4479.51
  • NASDAQ index up 228 points or 1.55% at 14942.65
  • Russell 2000 up 40.70 points or 1.88% at 2208.30

Moderna says its coronavirus vaccine will not be ready until 2021

  
  Analysis
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Moderna CEO Stéphane Bancel statements on Wednesday, carried in the Financial Times overnight ICYMI.

  • will not seek emergency authorization for Food and Drug Administration approval for its vaccine to use in frontline medical workers and at-risk individuals until Nov. 25 at the earliest.
  • company would not seek FDA approval for use in the general population until late January
  • If the vaccine is proven safe and effective, approval is unlikely to come until at least late March or early April
Link to FT, may be gated.

‘Game changer’ COVID-19 test approved by the US FDA over the weekend

  
  Analysis
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The US FDA authorised the emergency use of a new saliva based laboratory diagnostic test for coronavirus.

 A key difference is the speed of the test, its being described as a ‘game changer’.
The sped allows more people to access rapid easily.
Stephen Hahn, the Food and Drugs Administration Commissioner:
  • “Providing this type of flexibility for processing saliva samples to test for COVID-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents”
Its called SalivaDirect
  • has been tested amongst US National Basketball Association (NBA) players and staff
  • simpler, less expensive, less invasive than nasopharyngeal (NP) swabbing
  • yields similar outcomes as NP swabbing
Current testing:
The US FDA authorised the emergency use of a new saliva based laboratory diagnostic test for coronavirus.
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ps. For clarity, this is a test for the infection, not a treatment. That is clear above, but wanted to restate it.

Coronavirus – Some Remdesivir news crossing – FDA warns on reduced effectiveness

  
  Analysis
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US Food and Drug Administration (FDA) is warning about a newly discovered potential drug interaction related to the investigational antiviral drug remdesivir

  • Based on a recently completed non-clinical laboratory study, the FDA is revising the fact sheet for health care providers that accompanies the drug to state that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir.
ps. I am not a pharmaceutical PhD (yet 😀 ) so just passing this along, K? Report via Market Watch
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Hopes are high for Remdesivir, which has received emergency use authorization for the treatment of hospitalized COVID-19 patients with severe disease.
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