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Fauci: Political pressure won’t interfere with FDA decisions on COVID-19 vaccines

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The FDA has vowed not to let political pressure to approve a COVID-19 vaccine as soon as possible interfere with the regulatory process, Anthony Fauci told Reuters. Fauci’s comments come ahead of an election season in which the availability of a vaccine could influence the vote.

While some companies have expressed hopes that they will win approval for COVID-19 vaccines by the end of the year, the consensus is that the FDA is unlikely to authorize a product before the U.S. goes to the polls in early November. The likelihood that a vaccine will nearly, but not quite, be ready for market in the run up to the election has raised concerns that political pressure may lead the FDA to authorize a product prematurely.  

However Fauci, the director of the National Institute of Allergy and Infectious Diseases, is confident the FDA will decide whether to approve a vaccine or not on the strength of the evidence alone.

“They promise that they are not going to let political considerations interfere with a regulatory decision,” Fauci said. “We’ve spoken explicitly about that, because the subject obviously comes up, and the people in charge of the regulatory process assure us that safety and efficacy is going to be the prime consideration.”

Fauci went on to say he is “certain of what the White House would like to see” but is yet to see “any indication of pressure at this point to do anything different than what we’re doing.” 

Approving a vaccine before sufficient data are available to evaluate its safety and efficacy could cause harm. Notably, as the most closely watched prophylactics ever, postapproval safety problems with the COVID-19 products could significantly exacerbate existing vaccine hesitancy. 

President Donald Trump said this week that the approval of a COVID-19 vaccine in time for the election “wouldn’t hurt” his prospects but denied that was his motivation. “I want to save a lot of lives,” Trump said. Trump is optimistic the U.S. will have a vaccine against the coronavirus before the election, putting his stance at odds with the consensus of other observers. 

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Source: https://www.fiercebiotech.com/biotech/fauci-political-pressure-won-t-interfere-fda-decisions-covid-19-vaccines

Biotechnology

New patent for Bayer Healthcare drug VITRAKVI

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Copyright © DrugPatentWatch. Originally published at New patent for Bayer Healthcare drug VITRAKVI

Annual Drug Patent Expirations for VITRAKVI
Annual Drug Patent Expirations for VITRAKVI

Vitrakvi is a drug marketed by Bayer Hlthcare and Bayer Healthcare and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug.

This drug has one hundred and thirty-four patent family members in forty-two countries.

The generic ingredient in VITRAKVI is larotrectinib sulfate. One supplier is listed for this compound. Additional details are available on the larotrectinib sulfate profile page.

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com

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Copyright © DrugPatentWatch. Originally published at New patent for Bayer Healthcare drug VITRAKVI

Source: https://www.drugpatentwatch.com/blog/new-patent-for-bayer-healthcare-drug-vitrakvi/

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Biotechnology

New patent for Boehringer Ingelheim drug OFEV

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Copyright © DrugPatentWatch. Originally published at New patent for Boehringer Ingelheim drug OFEV

Annual Drug Patent Expirations for OFEV
Annual Drug Patent Expirations for OFEV

Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twelve patent family members in fifty-one countries.

The generic ingredient in OFEV is nintedanib esylate. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com

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Copyright © DrugPatentWatch. Originally published at New patent for Boehringer Ingelheim drug OFEV

Source: https://www.drugpatentwatch.com/blog/new-patent-for-boehringer-ingelheim-drug-ofev/

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Biotechnology

New patent expiration for Acorda drug INBRIJA

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Copyright © DrugPatentWatch. Originally published at New patent expiration for Acorda drug INBRIJA

Annual Drug Patent Expirations for INBRIJA
Annual Drug Patent Expirations for INBRIJA

Inbrija is a drug marketed by Acorda and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug.

This drug has one hundred and thirty-three patent family members in twenty-six countries.

The generic ingredient in INBRIJA is levodopa. One supplier is listed for this compound. Additional details are available on the levodopa profile page.

For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or visit www.DrugPatentWatch.com

Make Better Decisions with DrugPatentWatch

Get the Daily Briefing or Try a trial

Copyright © DrugPatentWatch. Originally published at New patent expiration for Acorda drug INBRIJA

Source: https://www.drugpatentwatch.com/blog/new-patent-expiration-for-acorda-drug-inbrija/

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