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%Start Preterm birth drug saga reflects broader issues with FDA process Drug Prices - Prescription Drugs HEAD TOPICS <h1>Preterm birth drug saga reflects broader issues with FDA process</h1>10/21/2022 10:32:00 AM <h2>Congress may still try to reform the FDA&#39 s accelerated approval process this year </h2> <h3>Drug Prices Prescription Drugs</h3> Source <h3> Axios </h3> An FDA advisory panel's recommendation to pull an early birth drug from the market is only the latest controversy surrounding a popular program aimed at getting promising new treatments to patients faster. Congress may still try to reform the FDA's accelerated approval process this year.
Isaac Schmidt Member
access_time 5 minutes ago
%Start Preterm birth drug saga reflects broader issues with FDA process Drug Prices - Prescription Drugs HEAD TOPICS

Preterm birth drug saga reflects broader issues with FDA process

10/21/2022 10:32:00 AM

Congress may still try to reform the FDA' s accelerated approval process this year

Drug Prices Prescription Drugs

Source

Axios

An FDA advisory panel's recommendation to pull an early birth drug from the market is only the latest controversy surrounding a popular program aimed at getting promising new treatments to patients faster. Congress may still try to reform the FDA's accelerated approval process this year.
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Hannah Kim 4 minutes ago
was poorly designed and didn't capture the drug's benefit."All of these issues are not ...
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Natalie Lopez 2 minutes ago
The manufacturer Biogen later Read more:
Axios » FDA authorizes Novavax's Covid shots as mi...
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was poorly designed and didn&#39;t capture the drug&#39;s benefit.&quot;All of these issues are not unique to Makena, but the manufacturer here has taken them to greater lengths than other manufacturers,&quot; said Rachel Sachs, a Washington University law professor. The big picture:Accelerated approval began drawing policymakers&#39; attention after it was used last year to approve Aduhelm, a controversial Alzheimer&#39;s drug that an FDA advisory panel had recommended the agency not approve.
Noah Davis Member
access_time 8 minutes ago
was poorly designed and didn't capture the drug's benefit."All of these issues are not unique to Makena, but the manufacturer here has taken them to greater lengths than other manufacturers," said Rachel Sachs, a Washington University law professor. The big picture:Accelerated approval began drawing policymakers' attention after it was used last year to approve Aduhelm, a controversial Alzheimer's drug that an FDA advisory panel had recommended the agency not approve.
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Sebastian Silva 5 minutes ago
The manufacturer Biogen later Read more:
Axios » FDA authorizes Novavax's Covid shots as mi...
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Jack Thompson 3 minutes ago
It's all a weird game, no single expert got problems with Novavax vaccine. Vaccine is safe for a...
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The manufacturer Biogen later Read more:<br>Axios &raquo; FDA authorizes Novavax's Covid shots as mix-and-match booster to Pfizer or Moderna FDA authorizes Novavax COVID vaccine booster for emergency use FDA panel backs removal of unproven pregnancy drug FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From Market <h3>Inside the only lithium producer in the U S which provides the critical mineral used in batteries by Tesla EV makers</h3> Silver Peak has gained newfound attention in recent years as the energy and transportation sectors race to wean themselves off climate-warming fossil fuels. Read more >> FDA authorizes Novavax&#39;s Covid shots as mix-and-match booster to Pfizer or ModernaNovavax&#39;s Covid shots rely on protein technology used in other vaccines for decades, rather than the messenger RNA used in the Pfizer and Moderna vaccines.
Henry Schmidt Member
access_time 6 minutes ago
The manufacturer Biogen later Read more:
Axios » FDA authorizes Novavax's Covid shots as mix-and-match booster to Pfizer or Moderna FDA authorizes Novavax COVID vaccine booster for emergency use FDA panel backs removal of unproven pregnancy drug FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From Market

Inside the only lithium producer in the U S which provides the critical mineral used in batteries by Tesla EV makers

Silver Peak has gained newfound attention in recent years as the energy and transportation sectors race to wean themselves off climate-warming fossil fuels. Read more >> FDA authorizes Novavax's Covid shots as mix-and-match booster to Pfizer or ModernaNovavax's Covid shots rely on protein technology used in other vaccines for decades, rather than the messenger RNA used in the Pfizer and Moderna vaccines.
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Grace Liu 5 minutes ago
It's all a weird game, no single expert got problems with Novavax vaccine. Vaccine is safe for a...
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James Smith 3 minutes ago
Moderna and Pfizer J&J ain't that safe as the company's claim. Google it yourself. Novav...
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It&#39;s all a weird game, no single expert got problems with Novavax vaccine. Vaccine is safe for all ages and efficient.
Andrew Wilson Member
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It's all a weird game, no single expert got problems with Novavax vaccine. Vaccine is safe for all ages and efficient.
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Madison Singh 3 minutes ago
Moderna and Pfizer J&J ain't that safe as the company's claim. Google it yourself. Novav...
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Moderna and Pfizer J&amp;J ain&#39;t that safe as the company&#39;s claim. Google it yourself. Novavax = safe and efficient HARD PASS FDA authorizes Novavax COVID vaccine booster for emergency useJUST IN: The FDA has issued an emergency use authorization for Novavax&#39;s COVID vaccine as a booster shot for all adults in the U.S., including those who initially received Pfizer’s or Moderna’s shots.
Lily Watson Moderator
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Moderna and Pfizer J&J ain't that safe as the company's claim. Google it yourself. Novavax = safe and efficient HARD PASS FDA authorizes Novavax COVID vaccine booster for emergency useJUST IN: The FDA has issued an emergency use authorization for Novavax's COVID vaccine as a booster shot for all adults in the U.S., including those who initially received Pfizer’s or Moderna’s shots.
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Surprise surprise Nope! Not ever.
Mason Rodriguez Member
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Surprise surprise Nope! Not ever.
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No way!!!!!! Need long term studies!
Emma Wilson Admin
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No way!!!!!! Need long term studies!
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Charlotte Lee 2 minutes ago
FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug ...
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FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn&#39;t work FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From MarketThe obstetricians and other reproductive-health experts voted after various studies found the drug didn’t provide a benefit but did increase the risk of blood clots and other side effects. So why is mrna injections pulled after the data was forcefully pulled from Pfizer instead of waiting 75 years?Bet there won&#39;t be an answer. FDA panel recommends revoking the approval of controversial drug for preterm birthsMakena, the only drug approved to prevent premature births, has not shown to be effective and exposes women to “serious risk,&#39; the agency&#39;s scientists said.
Mason Rodriguez Member
access_time 24 minutes ago
FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work FDA Advisers Recommend Pulling Drug to Prevent Preterm Births From MarketThe obstetricians and other reproductive-health experts voted after various studies found the drug didn’t provide a benefit but did increase the risk of blood clots and other side effects. So why is mrna injections pulled after the data was forcefully pulled from Pfizer instead of waiting 75 years?Bet there won't be an answer. FDA panel recommends revoking the approval of controversial drug for preterm birthsMakena, the only drug approved to prevent premature births, has not shown to be effective and exposes women to “serious risk,' the agency's scientists said.
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If it doesn’t work, shouldn’t it be mandatory? Call it a vaccine and have Fauci push it. &#128137;&#128137;&#128137;&#128137;&#128137;&#128137; YOU are the experiment FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn&#39;t work.
Noah Davis Member
access_time 36 minutes ago
If it doesn’t work, shouldn’t it be mandatory? Call it a vaccine and have Fauci push it. 💉💉💉💉💉💉 YOU are the experiment FDA panel backs removal of unproven pregnancy drugA panel of federal advisers says a pregnancy drug intended to prevent premature births should be withdrawn because it doesn't work.
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Noah Davis 18 minutes ago
First start with the Covid jab. Bit like that covid vaccine 💉💉💉💉 ...
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Lucas Martinez 7 minutes ago
&quot;All of these issues are not unique to Makena, but the manufacturer here has taken them to ...
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First start with the Covid jab. Bit like that covid vaccine &#128137;&#128137;&#128137;&#128137;&#128137;&#128137;&#128137; YOU are the experiment the confirmatory trial was poorly designed and didn&amp;#39;t capture the drug&amp;#39;s benefit.WATCH LIVE Key Points The FDA has authorized a third dose of Novavax&#39;s Covid vaccine for adults ages 18 and older.it had purchased over 3 million doses.By October 19, 2022 at 12:14 pm EDT Expand Pregnancy Drug-Removal This image provided by Covis Pharma shows packaging for the company&#39;s Makena medication.
Ryan Garcia Member
access_time 50 minutes ago
First start with the Covid jab. Bit like that covid vaccine 💉💉💉💉💉💉💉 YOU are the experiment the confirmatory trial was poorly designed and didn&#39;t capture the drug&#39;s benefit.WATCH LIVE Key Points The FDA has authorized a third dose of Novavax's Covid vaccine for adults ages 18 and older.it had purchased over 3 million doses.By October 19, 2022 at 12:14 pm EDT Expand Pregnancy Drug-Removal This image provided by Covis Pharma shows packaging for the company's Makena medication.
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&amp;quot;All of these issues are not unique to Makena, but the manufacturer here has taken them to greater lengths than other manufacturers,&amp;quot; said Rachel Sachs, a Washington University law professor. The big picture: Accelerated approval began drawing policymakers&amp;#39; attention after it was used last year to approve Aduhelm, a controversial Alzheimer&amp;#39;s drug that an FDA advisory panel had recommended the agency not approve.
Chloe Santos Moderator
access_time 11 minutes ago
&quot;All of these issues are not unique to Makena, but the manufacturer here has taken them to greater lengths than other manufacturers,&quot; said Rachel Sachs, a Washington University law professor. The big picture: Accelerated approval began drawing policymakers&#39; attention after it was used last year to approve Aduhelm, a controversial Alzheimer&#39;s drug that an FDA advisory panel had recommended the agency not approve.
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Novavax's third shot was developed against the original strain of Covid that first emerged in Ch...
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Novavax&#39;s third shot was developed against the original strain of Covid that first emerged in China in 2019 but it also induces an immune response against omicron BA. The manufacturer Biogen later largely gave up marketing the compound. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,&quot; Stanley Erck, president and CEO of Novavax, said in a statement Wednesday.
Jack Thompson Member
access_time 48 minutes ago
Novavax's third shot was developed against the original strain of Covid that first emerged in China in 2019 but it also induces an immune response against omicron BA. The manufacturer Biogen later largely gave up marketing the compound. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster," Stanley Erck, president and CEO of Novavax, said in a statement Wednesday.
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The more routine issue with the program is that drugmakers frequently miss their deadlines for completing confirmatory trials, yet their products remain on the market. In this article Follow your favorite stocks CREATE FREE ACCOUNT A healthcare worker prepares a dose of the Novavax Covid-19 vaccine at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug.
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The more routine issue with the program is that drugmakers frequently miss their deadlines for completing confirmatory trials, yet their products remain on the market. In this article Follow your favorite stocks CREATE FREE ACCOUNT A healthcare worker prepares a dose of the Novavax Covid-19 vaccine at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug.
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Both the House and the Senate have since proposed reforms to the program, and the FDA has asked specifically for more authority to ensure confirmatory studies &amp;quot;progress in a timely manner. (Covis Pharma via AP) (Uncredited) MATTHEW PERRONE October 19, 2022 at 12:14 pm EDT WASHINGTON — (AP) — Federal health advisers have concluded that a drug intended to prevent premature births hasn&#39;t been shown to work, clearing the way for U.
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Both the House and the Senate have since proposed reforms to the program, and the FDA has asked specifically for more authority to ensure confirmatory studies &quot;progress in a timely manner. (Covis Pharma via AP) (Uncredited) MATTHEW PERRONE October 19, 2022 at 12:14 pm EDT WASHINGTON — (AP) — Federal health advisers have concluded that a drug intended to prevent premature births hasn't been shown to work, clearing the way for U.
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&quot; However, lawmakers punted on any legislative reforms when they debated a must-pass FDA bi...
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The issue could resurface during a post-election lame duck session. By the numbers: ., including for...
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&amp;quot; However, lawmakers punted on any legislative reforms when they debated a must-pass FDA bill last month. Hannah Beier Bloomberg Getty Images The Food and Drug Administration has authorized Novavax&#39;s Covid boosters for adults in the U. The big picture: Novavax&#39;s vaccine is also the first and only protein-based vaccine authorized for use as a booster.
Dylan Patel Member
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&quot; However, lawmakers punted on any legislative reforms when they debated a must-pass FDA bill last month. Hannah Beier Bloomberg Getty Images The Food and Drug Administration has authorized Novavax's Covid boosters for adults in the U. The big picture: Novavax's vaccine is also the first and only protein-based vaccine authorized for use as a booster.
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The issue could resurface during a post-election lame duck session. By the numbers: ., including for...
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The issue could resurface during a post-election lame duck session. By the numbers: ., including for people who received Pfizer&#39;s or Moderna&#39;s shots as their primary series.
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The issue could resurface during a post-election lame duck session. By the numbers: ., including for people who received Pfizer's or Moderna's shots as their primary series.
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