US FDA declines to approve Regeneron's blood cancer therapy

 US FDA declines to approve Regeneron's blood cancer therapy

The U.S. Food and Drug Administration has declined to approve Regeneron's therapy for a common form of blood cancer, the company said on Tuesday.

Regeneron was seeking regulatory approval of its therapy, linvoseltamab, in patients with multiple myeloma whose cancer has returned or worsened after at least three prior lines of treatment.

The FDA, in a so-called "complete response letter", said the sole issue identified for approval is related to findings from a pre-approval inspection at a third-party manufacturer, the company said.

Regeneron said it is committed to working closely with the third-party manufacturer and the health regulator to bring linvoseltamab to patients, without giving any other details.

Regeneron said in early August that the FDA's concerns about a third-party manufacturer will cause a delay in the regulatory decision for linvoseltamab, even though the issues were resolved and unrelated to the drug's production.

 (Reporting by Bhanvi Satija, Sneha S K and Nilutpal Timsina in Bengaluru; Editing by Shailesh Kuber) Ruter

https://www.fiercebiotech.com/research/how-pythons-survive-swallowing-massive-meals-may-help-develop-new-human-heart-medicines 

Recalled Chocolates Sold In California Pose 'Life-Threatening' Health Risk By Logan DeLoye

Abdallah Candies voluntarily recalled a "limited quantity of Abdallah Candies 8 oz. sea salt almond alligators " on April 2nd due to an incorrect ingredient label. According to the U.S. Food & Drug Administration , the recalled products feature "a chocolate covered cherries label with code 0315," presenting a potentially dangerous issue for people with nut allergies.
Consumers who are allergic to almonds "run the risk of serious or life-threatening allergic reaction if they consume these products." An allergic reaction can be identified by the presence of "hives, hypotension, respiratory distress, or significant swelling of the tongue or lips," per the CDC .
The recalled Abdallah Candies 8 oz. sea salt almond alligators with incorrect labels were distributed to grocery stores and retail outlets nationwide . Affected lots were shipped out from March 1, 2024 to March 29, 2024. The identification code can be found "at the bottom center of the ingredient label" and should be noted for safety purposes.
The FDA advised consumers to "destroy" or return this product at the place it was purchased. As of April 2nd, no illnesses were reported regarding consumption of the product. This is the only Abdallah Candies product that is currently being recalled.
For more information and to see photos of the recalled product visit fda.gov .
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Comments / 20Add a CommentMommydoc3d agoIt’s only life-threatening to those with almond allergies. Stop making it sound like they were poisoned.Reply(1)
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Amy Knowles2d agoI'm deathly allergic to tree nuts. Almonds are by far the worst...I wouldn't buy something called sea salt ALMOND anything regardless of what the label on the back says..Reply(1)
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California residents are asked to stop using this hemorrhoid ointment if they own it and to not purchase any more of it. ( Newsbreak)

 

FOX40

California woman dies after using hemorrhoid ointment from Vietnam

By Sergio Robles,

4 days ago

California health officials said a Sacramento woman developed “severe” lead poisoning and died in March after she used a hemorrhoid ointment from Vietnam.

The ointment is called Cao Boi Tri Cay Thau Dau , health officials said. Pictures shared by officials show that it comes in a container with a green-colored label and the ointment itself is a dark green color.

Officials said the woman bought the ointment on Facebook and it was mailed to the United States by a relative who lives in Vietnam.

Sacramento County health officials said the California Dept. of Public Health tested a sample of the ointment and found that it had 4% lead, which it called a “dangerous amount.”

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Health officials said any amount of lead can harm health.

California residents are asked to stop using this hemorrhoid ointment if they own it and to not purchase any more of it.

Residents who have used it are advised to see their doctor and have their blood tested for lead. Household members should also have their blood tested, especially children, officials said.

Any purchased ointment of this kind can be placed in a sealed plastic bag and the item reported to 510-620-3620 or toxoutbreak@cdph.ca.gov.

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What are the signs and symptoms of lead poisoning?

Health officials say mild signs and symptoms of lead poisoning include fatigue, irritability or mood swings, difficulty concentrating, and difficulty sleeping.

Moderate signs and symptoms include muscle or joint pain, nausea, decreased appetite, stomach cramps, constipation or diarrhea, feeling tired or sleepy, headache, and tremors.

Signs and symptoms of severe poisoning include severe stomach cramping; a tingling, burning or numbness in the hands; seizures; coma; and death.

Copyright 2024 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

For the latest news, weather, sports, and streaming video, head to FOX40.

Unleash Your Super Brain To Learn Faster | Jim Kwik

Unleash Your Super Brain To Learn Faster | Jim Kwik

Tesla Orientation Day 2

 In 2012 bought factory 

NCS No copy right sounds

Model 3

Manufacturing essentials

There are many other reason 

The second reason

Expectation 

⏰Punctuality (disciplinary base on point system)

👩‍🏫Professionalism 

🤼Participation 

🟡Generation 

🟢Storage 

🔵Consumption 

🔹Cybertruck

🔹Semi

🔹Roadster 

🔸Attendance 

🔸Intro to ergonomics 

🔸Tesla flex

🔸Intro to traffic flow

🟩team wear

➖➖➖➖➖➖➖➖➖➖➖➖

Tesla safety core value

🟥ergonomics awareness 

(make the job fit the person )

Safety,quality,morality 

🚩🚩🚩🚩🚩🚩🚩🚩🚩

What is an MSD(85%to 90% of injuries at Tesla

❇️Rotation Task

Ergonomic Hit List

⚠️Common injuries (because of poor posture)