Newsletter Six Things to Know in October 1st & 2nd...

Six Things to Know in October 1st & 2nd Week

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A look at the first intestine transplant recipient, Eli Lilly’s success in combating obesity, but failure in quality control, and other top news this week! 

This week’s newsletter contains diverse news that features the pharmaceutical giants Eli Lilly not once, but twice, where the company’s quality control is in disarray, and where the FDA grants a rapid review of its drug. We also take a look at the uncertainty that surrounds Covid rebounds faced by multiple patients, Supernus’ Parkinson’s infusion device that faces the same fate, it did three years ago at the hands of the FDA, and the lucky Spanish baby girl who became the first intestine transplant recipient at the mere age of 13 months.

FDA review of Eli Lilly’s obesity drug

Eli Lilly’s Moujaro gets rapid review for the treatment of obesity following positive results in a study conducted a few months ago. The company reported patients losing over a fifth of their weight in a late-stage trial. According to Mohit Bansal, Wells Fargo analyst, the review could be completed within six months after the data is submitted. He also stated that if all goes well, approval could be granted by the end of 2023 and predicted sales boost peak of $18B.

For more on this, click here. 

Covid rebound due to strengthened immune system?

Some patients were faced with a Covid rebound after the use of Pfizer’s Paxlovid. Researchers of the United States government stated that it could be connected to the strong immune response because of the treatment. Researchers discovered a higher level of antibodies in the patients who faced a rebound of Covid. A lot of rebound cases were reported, President Joe Biden being one of them. These rebound cases raised fears about the treatment’s possible interference with the progress of a long-lasting immune response.

Read more about the topic here.

Supernus’ infusion device review rejected by the FDA… again

Supernus Pharmaceuticals failed to get approval for its infusion device two years ago on the grounds of a lack of information for complete review. The company has filed an application with the FDA again for the approval of the device to be used in combination with oral levodopa for continued treatment of Parkinson’s. After agreeing to review the application, FDA recognized the need for more information. Supernus vows to continue working with the FDA for the approval and had already planned to launch the device in the first quarter of 2023, prior to the rejection. Read more about the FDA’s decision here. 

Baby girl becomes the first beneficiary of intestinal transplant

A 13-month-old child has been the recipient of the world’s first intestinal transplant at the La Paz Hospital in Madrid. The organ was received through asystolic donation, which means the organ does not deteriorate. This was not believed to be true for intestines, which is why the technique was never used before. As the intestine is a part of the immune system, it is thought to be populated by a significant amount of germs, which makes the chances of infection as well as rejection, higher. Read more about the historic transplant here

Further quality issues found at Eli Lilly’s New Jersey plant

Eli Lilly’s plant faces federal investigation following reports of numerous new quality control problems from the U.S. drug inspectors. These new findings add to the already documented quality control issues from three years ago. The production area at the Branchburg, New Jersey plant had some unknown debris according to the inspectors. The 2019 inspection report showed that the quality control data had been deleted. A recent investigation revealed that numerous batches of multiple drugs had references removed. Lilly did not respond directly to the findings of the inspection. Lilly also denied accusations of forcing out an HR employee surrounding whistleblower claims following the deletion of records. Read more here.

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