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January 3, 2025 Toxic Exposures

Big Pharma NewsWatch

Common Drugs Taken by Millions of Pregnant Women Linked to Autism in Children + More

The Defender’s Big Pharma Watch delivers the latest headlines related to pharmaceutical companies and their products, including vaccines, drugs, and medical devices and treatments. The views expressed in the below excerpts from other news sources do not necessarily reflect the views of The Defender. Our goal is to provide readers with breaking news that affects human health and the environment.

Common Drugs Taken by Millions of Pregnant Women Linked to Autism in Children

Daily Mail reported:

Anti-inflammatory drugs taken by millions of pregnant women around the world may raise the risk of autism in their babies. A study looked at the impact on children who are exposed to glucocorticoids — a class of steroids — in the womb. Those prenatally exposed to the drugs were between 30 and 50% more likely to be diagnosed with autism compared to children whose mothers did not take them. The study also linked glucocorticoids — which include prednisone and cortisone — to a higher risk of intellectual disabilities, Attention-deficit/hyperactivity disorder (ADHD) and anxiety.

Glucocorticoids mimic the hormone cortisol, which is produced by the adrenal gland and known for its anti-inflammatory effect.  They are prescribed to pregnant women at risk of preterm births because they also help with the fetus’s organ development and maturation.  The drugs are also given to pregnant women suffering from autoimmune or inflammatory disorders such as rheumatoid arthritis, lupus and asthma because they dampen down the immune response. However, the new study suggests if babies are exposed to excess amounts of glucocorticoids it can alter their brain development in a negative way.

Are We Ready for Another Pandemic?

The Guardian reported:

Five years ago, the world was hearing the first reports of a mysterious flu-like illness emerging from Wuhan, China, now known as COVID-19. The pandemic that followed brought more than 14 million deaths, and sent shock waves through the world economy. About 400 million people worldwide have had long COVID. World leaders, recognizing that another pandemic was not a question of “if” but “when”, promised to work together to strengthen global health systems.

But negotiations on a new pandemic agreement stalled in 2024, even as further global public health threats and emergencies were identified. If a new pandemic threat emerges in 2025, experts are yet to be convinced that we will deal with it any better than the last.

BioNTech Inks Settlements With NIH, UPenn in COVID-19 Vaccine Royalty Disputes

Fierce Pharma reported:

After the University of Pennsylvania and the U.S. National Institutes of Health (NIH) separately pressed BioNTech for royalties on its Pfizer-partnered COVID-19 vaccine Comirnaty, the German drugmaker has agreed to pay up to resolve the disputes.

BioNTech will pay the NIH a total sum of $791.5 million, according to a securities filing. Of the sum, $750 million stems from claimed royalties on the vaccine from the years 2020 to 2023, while the remaining $41.5 million accounts for entry into an amended license agreement.

The deal also stipulates that the government agency will withdraw the “notice of default” it had issued the company back in March on funds it allegedly owed under the prior licensing agreement.

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Cold and Flu Medicine Recall Sparks Warning in 20 States

Newsweek reported:

LNK International Inc. is recalling Kirkland Signature Severe Cold and Flu Plus Congestion medicine over fears of potential contamination of foreign materials. Newsweek reached out to LNK International Inc. via email for comment on Thursday afternoon.

The medicine was sold at Costco stores in their Midwest and Southeast regional locations. The medicine was sold between October 30, 2024, and November 30, 2024. LNK International Inc. says it initiated the recall after the “accidental release and shipment” of units that were rejected. The voluntary recall comes amidst flu season in the United States. “Flu activity” peaks in December, January, and February, according to the Centers for Disease Control and Prevention.

Lilly Looks to ‘Protect Its Interests’ by Moving To Join FDA Lawsuit Over Compounded Tirzepatide

Fierce Pharma reported:

After plugging billions into its manufacturing network to meet rampant demand for Mounjaro and Zepbound, Eli Lilly is looking to protect its investment by wading into a lawsuit that seeks to allow compounding pharmacies to continue churning out knockoffs to the popular diabetes and obesity drugs. Lilly on Wednesday filed a motion to intervene in a lawsuit brought by compounding industry group the Outsourcing Facilities Association and compounder FarmaKeio Custom Compounding in U.S. District Court in Fort Worth, Texas.

The October lawsuit, which names the U.S. Food and Drug Administration and its current commissioner Robert Califf, M.D., as defendants, seeks to persuade the regulator to reverse its decision to formally declare a long-running shortage of Lilly’s dual GIP/GLP-1 meds resolved.

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