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November 13, 2024 Toxic Exposures

Big Pharma NewsWatch

What to Know About Trump and RFK Jr.’s ‘Make America Healthy Again’ Agenda + 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.

What to Know About Trump and RFK Jr.’s ‘Make America Healthy Again’ Agenda

MSN reported:

Robert F. Kennedy Jr. has outlined a number of promises to “Make America Healthy Again” under President-elect Donald Trump, vowing to combat an “epidemic” of chronic diseases that he has described as an “existential” threat to America’s future.

All are under the banner of fighting what Kennedy sees as a common thread behind a broad swath of ailments: that Americans have been “mass poisoned by big pharma and big food,” and that federal agencies have failed to stop it. In response, he has also floated a number of specific policy ideas to remake the federal government’s public health institutions.

“[Trump] asked me to end the chronic disease epidemic in this country. And he said, I want to see results, measurable results in the diminishment of chronic disease within two years. And I said, Mr. President, I will do that,” Kennedy said on Nov. 2.

With Trump Coming Into Power, the NIH Is in the Crosshairs

NPR reported:

As the next Trump administration overhauls the federal government, the National Institutes of Health (NIH) could be among the top targets for restructuring.

“I do think you probably will see changes in NIH, as well as other public health agencies like CDC and maybe even FDA,” says Dr. Joel Zinberg, a senior fellow at the Competitive Enterprise Institute and director of the Public Health and American Wellbeing Initiative at the Paragon Health Institute, both conservative think tanks. “And that’s primarily I think because there was a real erosion in trust in those agencies during the pandemic,” he says.

While the NIH — which gets $48 billion annually for biomedical research — has historically enjoyed bipartisan support, Trump proposed cutting its budget during his first term. And the pandemic didn’t leave positive feelings towards the agency in some quarters.

FDA Removes Clinical Trial Hold on Novavax COVID-Flu Combo and Flu Vaccines

CIDRAP reported

Novavax yesterday announced that the U.S. Food and Drug Administration (FDA) has released a clinical hold on its new drug application for its COVID-flu combination and standalone flu vaccines. In a statement, the company said the step paves the way for it to begin enrolling participants for a phase 3 trial.

The FDA announced the clinical hold on Oct. 16, following a report of a serious adverse event in a participant who received the combination vaccine as part of a phase 2 trial that wrapped up in 2023. The event was initially reported as motor neuropathy, which was later defined as amyotrophic lateral sclerosis (ALS), a condition not known to be immune-mediated or associated with vaccination. The FDA concluded that the event was not related to the vaccine.

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Potential Single-Dose Smallpox and Mpox Vaccine Moves Forward

MedicalXPress reported:

Vaccines that prevent smallpox and mpox come in two varieties. One uses a single shot of a live virus but carries the risk of serious side effects; the other, which is newer and made with replication deficient virus, has fewer side effects but requires two doses.

An experimental vaccine under development at Tonix Pharmaceuticals in Frederick, Md., aims to combine the benefits of both vaccine strategies. It uses the horsepox virus as a protective agent to confer the safety of a multi-dose vaccine in a single shot.

In mSphere, scientists at Tonix Pharmaceuticals report on studies suggesting that the horsepox virus in the experimental vaccine is substantially more attenuated — and thus less likely to trigger a systemic infection — than the vaccinia virus used in the single-dose vaccine already approved by the U.S. Food and Drug Administration.

Needle-Free Influenza Vaccine on the Horizon

MedicalXPress reported:

Hope is on the horizon for needle-phobic patients as Griffith University researchers have created a new influenza vaccine composition designed to be administered via the nose. Griffith University Principal Research Leader, Professor Bernd Rehm said his team reprogrammed bacterial cells to create a robust vaccine designed for intranasal delivery.

“The safe and synthetic particles mimic the actual virus and trigger an immune response, preventing infection,” Professor Rehm said.

The research paper “Intranasal epitope-polymer vaccine lodges resident memory T cells protecting against influenza virus” has been published in Advanced Healthcare Materials.

With High Hopes for the Economy, AstraZeneca Adds $2B to US Investment in Manufacturing, R&D

Fierce Pharma reported

Citing a rosy view of the U.S. economy’s potential for growth over the next several years, British Big Pharma AstraZeneca (AZ) is substantially boosting its investment in manufacturing and R&D in the country.

AstraZeneca on Tuesday revealed that it’s adding $2 billion more to its current outlay in the U.S., representing a total capital investment of $3.5 billion. The cash will be used to grow the company’s research and production footprint in the States by the end of 2026, generating more than 1,000 new jobs along the way, AZ said in a release issued Tuesday morning.

Chief among AZ’s U.S. manufacturing projects are the construction of a next-generation biologics plant in Maryland, a cell therapy capacity expansion on both the East and West Coast and the buildout of specialty manufacturing capabilities in Texas.

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