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August 22, 2023

Big Pharma News Watch

A Third of Adults Believe COVID Vaccines Caused Thousands of Sudden Deaths: Poll + 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.

A Third of Adults Believe COVID Vaccines Caused Thousands of Sudden Deaths: Poll

The Hill reported:

Belief in misinformation about key health issues persists among a good chunk of adults, with false claims about COVID-19, vaccines and reproductive health garnering a substantial amount of support, a new poll from KFF has found.

The new polling data found that a third of adults believed the COVID-19 vaccines “caused thousands of sudden deaths in otherwise healthy people,” with 10% believing that claim to be “definitely true” and 23% saying it was “probably true.” Another 34% said it was “probably false” and 31% said that claim was “definitely false.”

Nearly a third of people also said they believed the parasitic deworming medication ivermectin was an “effective treatment for COVID-19.” Among the naysayers, 44% said that claim was “probably false” and 22% said it was “definitely false.”

In the same poll, roughly a quarter of people said they believed vaccinations against measles, mumps and rubella caused autism in children and that COVID-19 vaccines cause infertility. No evidence has so far been found to indicate that immunization against SARS-CoV-2 affects male or female fertility.

FDA Approves First RSV Vaccine Given to Pregnant Mothers to Protect Babies

NBC News reported:

The Food and Drug Administration on Monday approved a vaccine that is administered to pregnant people to protect their babies from RSV, or respiratory syncytial virus, through their first six months.

The single-dose shot, made by Pfizer, spurs the production of protective antibodies that transfer from mother to infant through the placenta. It’s the first vaccine that can protect babies from RSV, which causes a lower respiratory illness that can be severe in infants.

However, last month the FDA also approved an injectable RSV drug for infants that delivers a dose of antibodies directly to the bloodstream.

Before Pfizer’s shot can be distributed to the public, an advisory committee to the Centers for Disease Control and Prevention must still recommend who should receive it. After that, it’s up to CDC Director Dr. Mandy Cohen to officially recommend the vaccine.

Teva, Glenmark Fined $255 Million by DOJ to Resolve Price-Fixing Charges

CNBC reported:

Drugmaker Teva Pharmaceuticals agreed to pay $225 million in criminal fines to resolve charges related to price fixing three medications, including a generic cholesterol drug that it has agreed to divest, the U.S. Department of Justice announced Monday.

Glenmark Pharmaceuticals will pay $30 million to resolve charges alleging that it conspired with Teva to fix prices for that cholesterol drug, called pravastatin. Glenmark will also divest its version of that drug.

Teva’s fine is the largest to date for a domestic antitrust case. Both settlements are the latest resolution in a string of cases related to price fixing, which refers to competitors banding together to artificially set the price of a product.

Since 2020, the DOJ’s antitrust division has charged five other pharmaceutical companies for participating in similar schemes affecting several generic drugs. Monday’s agreement means seven companies have resolved their criminal charges and collectively agreed to pay more than $681 million in criminal penalties.

Moderna Surges on a Second, Unexpected Shot at the Cancer Vaccine Market

Investor’s Business Daily reported:

Moderna (MRNA) stock surged Monday after the biotech company inked a deal with China’s Carsgen to study a new cancer vaccine regimen.

The regimen involves an experimental cell therapy from Carsgen and a potential cancer vaccine from Moderna. Carsgen, whose stock trades in Hong Kong, says its treatment has shown promise in gastric, pancreatic and other digestive system cancers.

The move gives Moderna a second stab at cancer vaccines. The company is partnered with Merck (MRK) on a bespoke vaccine for patients who’ve had their melanoma surgically removed. It’s also developing a cancer vaccine “off the shelf,” meaning the drug won’t be tailored to each individual patient.

Moderna’s second cancer vaccine also relies on messenger RNA technology. Messenger RNA, also known as mRNA, is the body’s mechanism for creating proteins. In this case, the cancer vaccine tells the body to make a protein involved in cells’ barriers. This protein has ties to several cancer types.

Novavax Shares Surge After Drugmaker Says New COVID Vaccine Was Effective Against Eris Variant

CNBC reported:

Shares of Novavax jumped more than 13% on Tuesday after the biotech company said its new COVID vaccine generated a broad immune response against the now-dominant Eris variant and another fast-spreading strain of the virus in small animal trials.

The updated shot is designed to target Omicron subvariant XBB.1.5, which is slowly declining nationwide.

But the trial results suggest that the shot may still be effective against newer COVID variants gaining a greater foothold in the U.S. That includes Eris and XBB.1.16.6 — both of which are also descendants of Omicron.

Novavax’s vaccine and new shots from Pfizer and Moderna are expected to roll out in the U.S. within weeks, pending potential approvals from the U.S. Food and Drug Administration.

Adderall Shortages Are Dragging On — Can Video Games Help?

Wired reported:

Earlier this month, facing an increasingly precarious situation, the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) joined forces to address the ongoing Adderall shortage. Technically, neither organization has the power to compel pharmaceutical companies to produce mixed amphetamine salts, but in the face of skyrocketing diagnoses of attention deficit hyperactivity disorder (ADHD) in the pandemic era of telemedicine, they wanted to reassure the public that they were looking into potential alternatives to stimulant medications. One suggestion: video games.

In a joint statement, the agencies acknowledged that while they were actively working with the pharmaceutical industry to address the shortages, the FDA did approve a “game-based digital therapeutic” to address ADHD symptoms in children back in 2020.

While it’s unclear whether digital therapeutics can replace stimulants entirely (they probably can’t), it is clear that people want options beyond amphetamines. And this summer, digital medicine company Akili Interactive dropped the first “over-the-counter” digital therapeutic for managing ADHD symptoms in adults, using the same technology underlying their previously FDA-approved prescription video game for kids.

The Supreme Court Should Bless the Purdue Pharma Settlement

The Washington Post reported:

The Supreme Court recently announced that it will review Purdue Pharma’s bankruptcy settlement, which would release the company’s owners, the Sackler family, from future civil liability for the harms they imposed on millions of opioid victims. Some see this as an opportunity to vindicate victims and prevent abusive bankruptcy settlements. That is wrong.

The reality is that the Supreme Court’s review comes at a major cost to opioid victims, potentially delaying compensation they would receive by months or even years. It might also cost the entire legal system. If the court rejects the settlement in this case, it would cripple our bankruptcy courts, which play a key role in remedying the mistreatment of mass tort victims by our legal system.

The harm to victims is hard to overstate, as is the malignancy of Purdue’s conduct. The company has twice pleaded guilty to criminal charges — first in 2007, for misleading the public about the safety of its products, and again in 2020, for defrauding the United States and violating the federal anti-kickback statute.

We Know Where New Weight Loss Drugs Came From, but Not Why They Work

The New York Times reported:

While other drugs discovered in recent decades for diseases like cancer, heart disease and Alzheimer’s were found through a logical process that led to clear targets for drug designers, the path that led to the obesity drugs was not like that.

In fact, much about the drugs remains shrouded in mystery. Researchers discovered by accident that exposing the brain to a natural hormone at levels never seen in nature elicited weight loss. They really don’t know why, or if the drugs may have any long-term side effects.

Although the drugs seem safe, obesity medicine specialists call for caution because — like drugs for high cholesterol levels or high blood pressure — the obesity drugs must be taken indefinitely or patients will regain the weight they lost.

Dr. Susan Yanovski, a co-director of the office of obesity research at the National Institute of Diabetes and Digestive and Kidney Diseases, warned that patients would have to be monitored for rare but serious side effects, especially as scientists still don’t know why the drugs work.

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