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December 14, 2023

Big Pharma News Watch

‘It’s Absolutely Heartbreaking’: Fentanyl Is Officially Los Angeles County’s Deadliest Drug + 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.

‘It’s Absolutely Heartbreaking’: Fentanyl Is Officially Los Angeles County’s Deadliest Drug

Los Angeles Times reported:

Fentanyl has continued to tighten its deadly grip on Los Angeles, with the synthetic opioid causing the majority of fatal overdoses countywide in 2022.

For the first time in recent years, fentanyl surpassed methamphetamine as the most common drug listed as a cause of overdose deaths, according to a recent report from the L.A. County Department of Public Health. Fentanyl was blamed in almost 60% of all accidental drug or alcohol overdoses in 2022, the report said and has continued to disproportionately kill Black Angelenos.

Overdoses in general increased again in almost every measure from the prior year, further escalating a crisis fueled by the opioid epidemic, which has devastated communities across the nation.

In just six years, fentanyl has become the prominent driver of opioid overdose deaths, going from causing about 20% of fatal opioid overdoses in 2016 to causing almost all of them — 92% — in 2022. Officials have already warned about other synthetic opioids even more potent than fentanyl that have been linked to overdose deaths across the nation.

Moderna Stock Soars After Cancer Vaccine’s Strong Test Results

Forbes reported:

Moderna’s new mRNA vaccine reduces the chance of relapse or death of skin cancer by half when paired with Merck’s immunotherapy drug Keytruda, new data shows, marking a step forward in the developing field of mRNA technology and sending Moderna’s stock soaring Thursday morning.

The experimental vaccine has been closely watched in the biotech industry, building on the same mRNA technology that created the COVID-19 vaccine. However, the vaccine is custom-built for each recipient, using the DNA of the patient’s tumor to help build their immunity. Thursday’s announcement is also a boon for Moderna, which posted some of its biggest stock gains of the year on the same day.

Those gains come after a more sluggish performance in recent months as demand for COVID-19 vaccines has continued to wane and after a decline on Tuesday after the departure of the company’s Chief Commercial Officer Arpa Garay. The company has bet big on building on the success of its mRNA COVID-19 vaccine, hoping to use the technology to develop additional vaccines, including for melanoma and influenza.

Poison Centers See Nearly 1,500% Increase in Calls Related to Injected Weight-Loss Drugs as People Accidentally Overdose

CNN Health reported:

Poison control centers across the U.S. say they are seeing a steep increase in calls related to semaglutide, an injected medication used for diabetes and weight loss, with some people reporting symptoms related to accidental overdoses.

Some have even needed to be hospitalized for severe nausea, vomiting and stomach pain, but their cases seem to have resolved after they were given intravenous fluids and medications to control nausea.

From January through November, America’s Poison Centers reported nearly 3,000 calls involving semaglutide, an increase of more than 15-fold since 2019. In 94% of calls, this medication was the only substance reported.

After Recalls and Infections, Experts Say Safer Eyedrops Will Require New FDA Powers

Associated Press reported:

When you buy eyedrops at a U.S. store, you might assume you’re getting a product made in a clean, well-maintained factory that’s passed muster with health regulators.

But repeated recalls involving over-the-counter drops are drawing new attention to just how little U.S. officials know about the conditions at some manufacturing plants on the other side of the world — and the limited tools they have to intervene when there’s a problem.

The Food and Drug Administration is asking Congress for new powers, including the ability to mandate drug recalls and require eyedrop makers to undergo inspections before shipping products to the U.S. But experts say those capabilities will do little without more staff and resources for foreign inspections, which were a challenge even before the COVID-19 pandemic forced regulators to skip thousands of visits.

An October recall of two dozen eyedrop brands came after FDA staff found cracked floors, barefoot workers and other unsanitary conditions at a Mumbai plant that supplied products to CVS, Walmart and other major retailers. It was the first time FDA staff had visited the site.

Big Pharma: Why the Drug Industry Faces a 3-Front Battle With the FTC, Medicare, and the White House

Yahoo!Finance reported:

The Federal Trade Commission had its first win earlier this week in its crusade to block drug company deals: Sanofi (SNY) on Monday ended its up-to-$735 million licensing deal with Maze Therapeutics.

It was a victory for FTC Chair Lina Khan, who is starting to make good on her threats to take a closer look at smaller deals — which is necessary, the agency believes, to slow down growing monopolies in the pharma business.

But the win was more than a move to block Sanofi’s ability to scale in the Pompe disease therapy market. The collapse of the deal is the latest example of how the pharmaceutical industry is battling the U.S. government on a number of fronts, including the White House’s move to license drugs that were developed with federal funding, the FTC’s scrutiny of deals, and the Medicare drug pricing talks.

FDA and HHS Sued for Concealing Documents Showing Suppression of HCQ and Ivermectin: America First Legal

The Epoch Times reported:

America First Legal (AFL) is suing the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) for failing to turn over documents related to the government’s suppression of the COVID-19 treatments hydroxychloroquine (HCQ) and ivermectin.

According to the lawsuit, AFL filed a Freedom of Information Act (FOIA) request in August 2022 with HHS and the FDA seeking information related to the anti-malarial drug HCQ from March 1 to Sept. 1, 2020. AFL received confirmation and tracking numbers from both agencies that its request had been received.

AFL, a nonprofit “working to promote the rule of law in the United States, prevent executive overreach, and ensure due process and equal protection for all Americans,” sought information to determine when and why government officials, including Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases, discouraged and suppressed the use of HCQ and ivermectin to treat COVID-19. Neither agency complied with the requests.

Despite hundreds of peer-reviewed studies supporting the effectiveness of both medications, the FDA has cautioned against using HCQ and ivermectin to prevent and treat COVID-19. On its website, the FDA states that “currently available data do not show ivermectin is effective against COVID-19,” yet half of the studies the agency uses to support its position support using ivermectin against COVID-19, according to a 2022 review by The Epoch Times.

Biden to Tout Efforts to Lower Prescription Drug Costs in NIH Visit

The Hill reported:

President Biden will travel to the National Institutes of Health in Maryland on Thursday to deliver remarks highlighting how a signature piece of legislation is capping prescription drug costs.

Biden will make the short trip to Bethesda to announce that dozens of pharmaceutical companies will be required to pay rebates to Medicare because they raised drug prices faster than the rate of inflation.

Ozempic Side Effects Led to Stomach Paralysis, Severe Pain, Emergency Room Visit, Lawsuit Claims

AboutLawsuits.com reported:

According to allegations raised in a recently filed product liability lawsuit, Novo Nordisk has failed to adequately warn consumers and the medical community about the risk of severe Ozempic side effects, which could cause users of the diabetes and weight loss drug to experience severe stomach paralysis from delayed gastric emptying.

In a complaint filed in the U.S. District Court for the Western District of New York on December 1, Holly Jones indicates that Ozempic left her with a medical condition known as gastroparesis, in which the stomach becomes paralyzed, leading to severe vomiting, persistent diarrhea, constant indigestion and pain so severe that it resulted in an emergency room visit.

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