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June 25, 2024 Toxic Exposures

Big Pharma News Watch

WHO, Scientists Call for Urgent Action on Mpox Strain + 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.

WHO, Scientists Call for Urgent Action on Mpox Strain

Reuters reported:

The spread of mpox in Africa needs to be addressed urgently, the World Health Organization said on Tuesday, as scientists warned separately of a dangerous strain in the Democratic Republic of Congo.

In a separate briefing, John Claude Udahemuka of the University of Rwanda, who has been working on an outbreak in Congo’s hard-to-reach South Kivu province, said the strain spreading there — a mutated version of the clade I mpox endemic in Congo for decades — was extremely dangerous. It has fatality rates of around 5% in adults and 10% in children.

This year, roughly 8,600 mpox cases have been reported in Congo, and 410 deaths, Cris Kacita, the doctor in charge of operations in the country’s mpox control program, told Reuters last week.

Vaccines and treatments were used to combat the global outbreak, but they are not available in Congo. The WHO and scientists said efforts were ongoing to address that.

Former Moderna Executive Launches Genome Editing Company

STAT News reported:

As chief medical officer of Moderna, Tal Zaks used to be skeptical of genome editing.

Why repair a patient’s broken gene, he would ask, with all the havoc CRISPR can wreak on DNA, when a company like Moderna can just replace that gene with regular, transient doses of mRNA? (One reason: Moderna was having immense difficulty doing just that.)

On Tuesday, though, Zaks emerged after years outside the spotlight as, of all things, acting CEO of a new genome editing company. Called Exsilio Therapeutics, the startup emerged from stealth with $82 million in Series A funding and a seed round led by OrbiMed, where Zaks has been a partner since shortly after he left Moderna in 2021.

Maker of Weight Loss Drugs to Build $4.1 Billion Factory in North Carolina

The Hill reported:

Novo Nordisk announced plans on Monday to build a $4.1 billion facility in North Carolina, as demand for its popular weight-loss drugs has only increased in recent months.

The plant will be the Danish company’s second fill and finishing manufacturing facility in Clayton, N.C., and its fourth facility in the area overall.

The life science investment marks the single largest in the state’s history, Novo Nordisk said. The company said it expects to add 1,000 new jobs, adding to the 2,500 in the region.

The goal, according to Novo Nordisk’s press release, is to expand the company’s ability “to produce current and future injectable treatments for people with obesity and other serious chronic diseases.”

Real-World Analysis Identifies Meds Tied to Higher Risk of Liver Injury — Case Reports May Not Be as Reliable, Researchers Say

MedPage Today reported:

Real-world data can be used to identify the most potentially hepatotoxic medications based on incidence rates of severe acute liver injury among patients without pre-existing liver or biliary disease, according to a series of cohort studies.

Of 194 suspected hepatotoxic medications, 17 dispensed in VA outpatient settings came with rates of severe acute liver injury at 5.0 or more events per 10,000 person-years, 11 of which were not included in the highest hepatotoxicity category by case reports, reported Vincent Lo Re III, MD, MSCE, of the University of Pennsylvania’s Perelman School of Medicine in Philadelphia, and colleagues in JAMA Internal Medicine.

“We identified multiple medications that are significantly higher or lower risk than previously suggested by case-based analyses,” Lo Re told MedPage Today.

Seven of the 17 medications — stavudine, erlotinib (Tarceva), lenalidomide (Revlimid) or thalidomide, chlorpromazine, metronidazole, prochlorperazine (Compazine), and isoniazid — were found to be the most hepatotoxic, with rates of 10.0 or more hospitalizations for severe acute liver injury per 10,000 person-years. The highest rate was observed with the HIV nucleoside reverse transcriptase inhibitor stavudine, at 86.4 events per 10,000 person-years.

The other 10 medications — moxifloxacin, azathioprine, levofloxacin, clarithromycin, ketoconazole, fluconazole, captopril, amoxicillin-clavulanate, sulfamethoxazole-trimethoprim, and ciprofloxacin — had rates between 5.0 and 9.9 events per 10,000 person-years.

Sanders Targets ‘Unacceptable’ Price of Weight-Loss Drugs Ozempic and Wegovy

The Guardian reported:

The blockbuster weight-loss drugs Wegovy and Ozempic are arguably as omnipresent in the American zeitgeist as Taylor Swift or the iPhone. The drugs and others in its class are associated with the sparkle of Hollywood, on the lips of Oprah and considered transformative by doctors.

But the giant market for drugs like Wegovy, including not just the roughly 11% of adults who have diabetes but also the 42% of adults who have obesity, has conjured one of the demons of American healthcare — price.

Americans paid 10 times more for Ozempic than patients in the United Kingdom in 2023 — $936 a month compared with $93. Wegovy costs Americans $1,349 a month, compared with $296 in the Netherlands (the drug is not yet available in the U.K.). That wild discrepancy has captured the attention of one of the drug industry’s loudest critics, the U.S. senator Bernie Sanders.

Sanders, an independent from Vermont and chairman of the powerful Senate health, education, labor and pensions (Help) committee, has used his pulpit to haul pharmaceutical executives before the public and demand lower prices. “You’re taking on a company which will make billions of dollars every single year, many billions of dollars from the U.S., on just this product,” said Sanders. “So, do I think this is going to be a difficult challenge? I do.”

For Diabetes Patients, Inhaled Insulin Is Shown Just as Effective as Injections and Pumps

Fox News reported:

Most of the 38 million people living with diabetes in the U.S. use daily injections or insulin pumps to keep glucose at safe levels — but new research suggests that a third option could be just as effective.

In a study led by Dr. Irl B. Hirsch, M.D., medical director of the Diabetes Care Center of the University of Washington Medical Center, an inhaled form of insulin — similar to an asthma inhaler — worked just as well as injections or pumps to control type 1 diabetes.

The research was presented last week at the American Diabetes Association (ADA)’s 84th Scientific Sessions in Orlando, Florida.

The clinical trial tested a product called Afrezza, an inhaled basal insulin made by MannKind Corporation in California. Afrezza, the only inhaled insulin on the market, has been available since getting FDA approval in June 2014.

The most common side effects noted in the study were hypoglycemia, cough and throat pain or irritation. Afrezza has been linked to a risk of acute bronchospasm in patients with chronic lung disease, such as asthma or COPD, according to the manufacturer.

Low Child Vaccine Uptake Sees Tipping-Point Warning

BBC News reported:

The U.K. is at a “tipping point”, with low uptake of routine vaccinations putting children at risk of catching severe diseases, health officials say.

Stalling vaccination rates against some diseases, such as whooping cough and measles, means population immunity is no longer high enough to stop outbreaks.

Latest figures from the U.K. Health Security Agency (UKHSA), for January-March, show a small increase in some vaccinations, including a 0.3% rise in pre-school booster jabs given to under-fives.

But targets are still being missed.

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