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August 1, 2024 Toxic Exposures

Big Pharma NewsWatch

Moderna Shares Fall Amid Lower Sales Outlook for RSV, COVID Shots + 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.

Moderna Shares Fall Amid Lower Sales Outlook for RSV, COVID Shots

BioPharmaDive reported:

Shares of Moderna fell nearly 20% on Thursday after the company lowered its 2024 financial forecasts amid slowing sales and growing competition for its vaccines.

Alongside its second-quarter earnings report, Moderna cut its projected product sales outlook this year from $4 billion to an expected $3 billion to $3.5 billion.

The biotechnology company cited multiple reasons for lowering its estimate, from expectations of lower COVID-19 vaccine sales in Europe, to deferred government contracts and tough competition from other vaccine developers.

The announcement triggered a stock sell-off and “raises doubt about hitting profitability and cash burn goals,” Jefferies analyst Michael Yee wrote in a research note Thursday.

Mpox Cases Have Surged by 160% in Africa so Far This Year, but Few Treatments and Vaccines Available

ABC News reported:

African health officials said Mpox cases have spiked by 160% so far this year, warning the risk of further spread is high given the lack of effective treatments or vaccines on the continent.

The Africa Centers for Disease Control and Prevention (CDC) said in a report released Wednesday that Mpox, also known as monkeypox, has now been detected in 10 African countries this year including Congo, which has more than 96% of all cases and deaths.

Officials said nearly 70% of cases in Congo are in children younger than 15, who also accounted for 85% of deaths.

There have been an estimated 14,250 cases so far this year, nearly as many as all of last year. Compared to the first seven months of 2023, the Africa CDC said cases are up 160% and deaths are up 19%, to 456.

Burundi and Rwanda both reported the virus for the first time this week.

Nasal COVID Vaccine Stops Infection in Animal Trials

MedicineNet reported:

A next-generation nasal vaccine for COVID-19 appears to do what injectable vaccines can’t — actually stop the spread of the virus from person to person.

Hamsters that received the nasal vaccine didn’t pass the virus on to others if they became infected, breaking the cycle of transmission, researchers reported July 31 in the journal Science Advances.

The animal study provides more evidence that vaccines delivered into the nose or mouth might be the key to controlling the spread of respiratory infections like influenza and COVID-19, researchers said.

“To prevent transmission, you need to keep the amount of virus in the upper airways low,” said senior researcher Jacco Boon, a professor of medicine, molecular microbiology and pathology & immunology with the Washington University School of Medicine in St. Louis.

Trust in Doctors Crashed During the COVID Pandemic — And Remains Low

MedPageToday reported:

Trust in physicians and hospitals decreased sharply during the COVID-19 pandemic, and higher levels of trust were tied to greater odds of getting vaccinated for COVID-19 or influenza, according to a survey study of U.S. adults.

Among over 400,000 unique respondents, the proportion of adults who agreed they had “a lot of trust” in physicians and hospitals declined from 71.5% in April 2020 to 40.1% in January, reported Roy Perlis, M.D., MSc, of Massachusetts General Hospital in Boston, and colleagues in JAMA Network Open.

“We were surprised by the magnitude of the shift,” Perlis told MedPage Today. “I think early in the pandemic trust likely increased above pre-pandemic levels, but it certainly came way down over the course of the pandemic.”

Copycat Weight-Loss Drugs Are Major Players With Consumers

KFF Health News reported:

As many as 1 in 8 American adults has tried one of the GLP-1 anti-obesity drugs, but a surprising number aren’t getting their supplies from pharma giants Novo Nordisk or Eli Lilly. Up to 30% of the market, by some estimates, is made up of copycat versions from compounding pharmacies.

Compounding is legal, though the resulting products sometimes fall into a gray area because they’re copies of drugs under patent and are not approved by the U.S. Food and Drug Administration.

Mark Mikhael, CEO of Orlando-based Olympia Pharmaceuticals, estimates that his and other large compounders provision up to 2 million Americans each month with semaglutide, the scientific name for Novo Nordisk’s Wegovy, Ozempic and Rybelsus formulations, or tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.

CDC Will Offer Seasonal Flu Shots to Farmworkers to Lower Bird Flu Risk

StatNews reported:

The Centers for Disease Control and Prevention (CDC) announced Tuesday that it is funding a $5 million program to vaccinate livestock industry workers against seasonal flu in a bid to reduce the pandemic risk posed by the ongoing H5N1 bird flu outbreak in cattle.

The voluntary program, which will be administered by state and local public health workers, is aimed at getting seasonal flu shots into as many people as possible who are working in proximity to animals — poultry, cows, or other livestock — that could be infected with H5N1.

Nirav Shah, the CDC’s principal deputy director, said there are an estimated 200,000 people officially working in this sector nationwide, though he acknowledged that number doesn’t encompass all people working with these animals.

The CDC’s Test for Bird Flu Works, but It Has Issues

MedicalXPress reported:

The Centers for Disease Control and Prevention (CDC) says a glitch in its bird flu test hasn’t harmed the agency’s outbreak response. But it has ignited scrutiny of its go-it-alone approach in testing for emerging pathogens.

The agency has quietly worked since April to resolve a nagging issue with the test it developed, even as the virus swept through dairy farms and chicken houses across the country and infected at least 13 farmworkers this year.

At a congressional hearing July 23, Rep. Brett Guthrie, R-Ky., asked about the issue. “Boy, that rings of 2020,” he said, referring to when the nation was caught off guard by the COVID-19 pandemic, in part because of dysfunctional tests made by the CDC.

GSK Continues To Settle Zantac Lawsuits Before Trial, While Maintaining Heartburn Drug Did Not Cause Cancers

AboutLawsuits.com reported:

GlaxoSmithKline, or GSK, has reportedly agreed to settle another Zantac lawsuit just before the case was set to go before a jury, but continues to refuse to make wider payouts to resolve tens of thousands of similar claims currently making their way through the U.S. court system, even though other manufacturers of the recalled heartburn drug have agreed to settlements over their role in the development and sale of the drug.

Zantac (ranitidine) was a widely used over-the-counter drug approved for treatment of heartburn and acid reflux, which was sold at different times by GSK, Pfizer, Sanofi, Boehringer Ingelheim and various generic manufacturers, until all versions of the drug were removed from the market more than four years ago.

The Zantac recalls were required by the U.S. Food and Drug Administration (FDA) after it was discovered that the active ingredient in the pills is inherently unstable, and produces high levels of the chemical byproduct N-Nitrosodimethylamine (NDMA), which is a known human carcinogen.

As a result of the drug makers’ failure to disclose this risk for years, nearly 100,000 Zantac lawsuits have been presented by former users who developed bladder cancer, liver cancer, pancreatic cancer, stomach cancer and other injuries.

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