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October 17, 2023

Big Pharma News Watch

Vaccine Stocks — Including Pfizer, Moderna, BioNTech and Novavax — Slide Amid Plummeting Demand + 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.

Vaccine Stocks — Including Pfizer, Moderna, BioNTech and Novavax — Slide Amid Plummeting Demand

Forbes reported:

Stocks of Pfizer and other COVID vaccine makers like BioNTech and Moderna fell in premarket trading Monday after the company slashed its revenue forecasts last week, a change in fortune for the sector as demand for the pandemic-related products that propelled them to record profits last year plummets.

Pfizer slashed its annual revenue forecast by 13% on Friday due to sliding demand for its COVID-19 products. Sales of the firm’s mRNA shot, produced jointly with BioNTech, and its antiviral drug Paxlovid helped it secure record profits last year but the firm has long warned about sliding demand as the world, and particularly the U.S., exits the pandemic this year.

The company cut its projections for Paxlovid by $7 billion and by around $2 billion for its COVID shots, which was greater than analysts expected. Pfizer said it was launching a $3.5 billion cost-cutting program covering jobs and expenses as it prepares for the hit to its revenues.

Pfizer said it would take a write-down of $5.5 billion in the third quarter due to shrinking demand for its COVID stock, most of which comes from inventory write-offs of Paxlovid worth $4.6 billion. The company also acknowledged a $900 million write-off from COVID vaccine stock, a write-off BioNTech also flagged on Monday on account of its profit-sharing agreement with Pfizer.

As the Number of Vaccines for Pregnant Women Rises, so Does Vaccine Hesitancy

NBC News reported:

As the winter respiratory illness season fast approaches, this is the first year that four vaccines are being recommended during pregnancy. Yet, there are already signs that fewer pregnant women are getting vaccinated — putting themselves and their newborns at increased risk of severe illness or death.

“We are meeting more resistance than I ever remember,” said Dr. Neil Silverman, a maternal-fetal medicine specialist at UCLA Health. “We didn’t get this kind of pushback on this scale before the pandemic. Now all vaccines are lumped together as ‘bad.”

In September, the Centers for Disease Control and Prevention recommended for the first time that pregnant people get the RSV vaccine to protect against an infection that is usually mild in healthy adults but can be dangerous for children younger than 5. The new guidance means pregnant women will be encouraged to get four vaccines to protect against the flu, COVID and pertussis (also called whooping cough), as well as respiratory syncytial virus, or RSV.

However, a recent CDC report found growing doubts about vaccination during pregnancy. Among almost 2,000 women who were pregnant during the height of last year’s cold and flu season or when the survey was conducted in March and April, almost a quarter said they were “very hesitant” about getting a flu shot.

That is a significant increase over the 17.2% who said they had the same level of reservations during the 2021-2022 respiratory illness season.

Our Expensive Obesity Drugs Are Worth It, Novo Nordisk and Eli Lilly Argue in Raft of Studies

STAT News reported:

Here at ObesityWeek, one of the largest conferences on obesity, Novo Nordisk and Eli Lilly are displaying more than a dozen studies that together carry the message: Our blockbuster weight loss treatments will be worth it for society.

But experts point out that much of this company-funded research does not include the cost of the drugs themselves, which sell at more than $10,000 per year in the U.S. and are meant to be taken indefinitely.

The two major pharmaceutical companies have seen interest skyrocket for their GLP-1-based drugs like Ozempic, Wegovy, and Mounjaro, a new generation of medications that can cut substantial amounts of weight. But insurance plans have been slow to grant wide access to obesity treatments, concerned that the vast amount of people eligible to take them, along with their high price, could lead to significant financial strain.

Here’s What It Would Take for Insurance to Cover Weight Loss Drugs

NBC News reported:

The makers of Ozempic, Wegovy and Mounjaro are racing to prove that the incredibly popular drugs have health benefits beyond weight loss and diabetes. Doing so, they say, will make it easier for patients to get insurance to cover the pricey medications.

Clinical trials are underway to see whether the drugs can reduce the risk of heart attack, stroke, kidney disease and other chronic diseases in people with obesity.

Even though obesity is associated with a number of health risks, insurance companies often don’t cover the cost of weight loss medications, which can exceed $1,000 for a month’s supply.

Another barrier is a 2003 law that prohibits Medicare from covering weight loss drugs, cutting off a huge group of potential patients. Private insurance companies also often take cues about what to cover from the federal program.

Johnson & Johnson Beats on Earnings and Hikes Outlook as Medtech, Pharmaceutical Sales Surge

CNBC reported:

Johnson & Johnson on Tuesday reported adjusted earnings and revenue that topped Wall Street’s expectations and lifted its full-year guidance as sales in the company’s pharmaceutical and medical devices businesses surged.

It marks J&J’s first quarterly results since it completed the separation from its consumer health spinoff Kenvue in August, the company’s biggest shake-up in its 137-year history. Upon that separation in August, J&J also lowered its full-year sales and profit guidance.

The drugmaker raised that revised outlook on Tuesday: J&J expects 2023 sales of $83.6 billion to $84 billion, compared with previous guidance of $83.2 billion to $84 billion in August.

J&J also expects adjusted earnings per share of $10.07 to $10.13, up from a previous forecast of $10.00 to $10.10.

Novel Vaccines Promising for Chikungunya, Cytomegalovirus — Trials Meet All Primary Aims, Poising Them to Advance Toward Clinical Use

MedPage Today reported:

Vaccine candidates for chikungunya virus and for the ubiquitous cytomegalovirus performed well in human clinical trials, researchers reported here at the annual IDWeek meeting.

In two phase III trials, the adjuvanted chikungunya virus vaccine achieved its primary and key secondary endpoints in healthy participants 12 years of age and older, reported Jason Richardson, Ph.D., clinical director of research for vaccine developer Bavarian Nordic in Toronto.

Researchers demonstrated in a phase II study that an mRNA vaccine candidate produced responses in patients who had documented infection with cytomegalovirus and in individuals who were free of infection with the pathogen, which is a widespread latent virus considered the leading infectious cause of birth defects globally and a substantial cause of morbidity in immunocompromised individuals.

In commenting on the studies, Satoshi Kamidani, MD, Ph.D., of Emory University School of Medicine in Atlanta, noted that pediatric studies are also planned, “so we can immunize children before they become adults and become pregnant, and in turn, prevent congenital infections. It seems that they are moving ahead with this vaccine candidate.”

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