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February 17, 2023

Big Pharma News Watch

Pfizer, Targeting a Younger Demographic, Enlists yet Another Celeb for Its Latest COVID Vaccine Ad + 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.

Pfizer, Targeting a Younger Demographic, Enlists yet Another Celeb for Its Latest COVID Vaccine Ad

Fierce Pharma reported:

Pfizer has enlisted yet another celebrity to push its flagging COVID-19 vaccine franchise. After targeting seniors with its Martha Stewart wields a samurai sword spot, the Big Pharma has swung to the opposite end of the age spectrum with an ad featuring a singer who first made their name on YouTube.

In the 30-second ad, Charlie Puth, a 31-year-old singer with 21 million TikTok followers, steps out of a car wearing sunglasses, at night and walks into a music venue flanked by a security guard. Once on the stage, Puth, now sans sunglasses and sitting behind a keyboard, says “out on tour, I got to help protect myself.”

Pfizer has put Puth at the heart of its attempts to court a younger demographic, with the latest spot following a Twitter video in which the star discussed his tour checklist — and revealed he had received his updated COVID-19 booster because “it’s important to prioritize my health while on tour.”

The Big Pharma is pushing its vaccine to young and old alike to soften the anticipated slump in Comirnaty sales. Management expects the COVID-19 vaccine to bring in $13.5 billion this year, well down on the $36 billion-plus that it generated in 2021 and 2022. With the U.S. switching to a commercial model for COVID-19 vaccines, branding and promotion could become increasingly important for Comirnaty.

The Race to an RSV Vaccine Could Soon Be Over, Decades After the First Attempt

NBC News reported:

Roughly six decades after the first attempt to develop a vaccine for respiratory syncytial virus, the Food and Drug Administration is poised to approve several shots by next winter.

No RSV vaccine has ever been approved in the U.S. The FDA is reviewing two applications — a vaccine from Pfizer and another from GlaxoSmithKline, both of which are for people ages 60 and up.

Close behind is a monoclonal antibody injection designed to protect babies from the virus. Although it is not technically a vaccine, it would serve the same purpose. The shot, from Sanofi and AstraZeneca, has already been approved in Europe, and the FDA began reviewing the companies’ applications in January.

Other notable vaccine candidates in the pipeline include a shot for older adults from Moderna, which the company has said could get submitted to the FDA for approval by July. Another candidate, from Bavarian Nordic, targets the same demographic, with phase 3 data expected by the middle of the year.

Bird Flu Alarm Drives World Towards Once-Shunned Vaccines

Reuters reported:

French duck farmer Herve Dupouy has culled his flock four times since 2015 to stop the spread of bird flu but as a wave of deadly outbreaks nears his farm once again, he says it’s time to accept a solution once considered taboo: vaccination.

Like Dupouy, more and more governments around the world are reconsidering their opposition to vaccines as culling birds or locking them inside has failed to prevent bird flu from returning to decimate commercial flocks year after year.

Reuters spoke to senior officials in the world’s largest poultry and egg producers, along with vaccine makers and poultry companies. They all said there had been a marked shift in the approach to vaccines globally due to the severity of this year’s bird flu outbreak, though the biggest exporter of poultry meat, the United States, told Reuters it remains reluctant.

Besides the cost of culling millions of chickens, ducks, turkeys and geese there is also a growing fear among scientists and governments that if the virus becomes endemic, the chances of it mutating and spreading to humans will only increase.

U.S. FDA Classifies Recall of Philips’ Respiratory Devices as Most Serious

Reuters reported:

The U.S. Food and Drug Administration (FDA) on Thursday classified the recall of Dutch medical devices maker Philips’ (PHG.AS) respiratory machines as most serious, saying their use could lead to injuries or death.

The U.S. health regulator said the silicon foam used in some reworked ventilator models may separate from plastic backing due to adhesive failure and can reduce the airflow as well as cause debris contamination.

The recall follows Philips’ move to call back millions of breathing devices and ventilators in June 2021 due to the potential of a foam part degrading and becoming toxic, possibly causing cancer.

First It Was Blood Pressure Medication. Now FDA Eyes More Drugs for Cancer-Causing Chemical.

USA TODAY reported:

For people managing high blood pressure, recent recalls of the carcinogen-tainted drug quinapril might sound familiar.

Since 2018, more than 12 million bottles of blood pressure-lowering drugs such as valsartan and losartan have been removed from the market because they contained cancer-risk chemicals called nitrosamines.

The same family of contaminants triggered recalls of the heartburn drug Zantac, the diabetes drug metformin and the smoking-cessation medication Chantix.

The federal regulator has asked drugmakers to evaluate all products for any risk they might contain nitrosamines. Companies that identify any such risk must conduct follow-up testing, report changes and take action by October.

Pfizer, Valneva to Stop Testing Lyme Disease Vaccine in Some U.S. Patients

Reuters reported:

Drugmaker Pfizer Inc (PFE.N) and France’s Valneva (VLS.PA) will stop testing a Lyme disease vaccine in roughly half of U.S. patients in a late-stage study, the companies said, citing a breach of clinical trial guidelines by a third-party contractor.

The joint statement on Friday did not disclose the number of patients affected but analysts at brokerage Rx Securities estimated it could impact about 2,000 participants.

The decision could delay the time to approval of a vaccine that Valneva expects could become a blockbuster shot as infections rise globally due to a burgeoning population of ticks, which usually cause Lyme disease.

Valneva has been pinning its hopes on the vaccine candidate, known as VLA15, to counter the impact of disappointing sales for its COVID shot. Paris-listed shares of Valneva fell nearly 10% to 5.72 euros following the news and U.S.-listed shares of Pfizer were down marginally in premarket trading.

Thousands of People Can’t Get Full Treatments of a Lifesaving Cancer Drug

CNN Health reported:

Dino Carlone was frightened when he was diagnosed with bladder cancer three years ago, but his spirits were buoyed when he learned that he could get help from a highly effective drug with a great track record. Carlone was supposed to receive treatment for several years, but he says he only got it for only a few months because his urologist told him there was a shortage of the drug, called Bacillus Calmette-Guérin, or BCG.

A new report estimates that more than 8,300 U.S. patients a year are not receiving full BCG treatments for their bladder cancer. BCG is an older drug — it has been around for more than 40 years — and is relatively inexpensive. Pharmaceutical companies aren’t clamoring to make it.

BCG is just one of many drugs in shortage, including other cancer drugs for adults and for children. Carlone wonders why the FDA can’t do more to persuade companies to make drugs that aren’t necessarily very lucrative.

According to the FDA statement, the agency “cannot require a pharmaceutical company to make a drug — or make more of a drug — even if it is medically necessary. In addition, we cannot control how much of a drug is distributed — or which purchasers will be given priority.”

Moderna Flu Vaccine Delivers Mixed Results in Trial, Shares Fall

Reuters reported:

Moderna Inc. (MRNA.O) on Thursday said its closely watched experimental messenger RNA-based influenza vaccine generated a strong immune response against A strains of the flu but failed to show it was at least as effective as an approved vaccine versus less prevalent influenza B.

The results dashed investor hopes that the company might plug its COVID franchise decline, sending Moderna’s shares down more than 6% in after-hours trading.

Moderna, whose only marketed product is its COVID-19 shot, has high hopes for its flu vaccine and aims to grab large portions of the respiratory syncytial virus (RSV) and seasonal flu markets with new mRNA vaccines.

Cowen analyst Tyler Van Buren said investors had hoped Moderna would replace its COVID revenue with RSV and flu vaccine income, especially after it delivered positive RSV vaccine efficacy results in January. He said physicians and patients might be put off by Moderna’s flu vaccine’s results for Influenza B and the high rate of side effects.

Poorly Substantiated Health Claims on Infant Formula

The BMJ reported:

Early infant feeding is critically important for the survival, development, and lifelong health of children. It is also a big business. In 2019, global sales of infant formula milk exceeded $55 billion (£45bn; €51bn). Even during the global economic crisis of 2008-09, sales of commercial milk formulas increased 8-9% year on year. Parents want to give their children the best start in life and understand that how they feed their infants contributes to those early health and development outcomes. The formula milk industry understands this too.

The linked study by Cheung and colleagues reports a survey conducted in 15 countries exploring the health and nutrition claims made in the marketing of infant formula products. The authors performed a systematic search of websites, examined the packaging of formula products, and documented claims made about the formula product and citations of scientific evidence supporting those claims. The most common claims were that formula products support brain development, strengthen healthy immune systems, help growth and development and are easy to digest.

Yet, the evidence to support claims for products or ingredients was not substantial and was of questionable scientific integrity. No scientific reference was provided for most products making specific health claims (74%). When references were provided, 56% reported findings of clinical trials while the rest were review articles, opinion pieces, cross-sectional studies or other types of research including animal studies.

Examining the comparative trials referenced in support of 51 claims, 90% were deemed to have a high risk of bias due to inappropriate exclusion of data from analyses, missing outcome data, or findings simply not supporting the claim. Furthermore, more than 80% of these trials had authors who either received formula industry funding or were directly affiliated with the industry.

After J&J’s Texas Two-Step Stumble, Another Talc Plaintiff Heads to Trial: Report

Fierce Pharma reported:

After a federal appeals court panel voted to shelve Johnson & Johnson’s Texas two-step strategy in its years-long talc litigation, the first plaintiff has stepped up to tango at trial.

Following a hold on nearly 40,000 lawsuits alleging J&J’s talc products cause cancer, U.S. bankruptcy judge Michael Kaplan on Tuesday agreed to let plaintiff Anthony Hernandez Valadez proceed with his case against the drug behemoth in California, multiple news outlets have reported.

“The pendulum has swung” against J&J and the bankrupt subsidiary it hoped to use to divert the lawsuits, LTL Management, Kaplan said at a hearing in Trenton, New Jersey, as quoted by Bloomberg.

As for Hernandez Valadez, the 24-year-old plaintiff sued J&J last year after being diagnosed with a malignant tumor. At the time, Kaplan stopped short of allowing the case to proceed to trial while J&J and LTL’s bankruptcy case was ongoing.

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