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September 28, 2023

Big Pharma News Watch

Mayo Clinic Nukes Hydroxychloroquine Information Page After People Take Notice + 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.

Mayo Clinic Nukes Hydroxychloroquine Information Page After People Take Notice

ZeroHedge reported:

One day after the Mayo Clinic’s endorsement of Hydroxychloroquine was highlighted for use in COVID-19 patients, they scrubbed the page and then blamed a 3rd party vendor for supplying the information.

The original page read: “Hydroxychloroquine may be used to treat coronavirus (COVID-19) in certain hospitalized patients,” which was highlighted by various people and outlets, including ZeroHedge, and former Trump official Peter Navarro.

Now, the Mayo Clinic redirects people to a “safe” page. Of course, pro-vax (we assume) outlets pounced on the fact that this information has been there since at least May of 2020.

Meanwhile, an analysis of dozens of studies on Hydroxychloroquine and COVID-19 reveals a 72% lower mortality risk when taken early, and a 41% lower mortality risk when given early into hospitalization (when both HCQ and Ivermectin are known to be less effective vs. at first symptoms).

Novo Nordisk’s Ozempic Gets FDA Label Update Flagging Risk of Intestinal Blockage Disorder

Fierce Pharma reported:

While GLP-1 drugs from Novo Nordisk and Eli Lilly are believed to be relatively free of serious side effects, a few problems have emerged as the treatments have gained wider and longer-term use.

One came last week, when the FDA revealed that it has updated the label for Novo’s Ozempic, warning of the potential of intestinal blockage. The condition, known as ileus, can be life-threatening and is already listed as a potential side effect on the labels of Eli Lilly’s diabetes drug Mounjaro and Novo’s weight-loss therapy Wegovy, which is the same formulation as Ozempic, just in a higher dose.

On the FDA’s Adverse Events Reporting System (FAERS) public dashboard, the agency has tracked 33 reports of ileus from GLP-1 users, with two deaths.

The risk of ileus was cited earlier this year by a group of Chinese scientists. They wrote that the use of GLP-1 drugs may cause continuous increases in intestinal length, causing it to “become as inelastic and fibrotic as a loose spring.” The possibility of having an intestinal blockage peaks after a year and a half of use, the researchers said, which is longer than the duration of most of the clinical studies involving GLP-1 therapies.

In all, the FDA has received more than 8,500 reports through FAERS of gastrointestinal disorders with the use of Novo’s Ozempic and Wegovy.

U.S. Government’s Next-Gen COVID Effort Gives Small Biotech up to $433 Million

STAT News reported:

The U.S. government’s “Project Nextgen,” its effort to accelerate and streamline the rapid development of the next generation of COVID vaccines and treatments, said Wednesday that it would give a small biotechnology firm, Gritstone bio, up to $433 million to conduct a 10,000-volunteer clinical trial testing a new approach to creating a vaccine.

The deal highlights the possibility of developing a new approach to COVID shots. But the huge amount of money and the large number of study subjects involved also show the challenges inherent in improving on the vaccines already manufactured by Moderna as well as by Pfizer and its partner BioNTech.

Gritstone CEO Andrew Allen said that the project will allow the company to develop a proof of concept for its vaccine platform that it might not be able to afford otherwise. “The thing that is super interesting about this is that this is the government innovating,” he said.

Flu, COVID Vaccination Rates Decline, as U.S. Health Officials Make New Push for Inoculations

STAT News reported:

Vaccination rates against flu and COVID-19 have declined since earlier in the pandemic and a new survey suggests significant portions of the U.S. population intend to forgo these vaccines this fall.

The survey, conducted by the National Foundation for Infectious Diseases, suggests only about one in five Americans worry that they or someone in their family will contract influenza, COVID, or RSV — respiratory syncytial virus.

About 43% of U.S. adults said they didn’t intend to get a flu shot or were uncertain about whether they would get one. Only 40% plan to get an updated COVID shot and only 40% of eligible adults — those aged 60 or older — plan to get one of the new RSV jabs.

RSV Vaccine Side Effects: What Older Adults Should Know Before the Shot

Y!Life reported:

With RSV (respiratory syncytial virus) season almost in full swing, medical professionals are urging people to speak to their healthcare providers about getting vaccinated.

Two vaccines, Arexvy (GSK) and Abrysvo (Pfizer), have already rolled out; both are single-dose and approved for people aged 60 and older, and Abrysvo has also been approved for those between 32 and 36 weeks pregnant to help protect newborns. These are the first RSV vaccines ever available.

According to the CDC, common vaccine side effects reported by clinical trial participants were swelling or pain at the injection site, fever, headache, nausea, diarrhea, and muscle or joint pain. These symptoms tended to be mild.

Some clinical trial participants reported developing inflammatory conditions, including Guillain-Barré syndrome (GBS), a rare neurological disorder in which the body’s immune system attacks part of the peripheral nervous system. But the CDC said it’s unclear whether the vaccines caused these conditions or if they would have developed anyway.

In light of the possibility that the vaccines may cause “inflammatory neurologic events,” the CDC recommends that only people “at the highest risk for severe RSV” be vaccinated.

Pharma Lobby Says EU Ban on ‘Forever Chemicals’ Would Halt Drug Production

Reuters reported:

European drugmakers warned that a proposed complete ban on substances known as PFAS or “forever chemicals” would render medicine production in the region impossible, part of a high-stakes wrangle between manufacturers and environmental regulators.

The European Union started to consider in February a ban on the widely used but potentially harmful substances, in what could become the bloc’s most extensive piece of regulation of the chemical industry.

A six-month consultation period to give impacted companies and industries an opportunity to put their views forward ended on Monday, with the European Chemicals Agency (ECHA) registering 5,600 comments.

“The entire pharmaceutical industry would no longer be able to manufacture active pharmaceutical ingredients … or associated medicinal products in the EEA,” if no exemptions, or derogations, are included in the draft, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said in a statement.

Merck, AstraZeneca, Bristol Myers Squibb to Participate in Medicare Drug Price Negotiations

CNBC reported:

Merck, AstraZeneca, Bristol Myers Squibb and Boehringer Ingelheim on Wednesday told CNBC they will agree to participate in the first round of Medicare drug price negotiations, even after all four drugmakers sued to halt the process last month.

Merck’s Type 2 diabetes drug Januvia, AstraZeneca’s own diabetes drug Farxiga, Boehringer Ingelheim’s diabetes drug Jardiance and Bristol Myers Squibb’s blood thinner Eliquis are among the first 10 drugs selected for price talks with Medicare.

The four companies appear to be the first manufacturers to indicate that they will comply with the negotiations, which seek to rein in the rising costs of prescription drugs for older Americans.

Manufacturers of the other six drugs selected have until Oct. 1 to sign an agreement to participate in the process. Those companies did not immediately respond to CNBC’s request for comment about their intentions.

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