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November 16, 2023

Big Pharma News Watch

No More Needles? Gates Foundation Funds Patch-Style Vaccine Technology + 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.

No More Needles? Gates Foundation Funds Patch-Style Vaccine Technology

Reuters reported:

The Bill & Melinda Gates Foundation has given $23.6 million to U.S.-based life science company Micron Biomedical to fund the first-ever mass production of needle-free vaccine technology. The technology works by delivering the vaccine via dissolvable microneedles attached to the skin on a patch-like device. Global health experts have long argued for the potential of similar technology to boost the uptake of life-saving shots.

It is simpler to transport and administer than traditional injections, particularly in low-income countries where reaching all of the children who need vaccines remains challenging. But scaling up production has been a hurdle.

It reduces the need for a cold chain for distribution and does not require a trained professional to give the vaccine. It could also help those with a fear of injections, the company said in a statement on Thursday.

The company has had several other grants from Gates, to help deliver the technology to “underserved populations around the world”, Micron’s CEO Steven Damon said.

Concerns Over Informed Consent for Pregnant Women in Pfizer’s RSV Vaccine Trial

The BMJ reported:

A debate has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus (RSV) vaccination that a trial of a similar vaccine was halted over a safety signal around preterm birth, The BMJ can report. Both GSK and Pfizer were developing recombinant RSV F protein vaccines to inoculate pregnant women and protect their babies against RSV, a major cause of infant death globally.

GSK halted its phase 3 vaccine trial on February 28, 2022, after a safety signal emerged: a possible increased risk of preterm births and neonatal deaths. In the vaccine arm, 6.81% of births were preterm (95% confidence interval 5.99% to 7.69%) compared with 4.95% (3.97% to 6.07%) in the placebo arm. For neonatal deaths, the percentage was 0.37% (0.20% to 0.64%) in the vaccine versus 0.17% (0.04% to 0.50%) in the placebo arm.

After GSK’s trial was halted, opinion was split among clinical trial ethicists and some vaccine researchers over whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms. Some think that only women who had not yet been vaccinated needed to be informed, whereas others think that because there is currently neither convincing evidence nor an explanation for the increased preterm risk, informing expectant mothers would have only caused unnecessary anxiety.

Charles Weijer, bioethics professor at Western University in London, Canada, told The BMJ that informing pregnant women in Pfizer’s trial about GSK’s results would have allowed women who had not yet received the jab to consider whether they still wanted to get it and women who had already received it to seek additional medical advice and follow-up. “Any failure to provide new and potentially important safety information data to trial participants is ethically problematic,” Weijer said.

As Pfizer didn’t respond to the questions about whether it had informed expectant mothers in its trial about GSK’s results, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites, as well as more than 80 trial investigators, and none answered saying that it had. Some confirmed that Pfizer continued to enroll and vaccinate women for months after the news of the potential risk of preterm birth in GSK’s vaccine trial was made public.

COVID and Flu Vaccine Rates Are Declining for U.S. Healthcare Workers, CDC Reports: ‘Disturbing Trend’

Fox News reported:

Fewer U.S. healthcare workers are keeping up to date on their COVID-19 and flu vaccinations, according to two separate reports this week from the Centers for Disease Control and Prevention (CDC).

For the first study, researchers pulled data from the CDC’s National Healthcare Safety Network (NHSN) for January to June 2023. They found that flu vaccine coverage was 81% among healthcare employees at hospitals and 47.1% at nursing homes.

In terms of COVID vaccine coverage for medical workers, it was at just 7.2% at hospitals and 22.8% at nursing homes. For COVID, “up-to-date” vaccination was defined as “receipt of a bivalent COVID-19 mRNA vaccine dose or completion of a primary series within the preceding two months.”

In a second study, the CDC researchers analyzed the same data to determine the level of flu vaccination among healthcare personnel. Prior to the COVID pandemic, flu vaccine coverage rose from 88.6% in 2017-2018 to 90.7% in 2019-2020. However, the rate declined to 85.9% in the 2020-2021 season and dropped again to 81.1% in 2022-2023.

The Future of Obesity Drugs Just Got Way More Real

The Atlantic reported:

In the past year, as more Americans have learned about semaglutide, which is sold for diabetes under the brand name Ozempic and for obesity under the name Wegovy, hype has become completely divorced from reality.

For all the grand predictions, just a fraction of Americans who qualify for obesity drugs are on them. With a list price of roughly $1,350 a month, Wegovy is far too expensive, under-covered by insurance, and in limited supply to be a routine part of healthcare.

But that possibility is beginning to seem very real. The results of a highly anticipated study published on Saturday indicate that Wegovy can have profound effects on heart health, which potentially opens up the drug to even more patients.

A few days earlier, the FDA approved Zepbound, an obesity drug that is a bit cheaper and appears more potent than Wegovy. If there was any doubt before, now it is undeniable: Obesity drugs “are here to stay,” Kyla Lara-Breitinger, a cardiologist at the Mayo Clinic, told me. “There’s only going to be more and more of them.” They are now poised to become deeply entrenched in American healthcare, perhaps eventually even joining the ranks of commonly used drugs such as statins and metformin.

Biden and Xi Agree to Curb Fentanyl Production

Axios reported:

President Biden said Chinese leader Xi Jinping on Wednesday agreed to take steps to crack down on companies in China that produce chemical precursors for fentanyl. Why it matters: An epidemic of fentanyl-related deaths in the U.S. is worsening as bipartisan consensus erodes about the causes and possible solutions.

By the numbers: Nearly 107,000 Americans died from a drug overdose in 2021, and three-quarters of those deaths involved opioids, per the CDC. The vast majority of opioid deaths were from synthetic opioids, which include fentanyl.

Details: The agreement is aimed at limiting the manufacturing and export of fentanyl precursor molecules from China to Mexico, where much of the synthetic opioid in the U.S. now originates.

What they’re saying: “To be clear, this agreement will not end our fentanyl problem, but it will create challenges for drug traffickers and that’s a good thing,” said Keith Humphreys, a professor at Stanford University.

CDC Updates Advice for Preventing, Treating Anthrax

CIDRAP reported:

The U.S. Centers for Disease Control and Prevention (CDC) has updated its recommendations for the postexposure prevention and treatment of Bacillus anthracis infection (anthrax).

The CDC based the updates on systematic reviews of studies involving in vitro antimicrobial drug activity against B anthracis, in vivo antimicrobial drug efficacy for postexposure prevention and treatment, in vivo and human antitoxin efficacy for prevention or treatment, and survival after antimicrobial drug prevention and treatment of localized anthrax, systemic anthrax, and anthrax meningitis.

The updates to the 2014 guidelines on naturally occurring anthrax, published today in Morbidity and Mortality Weekly Report, include an expanded list of alternative antimicrobial drugs to use if first-line drugs are contraindicated, not tolerated, depleted, or ineffective after a bioterroristic release of aerosolized B anthracis or a multidrug-resistant genetically engineered strain of the bacterium.

The CDC also issued new recommendations on the diagnosis and treatment of anthrax meningitis and its comorbid, social, and clinical predictors.

Novo Nordisk Fights Back at Lilly With Wegovy Combo Trial Against Zepbound in Obesity

Fierce Pharma reported:

In response to an onslaught from Eli Lilly, Novo Nordisk is escalating the obesity market battle with a new head-to-head trial against its archrival.

Novo has unveiled a new phase 3 trial pitting CagriSema, a fixed-dose combination of Wegovy and the investigational drug cagrilintide, against Lilly’s Zepbound in people with obesity, according to a clinicaltrials.gov entry.

The study plans to enroll 800 patients, and those with diabetes are excluded. Its primary goal is to evaluate how well the two companies’ therapies could help people lose weight relative to each other after 72 weeks of treatment.

The Novo trial comes about seven months after Lilly launched a head-to-head phase 3 study testing Zepbound — also known as Mounjaro in diabetes treatment — against Wegovy in obese patients or those who are overweight with certain health conditions.

Zepbound, a.k.a. tirzepatide, gained an FDA nod last week for chronic weight management in people with obesity or who are overweight. The GIP/GLP-1 duo agonist has shown better weight reduction results than Wegovy did in separate trials.

EU to Renew Herbicide Glyphosate Approval for 10 Years

Reuters reported:

The European Union will extend glyphosate’s authorization for 10 years, even though its member states failed to agree over the active ingredient in Bayer AG’s (BAYGn.DE) Roundup weedkiller.

Glyphosate has proved divisive since the World Health Organization’s cancer research agency concluded in 2015 that it was probably carcinogenic to humans. Other agencies around the world, including the U.S. Environmental Protection Agency (EPA) and EU agencies, have classified it as non-carcinogenic.

The European Commission said on Thursday it would renew glyphosate’s approval based on European Food Agency and European Chemicals Agency safety assessments and subject to new conditions and restrictions, such as maximum application rates.

Bayer welcomed the EU executive’s decision, which was condemned by environmental groups including Greenpeace. The German company, which acquired Roundup through its $63 billion purchase of Monsanto in 2018, faces thousands of cancer lawsuits from plaintiffs across the United States.

U.K. Authorizes Gene Therapy for Blood Disorders in World First

Reuters reported:

Britain has authorized a gene therapy that aims to cure sickle-cell disease and another type of inherited blood disorder for patients aged 12 and over, the country’s medical regulator said on Thursday, becoming the first in the world to do so.

Casgevy is the first medicine to be licensed that uses the gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020, Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) said.

The medicine is administered by taking stem cells out of a patient’s bone marrow and editing a gene in the cells in a laboratory, with the modified cells then infused back into the patient after conditioning treatment to prepare the bone marrow.

U.S.-based companies Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN) welcomed the approval in a separate statement.

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