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WHO Grants Emergency Listing for Corbevax COVID Vaccine
The World Health Organization (WHO) has approved another COVID-19 vaccine for emergency use listing (EUL): Corbevax, a recombinant protein-based vaccine developed by scientists at Texas Children’s Hospital and Baylor College of Medicine.
During the EUL process, WHO advisory groups evaluated the vaccine to ensure that it meets the WHO’s standards for protection and safety, with a goal of speeding the availability of products to people who need them. Corbevax is the 14th COVID vaccine to receive the WHO EUL.
Texas researchers licensed its vaccine technology for making the SARS-CoV-2 receptor binding domain (RBD) protein to India-based Biological E Limited in 2020. The company scaled up manufacturing and advanced Corbevax through clinical trials. In 2022, Indian regulators granted the vaccine emergency use authorization, first as a 2-dose primary series, and then for use as a booster.
Scientists Will Test a Cancer-Hunting mRNA Treatment
As the first vaccines for COVID-19 rolled out at the end of 2020, messenger RNA catapulted into public awareness. Now, a few years later, interest in mRNA has exploded. Clinical trials are underway for dozens of mRNA vaccines, including ones for flu and herpes. And scientists are hoping to use mRNA to treat disease, not just prevent it. One of the biggest targets is cancer.
But a major obstacle is how to deliver the molecule to the place in the body that needs to be treated. Fatty bubbles called lipid nanoparticles can carry RNA into cells, and they can ferry it to a wide range of tissues but not to anywhere specific. That’s a problem for cancer, says Jake Becraft, cofounder and CEO of Boston-based Strand Therapeutics, because many cancer treatments “can be incredibly toxic in off-target tissues.” But his company may have found a solution.
Strand has figured out how to “program” mRNA much like computer code, allowing it to perform certain functions — such as turning on only in specific cell types, at specific times, and in specific amounts. Today, the biotech company announced that the U.S. Food and Drug Administration has greenlit a clinical trial testing the approach in cancer patients with solid tumors. Strand plans to begin enrolling patients this spring. It will be the first time a programmable mRNA therapy will be tested in people.
Researchers have long eyed IL-12 as a potential cancer therapy. But in the 1990s, early trials of IL-12 were halted when patients experienced toxic side effects. In those studies, the protein was delivered directly into the bloodstream, which activated a severe inflammatory response throughout the body. Several companies have tried to make safer versions of IL-12, but interest from Big Pharma seems to be waning. Last year, Bristol Myers Squibb dropped its effort, with AstraZeneca and partner Moderna following suit.
J&J Agrees to Resolve 42 U.S. States’ Talc Investigations
Johnson & Johnson (JNJ.N) on Tuesday said it had reached a tentative settlement to resolve probes by U.S. states into whether it misled consumers about the safety of its talc products, which thousands of lawsuits claim can cause cancer.
The deal includes 42 states and Washington, DC. The company tentatively agreed to pay about $700 million to settle the states’ claims, according to the Wall Street Journal.
The settlement does not extend to private plaintiffs’ cases against the company, some of which are expected to go to trial later this year.
The company, which reported fourth-quarter results on Tuesday, still faces more than 50,000 lawsuits over talc, most by women with ovarian cancer. A minority of the cases involve people with mesothelioma, a type of cancer linked to asbestos. It recently settled some of the mesothelioma cases for an undisclosed amount but has maintained that its talc did not contain asbestos.
CDC Warns About RSV Vaccine Administration Errors in Babies, Pregnant Women
The Centers for Disease Control and Prevention (CDC) today warned clinicians about errors in respiratory syncytial virus (RSV) administration in young children and pregnant women, which follows the release of two newly approved RSV vaccines for adults and an injectable RSV monoclonal antibody preventive called nirsevimab (Beyfortus) for babies and young children.
The errors were reported through the CDC’s Vaccine Adverse Event Reporting System (VAERS). The CDC described the situation in a COCA Now clinician outreach email.
The events involving children younger than 2 years old who received Pfizer‘s Abrysvo or GSK‘s Arexvy were rare, with 25 such cases reported. Most occurred in babies younger than 8 months and in outpatient settings.
Meanwhile, about 128 instances of pregnant women mistakenly getting Arexvy were reported, also most commonly reported in outpatient settings, including pharmacies. Abrysvo is the only RSV vaccine recommended for pregnant women as a tool for protecting young babies from RSV infection.
These New Synthetic Opioids Could Make Fentanyl Crisis Look Like ‘the Good Old Days’
The Centers for Disease Control and Prevention recently reported that in the 12-month period ending last August, about 74,000 people died from fentanyl-related overdoses.
While politicians and policymakers amp up calls for more brutal crackdowns on fentanyl smuggling, a “new” class of synthetic opioids has been showing up in overdose victims with the potential to make America look back on the fentanyl crisis as “the good old days.”
Chemists refer loosely to this category of drugs as “nitazenes,” even though the term is incorrect; it should be “benzimidazole-based opioids.” The Swiss drug maker CIBA, now part of Novartis, developed the first nitazenes in the late 1950s as potential pain treatments. However, none was approved because they were too dangerously potent.
In 2020, the World Health Organization reported that isotonitazene (which drug users call “iso” or “tony”) began appearing in forensic toxicology reports in six European countries, Canada and the United States. In 2022, the Tennessee Department of Health reported that overdose deaths from synthetic opioids classified as nitazenes have increased fourfold in just two years.
How Big Pharma Is King of the Hill in M&A
According to Ernst & Young (EY), 67% of merger & acquisition investment in 2023 came specifically from big pharma, compared to 38% in 2022. A number of deals between healthcare companies have already been announced for 2024, leading to the potential for growth in the category.
Arda Ural, EY Americas Industry Markets Leader for Health Sciences and Wellness, explains part of the reason for the uptick in M&A activity:
“When the Fed gave the signal that they will pause the hikes, I think that was a good relief for the industry. And the other thing is the industry has been waiting to replenish the top line with the right assets, with the late de-risked assets. The industry has a challenge in the amount of $350 billion over the next couple of years, between ’23 and ’28, to replace the loss of exclusivity that’s … coming from losing the patents of some lead biologics products.”
Fate of Most Remaining Zantac Lawsuits Weighed by Delaware Judge
GSK (GSK.L), Pfizer (PFE.N) and other pharmaceutical companies are urging a judge in Delaware this week to find that evidence plaintiffs’ lawyers want to use in about 72,000 lawsuits claiming that the discontinued heartburn drug Zantac caused cancer is not supported by science.
If they are successful, that could end much of the long-running litigation over the drug and greatly reduce the risk of hefty damage awards or settlements, which has weighed on companies’ shares in recent years.
In 2019, some manufacturers and pharmacies halted Zantac sales after NDMA was detected in some pills. Shortly afterward, lawsuits began piling up from people who said they developed cancer after taking Zantac. Plaintiffs said the companies knew or should have known, that ranitidine posed a cancer risk and that they failed to warn consumers.
Brent Wisner, a lawyer for the plaintiffs, said the experts did not have to rely on evidence directly linking Zantac use to cancer. Instead, he said, they could show that the drug contains NDMA, and present evidence that NDMA can cause cancer.
The drugmakers, which also include Sanofi (SASY.PA) and Boehringer Ingelheim, notched a significant win in 2022 when another judge dismissed about 50,000 lawsuits making similar claims that had been consolidated in federal court in Florida. That judge concluded that the opinions of the plaintiffs’ expert witnesses that Zantac can cause cancer were not supported by sound science. The plaintiffs are appealing that ruling.
Why Many More People Are Lining Up for a Flu Shot Than a COVID Vaccine
America is over the COVID vaccine. Frantic lineups for scarce doses when COVID vaccines first became available have long since given way to widespread indifference. Each new round of boosters has drawn fewer bared arms than the round before it.
The Centers for Disease Control and Prevention estimates that, as of Jan. 6, a mere 21.5% of Americans aged 18 and older and 11% of children have been vaccinated with the latest COVID vaccine.
But before you write off that number as a reflection of hesitancy over vaccines overall, consider this: 46.7% of Americans aged 18 and older and 47.5% of children have been vaccinated against influenza for this cold and flu season. In older adults, who are at the greatest risk from COVID, the gap is wider still; 73% of people 65 and older have received a flu shot, but only 41% have taken the COVID booster.
Why the disparity? Americans who regularly get a flu shot are just the type of people you’d expect would routinely get vaccinated against COVID. Yet as the statistics reveal, even many of them appear to have declined the latest booster.
FDA Wants Classwide Boxed Warning on All Commercial CAR-T Therapies Amid Secondary Cancer Safety Probe
As many have feared, the FDA’s investigation into secondary T-cell cancers following treatment with existing CAR-T therapies is poised to lead to a classwide black box warning.
For all six commercial CAR-T therapies, the FDA is requiring label updates to include T-cell malignancies in the boxed warning section of each product’s label, according to the agency’s separate notification letters dated Jan. 19 to Bristol Myers Squibb, Gilead Sciences’ Kite Pharma, Johnson & Johnson and Novartis. A black box warning is the most serious safety alert on a medication’s label.
The products involved are Bristol’s Abecma and Breyanzi, Kite’s Yescarta and Tecartus, J&J’s Legend Biotech-partnered Carvykti and Novartis’ Kymriah. The products are separately approved to treat multiple myeloma, large B-cell lymphoma, among other blood cancers.
Specifically, the U.S. agency wants the companies to include a paragraph in those boxed warnings to say, “T-cell malignancies may occur following treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including,” followed by the product’s name. The same language is also required as part of the “secondary malignancies” item in the less prominent “Warnings and Precautions” section of a drug’s label.
