Toxic Exposures
Fentanyl Is Fueling Record Number of Youth Drug Deaths + 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.
Fentanyl Is Fueling a Record Number of Youth Drug Deaths
Fentanyl, a pervasive killer in America’s illicit drug supply, is increasingly landing in the hands of teens across the region and nation, worrying providers who say treatment options for youths are limited.
Across the country, fentanyl has largely fueled a more than doubling of overdose deaths among children ages 12 to 17 since the start of the pandemic, according to a Washington Post analysis of Centers for Disease Control and Prevention data released this month.
Fatal overdoses in D.C., Maryland and Virginia are in keeping with the national increase in opioid fatalities, which until recently primarily claimed the lives of adults. In 2022, 45 teens succumbed to opioids locally, a number roughly equal to the previous three years combined, data show. And incomplete data for 2023 show no sign of the crisis abating in young people.
Easy to get from friends or through social media, potent pills masquerading as prescription Percocet or oxycodone cost a few dollars each and seemed to flood the market as students reeling from the isolation and the trauma of the pandemic returned to school, treatment providers said in interviews.
HHS Advances Plan to Produce 4.8 Million H5N1 Vaccine Doses
Response (ASPR) at the U.S. Department of Health and Human Services (HHS) said officials are moving forward with a plan to produce 4.8 million doses of H5N1 avian flu vaccine for pandemic preparedness.
Dawn O’Connell, JD, said health officials have identified a manufacturing line at one of its manufacturing partners for fill-and-finish steps, without disrupting production of seasonal flu vaccine. Currently, the vaccine is in bulk form and will be produced in multidose vials. She said it takes a couple of months to fill and finish the vaccine doses, which would save time in case a vaccine is needed. Federal health officials have said one of two H5N1 candidate vaccine viruses is well matched to the circulating strain.
‘Connell added that active discussions are underway across federal agencies about what the key triggers would be for deploying H5N1 vaccine doses. She also said discussions are still underway with mRNA vaccine makers Pfizer and Moderna, with an announcement expected soon on how the companies might be involved in vaccine development.
Nirav Shah, MD, JD, principal deputy director at the Centers for Disease Control and Prevention (CDC) said potential trigger factors might include a change in transmission propensity, such as human-to-human in addition to animal-to-human spread, and any sign of increased illness severity.
Vaccine Makers Receive Stock Boost After Third Human Bird Flu Case in U.S.
Shares in some companies that produce vaccines have seen stock boosts following a small number of reports of bird flu among people in the U.S. On Wednesday, the Centers for Disease Control and Prevention (CDC) announced a second case of a farmworker contracting the “highly pathogenic avian influenza virus” H5N1 from dairy cows in Michigan, which is a disease “caused by infection with avian influenza Type A viruses.”
While the CDC said the risk to humans remains low, with the only symptom reported by people with the infection being conjunctivitis, shares went up in some companies that could develop a vaccine if a bird flu pandemic materializes.
CureVac, a Germany-based company, announced an early-stage H5N1 vaccine trial in collaboration with GSK last month. Its shares rose 18%, while GSK’s gained 7.87%. In the past month, Moderna, which is in discussions with the U.S. government over advancing its flu vaccine development, gained 13.7%. BioNTech rose 11% in the last month, while Pfizer‘s share price increased by 12.46%, according to Google Finance data.
Including the U.S. cases, there have been eight human bird flu infections worldwide. Earlier this month, government officials said they were looking into vaccines against bird flu that could be ready within weeks.
Cancer Victims Sue J&J Over ‘Fraudulent’ Bankruptcies
A group of cancer victims sued Johnson & Johnson (JNJ.N) on Wednesday, accusing the healthcare company of committing fraud through repeated and continued efforts to use a shell company’s bankruptcy to resolve tens of thousands of lawsuits alleging its talc products contained asbestos and caused cancer.
Five plaintiffs who seek to represent over 50,000 people who have sued J&J over its talc products filed the proposed class action in New Jersey federal court. They allege that J&J’s bankruptcy strategy put billions of dollars out of the reach of plaintiffs in an attempt to “hinder, delay, and defraud these women and prevent them from ever having their day in court.”
Most of the talc lawsuits have been brought by women with ovarian cancer, while other cases involve people with mesothelioma, a deadly cancer linked to asbestos exposure.
One Health: Climate Vaccines Are Coming for the Cattle, Then for Humans
Climate vaccine developer ArkeaBio has raised $26.5 million in Series A funding, the company announced last week. ArkeaBio aims to fight climate change by vaccinating livestock.
A vaccine being developed by the company is designed to prevent animals from releasing methane emissions. Once vaccinated with the AkreaBio shot, an animal’s immune system is supposed to create antibodies that will target methane-producing microbes.
The Boston-based startup secured its first major investment in late 2022 from Breakthrough Energy Ventures, an investment fund founded by billionaire Bill Gates.
While ArkeaBio hopes to deploy the vaccines worldwide for livestock, it has not yet announced plans to develop climate vaccines for humans.
But human-targeted climate vaccines do appear to be in the works. Researchers at Gingko Bioworks, a biotech firm also backed by Gates, have floated mRNA injections as a measure to mitigate the impact of global warming. The World Economic Forum has also expressed support for climate vaccines.
GLP-1 Agonist Scripts Jumped 600% for Teens, Young Adults Since 2020 — Females Accounted for Most of the Prescription Fills
The number of adolescents and young adults prescribed a glucagon-like peptide-1 (GLP-1) receptor agonist increased by nearly 600% over the past few years, pharmacy data indicated.
From 2020 to 2023, the number of individuals ages 12 to 25 years who received a prescription for diabetes or weight-loss drugs grew from 8,722 to 60,567 per month, representing a 594.4% increase, reported Joyce M. Lee, MD, MPH, of the University of Michigan Medical School in Ann Arbor, and colleagues.
As a point-of-reference, the prescription rate of all other pharmacy drugs doled out to individuals in this age group decreased by 3.1% during the same timeframe, the study authors noted in their JAMA research letter.
There were stark jumps in GLP-1 agonist dispensing across the board, but girls and young women accounted for a majority of the prescription fills during the study period. “This disproportionate dispensing may reflect a societal bias towards weight in females,” she suggested.
At a Flashy New Research Hub, AstraZeneca Lays Out Ambitious Growth Goals
On a bit of a roll, AstraZeneca on Tuesday laid out ambitious growth goals for the rest of the decade, seeking to build on its momentum in fields like oncology as it said it would nearly double its revenue to $80 billion by 2030.
Hitting such a target would depend on the launch of 20 new medicines and the continued growth of its cancer and rare disease therapies, as well as other drugs. It would also require outpacing the targets laid out by AstraZeneca’s large pharma peers.
But at an investor day here at the company’s shiny new Discovery Centre, CEO Pascal Soriot opened his presentation by bringing up the goal set by the company a decade ago — $45 billion in revenue by 2023. The company faced some declines early in that period, but after surging in the past few years, it hit that target, bringing in $45.8 billion last year. Its recent growth has also propelled the company’s share price.
CARB-X to Fund Neonatal Sepsis Vaccine Candidate
CARB-X announced an award of $3.96 million to the University of Maryland School of Medicine to develop a vaccine to prevent neonatal sepsis.
The funding from CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) will help the Center for Vaccine Development and Global Health (CVD) develop a maternal vaccine that targets the surface sugars of Klebsiella pneumoniae, one of the leading causes of neonatal sepsis. The hope is that giving the vaccine to pregnant women will help protect their newborns from infection.
The neonatal sepsis vaccine candidate is the second to receive funding through CARB-X’s 2022-2023 funding call. In January, the public-private partnership awarded Syntiron of St. Paul, Minnesota, $1.7 million to develop a maternal vaccine targeting neonatal sepsis caused by K pneumoniae and Escherichia coli.
Serum Institute Deploys First Doses of Oxford, Novavax-Partnered Malaria Shot to Africa
As some industry efforts to deliver vaccines to Africa have fallen by the wayside, the Serum Institute of India (SII), together with the U.K.’s University of Oxford and U.S.-based Novavax, are making good on their pledge.
On Monday, SII — the world’s biggest vaccine producer by number of doses — said it shipped the first tranche of R21/Matrix-M malaria vaccines to Africa. The initial shipment is headed for the Central African Republic, while subsequent deliveries to South Sudan and the Democratic Republic of the Congo are expected to arrive in the “next coming days,” SII said in a press release.
SII said it has released 43,200 doses so far for the Central African Republic. To date, SII claims it has cranked out 25 million doses of the shot, with capacity on deck to scale up to 100 million doses annually in the future.
The vaccine — the second authorized option for use in kids in malaria-endemic regions behind GSK’s Mosquirix — utilizes Novavax’s Matrix-M adjuvant. The R21/Matrix-M shot itself was co-developed by SII and the University of Oxford.
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