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U.S. Reports Fourth Case of Bird Flu in Humans
The U.S. announced its fourth human case of bird flu, in a Colorado dairy worker, on Wednesday, as officials work to expand the availability of potential vaccines and commercial tests and open up financial assistance for affected farmers.
The dairy worker was in close contact with cows that had tested positive for H5N1, a highly pathogenic bird flu, and the worker reported only “eye symptoms,” according to the Centers for Disease Control and Prevention (CDC). The person took antiviral medication and has recovered, the CDC said. The agency is sequencing a sample of the virus to see if it has developed any concerning mutations.
The U.S. is partnering with the vaccine maker Moderna to help develop and manufacture mRNA bird flu vaccines “if needed”, said Dawn O’Connell, assistant secretary for preparedness and response (ASPR). Trials for safety and efficacy in people would probably begin next year, she said.
While the $176m contract focuses on H5N1 vaccines, it could also be used on developing or procuring vaccines targeting other strains of influenza or emerging infectious diseases, McConnell said. The U.S. has also ordered 4.8m doses of another type of H5N1 vaccine, which are expected to come off the production line in the middle of July, “faster than we had initially anticipated”, McConnell said.
Novo’s Ozempic, Wegovy Linked to Potential Eye Problem? Not so Fast, Analysts Say
Novo Nordisk’s massively successful GLP-1 analog semaglutide, the active ingredient in the popular diabetes and obesity meds Ozempic and Wegovy, may be linked to a vision loss disorder, a new study suggests. But one team of analysts cautioned against reading too much into the analysis.
The study found that people taking semaglutide were four to nearly eight times more likely to develop nonarteritic anterior ischemic optic neuropathy (NAION) than their peers on other non-GLP-1 meds for diabetes and weight loss. The study was conducted by researchers at Harvard University and published last week in JAMA Ophthalmology.
NAION is an eye condition that’s marked by decreased blood supply to the optic nerve, causing vision loss. It’s the second most common form of optic nerve damage, with an annual incidence rate estimated at around 2.3 to 10.2 per 100,000 among people over 50 years of age in the U.S., according to the American Academy of Ophthalmology.
The study raises questions, but a Leerink Partners team led by David Risinger said in a Thursday note that they “do not expect this single analysis to impact prescribing trends” of Ozempic and Wegovy. That’s because, as the study authors themselves noted, the analysis was designed to report an “association” but not to establish a causal relationship.
NAION is currently not listed as a side effect on the labels of Ozempic or Wegovy.
The Battle Over J&J’s Bankruptcy Plan to End Talc Lawsuits
After being rebuffed twice by federal courts, the $350 billion healthcare giant is attempting again to end the litigation in a so-called “Texas two-step” bankruptcy. The maneuver involves offloading its talc liability onto a newly created subsidiary, which then declares Chapter 11. The goal is to use the proceeding to force all plaintiffs into one settlement — without requiring J&J itself to file bankruptcy.
But the company needs the votes of 75% of claimants before the subsidiary can ask a bankruptcy judge to impose the deal on all of them. J&J faces lawsuits from more than 61,000 plaintiffs but the figure swells as high as 100,000 when counting claimants who haven’t sued, according to Erik Haas, J&J’s global vice president of litigation. The company maintains its talc products are safe and do not cause cancer.
“While no amount of money is ever enough for the horrific suffering these women have undergone, this is an opportunity to get money now and avoid many years of additional protracted litigation,” attorney Jim Onder told Reuters.
But a coalition of other plaintiffs’ lawyers is fighting back, saying J&J’s bankruptcy maneuver should not be legally allowable — given that the company itself is immensely profitable — and that its $6.48 billion offer is too low.
HilleVax to Discontinue Development of Norovirus Vaccine for Infants; Shares Plummet
Shares of HilleVax (HLVX.O) plunged as much as 87.6% to a record low of $1.75 on Monday after the biotech company said it will discontinue the development of its norovirus vaccine candidate for infants.
The vaccine, named HIL-214, showed an efficacy of only 5%, failing to meet the main goal in the mid-stage study conducted on more than 2,800 infants. It also did not show any clinical benefits across the secondary goals of the study.
HilleVax said it will discontinue further development of HIL-214 in infants and will explore whether it can continue the same in adults.
The company said it will also examine whether to develop HIL-216, its other experimental vaccine, in adults after the trial failure.
Study Finds Pfizer’s RSV Vaccine Not Tied to Higher Risk of Pre-Term Births
Pfizer‘s (PFE.N) respiratory syncytial virus (RSV) vaccine for pregnant women was not tied to a higher risk of pre-term or early births, according to a study published on Monday that analyzed real-world use of the shots. The vaccine Abrysvo was approved by the U.S. Food and Drug Administration last year for women in their second or third trimesters of pregnancy to prevent infections tied to RSV in babies in the first six months after birth.
However, some experts had raised concerns over a higher number of pre-term births among participants taking the Pfizer shot compared to those who received a placebo in the company’s clinical trial.
Health regulators however recommended a narrower gestational window, said Annette Regan, from the University of San Francisco’s School of Nursing and Health Professions, in an editorial accompanying the study.
“Despite the need for further research and surveillance, results from this study should offer initial reassurance to regulators, policymakers, health care professionals, and pregnant patients,” Regan wrote in the article published in JAMA.
Lilly to Buy Morphic in $3 Billion Bet on Inflammation Drug
Eli Lilly plans to spend $3.2 billion acquiring a Massachusetts-based biotechnology company and its experimental pill for inflammatory bowel disease.
Announced Monday, the all-cash deal has Lilly buying all the outstanding shares of Morphic Therapeutics for $57 apiece — a nearly 80% premium to the stock’s closing price on Friday. The companies expect their deal to close by the end of September.
Morphic formed in 2015, was built around discoveries from the lab of Timothy Springer, an immunologist and Harvard University professor who was also a founding investor in Moderna. Morphic’s aim has been to develop oral drugs that inhibit “integrins,” a type of protein involved with a variety of important body processes, including inflammation.
Scientists Discover How to Improve Vaccine Response to Potentially Deadly Bacterium
Researchers from Trinity College Dublin have taken a leap forward in understanding how we might fight back against the potentially deadly MRSA bacterium. They have shown in an animal model that targeting a key suppressive immune molecule (IL-10) during the delivery of a vaccine improves the ability of the vaccine to protect against infection.
The bacterium Staphylococcus aureus is one of the leading causes of community- and hospital-acquired bacterial infection and is associated with over one million deaths worldwide each year. Unfortunately, antibiotics are becoming increasingly less effective against this bacterium with the antibiotic-resistant form, MRSA, responsible for the highest number of deaths in high-income countries that are attributable to antimicrobial-resistant bacterial infections.
As a result, scientists are keenly focused on finding solutions to turn the tide in fighting S. aureus-related infections. One hugely appealing option is a vaccine but, while some progress has been made on that front in recent years, a number of major hurdles remain.
One of these appears to be the bacterium’s ability to dampen the immune response by turning on one of the natural breaks that exist within the immune system, an important immune-suppressive molecule known as interleukin-10 (IL-10), which acts to reduce inflammation in the body.
