Pfizer targets obesity with new once-daily Danuglipron drug
(NEW YORK) — Pfizer announced early Thursday morning that it has selected its preferred once-daily modified release formulation of danuglipron, a move that it said was a significant milestone in the obesity drug’s development.
Danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist, will undergo dose optimization studies in the second half of 2024 as Pfizer seeks to evaluate multiple doses of the formulation which they hope will inform the registration-enabling studies.
“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates. The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space,” said Mikael Dolsten, MD., PhD., chief scientific officer & president, Pfizer Research and Development. “Following a thorough analysis of our previous Phase 2b data and trial design, we believe that with the preferred modified release formulation and future trial design optimization, we can advance a competitive oral GLP-1 molecule into registration enabling studies, with the goal of addressing the present and persistent medical needs of people living with obesity.”
Participants in the study so far have included healthy adults aged 18 years or older and the results thus far have shown a profile that supports once-daily dosing, which is consistent with previous danuglipron studies. Notably, there have been no liver enzyme elevations observed among the more than 1,400 study participants.
Danuglipron is an investigational medicine that is taken as a tablet by mouth and is currently not approved for use by health authorities.
Current popular FDA approved weight loss medications Wegovy and Zepbound are weekly injections.
Pfizer will still need to do large scale clinical trials to produce the data necessary to show it’s safe, effective and tolerable and then submit to FDA — a process which is still likely much further down the line.
(NEW YORK) — A new study of common baby foods sampled from grocery stores in the United States found that roughly two-thirds did not meet standards for healthy baby food set by the World Health Organization.
Researchers who led the study, published Wednesday in the journal Nutrients, said parents should be aware that although more convenient, packaged baby food should be eaten in moderation.
When possible financially and practically, kids’ diets should consist of whole foods, including grains, fruits and vegetables.
For the study, researchers looked at data on more than 600 infant and toddler food products sold in the top 10 grocery store chains in the U.S.
The products analyzed are intended for children ages 6 to 36 months, according to the study.
Of the more than 600 products, 70% did not meet protein requirements set by the WHO, and 25% failed to meet calorie recommendations.
When it came to sugar content, 44% of products exceeded sugar requirements and 74% contained added sugar or sweeteners, according to the study.
In addition, the study found that all of the products had at least one claim on their packaging that did not meet WHO standards.
Products that came in snack-size packaging were found by researchers to have the lowest nutritional compliance.
“These findings highlight that urgent work is needed to improve the nutritional quality of commercially produced infant and toddler foods in the United States,” the researchers wrote.
Emphasis on fresh, whole foods for kids
The U.S. Department of Agriculture recommends that caregivers start to introduce solid foods to infants around 6 months of age.
Infants and toddlers should have no added sugars in their diets, including in drinks, according to the USDA.
As with adults, it’s important that kids eat a variety of foods, with an emphasis on foods that are non-processed.
For grains, the USDA recommends that parents and caregivers look closely at ingredient lists for words like “whole wheat flour” and “whole grain.”
Vegetables are important to vary and can be served to toddlers and infants in a variety of ways, including roasted, steamed or mashed, according to the USDA.
Fruits can be served to infants and toddlers fresh, frozen or canned, but should also include no added sugar, according to the USDA.
USDA guidelines also say foods high in sodium should be limited for infants and toddlers.
(PORTLAND, Ore.) — A lawsuit is accusing an Oregon health care system of negligence after more than 2,000 patients were possibly exposed to HIV and hepatitis.
The plaintiffs — known as E.P, K.R., C.R. and D.C. — all of whom live in Clackamas County, Oregon, said they all received anesthesia for surgeries at various medical centers under Providence Health between March 2022 and February 2024, according to the complaint.
All the patients were later informed that the physician who administered anesthesia “failed to adhere to infection control procedures” and, as a result, all had potentially been exposed to hepatitis B, hepatitis C and HIV, the complaint says.
It is unclear which protocols were violated. Providence Health declined ABC News’ request for comment, citing “pending litigation.”
Hospital and health officials announced earlier this month that as many as 2,200 patients were possibly exposed to the infections. Providence said in a statement on July 11 that patients were at low risk of exposure and that those who were exposed would either receive a letter in the mail or a notification on the MyChart portal used by Providence.
“Out of an abundance of caution, we are encouraging these patients to get a blood test to screen for the aforementioned infections, at no cost,” Providence said in a statement. “If a patient tests positive, Providence will reach out to discuss their test results and next steps. ”
At the time, Oregon Health Authority said in a statement there were no investigations underway but “acknowledge[d] the worry, pain and loss suffered by anyone affected by a health care-associated infection (HAI).”
According to the complaint, the anesthesiologist was employed by Oregon Anesthesiology Group (OAG) but treated patients at various Providence medical centers between 2017 and 2023.
OAG stopped providing services to Providence in November 2023. In June 2024, OAG learned that one of its anesthesiologists had violated infection control practices. The physician was suspended and, following an investigation, terminated, the lawsuit states.
The group did not immediately respond to ABC News’ request for comment.
“The safety of our patients is our top priority. When we learned that the physician had violated infection control practices, we suspended him, informed our partners Legacy Health and Providence, and then began an investigation that resulted in the physician’s termination,” OAG said in a statement earlier this month, according to USA Today. “Even though the risk of infection was low, new protocols and procedures have been put in place to prevent similar incidents in the future.”
The lawsuit states that the patients now have to undergo medical treatment for exposure “which would not have been necessary in the absence of [the d]efendants’ violations alleged herein, and have to live with severe emotional and mental anguish due to [the defendants’] negligence.”
Additionally, the complaint states that hepatitis and HIV are often not detectable for months after initial infections, so the patient “will live with the anxiety, stress, and emotional distress that they may be infected with hepatitis B, hepatitis C and/or HIV.”
The Centers for Disease Control and Prevention states that HIV and Hepatitis C may be detected as early as weeks after exposure.
The plaintiffs are suing for negligence and/or gross negligence on the part of Providence and OAG and have asked for a jury trial. They are seeking class action certification and also asking for an unspecified amount in damages, injunctive relief, declaratory judgments, costs and attorneys’ fees, according to the complaint.
“Over 2,000 patients have now learned they were at risk of having contracted an infectious disease because of the defendants’ alleged failure to implement proper protocols to prevent this possible exposure,” Adam Polk of Girard Sharp, one of the attorneys representing the plaintiffs, said in a statement to ABC News.
“Since shortly after these notifications were sent out, we have been speaking with patients on a daily basis who were impacted by the potential exposure, they are obviously distressed and concerned about their health and the health of their loved ones,” attorney Joe Sauder of Sauder Schelkopf, who is also representing the plaintiffs, told ABC News in a statement.
(HOUSTON) — A family in Texas has welcomed home all four of their rare identical quadruplets after the infants spent over three months in the neonatal intensive care unit (NICU).
The sisters — named Hannah Grace, Lucy Marie, Rebecca Claire and Petra Anne — were born on May 1, after their mom, Mercedes Sandhu, delivered them at 29 weeks and three days.
Sandhu carried what is known as a monochorionic pregnancy, meaning all four babies shared the same placenta, according to Texas Children’s Hospital, where Sandhu gave birth.
The babies were born just before Mother’s Day, but Sandhu did not have all four daughters at home until Thursday, when Rebecca was discharged from the NICU.
Hannah and Petra were discharged on July 12, followed by Lucy nearly one week later.
“We’re so happy they can be together too,” the babies’ father, Jonathan Sandhu, told Good Morning America. “The past few weeks are the only moments they have ever been apart. Even in the NICU, they were always within a few feet of each other.”
The quadruplets’ reunion at home was also the first time all four sisters got to meet their older brothers, Luke, 4, and Aaron, nearly 2, who were not allowed in the NICU because of their ages, according to Jonathan Sandhu.
“The best part has been watching our boys welcome their baby sisters … They are obsessed with the girls,” he said. “Seeing our little family come together has been the most heartwarming moment of our lives.”
The quadruplets’ birth on May 1, meant the Sandhus had welcomed six kids in a span of four years. The quadruplets were conceived naturally, without the help of fertility treatments.
When it comes to being able to differentiate the quadruplets, Jonathan Sandhu said they are able to tell two of the babies apart because they were born with hemangiomas, a benign growth of extra blood cells in the skin that is one of the most common skin conditions among infants, according to Texas Children’s Hospital.
The couple also keeps the babies in labeled bassinets and lines them up in birth order — Hannah, Lucy, Rebecca, Petra, for feedings.
“Because they’re identical, they literally have the exact same DNA so keeping them correctly identified is pretty important,” Jonathan Sandhu told GMA.
The Sandhus have been documenting the journey of their “miracle” babies on their Instagram account, @thesandhucrew.
They said the babies are proving to be healthy and happy at home, with no ongoing medical needs after their time in the NICU.
“With high order multiples, all sharing one placenta, they were at elevated risks for nearly all the bad things that can accompany premature infants,” Jonathan Sandhu said. “We’ve had a few little bumps, but nothing that ever became life-threatening or would need life-long care.”
Jonathan Sandhu said he and his wife are dealing with the normal challenges that accompany a newborn — like sleep deprivation — but multiplied by four.
“If you’ve ever taken care of a newborn at night, imagine that, but with a few more crying mouths and dirty diapers,” he explained. “My wife and I take shifts at night and one person feeding and changing multiple babies can take two hours. Then you have to repeat it all a few hours later.”