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GLP-1 Drugs From Novo, AZ, Lilly and Sanofi Under UK Probe for Potential Suicide Risks: Reuters
Following in European Union (EU) regulators’ footsteps, the U.K. has reportedly launched a probe into potential suicide risks for popular diabetes and weight-loss drugs.
The Medicines and Healthcare products Regulatory Agency (MHRA) is looking into data on suicidal behaviors around GLP-1 receptor agonists, Reuters reports.
The move comes shortly after the European Medicines Agency initiated a similar probe triggered by reports of suicidal thoughts and self-injury in people who took GLP-1 drugs.
The U.K. probe is wide-ranging, according to the report. It covers not only Novo Nordisk’s Type 2 diabetes therapy Ozempic and sister weight-loss treatment Wegovy, but also the company’s first-generation obesity med Saxenda, plus AstraZeneca’s diabetes drug Bydureon, Eli Lilly’s Trulicity and Sanofi’s Lyxumia.
The MHRA didn’t immediately respond to a request for comment from Fierce Pharma.
Maternal Labor Epidural Analgesia May Be Linked to Autism in Children
Maternal labor epidural analgesia (LEA) was associated with an increased risk for autism spectrum disorder (ASD) among offspring, according to a study published online July 21 in JAMA Network Open.
Chunyuan Qiu, M.D., from Kaiser Permanente Baldwin Park Medical Center in California, and colleagues examined the independent associations of LEA and oxytocin during labor and delivery with ASD using data from 205,994 singleton births with vaginal deliveries in a single integrated health care system from 2008 to 2017. Children were followed through Dec. 31, 2021.
Within the cohort, 153,880 and 117,808 children (74.7 and 57.2%, respectively) were exposed to maternal LEA and to oxytocin during labor and delivery. The researchers found that during follow-up, 5,146 (2.5%) had ASD diagnosed. Oxytocin exposure was higher among LEA-exposed than LEA-unexposed children (67.7 versus 26.1%).
1 in 6 Kids Haven’t Gotten All of Their Vaccines. Why?
There are many reasons that kids aren’t completing their vaccine series, according to researchers. Some families may have moved across state lines and others may lack health insurance, they say.
For the study, a team led by the University of Montana’s Sarah Michels examined immunization rates for the series of seven vaccines that protects against diphtheria, pertussis (whooping cough), tetanus, polio, measles, mumps, rubella, hepatitis b, Haemophilus influenzae type b, varicella and pneumococcal infections. The data included more than 16,300 toddlers nationwide who were between 19 and 35 months of age in 2019.
Close to 73% completed the combined seven-vaccine series, the data showed. Just shy of 10% did not initiate one vaccine series or more. And 17.2% began but did not complete one or more multidose vaccine series, the new study showed.
Just over 8% of children needed only one additional vaccine dose to complete the series. And, 1.1% of children were completely unvaccinated, the study found.
Black children were less likely to have completed their vaccination series. What’s more, children living in lower-income households and rented homes were up to 30% more likely to not finish the vaccine series, the study showed.
The findings were published July 25 in the journal Pediatrics.
Moderna, Merck Advance Cancer Vaccine Into Late-Stage Test
Moderna and Merck & Co. are pushing ahead with the industry’s most-advanced experimental cancer vaccine, announcing Wednesday they’ve begun enrolling patients in a Phase 3 trial aimed at preventing the return of melanoma after surgery.
Initiation of the trial marks another milestone for a new type of cancer vaccine, one that’s personalized to the tumor mutations of each patient. The companies’ messenger RNA vaccine, which was invented by Moderna, can trigger an immune response to up to 34 “neoantigens,” or unique protein flags on the surface of tumors.
The partners are followed closely by Moderna’s mRNA rival BioNTech and its partner Roche, which are testing a combination of a cancer vaccine and the immunotherapy Keytruda in previously untreated melanoma patients, along with Gritstone Bio, which has an off-the-shelf vaccine.
FDA Inspection Underscores Problem at Major U.S. Compounder Behind Hospital Drug Recalls
One of the largest compound pharmacy operations in the U.S. recently recalled a slew of injectable medicines used by hospitals over concerns about possible side effects and a newly released regulatory report underscores the extent of the problem.
The U.S. Food and Drug Administration (FDA) found several issues that raised the possibility of contamination during an inspection of an Allentown, Pa., facility run by Central Admixture Pharmacy Services.
These issues included inadequate environmental monitoring and follow-up investigations, according to an inspection report posted online this week.
