Of the many things new, the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with moderately to severely active Crohn's disease.

What is Crohn's Disease?

Crohn's disease is a type of inflammatory bowel disease (IBD) that causes swelling and irritation of the tissues, called inflammation, in the digestive tract. This can lead to belly pain, severe diarrhea, fatigue, weight loss and malnutrition.

What does Tremfya do?

It contains the active ingredient guselkumab, which is a prescription drug to treat moderate to severe plaque psoriasis, psoriatic arthritis, and ulcerative colitis in adults, recently it has been approved for Crohn's disease.

Guselkumab targets the IL-23 subunit alpha which prevents it from binding to cell receptors that would otherwise be activated by its presence. It was first developed by Janseen Pharmaceuticals and in November 2016, a Biologics License Application to FDA was submitted to seek for its approval.

Tremfya blocks interleukin-23 or IL-23, which is a cytokine responsible for inflammation and binds to CD64, which is a receptor on cell that produce IL-23. The CD64 cells are the source of IL-23, which causes inflammation in Crohn's disease.

This approval is the fourth indication for this dual IL-23 inhibitor in the United States, which makes Tremfya the first and only IL-23 inhibitor that offers subcutaneous and intravenous induction options for adults with Crohn's disease.

How Was It Approved?

The approval is based on the data from a 3-phase trial. In the GRAVITI study, 400mg of Tremfya was administered through subcutaneous induction at 0,4,and 8 weeks. This led to a significantly higher clinical remission and endoscopic response when compared with the placebo. The clinical remission was 56% while placebo noted for only 22%, whereas endoscopic response was 35% and placebo had a 15% impact. Similar results were also seen in the second and third phase of trials which compared Tremfya 200mg intravenous induction at weeks 0,4, and 8 with placebo.

"Despite the progress in the management of Crohn's disease, many patients experience debilitating symptoms and are in need of new treatment options," lead investigator of the GRAVITI study, Remo Panaccione, M.D., from the University of Calgary in Alberta, Canada, said in a statement. "Importantly, the fully subcutaneous regimen offers choice and flexibility for patients and providers that have not been available before."

What Are The Symptoms Of Crohn's Disease?

• Diarrhea
• Fever
• Fatigue
• Belly pain and cramping
• Blood in the stool
• Mouth sores
• Reduce appetite and weight loss
• Pain or damage near or around the anus due to inflammation

It can also affect any part of the small or large intestine and could in fact involve multiple segments or may be continuous. It most commonly involves the last part of small intestine. In some people, the disease is only in the colon or the large intestine.

While symptoms of Crohn's disease can range from mild to severe, they usually develop gradually. However, sometimes it may also come suddenly without a warning. So, someone with Crohn's disease may have periods of time without any symptoms, called remission.

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved the use of the SAPIEN 3 transcatheter aortic valve replacement (TAVR) platform for patients with severe aortic stenosis who show no symptoms. This is the first-ever approval of TAVR therapy for asymptomatic patients, marking a significant shift in how this life-threatening condition may be treated going forward.

What Is Severe Aortic Stenosis?

Aortic stenosis is a narrowing of the aortic valve opening, which restricts blood flow from the heart to the rest of the body. In severe cases, the heart must work harder to pump blood, which can eventually lead to heart failure. While some patients experience chest pain, breathlessness, or fainting, others show no outward symptoms despite the seriousness of the condition.

The danger lies in the unpredictability—many asymptomatic patients may suddenly deteriorate, experiencing life-threatening events without warning. Until now, clinical guidelines advised “watchful waiting” for these patients, meaning treatment was delayed until symptoms appeared.

What Is TAVR and the SAPIEN 3 Platform?

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure that replaces the narrowed aortic valve without the need for open-heart surgery. The SAPIEN 3 is a next-generation TAVR device developed by Edwards Lifesciences. It is inserted via a catheter, usually through the femoral artery in the leg, and guided to the heart, where it expands and takes over the function of the diseased valve.

SAPIEN 3 is already widely used in patients with symptomatic severe aortic stenosis. With this new FDA approval, its use extends to a new, broader population of asymptomatic patients.

What Prompted the FDA Approval?

The decision was largely based on findings from the EARLY TAVR trial, a randomized clinical study that enrolled over 900 patients with severe aortic stenosis who had no symptoms. Participants were divided into two groups: one received TAVR using the SAPIEN 3 valve, while the other was monitored with watchful waiting.

After a median follow-up of 3.8 years, the trial found that:

• 26.8% of patients in the TAVR group experienced death, stroke, or unplanned cardiovascular hospitalization.

• In contrast, 45.3% of patients in the watchful waiting group faced such outcomes.

• These significant differences show that even patients without symptoms can benefit from early intervention, reducing the risk of sudden health events and hospitalizations.

What This Approval Means

The FDA’s approval of the SAPIEN 3 platform for asymptomatic severe aortic stenosis patients could lead to changes in clinical guidelines, encouraging earlier evaluation and treatment.

“There is an urgent need to change practice and TAVR guidelines,” said Dr. Philippe Genereux of Morristown Medical Center, who was involved in the EARLY TAVR trial. He emphasized that patients who seem stable can become symptomatic without warning, and early TAVR offers an opportunity to improve outcomes and ease the burden on the health care system.

Poultry-related outbreak has been on going in the US, especially with the ever on going bird flu. Recently, yet another outbreak has been associated with backyard poultry which has sickened at least seven people in six states. This is the new salmonella outbreak. The health officials have confirmed its news this Monday.

As per the Centers for Disease Control and Prevention (CDC), two cases were identified in Missouri, and one each in Florida, Illinois, South Dakota, Utah and Wisconsin.

The CDC noted that most people started falling sick in February and March of this year. All of them had the same strain of salmonella, which is a version that has been traced to hatcheries in the past. The health officials confirmed that investigation with regards to this recent outbreak is on going.

What Is Salmonella?

As per the US Food and Drugs Administration (FDA), Salmonella are a group of bacteria that can cause gastrointestinal illness and fever called salmonellosis. It can be spread by food handlers who do not wash their hands and/or the surfaces and tools they use between food preparation steps. It can also happen when people consume uncooked and raw food. Salmonella can also spread from animal to people.

FDA notes that people who have direct contact with certain animals, including poultry and reptiles can spread the bacteria from the animal to food if hand washing hygiene is not practiced.

Pets too could spread the bacteria within the home environment if they eat food contaminated with Salmonella.

Is It Caused Only By Poultry?

Salmonella bacteria leads to infections in around 1.35 people in the United States, every year. However, the source does not always remain poultry. As per the CDC website Salmonella outbreaks previously have been linked with cucumbers, pet bearded dragons or gecko, eggs, small turtles, poultry, charcuterie meat, cantaloupes, diced onions, cookie dough, and flour.

Backyard Poultry As A Source

The biggest concern with backyard poultry is that even if the chickens look clean and healthy, they could still carry salmonella bacteria. A backyard poultry associated outbreak which ended last year caused 470 cases, which were spread across 48 states and including one death.

What Are The Symptoms Like?

FDA notes that most people infected with Salmonella will begin to develop symptoms 12 to 72 hours of the infection, which lasts for about four to seven days. Most people recover without treatment.

Most people experience these following symptoms:

• Diarrhea
• Fever
• Abdominal Cramps

In severe cases of salmonella, you may experience:

• High fever
• Aches
• Headaches
• Lethargy
• A rash
• Blood in urine and stool

As per the CDC, each year, around 450 people diet in the United States due to acute salmonellosis.

Who Are At More Risk?

Children who are younger than five and the elderly, and people with weakened immune system could be more at risk to have severe salmonellosis infections.

What Can You Do To Be Safe?

• Clean and sanitize all surfaces and items that may have come into contact with contaminated food. This includes the inside walls and shelves of your refrigerator, cutting boards, countertops, and utensils. Use a solution of one tablespoon of chlorine bleach mixed with one gallon of hot water. Wipe dry with a clean, unused cloth or paper towel.

• Also clean and disinfect any surfaces used to store or serve potentially contaminated products.

• After cleaning and sanitizing, wash your hands thoroughly with warm water and soap.

• Children, older adults, pregnant women, and individuals with weakened immune systems should avoid eating raw sprouts of any kind.

• Pet owners should be especially careful to prevent cross-contamination. Wash your pet’s food dishes right after each use, and avoid letting high-risk individuals (like children or the elderly) handle pet food or come into contact with animals that may have eaten contaminated food.

• Consumers may also voluntarily report complaints, illnesses, or serious allergic reactions related to any food product.

United States is experiencing its deadliest flu season for children in 15 years, according to a federal report released Friday. The Centers for Disease Control and Prevention (CDC) has reported 216 pediatric deaths so far this flu season—surpassing last year's 207 fatalities and marking the highest number since the 2009-2010 H1N1 pandemic.

The season is not yet over, making this already grim milestone even more concerning. In fact, the final death toll for the 2023-2024 flu season won’t be confirmed until later this year. "This number that we have now is almost certainly an undercount,” said Dr. Sean O’Leary of the American Academy of Paediatrics. “When the season is declared over, and they compile all the data, it’s almost certain to go up.”

O’Leary, who is also a pediatric infectious diseases specialist at the University of Colorado, pointed to declining flu vaccination rates among children as a key factor in this season’s severity. Over the past five years, the flu vaccination rate for children in the U.S. has dropped from about 64 per cent to just 49 per cent.

While flu vaccines do not always prevent infection, they are highly effective at reducing hospitalisations and deaths. "Flu vaccinations may not prevent people from coming down with symptoms, but research shows they are highly effective at preventing hospitalisations and deaths," O’Leary said.

This flu season has proven severe not only for children but for the general population as well. CDC estimates indicate at least 47 million illnesses, 610,000 hospitalisations, and 26,000 deaths so far. Among 5,200 adults hospitalised with the flu, 95 per cent had at least one pre-existing condition. In contrast, among 2,000 hospitalised children with more detailed health data, only about 53 per cent had underlying health issues such as asthma or obesity.

The CDC report did not include information on how many of the children who died had received the flu vaccine. Additionally, the agency did not provide a spokesperson to discuss the current season’s trends.

There is, however, a positive sign: flu activity has been declining since February. Last week, all 50 states reported low or minimal flu activity. The season also saw an unusual mix of circulating strains, with both H1N1 and H3N2 Type A viruses contributing significantly to infections. Earlier CDC data suggested that the flu vaccines offered this season were relatively effective in preventing hospitalisations and deaths.

The CDC continues to advise that everyone aged 6 months and older receive an annual flu vaccine.

The broader decline in childhood vaccinations is being fueled by online misinformation and the politicisation of vaccines, especially since the COVID-19 pandemic. Robert F. Kennedy Jr., who recently assumed the role of U.S. health secretary, has echoed antivaccine rhetoric, further influencing public opinion.

According to O’Leary, other factors may also be impacting flu vaccination rates. Pediatric clinics are often short-staffed and no longer holding as many after-hours vaccination events. Additionally, while more Americans are getting vaccinated at pharmacies, some drugstores do not offer flu shots for children.

"My hope is that this season will be a bit of a wake-up call for folks—that we actually do need to vaccinate our kids against influenza," O’Leary said.