Health

FDA Approved The First Pill Manufactured From Bacteria Found In Human Feces

(CTN News) – On Wednesday, U.S. health officials approved the first tablet manufactured from beneficial bacteria found in human feces to treat deadly gut infections, making it simpler to carry out so-called faecal transplants.

To help patients, certain medical practitioners have used stool-based procedures for more than ten years. The new treatment from Seres Therapeutics offers a more straightforward, thoroughly tested alternative.

The capsules were approved by the Food and Drug Administration for use by adults age 18 and older who run the risk of contracting Clostridium difficile, a bacterium that can result in severe nausea, cramps, and diarrhoea.

When C. diff recurs, it is more hazardous and causes 15,000–30,000 fatalities annually

Antibiotics can eliminate it, but they also kill the beneficial bacteria that exist in the stomach, making the body more vulnerable to further infections.

For patients who have already undergone antibiotic therapy, the new pills have been approved.

In order to restore the gut’s normal balance and avoid reinfections, several doctors started reporting success with faecal transplants more than ten years ago. These procedures use stool from a healthy donor.

Last year, a competing pharmaceutical company, Ferring Pharmaceuticals, submitted the first medication in pharmaceutical-grade form to the FDA for approval.

However, like most of the original methods, the company’s product needs to be given through the rectum.

Cambridge Massachusetts-based Seres will market its drug as a less invasive option

The medication, which will be offered under the trade name Vowst, is administered as a course of four daily pills over the course of three days.

The pharmaceutical industry has spent years studying the microbiome, or the population of bacteria, viruses, and fungi that dwell in the gut, and two recent FDA approvals are the results of that research.

Currently, a network of stool banks that have appeared in medical facilities and hospitals around the nation offer the majority of faecal transplants.

While the demand for donations from stools banks is anticipated to decline as new FDA-approved alternatives become available, some intend to continue operating.

The largest stool bank in the United States, OpenBiome, has stated that it will continue to assist patients who are not qualified for FDA-approved medicines, such as youngsters and adults with illnesses that are resistant to therapy.

Since 2013, it has provided more than 65,000 stool samples for C. diff patients.

Dr. Majdi Osman, the organization’s chief medical officer, stated that “OpenBiome is committed to maintaining safe access to ‘faecal transplantation’ for these patients as a vital last line of defence.”

The usual stool treatment from OpenBiome costs less than $1,700 and is typically shipped as a frozen solution within days of placing an order.

In a statement released on Wednesday night, Seres omitted to include the cost of its capsules.

Eric Shaff, the company’s chief executive officer, stated in an interview conducted prior to the release that “we want to make the commercial experience for physicians and patients as easy as possible.”

“In our opinion, one of the aspects of the value we’re delivering is ease of administration.”

Thousands of capsules can be made from each stool sample

Together with Swiss food juggernaut Nestle, Seres will co-market the treatment, sharing earnings in the process. With regard to the FDA approval, Seres will get a $125 million milestone payment from Nestle.

The FDA has faced regulatory challenges overseeing the nascent U.S. stool bank industry since it doesn’t typically regulate handmade items and practices used in medical offices.

The FDA initially cautioned consumers about the dangers of possible illnesses from faecal transplants as some people looked for dubious “do it yourself” techniques on YouTube and other websites.

Executives from Seres claim that their manufacturing process uses the same methods and tools for blood product and other biologic therapy purification.

The business begins with faeces that is given by a select group of donors who are examined for a variety of health issues. Additionally, dozens of potential viruses, illnesses, and parasites are examined in their stool.

The business then refines the samples to eliminate waste, isolate good bacteria, and eradicate any leftover microorganisms.

Common Side Effects

According to the business, it is a more effective procedure than current faecal transplants because thousands of capsules may be produced from each stool sample.

The FDA stated that the medicine “may carry a risk of transmitting infectious agents” in its statement of approval

Additionally, Vowst may contain food allergies, the government stated.

Based on a 180-patient research, the FDA approved the therapy because, compared to 60% of patients who got placebo tablets, over 88% of those receiving the capsules did not have reinfection after 8 weeks.

Constipation, diarrhea, and abdominal swelling were frequent adverse effects.

Health

Report Causes Pfizer Stock to Climb Approximately $1 Billion Acquired by Starboard

(VOR News) – According to a rumor that activist investor Pfizer Starboard Value has taken a holding in the struggling pharmaceutical business that is expected to be worth around one billion dollars, the stock of Pfizer (PFE) is on the increase in premarket trading on Monday.

This comes after the report was made public. The report was made available to the general public following this. Starboard Value was successful in moving forward with the acquisition of the position.

Starboard is said to have approached Ian Read, a former chief executive officer of Pfizer, and Frank D’Amelio, a former chief financial officer, in order to seek assistance with its goals of boosting the performance of the company, according to the Wall Street Journal. Read and D’Amelio are both former Pfizer executives.

The purpose of this is to facilitate the accomplishment of its objectives, which include enhancing the overall performance of the firm.

In their previous jobs, D’Amelio and Read were chief financial officers.

It is stated in the report that the hedge fund is of the opinion that Pfizer, which is currently being managed by Albert Bourla, who succeeded Read as Chief Executive Officer (CEO) in 2019, does not demonstrate the same level of mergers and acquisitions (M&A) discipline that Read did. Bourla took over for Read in 2019. Read was succeeded by Bourla in the year 2019.

Pfizer, a multinational pharmaceutical conglomerate, has made substantial investments in the acquisition of more companies that are involved in the research and development of cancer medicines.

These businesses have been acquired for billions of dollars. The biotechnology company Seagen, which was acquired by Pfizer in the previous year for a price of $43 billion, is included in this category. One of the businesses that can be classified as belonging to this category is Seagen.

In spite of the fact that the S&P 500 Index experienced a 21% increase in 2024.

No major trading occurred in Pfizer stock that year.

Due to the fact that the demand for Pfizer’s COVID-19 vaccines fell after the firm reached its pandemic peak in 2021, the share price of the corporation has decreased by over fifty percent since that time.

This drop has occurred ever since the company’s shares reached their maximum peak, which was during the time that this decline occurred. Not only have they not changed at all, but they have also remained essentially stable. This is in contrast to the S&P 500, which has gained 21% since the beginning of this year.

Recently, the corporation was forced to take a hit when it decided to recall all of the sickle cell illness medications that it had distributed all over the world.

Fears that the prescription could lead patients to experience severe agony and possibly even death were the impetus for the decision to recall the product. In spite of the fact that Pfizer’s stock is increasing by almost three percent as a result of the news that followed the company’s decision, this is the circumstance that has come about.

SOURCE: IPN

Health

New Study Reveals Drinking Soda Pop Increases the Risk of Stroke

If you drink too much soda, fruit juice and coffee, beware!

A recent report from global research indicates that excessive consumption of coffee or soda pop is associated with an increased risk of stroke, although the intake of black and green tea is correlated with a reduced risk. Excessive consumption of soda pop or coffee warrants caution!

Recent research indicates that it may substantially elevate the risk of stroke.

Consuming four cups of coffee daily elevates the risk of stroke, according to studies, although ingesting 3-4 cups of black or green tea daily typically offers protection against stroke. Additionally, consume more coffee; it may reduce your risk of mortality.

Recent findings from global research studies co-led by the University of Galway and McMaster University, alongside an international consortium of stroke researchers, indicate that soda, encompassing both sugar-sweetened and artificially sweetened variants such as diet or zero sugar, is associated with a 22 percent heightened risk of stroke. The risk escalated significantly with the consumption of two or more of these beverages daily.

Stroke Risk Fizzy Drinks and Soda Pop

The correlation between fizzy drinks consumption and stroke risk was most pronounced in Europe, the Middle East, Africa, and South America. Women exhibit the most elevated risk of stroke from bleeding (intracranial hemorrhage) associated with fruit juice beverages. Consuming over 7 cups of water daily diminishes the likelihood of stroke due to a clot.

Researchers observed that numerous items advertised as fruit juice are derived from concentrates and have added sugars and preservatives, potentially negating the advantages often associated with fresh fruit and instead elevating stroke risk.

Fruit juice beverages were associated with a 37 percent heightened risk of stroke resulting from bleeding (intracranial hemorrhage). Consuming two of these beverages daily increases the risk thrice.

Consuming over four cups of coffee daily elevates the risk of stroke by 37 percent, although lower consumption levels do not correlate with stroke risk. Conversely, tea consumption was associated with an 18-20 percent reduction in stroke risk. Additionally, consuming 3-4 cups daily of black tea, such as Breakfast and Earl Grey varieties, excluding green and herbal teas, was associated with a 29 percent reduced risk of stroke.

Consuming 3-4 cups of green tea daily was associated with a 27 percent reduction in stroke risk. Notably, the addition of milk may diminish or inhibit the advantageous effects of antioxidants present in tea. The lower risk of stroke associated with tea consumption was negated for individuals who added milk.

Disclaimer: This article is intended solely for informational reasons and should not be considered a replacement for professional medical counsel. Consistently consult your physician regarding any inquiries pertaining to a medical problem.

Starbucks Faces Sales Decline Amid Price Fatigue and Rising Competition

Starbucks Faces Sales Decline Amid Price Fatigue and Rising Competition

Health

Following a Diagnosis of Breast Cancer, What Else Should You Know?

(VOR News) – Even though breast cancer affects one in eight American women, receiving a diagnosis can make a woman feel isolated.

Experts in breast cancer from the American College of Physicians (ACS) advise patients on how to manage their disease so that they may better cope with this awful information.

First, the kind and stage of breast cancer dictates the course of your care.

In addition to immunotherapy and chemotherapy, there are various surgical options available for the treatment of breast cancer.

Women of African descent are disproportionately affected by triple-negative breast cancer, an extremely aggressive form of the disease that has never proven easy to treat.

According to the American Cancer Society, pembrolizumab (Keytruda), an immunotherapy, has been shown to be helpful when combined with chemotherapy and is currently the recommended course of treatment for certain combinations of triple-negative breast cancer.

In her presentation, Dr. Katharine Yao said, “It’s really important that the patient and physician discuss the patient’s preferences and values when deciding what type of treatment to pursue and that they have an honest, individualized discussion with their care team.”

She is currently responsible for developing breast cancer treatment recommendations for more than 575 hospitals and institutions nationwide in her role as chair of the American College of Surgeons’ National Accreditation Program for Breast Institutions (NAPBC).

Yao, vice chair of research at Endeavor Health NorthShore Hospitals in New York, pointed out that each decision made about a patient’s treatment plan should take her preferences and diagnosis into consideration.

She ought to think about whether she would prefer a mastectomy—a surgical procedure that involves removing the entire breast with or without reconstruction—or a lumpectomy, which involves a surgical procedure that spares part of the breast tissue.

She stated that “the breast cancer you have may be very different from the breast cancer you hear about in your neighbor, colleague, or friend” in a press release issued by the American Cancer Society (ACS).

“Consider that while discussing breast cancer with others.”

Throughout your journey, it is critical that you look after your emotional health because having breast cancer may have a detrimental impact on your mental health.

“Getting a cancer diagnosis does not mean that everything in your life stops to be normal.” Director of the Fellowship in the Diseases of the Breast program at the Winthrop P. Rockefeller Cancer Institute at the University of Arkansas and state head of the American Cancer Society Commission on Cancer for Arkansas, Dr. Daniela Ochoa She thinks adding the burden of a cancer diagnosis and treatment to all the other pressures in life may be taxing.

“Managing stress and emotional health is vital component of a treatment plan.”

Ochoa recommends clinically trained psychologists and social workers who have assisted people in coping with cancer to anyone receiving treatment. Learning coping techniques might also be facilitated by joining cancer support groups or cancer wellness initiatives.

Breast cancer specialists say your care team is crucial.

The American Cancer Society (ACS) defines comprehensive care as having support at every stage of the procedure from surgeons, oncologists, patient navigators, nurses, social workers, psychologists, and other specialists.

After receiving a breast cancer diagnosis, women should see a surgeon or medical oncologist to explore their options; nevertheless, treatment shouldn’t be discontinued after just one appointment or after surgery is over.

Additionally, you can ask trustworthy friends or family members to accompany you to appointments and aid you with research or notes. They could serve as a network of support for you.

Yao stated in his talk that “one of the most important things is that patients should search out a team they have confidence in, that they trust will have their back when they need it, and a team they feel they can get access to and that will help them when they are in need.”

SOURCE: MP