Health
Unproven Birth Drug ‘Makena’ To Be Withdrawn From The US Market
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(CTN NEWS) – After regulators indicated they would proceed with a long-delayed campaign to remove the product Makena from the market.
The manufacturer of an unproven medication meant to prevent preterm births has announced that it will voluntarily remove the medicine from the United States.
Makena is a synthetic progesterone hormone required to sustain a pregnancy. It is the only medication for lowering the risk of premature birth with FDA approval.
Around four years after Makena failed to demonstrate a benefit in assisting mothers to bring pregnancies to term, Covis Pharma announced its removal on Tuesday.
The Food and Drug Administration has been working to take the medication off the market ever then, despite Covis’s repeated requests for more time to carry out additional research.
The injectable drug symbolizes the FDA’s struggles to recall a drug when the maker won’t do so voluntarily.
It’s still unclear when the medicine will be removed.
![](https://www.chiangraitimes.com/wp-content/uploads/2023/03/makena-1.webp)
Makena
Birth Drug ‘Makena’ To Be Withdrawn
Covis, a Swiss company, claimed in a press release that FDA officials turned down its request to gradually reduce medicine use over several months.
The medicine is administered by weekly injections beginning after 16 weeks of pregnancy, and the business claimed that the longer off-ramp will enable women who are still getting time to complete their course of therapy.
The business claims that the FDA made it plain that it will continue to remove the medicine under its own terms.
The agency’s drug regulators suggested making the withdrawal “immediately effective” in a separate file on Wednesday.
The agency stated no evidence of “harm from stopping Makena, such as withdrawal signs or symptoms.”
Robert Califf, the FDA commissioner, is anticipated to decide the drug’s future shortly after consulting with the agency’s top scientist.
Covis To Collaborate With FDA
Following a public meeting in October when it was unanimously decided that Makena had not been demonstrated to work and that its approval should be canceled, Covis made its application to the FDA.
Despite hours of presentations and discussion, the panel was not persuaded by Covis’s claims that the medicine may be helpful for a group of women.
Such hearings are uncommon and only occur when a manufacturer refuses early FDA demands to halt the sale of its product.
In a statement, Raghav Chari, chief information officer of Covis, stated that the company “stands by Makena’s attractive benefit-risk profile, particularly its efficacy in women at highest risk of preterm birth.”
However, the company is looking to voluntarily withdraw the product and is collaborating with the FDA to implement an orderly wind-down.
Despite differences of opinion over the timeline, the business noted that it “remains ready to work amicably with the agency” to remove the drug.
10% of births in the US occur before 37 weeks, which increases the likelihood that the child will experience major health issues or perhaps pass away. The issue affects African women more frequently.
Based on a limited trial of women with a history of early deliveries, the FDA approved Makena in 2011.
A lengthier follow-up research was required to confirm whether the medicine gave newborns healthier outcomes before the accelerated approval was granted.
The 1,700-patient international study’s 2019 findings revealed neither the drug’s initial hypothesised reduction in preterm deliveries nor the improvement in newborn health.
Despite such findings, reproductive experts, including members of the American College of Obstetricians and Gynecologists, have pushed for maintaining the drug’s availability until additional research is conducted.
The organization declared on Wednesday that its present policies would continue to be in place until FDA made a final determination.
For the sake of the patients’ and their family’s health and well-being, the group emphasized the need to find further, successful strategies to stop recurring preterm birth.
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Health
Report Causes Pfizer Stock to Climb Approximately $1 Billion Acquired by Starboard
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(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
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Health
New Study Reveals Drinking Soda Pop Increases the Risk of Stroke
![Soda Pop Increases the Risk of Stroke](https://www.chiangraitimes.net/wp-content/uploads/2024/10/Soda-Pop-Increases-the-Risk-of-Stroke.jpg)
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.
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Health
Following a Diagnosis of Breast Cancer, What Else Should You Know?
![Breast Cancer](https://www.chiangraitimes.net/wp-content/uploads/2024/10/Breast-Cancer.webp)
(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
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