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FDA Approves Xolair for Multiple Food Allergy Relief

FDA Approves Xolair for Multiple Food Allergy Relief

(CTN News) – The US Food and Drug Administration authorised Xolair, a medicine that reduces the intensity of allergy reactions in those who are allergic to various foods.

Xolair, developed and co-marketed by Genentech and Novartis in the United States, was first licenced in 2003 for the treatment of moderate to severe persistent allergic asthma in select patients.

Xolair, also known as omalizumab, is administered via injection in doses ranging from 75 mg to 600 mg every 2 to 4 weeks by a healthcare provider or self-injection at home, according to Novartis. A patient’s weight determines the dosage and frequency of administration.

The FDA reports that using the medicine on a regular basis can lower the risk of allergic reactions, including anaphylaxis, in people and children as young as one year who have been accidentally exposed to foods including peanuts, milk, eggs, and wheat.

However, Xolair “is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis,” according to the FDA.

Anaphylaxis is a severe allergic reaction that requires prompt medical attention, including epinephrine injections.

The FDA emphasises that Xolair patients should continue to avoid items that cause allergic reactions.

“This newly approved use of Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies,” said Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Centre for Drug Evaluation and Research.

“While it will not eliminate food allergies or allow patients to consume food allergens freely, its repeated use will help reduce the health impact if accidental exposure occurs.”

“Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction that could happen as a result,” said Reshema Kemps-Polanco, executive vice president and chief commercial officer of Novartis US.

Novartis describes the newly approved usage of Xolair as a new tool for controlling life-threatening food allergies.

The FDA granted permission based on a Phase 3 placebo-controlled research. According to the FDA, researchers studied 168 individuals aged 1 to 55 who were allergic to peanuts and at least two additional dietary allergens, such as milk, egg, wheat, cashew, hazelnut, or walnut.

“The primary measure of Xolair’s efficacy was the percentage of subjects who were able to eat a single dose (600 milligrammes or greater) of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms, such as moderate to severe skin, respiratory or gastrointestinal symptoms, at the end of the 16-to-20-week treatment course.”

Of the individuals who got Xolair, 68% were able to ingest a single dosage of peanut protein without experiencing moderate to severe allergy symptoms such as whole-body hives, persistent coughing, or vomiting, compared to 6% who received a placebo.

However, results suggest that 17% of patients who got the drug experienced no significant change in their tolerance for peanut protein.

The FDA states that Xolair has been associated with adverse effects such as injection site reactions and fever.

“Xolair comes with certain warnings and precautions, such as anaphylaxis, malignancy, fever, joint pain, rash, parasitic (worm) infection and abnormal laboratory tests,” the Food and Drug Administration (FDA) states.

In 2021, about 6% of the US population had a food allergy that could cause life-threatening reactions, as reported by the US Centres for Disease Control and Prevention.

Food allergies are currently incurable, according to health professionals.

“The stress of living with food allergies can weigh heavily on people and their families, particularly when navigating events like children’s birthday parties, school lunches and holiday dinners with friends and family,” stated Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America.

“Given the rising frequency of food allergies, this revelation provides hope to the many children and adults who could benefit from a novel strategy to manage their allergies.

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Google’s Search Dominance Is Unwinding, But Still Accounting 48% Search Revenue

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Google is so closely associated with its key product that its name is a verb that signifies “search.” However, Google’s dominance in that sector is dwindling.

According to eMarketer, Google will lose control of the US search industry for the first time in decades next year.

Google will remain the dominant search player, accounting for 48% of American search advertising revenue. And, remarkably, Google is still increasing its sales in the field, despite being the dominating player in search since the early days of the George W. Bush administration. However, Amazon is growing at a quicker rate.

google

Google’s Search Dominance Is Unwinding

Amazon will hold over a quarter of US search ad dollars next year, rising to 27% by 2026, while Google will fall even more, according to eMarketer.

The Wall Street Journal was first to report on the forecast.

Lest you think you’ll have to switch to Bing or Yahoo, this isn’t the end of Google or anything really near.

Google is the fourth-most valued public firm in the world. Its market worth is $2.1 trillion, trailing just Apple, Microsoft, and the AI chip darling Nvidia. It also maintains its dominance in other industries, such as display advertisements, where it dominates alongside Facebook’s parent firm Meta, and video ads on YouTube.

To put those “other” firms in context, each is worth more than Delta Air Lines’ total market value. So, yeah, Google is not going anywhere.

Nonetheless, Google faces numerous dangers to its operations, particularly from antitrust regulators.

On Monday, a federal judge in San Francisco ruled that Google must open up its Google Play Store to competitors, dealing a significant blow to the firm in its long-running battle with Fortnite creator Epic Games. Google announced that it would appeal the verdict.

In August, a federal judge ruled that Google has an illegal monopoly on search. That verdict could lead to the dissolution of the company’s search operation. Another antitrust lawsuit filed last month accuses Google of abusing its dominance in the online advertising business.

Meanwhile, European regulators have compelled Google to follow tough new standards, which have resulted in multiple $1 billion-plus fines.

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Pixa Bay

Google’s Search Dominance Is Unwinding

On top of that, the marketplace is becoming more difficult on its own.

TikTok, the fastest-growing social network, is expanding into the search market. And Amazon has accomplished something few other digital titans have done to date: it has established a habit.

When you want to buy anything, you usually go to Amazon, not Google. Amazon then buys adverts to push companies’ products to the top of your search results, increasing sales and earning Amazon a greater portion of the revenue. According to eMarketer, it is expected to generate $27.8 billion in search revenue in the United States next year, trailing only Google’s $62.9 billion total.

And then there’s AI, the technology that (supposedly) will change everything.

Why search in stilted language for “kendall jenner why bad bunny breakup” or “police moving violation driver rights no stop sign” when you can just ask OpenAI’s ChatGPT, “What’s going on with Kendall Jenner and Bad Bunny?” in “I need help fighting a moving violation involving a stop sign that wasn’t visible.” Google is working on exactly this technology with its Gemini product, but its success is far from guaranteed, especially with Apple collaborating with OpenAI and other businesses rapidly joining the market.

A Google spokeswoman referred to a blog post from last week in which the company unveiled ads in its AI overviews (the AI-generated text that appears at the top of search results). It’s Google’s way of expressing its ability to profit on a changing marketplace while retaining its business, even as its consumers steadily transition to ask-and-answer AI and away from search.

google

Google has long used a single catchphrase to defend itself against opponents who claim it is a monopoly abusing its power: competition is only a click away. Until recently, that seemed comically obtuse. Really? We are going to switch to Bing? Or Duck Duck Go? Give me a break.

But today, it feels more like reality.

Google is in no danger of disappearing. However, every highly dominating company faces some type of reckoning over time. GE, a Dow mainstay for more than a century, was broken up last year and is now a shell of its previous dominance. Sears declared bankruptcy in 2022 and is virtually out of business. US Steel, long the foundation of American manufacturing, is attempting to sell itself to a Japanese corporation.

Could we remember Google in the same way that we remember Yahoo or Ask Jeeves in decades? These next few years could be significant.

SOURCE | CNN

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The Supreme Court Turns Down Biden’s Government Appeal in a Texas Emergency Abortion Matter.

Supreme Court

(VOR News) – A ruling that prohibits emergency abortions that contravene the Supreme Court law in the state of Texas, which has one of the most stringent abortion restrictions in the country, has been upheld by the Supreme Court of the United States. The United States Supreme Court upheld this decision.

The justices did not provide any specifics regarding the underlying reasons for their decision to uphold an order from a lower court that declared hospitals cannot be legally obligated to administer abortions if doing so would violate the law in the state of Texas.

Institutions are not required to perform abortions, as stipulated in the decree. The common populace did not investigate any opposing viewpoints. The decision was made just weeks before a presidential election that brought abortion to the forefront of the political agenda.

This decision follows the 2022 Supreme Court ruling that ended abortion nationwide.

In response to a request from the administration of Vice President Joe Biden to overturn the lower court’s decision, the justices expressed their disapproval.

The government contends that hospitals are obligated to perform abortions in compliance with federal legislation when the health or life of an expectant patient is in an exceedingly precarious condition.

This is the case in regions where the procedure is prohibited. The difficulty hospitals in Texas and other states are experiencing in determining whether or not routine care could be in violation of stringent state laws that prohibit abortion has resulted in an increase in the number of complaints concerning pregnant women who are experiencing medical distress being turned away from emergency rooms.

The administration cited the Supreme Court’s ruling in a case that bore a striking resemblance to the one that was presented to it in Idaho at the beginning of the year. The justices took a limited decision in that case to allow the continuation of emergency abortions without interruption while a lawsuit was still being heard.

In contrast, Texas has been a vocal proponent of the injunction’s continued enforcement. Texas has argued that its circumstances are distinct from those of Idaho, as the state does have an exemption for situations that pose a significant hazard to the health of an expectant patient.

According to the state, the discrepancy is the result of this exemption. The state of Idaho had a provision that safeguarded a woman’s life when the issue was first broached; however, it did not include protection for her health.

Certified medical practitioners are not obligated to wait until a woman’s life is in imminent peril before they are legally permitted to perform an abortion, as determined by the state supreme court.

The state of Texas highlighted this to the Supreme Court.

Nevertheless, medical professionals have criticized the Texas statute as being perilously ambiguous, and a medical board has declined to provide a list of all the disorders that are eligible for an exception. Furthermore, the statute has been criticized for its hazardous ambiguity.

For an extended period, termination of pregnancies has been a standard procedure in medical treatment for individuals who have been experiencing significant issues. It is implemented in this manner to prevent catastrophic outcomes, such as sepsis, organ failure, and other severe scenarios.

Nevertheless, medical professionals and hospitals in Texas and other states with strict abortion laws have noted that it is uncertain whether or not these terminations could be in violation of abortion prohibitions that include the possibility of a prison sentence. This is the case in regions where abortion prohibitions are exceedingly restrictive.

Following the Supreme Court’s decision to overturn Roe v. Wade, which resulted in restrictions on the rights of women to have abortions in several Republican-ruled states, the Texas case was revisited in 2022.

As per the orders that were disclosed by the administration of Vice President Joe Biden, hospitals are still required to provide abortions in cases that are classified as dire emergency.

As stipulated in a piece of health care legislation, the majority of hospitals are obligated to provide medical assistance to patients who are experiencing medical distress. This is in accordance with the law.

The state of Texas maintained that hospitals should not be obligated to provide abortions throughout the litigation, as doing so would violate the state’s constitutional prohibition on abortions. In its January judgment, the 5th United States Circuit Court of Appeals concurred with the state and acknowledged that the administration had exceeded its authority.

SOURCE: AP

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Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli, To repay $6.4 Million

shkreli

Washington — The Supreme Court rejected Martin Shkreli’s appeal on Monday, after he was branded “Pharma Bro” for raising the price of a lifesaving prescription.

Martin appealed a decision to repay $64.6 million in profits he and his former company earned after monopolizing the pharmaceutical market and dramatically raising its price. His lawyers claimed the money went to his company rather than him personally.

The justices did not explain their reasoning, as is customary, and there were no notable dissents.

Prosecutors, conversely, claimed that the firm had promised to pay $40 million in a settlement and that because Martin orchestrated the plan, he should be held accountable for returning profits.

shkreli

Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli

Martin was also forced to forfeit the Wu-Tang Clan’s unreleased album “Once Upon a Time in Shaolin,” which has been dubbed the world’s rarest musical album. The multiplatinum hip-hop group auctioned off a single copy of the record in 2015, stipulating that it not be used commercially.

Shkreli was convicted of lying to investors and defrauding them of millions of dollars in two unsuccessful hedge funds he managed. Shkreli was the CEO of Turing Pharmaceuticals (later Vyera), which hiked the price of Daraprim from $13.50 to $750 per pill after acquiring exclusive rights to the decades-old medicine in 2015. It cures a rare parasite condition that affects pregnant women, cancer patients, and HIV patients.

shkreli

He defended the choice as an example of capitalism in action, claiming that insurance and other programs ensured that those in need of Daraprim would eventually receive it. However, the move prompted criticism, from the medical community to Congress.

shkreli

Supreme Court Rejects Appeal From ‘Pharma Bro’ Martin Shkreli

Attorney Thomas Huff said the Supreme Court’s Monday ruling was upsetting, but the high court could still overturn a lower court judgment that allowed the $64 million penalty order even though Shkreli had not personally received the money.

“If and when the Supreme Court does so, Mr. Shkreli will have a strong argument for modifying the order accordingly,” he told reporters.

Shkreli was freed from prison in 2022 after serving most of his seven-year sentence.

SOURCE | AP

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