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FDA Rejects ‘Neffy’ Epinephrine Nasal Spray Despite Positive Advisory Committee Vote

Nasal Spray

(CTN News) – In an unexpected turn of events, the Food and Drug Administration (FDA) has chosen not to grant approval for an epinephrine nasal spray, which could have marked a groundbreaking, needle-free alternative to epinephrine autoinjectors like EpiPens.

According to a statement released by ARS Pharmaceuticals late Tuesday night, the FDA has requested that the company conduct an additional study on the drug, known as Neffy, in order to provide further evidence to support its approval.

This rejection comes as a surprise, especially considering that the FDA‘s advisory committee had previously voted in favor of recommending Neffy’s approval for use in both children and adults back in May.

It is worth noting that it is relatively rare for the FDA to decline approval for drugs that have received a positive recommendation from its advisory committees.

“We are genuinely taken aback by this development,” expressed Richard Lowenthal, the CEO of ARS Pharmaceuticals, in the company’s official statement.

Nasal Sprays: Types, Uses, and Guidelines

Nasal spray is a medication delivery method used to administer drugs directly into the nasal passages. It is commonly used to treat various conditions, including allergies, congestion, and nasal infections. Here are some key points about nasal sprays:

  1. Types of Nasal Sprays:
    • Decongestant Nasal Sprays: These provide temporary relief from nasal congestion and are available over-the-counter. They work by narrowing blood vessels in the nasal passages.
    • Steroid Nasal Sprays: These are used to treat allergies and inflammation. They help reduce inflammation in the nasal passages and can be prescribed by a doctor.
    • Saline Nasal Sprays: These contain a saltwater solution and are used to moisturize and flush out nasal passages. They are often used for nasal irrigation.
  2. Common Uses:
    • Allergies: Nasal sprays can alleviate symptoms of seasonal or year-round allergies, such as sneezing, runny nose, and congestion.
    • Nasal Congestion: Decongestant nasal sprays can provide quick relief from nasal congestion due to colds or allergies.
    • Nasal Polyps: Steroid nasal sprays may be prescribed to reduce inflammation associated with nasal polyps.
    • Sinus Infections: They can help manage symptoms of sinusitis, such as sinus pressure and congestion.
  3. How to Use Nasal Sprays:
    • Follow the instructions provided with the specific nasal spray product.
    • Typically, you’ll insert the nozzle into your nostril, aim slightly outward, and spray while inhaling gently. Avoid tilting your head back too far.
    • After using a nasal spray, it’s important to clean the nozzle to prevent contamination.
  4. Side Effects:
    • Common side effects may include nasal dryness, irritation, or a mild burning sensation.
    • Overusing decongestant nasal sprays can lead to a condition called “rebound congestion.”
  5. Consult a Healthcare Professional:
    • If you have chronic nasal symptoms or are considering using a nasal spray long-term, it’s advisable to consult a healthcare provider for proper guidance and to rule out underlying conditions.

Please note that this information is for general understanding, and it’s essential to consult a healthcare professional or read the specific instructions provided with any nasal spray product for proper usage and potential side effects.

ARS Pharmaceuticals to Contest FDA’s Data Demand for Needle-Free Epinephrine

ARS Pharmaceuticals has announced its intention to challenge the FDA’s demand for additional data.

Epinephrine, a life-saving medication that has been in use in the United States since 1901, is highly effective in reversing anaphylaxis, the most severe form of allergic reaction.

Anaphylaxis can occur within minutes of exposure to an allergen, such as peanuts or cat dander, and without prompt treatment, it can prove fatal.

However, all currently available epinephrine treatments require injection, which poses a challenge for individuals with a fear of needles.

Dr. Zachary Rubin, an allergist at Oak Brook Allergists in Illinois, expressed his astonishment at the FDA’s decision, stating, “I’m shocked.” Dr. Rubin, who is not a member of the FDA’s advisory committee, emphasized the lack of viable alternatives at present.

He noted, “Currently, we essentially have epinephrine autoinjector devices, needle-based options, and people have been advocating for years for a needle-free alternative.”

During the advisory committee meeting in May, a major concern revolved around the insufficient clinical data, particularly the absence of studies involving individuals experiencing anaphylaxis.

ARS Pharmaceuticals argued that their nasal spray demonstrated “comparable” effectiveness to an EpiPen, based on research conducted in both animals and individuals who did not have anaphylaxis.

Despite these concerns, the advisory panel ultimately voted 16-6 in favor of the drug for use in adults and 17-5 in favor of its use in children.

Ethical Challenges in Studying Life-Saving Allergy Drug: Dr. Amirshahi’s Perspective

For Dr. Maryann Amirshahi, a professor specializing in emergency medicine at Georgetown University School of Medicine and a member of the advisory committee, the absence of data concerning patients with anaphylaxis remained a significant concern.

Consequently, she cast her vote against the drug on both occasions.

Amirshahi expressed her perspective in an email to NBC News on Tuesday, saying, “I listened to the parents during the hearing, and I heard them discuss the trauma associated with administering a shot to their children.

However, as a parent myself, a panel member, a pharmacologist, and an ER physician who has encountered numerous cases of anaphylaxis, the most concerning aspect for me was not the injection, but the potential failure of a drug to effectively treat a life-threatening condition.”

The ethical challenges of studying a drug designed for emergency treatment of life-threatening allergic reactions are complex.

Conducting a randomized controlled trial, in which both adults and children experiencing severe allergic reactions are given either the treatment or a placebo, would be ethically problematic, according to Rubin.

Amirshahi suggested that it might be feasible to study the drug in individuals experiencing anaphylaxis in controlled settings like an allergist’s office or an emergency room, where there would be a backup treatment readily available.

She expressed hope that the FDA’s rejection would provide an opportunity to conduct comprehensive research on the drug to ensure its effectiveness. She remarked, “While I believe the drug has potential, it currently lacks sufficient efficacy data.”

In response to the FDA’s decision, the agency has requested an additional study comparing Neffy to an epinephrine autoinjector in individuals experiencing nasal symptoms induced by allergens, such as sneezing, itching, and congestion.

The drug manufacturer has indicated its intention to resubmit the application to the FDA in the first half of 2024.

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

Google

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.

google

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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2024 | Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

trump

Washington — Trump Media,  The Supreme Court announced Monday that it will not hear an appeal from social media platform X about a search warrant acquired by prosecutors in the election meddling case against former President Donald Trump.

The justices did not explain their rationale, and there were no recorded dissents.

The firm, which was known as Twitter before being purchased by billionaire Elon Musk, claims a nondisclosure order that prevented it from informing Trump about the warrant obtained by special counsel Jack Smith’s team violated its First Amendment rights.

The business also claims Trump should have had an opportunity to exercise executive privilege. If not reined in, the government may employ similar tactics to intercept additional privileged communications, their lawyers contended.

trump

Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

Two neutral electronic privacy groups also joined in, urging the high court to hear the case on First Amendment grounds.

Prosecutors, however, claim that the corporation never shown that Trump utilized the account for official purposes, therefore executive privilege is not a problem. A lower court also determined that informing Trump could have compromised the current probe.

trump

Trump utilized his Twitter account in the weeks preceding up to his supporters’ attack on the Capitol on January 6, 2021, to spread false assertions about the election, which prosecutors claim were intended to create doubt in the democratic process.

The indictment describes how Trump used his Twitter account to encourage his followers to travel to Washington on Jan. 6, pressuring Vice President Mike Pence to reject the certification, and falsely claiming that the Capitol crowd, which battered police officers and destroyed glass, was peaceful.

musk trump

Supreme Court Won’t Hear Appeal From Elon Musk’s X Platform Over Warrant In Trump Case

That case is now moving forward following the Supreme Court’s verdict in July, which granted Trump full immunity from criminal prosecution as a former president.

The warrant arrived at Twitter amid quick changes implemented by Musk, who bought the company in 2022 and has since cut off most of its workforce, including those dedicated to combating disinformation and hate speech.

He also welcomed back a vast list of previously banned users, including Trump, and endorsed him for the 2024 presidential election.

SOURCE | AP

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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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Could Last-Minute Surprises Derail Kamala Harris’ Campaign? “Nostradamus” Explains the US Poll.

Scientists Awarded MicroRNA The Nobel Prize in Medicine.

US Inflation will Comfort a Fed Focused on Labor Markets.

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