New FDA rules affect GLP-1S; Apple adds the latest clock to health tools
FileToto: The headquarters of the US Food and Drug Administration (FDA) can be seen in Silver Spring, Maryland, November 4, 2009.
Jason Reed | Reuters
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The Food and Drug Administration has taken a new step to maintain the use of cheaper, imitators of popular weight loss and diabetes medication.
Although it is good news for American consumers, this is not exactly a victory for top GLP 1 manufacturers Eli Lilly And Novo Nordisk. The shares of both companies decreased by more than 2% on Friday after the announcement.
The FDA said on Friday that it would publish a “green list” of RAW-GLP-1 ingredients from foreign suppliers, whose institutions were inspected by the agency and classified as conformity with “strict” US standards. Compounding pharmacies use these so-called active pharmaceutical ingredients or APIs to make copies of GLP-1.
The list currently contains over three dozen suppliers and their ingredients, but their names are reduced. The majority of these suppliers seem to be in China, while others are based in Belgium, Italy, Canada and India.
In the meantime, APIs are “imprisoned” without a physical examination if they are imported into the USA according to an FDA publication. The FDA said it aims to block the import of potentially dangerous versions of the APIs that are used in compound GLP-1S.
In recent years, consumers have flocked to these composite treatments as insurance protection and care with obesity medications such as Nordisks Wegovy and Eli Lillys Zepbound were limited. Since then, the companies have solved these bottlenecks. The FDA previously identified serious concerns regarding Semaglutid and Tirepatid versions – the APIs used in wide houses and zepbound – such as dosage errors that lead to hospital admissions.
“By strengthening surveillance, APIs imported and by intervening illegal drugs that enter the United States, we take aggressive measures to protect consumers from medicinal products with poor quality or dangerous GLP-1 drugs,” said FDA commissioner Marty Makary in release.
However, some analysts said that the FDA’s new effort no longer aggressively restricted the use of compound GLP-1.
Here is the BMO Capital Markets Analyst Evan Seogerman: the list “is probably positive for patient safety, but a negative” for shares of Novo Nordisk and Eli Lilly.
The green list “recognizes the challenges of the network without ending an attitude that you want to end for GLP-1 products as a whole”, he wrote in a note on Friday. Seigerman said that the FDA probably appears with the enabling of some increased versions on the market, as long as they correspond to the quality standards, regardless of the availability of the brand GLP-1S.
But he said
Seigerman said it was clear that Novo Nordisk and Eli Lilly have to rely on legal disputes in order to stop the production of composed GLP-1. In the past two years, both companies have initiated legal steps against dozens of Compounding pharmacies, Med -Spas and other suppliers in order to prevent them from making and selling.
He said that if Novo Nordisk submits a lawsuit against Telehealth Company Hims & Huls, this could “be a gamuchanger”. HIMS & HINS continues to offer tightened Semaglutid.
In a statement, a spokesman for Eli Lilly said that the FDA’s step was “an important first step, but more must be done.”
The spokesman said that compounding pharmacies have already imported large quantities of illegal tirepatide. The spokesman asked the FDA and other supervisory authorities to “do more to stop the illegal integration before more people are injured”.
In a separate explanation, a Novo Nordisk spokesman “It is important that the FDA against the imports of illegal Semaglutid; API and measures to protect patients from the security risks, which were taken by taking Knockoff medication with unspeakable, inferior API, including the API imported in the USA.
Feel free to send Annikakim.constantino@nbcuni.com tips, suggestions, ideas and data to Annika.
The latest in Health-Care Tech: Apple announces two new health functions for Apple Watch during the annual hardware event
Customers are waiting for the new iPhone 16 and the Apple Watch Series 10 in the Fifth Avenue Apple Store on September 20, 2024 in New York City.
Timothy A. Clary | AFP | Getty pictures
Apple Unveiled new iPhones, Apple watches and Airpods during an event in the Cupertino headquarters on Tuesday, and a few remarkable new heart and sleep functions come to observe users.
The company has pushed deeper into health care in recent years and announced the Apple Watch Series 11, which “has so far contained the most comprehensive health functions”, said Apple in a publication.
Users can draw attention to possible high blood pressure or high blood pressure, which affects around 1.3 billion people around the world, according to the company. According to the Mayo clinic, high blood pressure can lead to serious health problems such as heart attack or stroke, heart failure, kidney diseases and other diseases.
Apple has developed an algorithm that analyzes how blood vessels react with the optical heart sensor of the watch to the heart of the heart. It works in the background and checks the data over months. Apple notifies users when it identifies patterns for possible high blood pressure.
It is important that the feature is not an official diagnosis and does not measure blood pressure directly. If users receive a high blood pressure notification, you should speak to your doctor, said Apple.
“We assume that over 1 million people with non -diagnosed high blood pressure will be notified in the first year alone,” said Dr. Sumbul Desai, Vice President of Health from Apple, in a recorded video during the event.
According to Desai, Apple expects the US Food and Drug Administration to delete the characteristic “soon”. It will be available with Watchos 26 on the Apple Watch Series 9 and later and later and later with Apple Watch Ultra 2.
Users also receive access to a new Sleep score function to help people understand the quality of their sleep. The tool offers users a score of 100 marked points, based on their consistency before going to bed, how often they wake up, the duration of their sleep and how much time they spend in every sleep.
Sleep score will be available with Watchos 26. Users can find it in the sleep app and follow their results over time in the Health app.
“The Apple Watch Series 11 is an indispensable companion who supports the health, fitness, security and connectivity of the users during the day and night,” said Stan ng, Vice President of Apple Watch and Health Product Marketing.
The Apple Watch Series 11 starts at 399 US dollars and users can now pre -order. The watch is officially available from September 19.
Read Apple’s full blog post here.
Feel free to send tips, suggestions, story ideas and data to Ashley at Ashley.capoot@nbcuni.com.
