New FDA rules affect GLP-1s; Apple adds health tools to latest Watch

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Food and Medicine Administration has taken a new step to reduce the use of cheaper, imitating versions of popular weight loss and diabetes drugs.

Although it is good news for American consumers, it is not exactly a profit for the best GLP-1 manufacturers. Hand Lilly And Novo Nordisk. Following the announcement, the shares of both companies fell more than 2% on Friday.

FDA Say on Friday Will publish “green list” The raw GLP-1 components of foreign suppliers, whose facilities are supervised by the agency and are considered in accordance with “meticulous” US standards. Compound pharmacies use active pharmaceutical components or APIs to make copies of GLP-1s.

List Currently, it contains more than three dozens of suppliers and materials, but their names have been corrected. While the majority of these suppliers appear in China, others are among other countries in Belgium, Italy, Canada and India.

In the meantime, according to an FDA version, the APIs from other suppliers are imported to the USA “physical examination will be subject to detaine”. The FDA said it aims to prevent the importation of potentially dangerous versions of APIs used in compound GLP-1s.

In recent years, consumers have limited the supply of branded obesity drugs such as insurance scope and Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Companies have solved these problems since then. The FDA previously described serious concerns with the compound versions of the APIs used in Wegovy and Zepbound, respectively, such as dosing errors that resulted in hospitalization, respectively.

“We take aggressive actions to protect consumers from low-quality or dangerous GLP-1 drugs by strengthening the surveillance of imported APIs and destroying illegal drugs entering the United States.” He said.

However, some analysts said FDA’s new effort stopped aggressively restricting the use of compound GLP-1s.

Here is BMO Capital Markets Analyst Evan Seigerman’s Receiving: List “probably positive for patient safety, but novo Nordisk and Eli Lilly’s shares of the shares”.

“In a note on Friday, the Green list accepts the compound difficulties without putting a complete stance for GLP-1 products,” Green List wrote. Seigerman, FDA’s branded GLP-1s, regardless of the availability of quality standards as long as they meet some compound versions in the market, he said.

However, Novo said that there was a greater problem for Nordisk than Eli Lilly: in July, the company has partially stopped sales guidance for Wegovy due to competition from the compound versions of the drug in the United States.

Seigerman, Novo Nordisk and Eli Lilly’nin compound GLP-1s to stop the production of the case said. In the last two years, both companies have been legally treated to prevent dozens of merger pharmacies from making and selling copies against MED SPA and other suppliers.

“It could be a Gamechanger,” said Novo Nordisk filed against Telehealth Company HIMS & Hers. HIMS & HERS continues to offer compound semaglutid.

In a statement, one hand Lilly spokesman FDA’s movement is “an important first step, but more should be done,” he said.

The spokesman said that the unification pharmacies have already imported large amounts of illegal drinker. The spokesman called FDA and other regulators “to do more to stop illegal compounds before more people hurt.”

In a separate statement, a Novo Nordisk spokesman said, “FDA is illegal ‘Semaglid; API is imported into imports and action to protect patients from protection risks by taking knockoff drugs made with API, including the API imported to the US,” He said.

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Apple During an event at the Cupertino center on Tuesday, new iPhones, Apple Watches and AirPods were introduced and a few new heart health and sleep features come to watch users.

In recent years, the company has been progressing deeper to health services and Apple has announced the Apple Watch Series 11, which includes “the most comprehensive health features so far”. release.

The company said users can be stimulated for possible hypertension or high blood pressure, which can affect about 1.3 billion people around the world. It can cause serious health problems such as high blood pressure, heart attack or stroke, heart failure, kidney disease and other cases. Swimwear clinic.

Apple developed an algorithm that analyzes how blood vessels reacts to the beats of the heart using the optical heart sensor of the watch. It works in the background and reviews the data for a month, and Apple informs users if it defines possible hypertension patterns.

Outical, the feature is not an official diagnosis and does not measure blood pressure directly. Apple, users receive a notification of hypertension, said they should talk to their doctors.

Apple’s Vice President of Health. “We hope to inform more than 1 million people with non -diagnosed hypertension in the first year,” Sumbul Desai said in a pre -recorded video during the event. He said.

Desai said Apple expects the US Food and Pharmaceutical Administration to clean the “Soon” feature. The Apple Watch Series will be available in the Watchos 26 and Apple Watch Ultra 2 and subsequent versions in the following versions.

Users will also reach a new sleep score feature that aims to help people understand the quality of their sleep. The vehicle gives users a score from 100, depending on how often they wake up, how often they wake up, the duration of sleep and how much time they spend during the sleep stage.

The sleep score will be available with Watchos 26. Users can find in the sleeping application and monitor their results over time in health application.

Apple’s Apple Watch and Health Product Marketing Vice President Stan NG, Apple, “Apple Watch series 11, users are an indispensable friend who supports users during day and night, supporting health, fitness, security and connection.” He said.

The Apple Watch Series starts at $ 11 399 and users can now pre -order. The clock is officially available since September 19.

Read Apple’s Full Blog Post Here.

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