The new FDA rules affect GLP-1; Apple adds health tools to the last watch

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The Food and Drug Administration has taken a new step to suppress the use of cheaper versions and to copy popular weight loss and diabetes drugs.

Although this is good news for American consumers, this is not exactly a victory for the best GLP-1 manufacturers Eli Lilly And Novo Nordisk. The actions of the two companies fell by more than 2% on Friday after the announcement.

On Friday, the FDA said that it would publish a “green list” of the GLP-1 gross ingredients of foreign suppliers whose facilities were inspected by the agency and deemed in accordance with American “rigorous” American standards. Composition pharmacies use these so-called active pharmaceutical ingredients, or API, to make copies of GLP-1.

The list currently includes more than three dozen suppliers and their ingredients, but their names are expurgated. The majority of these suppliers seem to be in China, while others are based in Belgium, Italy, Canada and India, among other countries.

Meanwhile, the APIs of other suppliers will be “subject to detention without physical examination” if they are imported in the United States, according to an FDA statement. The FDA said it aims to block the importation of potentially dangerous versions of the APIs used in compounds GLP-1.

Consumers have flocked to these treatments composed in recent years, as insurance coverage and the supply of brand obesity drugs such as Wegovy de Novo Nordisk and Zepbound of Eli Lilly were limited. Companies have since resolved these shortages. The FDA previously identified serious concerns with the versions composed of the semaglutide and shooting – the APIs used in Wegovy and Zepbound, respectively – such as dosage errors that cause hospitalizations.

“By strengthening the surveillance of imported APIs and repressing illegal drugs entering the United States, we take aggressive measures to protect consumers from poor quality or dangerous GLP-1 drugs,” said FDA commissioner Marty Makary in the statement.

But some analysts have said that the new FDA effort was no restriction on the use of compound GLP-1s.

Here is the BMO analyst on the Evan Seigerman’s Taw capital markets: the list “is probably a positive for patient safety, but a” negative “for the actions of Novo Nordisk and Eli Lilly.

The green list “recognizes the challenges of the composition without putting a full stop position which they will seek to end the GLP-1 products largely,” he wrote in a note on Friday. Seigerman said that the FDA seems comfortable with the authorization of certain versions composed on the market as long as they meet quality standards, regardless of the availability of brand GLP-1.

But he said that it was a more important problem for Novo Nordisk than for Eli Lilly: the company in July reduced its sales advice for Wegovy, partly due to competition from the versions composed of the drug in the United States

Seigerman said it is clear that Novo Nordisk and Eli Lilly were to count on disputes to stop the production of compounds GLP-1. Over the past two years, the two companies have brought legal action against dozens of composition pharmacies, spas med and other suppliers to prevent them from manufacturing and selling copies.

He said that if Novo Nordisk files a trial against the Hims & Hers TV company, this “could be a Gamechanger”. Hims & Hers continues to offer composed semaglutide.

In a press release, a spokesperson for Eli Lilly said that the FDA move “is an important first step, but it is necessary to do more.”

The spokesman said that the composition of pharmacies had already imported large quantities of illegal shooting. The spokesman urged the FDA and other regulators to “do more to stop the illegal composition before more people are injured”.

In a separate declaration, a spokesperson for Novo Nordisk said that “it is important that the FDA retracts the imports of semaglutide” illicit; API and act to protect patients from safety risks posed by taking medication at the idea of ​​picking up in the United States. “”

Do not hesitate to send advice, suggestions, history ideas and data to Annikakim.constantino@nbcuni.com.

Apple Unveiled new iPhones, Apple Watchs and Airpods during an event at its headquarters in Cupertino on Tuesday, and some new notable features of heart and sleep health arrives for users.

The company has deepened health care in recent years, and has announced the Apple Watch Series 11, which includes “the most complete whole of health features to date,” Apple said in a statement.

Users can be alerted to possible hypertension, or high blood pressure, which affects approximately 1.3 billion people worldwide, said the company. High blood pressure can cause serious health problems such as a heart attack or stroke, heart failure, kidney disease and other conditions, according to Mayo Clinic.

Apple has developed an algorithm that analyzes how blood vessels react to heartbeat using the watch’s optical cardiac sensor. It works in the background and examines data over periods of one month, and Apple will inform users if it identifies possible hypertension models.

Above all, the characteristic is not an official diagnosis and does not directly measure blood pressure. If users obtain a hypertension notification, they should speak with their doctor, said Apple.

“We expect to inform more than a million people with unheeded hypertension in the first year only,” said Dr. Sumbul Desai, Apple health vice-president, in a pre-recorded video during the event.

Desai said that Apple expects the American Food and Drug Administration to erase the “soon” functionality. It will be available with Watchos 26 on the Apple Watch 9 series and later and Apple Watch Ultra 2 and later.

Users will also have access to a new sleep score functionality, which aims to help people understand the quality of their sleep. The tool gives users a score in 100 according to their coherence at bedtime, how often they wake up, the duration of their sleep and the time they spend at each sleep stage.

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

“Apple Watch Series 11 is an essential companion that supports the health, physical form, safety and connectivity of users throughout the day and night,” said Stan NG, vice-president of Apple Watch and health products in a statement.

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

Read Apple’s full blog here.

Do not hesitate to send advice, suggestions, history ideas and data to Ashley to Ashley.capoot@nbcuni.com.