Healthy Returns: New FDA rules affect copycat GLP-1s, and Apple adds health tools to its latest Watch

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The Food and Drug Administration took a caller measurement to ace down connected the usage of cheaper, copycat versions of fashionable value nonaccomplishment and diabetes drugs. 

While it's bully quality for American consumers, it's not precisely a triumph for apical GLP-1 manufacturers Eli Lilly and Novo Nordisk. Shares of some companies fell much than 2% connected Friday pursuing the announcement.

The FDA connected Friday said it will people a "green list" of earthy GLP-1 ingredients from overseas suppliers whose facilities person been inspected by the bureau and deemed compliant with "rigorous" U.S. standards. Compounding pharmacies usage those alleged progressive pharmaceutical ingredients, oregon APIs, to marque copies of GLP-1s. 

The list presently includes implicit 3 twelve suppliers and their ingredients, but their names are redacted. The bulk of those suppliers look to beryllium successful China, portion others are based successful Belgium, Italy, Canada, and India, among different countries. 

Meanwhile, APIs from different suppliers volition beryllium "subject to detention without carnal examination" if they are imported into the U.S., according to an FDA release. The FDA said it aims to artifact the importation of perchance unsafe versions of the APIs utilized successful compounded GLP-1s. 

Consumers flocked to those compounded treatments successful caller years arsenic security sum and proviso of branded obesity drugs specified arsenic Novo Nordisk's Wegovy and Eli Lilly's Zepbound was limited. The companies person since resolved those shortages. The FDA has antecedently identified superior concerns with compounded versions of semaglutide and tirzepatide – the APIs utilized successful Wegovy and Zepbound, respectively – specified arsenic dosing errors that effect successful hospitalizations. 

"By strengthening oversight of imported APIs and cracking down connected amerciable drugs entering the U.S., we are taking assertive enactment to support consumers from poor-quality oregon unsafe GLP-1 drugs," said FDA Commissioner Marty Makary successful the release. 

But immoderate analysts said the FDA's caller effort stops abbreviated of aggressively restricting the usage of compounded GLP-1s. 

Here's BMO Capital Markets expert Evan Seigerman's take: The database "is apt a affirmative for diligent information but a negative" for shares of Novo Nordisk and Eli Lilly.

The greenish database "acknowledges the challenges of compounding without putting a afloat halt stance that they volition look to extremity compounding for GLP-1 products broadly," helium wrote successful a enactment connected Friday. Seigerman said the FDA appears comfy with allowing immoderate compounded versions connected the marketplace arsenic agelong arsenic they conscionable prime standards, careless of the availability of the branded GLP-1s.

But helium said it's a bigger contented for Novo Nordisk than for Eli Lilly: The institution successful July slashed its income guidance for Wegovy, successful portion owed to contention from compounded versions of the cause successful the U.S. 

Seigerman said it is wide that Novo Nordisk and Eli Lilly request to trust connected litigation to halt the accumulation of compounded GLP-1s. Over the past 2 years, some companies person taken ineligible enactment against dozens of compounding pharmacies, med spas and different suppliers to halt them from making and selling copycats. 

He said if Novo Nordisk files a suit against telehealth institution Hims & Hers, it "could beryllium a gamechanger." Hims & Hers continues to connection compounded semaglutide.

In a statement, an Eli Lilly spokesperson said the FDA's determination "is an important archetypal measurement but much indispensable beryllium done." 

The spokesperson said compounding pharmacies person already imported ample quantities of amerciable tirzepatide. The spokesperson urged the FDA and different regulators to "do much to halt unlawful compounding earlier much radical get hurt."

In a abstracted statement, a Novo Nordisk spokesperson said "it is important that FDA ace down connected imports of illicit 'semaglutide; API and instrumentality enactment to support patients from the information risks posed by taking knockoff drugs made with inauthentic, substandard API, including API that has already been imported into the US."

Feel escaped to nonstop immoderate tips, suggestions, communicative ideas and information to Annika at annikakim.constantino@nbcuni.com.

Apple unveiled caller iPhones, Apple Watches and AirPods during an lawsuit astatine its Cupertino office connected Tuesday, and a mates notable caller bosom wellness and slumber features are coming to Watch users.  

The institution has been pushing deeper into wellness attraction successful caller years, and it announced the Apple Watch Series 11, which includes "the astir broad acceptable of wellness features yet," Apple said successful a release. 

Users tin get alerted to imaginable hypertension, oregon precocious humor pressure, which affects astir 1.3 cardinal radical astir the globe, the institution said. High humor unit tin pb to superior wellness problems similar a bosom onslaught oregon stroke, bosom failure, kidney illness and different conditions, according to the Mayo Clinic. 

Apple has developed an algorithm that analyzes however humor vessels respond to beats of the bosom utilizing the Watch's optical bosom sensor. It operates successful the inheritance and reviews information implicit month-long periods, and Apple volition notify users if it identifies patterns of imaginable hypertension. 

Importantly, the diagnostic is not an authoritative diagnosis and does not measurement humor unit directly. If users get a hypertension notification, they should speech with their doctor, Apple said.

"We expect to notify implicit 1 cardinal radical with undiagnosed hypertension successful the archetypal twelvemonth alone," Dr. Sumbul Desai, Apple's vice president of health, said successful a prerecorded video during the event. 

Desai said Apple expects the U.S. Food and Drug Administration to wide the diagnostic "soon." It volition beryllium disposable with watchOS 26 connected Apple Watch Series 9 and aboriginal and Apple Watch Ultra 2 and later. 

Users volition besides get entree to a caller slumber people feature, which aims to assistance radical recognize the prime of their sleep. The instrumentality gives users a people retired of 100 based connected their bedtime consistency, however often they aftermath up, the duration of their slumber and however overmuch clip they walk successful each slumber stage. 

Sleep people volition beryllium disposable with watchOS 26. Users tin find it successful the Sleep app and way their results implicit clip successful the Health app.

"Apple Watch Series 11 is an indispensable companion that supports users' health, fitness, safety, and connectivity passim the time and night," Stan Ng, Apple's vice president of Apple Watch and wellness merchandise marketing, said successful a statement.

The Apple Watch Series 11 starts astatine $399, and users tin preorder it now. The Watch is officially disposable starting connected Sept. 19.

Read Apple's afloat blog station here. 

Feel escaped to nonstop immoderate tips, suggestions, communicative ideas and information to Ashley astatine ashley.capoot@nbcuni.com.