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What We’re Reading: Crackdown on Counterfeit Ozempic; ALS Drug Fails in Clinical Trial; Cyberattack Profit Losses

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Novo Nordisk is working with authorities in several countries to tackle counterfeit versions of popular diabetes drug semaglutide (Ozempic); Amylyx’s controversial amyotrophic lateral sclerosis (ALS) drug failed to help patients in a large follow-up study; disruptions from the Change Healthcare cyberattack are costing health providers as much as $1 billion a day.

Novo Nordisk, Global Authorities Take on Counterfeit Ozempic

After new reports of patient harm, Novo Nordisk’s CEO announced on Friday that the company is working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug semaglutide (Ozempic), according to Reuters. Because the surging demand for these drugs far outpaces supply, there is an increasing concern about unregulated and counterfeit medicines. The Partnership for Safe Medicines reported that counterfeit Ozempic has been found in as many as 16 countries so far. Patients who took counterfeit medication last year in Belgium, Iraq, Serbia, and Switzerland suffered hyperglycemia; these reports add to previously confirmed cases in countries including Austria, Lebanon, Britain, and the US. Consequently, Novo Nordisk has been testing suspicious products in collaboration with authorities in countries where counterfeits are found.

Maker of ALS Drug May Stop Selling It After Failed Clinical Trial

Amylyx Pharmaceuticals, the maker of much-debated amyotrophic lateral sclerosis (ALS) drug sodium phenylbutyrate and taurursodiol (Relyvrio), announced on Friday that the treatment failed to help patients in a large follow-up study, according to the Associated Press. The drug received FDA approval in September 2022 based on results from 1 small study. Also, an external committee of experts initially voted against the drug but later reversed the decision in a follow-up meeting requested by patient advocates. Amylyx told FDA regulators it would voluntarily withdraw the drug from the market if subsequent research did not confirm its efficacy. The latest company study showed that the drug did not slow ALS compared with placebo; it also failed to show improvement on any secondary end points, such as muscle strength. Consequently, Amylyx said it would discuss its plans for Relyvrio with patients and the FDA, which may include voluntarily withdrawing it from the US drug market.

Health Care Providers Lose Up to $1 Billion a Day from Cyberattack

Industry officials reported that disruptions from the Change Healthcare cyberattack are costing providers as much as $1 billion a day and impacting first-quarter earnings, according to Axios. Providers that use Change Healthcare systems have seen some or nearly all of their revenue vanish since systems for filing claims or having them paid went offline on February 21. UnitedHealth Group, Change Healthcare’s parent company, announced that it has a timeline for restoring the third-party payment systems that roughly half of the US health care system relies on. Despite this, hospitals, doctors, pharmacies, and medical equipment vendors could spend weeks or months sorting out patient eligibility, filing claims, and paying additional staff to handle the extra administrative burden. Also, once the funds start flowing again, a significant amount of money due will likely not be paid out because of paperwork errors and lack of prior authorizations.

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