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		<title>Judge approves overseas travel in Hafa Adai Bingo case</title>
		<link>https://www.ourstoryinsight.com/judge-approves-overseas-travel-in-hafa-adai-bingo-case/</link>
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		<pubDate>Wed, 07 Jan 2026 03:18:00 +0000</pubDate>
				<category><![CDATA[Technology]]></category>
		<category><![CDATA[Adai]]></category>
		<category><![CDATA[Approves]]></category>
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		<category><![CDATA[Hafa]]></category>
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		<category><![CDATA[travel]]></category>
		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=12123</guid>

					<description><![CDATA[<p>A federal judge in the U.S. District Court of Guam has approved a request by a defendant in the high-profile Hafa Adai Bingo case to travel overseas. The accused is part of the ongoing case and has her itinerary approved to visit South Korea, despite ongoing proceedings tied to illegal gambling and money-laundering allegations. Judge [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/judge-approves-overseas-travel-in-hafa-adai-bingo-case/">Judge approves overseas travel in Hafa Adai Bingo case</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>A federal judge in the U.S. District Court of Guam has approved a request by a defendant in the high-profile Hafa Adai Bingo case to travel overseas.</p>
<p>The accused is part of the ongoing case and has her itinerary approved to visit South Korea, despite ongoing proceedings tied to illegal gambling and money-laundering allegations.</p>
<h2><span id="judge_approves_travel_for_hafa_adai_bingo_defendant">Judge approves travel for Hafa Adai Bingo defendant</span></h2>
<p>Won Sun Min, one of several defendants charged in connection with the alleged illegal bingo operation, has been granted permission to travel to South Korea between January 6 and January 15, 2026, according to court documents.</p>
<p>Federal prosecutors have put forward an argument that says the actions of these individuals, including Min, generated millions of dollars in proceeds, violated U.S. laws governing illegal gambling businesses, and their actions involved money-laundering conspiracies to conceal or distribute proceeds.</p>
<p>Min has already pleaded guilty to some charges and agreed to forfeit $930,143.07 of the illegally gained proceeds.</p>
<h2><span id="mins_travel_green_lit_despite_federal_allegations">Min’s travel green lit despite federal allegations</span></h2>
<p>“The defendants operated Hafa Adai Bingo as an illegal gambling business by conducting bingo games, retaining and diverting bingo profits and proceeds,” read the court filing against the accused.</p>
<p>Magistrate Judge Michael Bordallo has approved the request on medical grounds, said the Pacific Daily News. The case centers around allegations that defendants operated an illegal gambling enterprise under the guise of a charitable bingo operation connected to the Guam Shrine Club (GSC).</p>
<p>“Instead, the GSC officers issued profit distribution and other checks to co-conspirator Won Sun Min (‘Min’) and defendant Marasigan. Min and Marasigan received over $2 million and $15 million of bingo proceeds, respectively, from GSC.”</p>
<p>Under federal law, an “illegal gambling business” is defined as one that violates state or territorial law, involves five or more persons, and remains in substantially continuous operation for more than 30 days or generates more than $2,000 in a single day.</p>
<p>If the federal argument is successful, Min could face up to five years in federal prison and a fine of up to $250,000 for the illegal gambling allegations.</p>
<p>On money-laundering conspiracy charges, there is a possible 20-year custodial term and a fine of up to $500,000, or twice the value of the laundered funds.</p>
<p>Featured image: Adobe Firefly</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/judge-approves-overseas-travel-in-hafa-adai-bingo-case/">Judge approves overseas travel in Hafa Adai Bingo case</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk</title>
		<link>https://www.ourstoryinsight.com/fda-approves-first-glp-1-pill-for-obesity-from-wegovy-maker-novo-nordisk/</link>
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		<pubDate>Tue, 23 Dec 2025 10:44:20 +0000</pubDate>
				<category><![CDATA[Business]]></category>
		<category><![CDATA[Approves]]></category>
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		<category><![CDATA[GLP1]]></category>
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		<category><![CDATA[Nordisk]]></category>
		<category><![CDATA[Novo]]></category>
		<category><![CDATA[obesity]]></category>
		<category><![CDATA[pill]]></category>
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		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=11789</guid>

					<description><![CDATA[<p>The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, Nov. 24, 2025. Tom Little &#124; Reuters The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker Novo Nordisk, a landmark decision that health experts [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-first-glp-1-pill-for-obesity-from-wegovy-maker-novo-nordisk/">FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0" /></p>
<p>The logo of pharmaceutical company Novo Nordisk is displayed in front of its offices in Bagsvaerd, on the outskirts of Copenhagen, Denmark, Nov. 24, 2025. </p>
<p>Tom Little | Reuters</p>
<p>The U.S. Food and Drug Administration on Monday approved the first-ever GLP-1 pill for obesity from Wegovy maker <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag" /></span></span></span>, a landmark decision that health experts say could open up treatment access to more patients. </p>
<p>Novo Nordisk said it expects to launch the pill in early 2026. The Danish drugmaker said starting in early January, the starting dose of 1.5 milligrams will be available in pharmacies and via select telehealth providers with savings offers for $149 per month. </p>
<p>That&#8217;s the same price that cash-paying patients can access the starting dose of the pill on President Donald Trump&#8217;s direct-to-consumer website, TrumpRx, under a deal Novo Nordisk struck with his administration last month. Trump&#8217;s site also launches in January. </p>
<p>Novo Nordisk did not say how much higher doses of the drug would cost, but said additional information on coverage and savings options for eligible patients will be available at that time as well.</p>
<p>Shares of Novo Nordisk gained roughly 10% in extended trading Monday. </p>
<p>The FDA&#8217;s approval also clears the pill for use to reduce the risk of major cardiovascular events, such as death, heart attack or stroke, in adults with obesity and established cardiovascular disease, according to Novo Nordisk. </p>
<p>That&#8217;s consistent with the approval label of the company&#8217;s blockbuster weight loss drug Wegovy, which shares the same active ingredient, semaglutide. Both work by mimicking the gut hormone GLP-1 to suppress appetite. </p>
<p>&#8220;What we&#8217;ve learned through years of research is that having an oral option really kind of opens up, activates and motivates different segments to seek treatment,&#8221; Dave Moore, Novo Nordisk&#8217;s executive vice president of U.S. operations, told CNBC ahead of the approval. &#8220;To have that conversation with their doctor to see if this is something that might be right for them.&#8221;</p>
<p>&#8220;That&#8217;s what we&#8217;re excited about — to be able to give people an option and make sure we have access and ease of access like we have been doing with our injections,&#8221; he continued. He added that patients will have the &#8220;comfort and familiarity&#8221; on the safety and efficacy side since the pill contains the same active ingredient as Wegovy. </p>
<p>Some health experts said pills could reach people who are afraid of needles or patients who might benefit from the existing injections but don&#8217;t take them because they don&#8217;t view their need as severe enough. </p>
<p>It&#8217;s unclear exactly how many people are using GLP-1s in the U.S., especially for obesity in particular. But around 1 in 8 adults said they were taking a GLP-1 drug to lose weight or treat another chronic condition as of November, according to a poll from health policy research organization KFF.</p>
<p>The approval gives Novo Nordisk a head start over its chief rival <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-6">Eli Lilly,<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag" /></span></span></span> which is currently the dominant player in the market and is racing to launch its own obesity pill. Pills are the next battleground for the two drugmakers, which established the booming GLP-1 space that some analysts say could be worth roughly $100 billion by the 2030s.</p>
<p>Wall Street thinks there&#8217;s plenty of room for pills in the market, with Goldman Sachs analyst saying in August that pills could capture a 24% share — or around $22 billion — of the 2030 global weight loss drug market.</p>
<p>In a note Monday, BMO Capital Markets analyst Evan Seigerman said the approval of Novo Nordisk&#8217;s pill gives the company a &#8220;much-needed win in light of recent challenges maintaining incretin market share dominance.&#8221; </p>
<p>Incretins refer to treatments that mimic gut hormones such as GLP-1. Eli Lilly earlier this year gained the majority share of the market thanks to its blockbuster obesity injection Zepbound, which has shown to be more effective than Novo Nordisk&#8217;s Wegovy. </p>
<p>&#8220;Novo will likely benefit from first-mover advantage, capturing patients with a preference for convenience and comfort provided by an oral dosing regimen,&#8221; Seigerman said. But he also noted that the market is &#8220;rapidly evolving with competitive assets in development&#8221; and an approval for Eli Lilly&#8217;s pill, orforglipron, &#8220;just around the corner.&#8221;</p>
<h2 class="ArticleBody-subtitle">What to know about the Wegovy pill </h2>
<p>The approval is based on a phase three trial that followed more than 300 adults with obesity but not diabetes.</p>
<p>In that study, a 25-milligram dose of Novo Nordisk&#8217;s oral semaglutide helped patients lose up to 16.6% of their weight on average after 64 weeks, according to results from the trial presented at a medical conference in 2024. That weight loss was 13.6% when the company analyzed all patients regardless of whether they stopped the drug.</p>
<p>The pill appears to be slightly more effective than an experimental oral drug from Eli Lilly, which is still waiting for FDA approval.</p>
<p>But unlike Novo Nordisk&#8217;s pill, Eli Lilly&#8217;s treatment is not a peptide medication. That means it is absorbed more easily by the body and does not require dietary restrictions. People who take Novo Nordisk&#8217;s pill have to wait 30 minutes before eating or drinking each day.</p>
<p>But Moore said several existing medicines have the same dietary requirements, so &#8220;we don&#8217;t see it as something that impacts adherence to treatment.&#8221; He noted that Novo Nordisk&#8217;s research has found that it helps patients to remember to take their medicine in the morning with a few sips of water.</p>
<p>&#8220;It&#8217;s actually a reinforcement factor for patients,&#8221; Moore said. </p>
<p>He added that the prices of the pill get costs closer to what some people are paying for unapproved, compounded versions of branded GLP-1s, some of which are still being illegally mass-marketed and sold in the U.S.</p>
<p>Patients flocked to the cheaper copycats when Ozempic and Wegovy were in short supply over the last two years due to skyrocketing demand, or if they didn&#8217;t have insurance coverage for the costly treatments. During FDA-declared shortages, pharmacists can legally make compounded versions of brand-name medications. But the agency earlier this year determined that the shortage of semaglutide is over, barring the practice in many cases.</p>
<p>&#8220;It continues to be alarming and disturbing for us,&#8221; Moore told CNBC, referring to illegitimate ingredients that are imported into the U.S. illegally and used by some compounding pharmacies to create copycat versions of branded GLP-1s.</p>
<p>In terms of manufacturing, Moore said the company is &#8220;prepared to be able to satisfy a big demand here in the U.S., and we&#8217;re pretty excited about it.&#8221; Novo Nordisk said manufacturing is underway at its North Carolina facilities.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-first-glp-1-pill-for-obesity-from-wegovy-maker-novo-nordisk/">FDA approves first GLP-1 pill for obesity from Wegovy maker Novo Nordisk</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves Signos glucose monitoring for weight loss</title>
		<link>https://www.ourstoryinsight.com/fda-approves-signos-glucose-monitoring-for-weight-loss/</link>
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		<pubDate>Wed, 20 Aug 2025 05:03:44 +0000</pubDate>
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		<category><![CDATA[glucose]]></category>
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		<category><![CDATA[Signos]]></category>
		<category><![CDATA[weight]]></category>
		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=8905</guid>

					<description><![CDATA[<p>Woman with Signos wearable and app Source: Signos The Food and Drug Administration on Wednesday approved the first-ever glucose monitoring system specifically for weight loss from the startup Signos, establishing a new option for Americans to manage their weight.  Current treatment options for losing weight – popular drugs like GLP-1s and surgical interventions – are [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-signos-glucose-monitoring-for-weight-loss/">FDA approves Signos glucose monitoring for weight loss</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>Woman with Signos wearable and app</p>
<p>Source: Signos</p>
<p>The Food and Drug Administration on Wednesday approved the first-ever glucose monitoring system specifically for weight loss from the startup Signos, establishing a new option for Americans to manage their weight. </p>
<p>Current treatment options for losing weight – popular drugs like GLP-1s and surgical interventions – are typically limited to patients with obesity or a certain BMI. Obesity drugs such as <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-3">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s Wegovy and <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-4">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s Zepbound can also be difficult to access due to their high costs, limited U.S. insurance coverage and constrained supply.</p>
<p>But now, any patient can purchase a Signos membership to access its system. It uses an AI platform and an off-the-shelf continuous glucose monitor, or CGM, from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-5">Dexcom<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span> to offer personalized, real-time data and lifestyle recommendations for weight management. </p>
<p>&#8220;There is now a solution that everybody can use to help on the weight loss journey, and you don&#8217;t have to be a certain number of pounds to use it. It&#8217;s available for the average American who needs it,&#8221; said Sharam Fouladgar-Mercer, Signos&#8217; co-founder and CEO, in an interview on Tuesday ahead of the approval. &#8220;The average person might have five pounds to lose, or others might have 100 pounds to lose. We are here to help them at any point in that journey.&#8221;</p>
<p>The obesity epidemic costs the U.S. health-care system more than $170 billion a year, according to Centers for Disease Control and Prevention data. Almost 74% of Americans are overweight or obese, government data says. Signos hopes it can make a &#8220;real big dent in that curve for the betterment of many of us,&#8221; Fouladgar-Mercer said. </p>
<p>Customers who sign up for Signos can choose a three-month or six-month plan, which currently costs $139 and $129, respectively. The company will ship out all of the CGMs a patient needs for the number of months in the plan they choose.  </p>
<p>Insurers currently don&#8217;t cover the system for weight management, but the plans are a fraction of the roughly $1,000 monthly price of GLP-1s in the U.S. Signos is working with health insurance companies and employers to get coverage for the system, the company said in a statement to CNBC. Signos said it expects &#8220;this to evolve quickly as interest for tackling weight continued to expand.&#8221; </p>
<p>The Signos system can be used in combination with GLP-1s or bariatric surgery, said Fouladgar-Mercer. He said patients can also use the system after getting off a GLP-1 to maintain their weight loss. </p>
<p>CGMs are small sensors worn on the upper arm that track glucose levels, mainly for people with diabetes. That data is wirelessly sent to Signos&#8217; app, which also allows patients to log their food intake and exercise levels, among other information that the AI platform uses to make recommendations. </p>
<p>Apart from helping people lose pounds, the system aims to help users understand how their bodies respond to specific foods and exercise patterns and make the right behavioral changes to manage and maintain their weight in the long term. </p>
<p>Signos did not share how many patients are currently using its glucose monitoring system, but Fouladgar-Mercer said tens of thousands of people have already tried it over time. He said Signos has scaled up its CGM inventory and software capacity to &#8220;handle a pretty massive scale&#8221; following the approval.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-signos-glucose-monitoring-for-weight-loss/">FDA approves Signos glucose monitoring for weight loss</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FCC approves $8 billion Paramount-Skydance merger</title>
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		<pubDate>Fri, 25 Jul 2025 08:00:33 +0000</pubDate>
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		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=8401</guid>

					<description><![CDATA[<p>The Paramount Global headquarters in New York, US, on Tuesday, Aug. 27, 2024.  Yuki Iwamura &#124; Bloomberg &#124; Getty Images The Federal Communications Commission cleared the way Thursday for an $8 billion merger between Paramount and Skydance Media. The deal, which was announced more than a year ago, includes the CBS broadcast television network, Paramount [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fcc-approves-8-billion-paramount-skydance-merger/">FCC approves $8 billion Paramount-Skydance merger</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>The Paramount Global headquarters in New York, US, on Tuesday, Aug. 27, 2024. </p>
<p>Yuki Iwamura | Bloomberg | Getty Images</p>
<p>The Federal Communications Commission cleared the way Thursday for an $8 billion merger between <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">Paramount<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span> and Skydance Media.</p>
<p>The deal, which was announced more than a year ago, includes the CBS broadcast television network, Paramount Pictures and the Nickelodeon channel.</p>
<p>&#8220;Americans no longer trust the legacy national news media to report fully, accurately, and fairly,&#8221; Brendan Carr, chairman of the FCC, wrote in a statement Thursday. &#8220;It is time for a change. That is why I welcome Skydance&#8217;s commitment to make significant changes at the once storied CBS broadcast network.&#8221;</p>
<p>Carr said Skydance had made written commitments to ensure the new company&#8217;s programing would have a diversity of viewpoints across the political and ideological spectrum. Skydance also said it would hire a third-party impartial outsider to report to the president of the new company to evaluate complaints of bias.</p>
<p>The FCC chairman noted that Skydance does not have any DEI programs in place and has agreed not to establish any such initiatives at the new company.</p>
<p>Paramount chair Shari Redstone is set to depart the company&#8217;s board once the Skydance merger is complete. Her family&#8217;s company National Amusements is selling its controlling stake in Paramount to Skydance.</p>
<p>Skydance is owned by David Ellison, the soun of Oracle founder and billionaire Larry Ellison.</p>
<p>The decision by the FCC to greenlight the merger was not unanimous. Commissioner Anna Gomez, the lone Democrat on the three-person commission, opposed the move, saying she was troubled by Paramount&#8217;s recent payment to settle a suit brought by President Donald Trump against CBS&#8217;s &#8220;60 Minutes.&#8221;</p>
<p>&#8220;The Paramount payout and this reckless approval have emboldened those who believe the government can — and should-abuse its power to extract financial and ideological concessions, demand favored treatment, and secure positive media coverage,&#8221; she wrote in a dissent statement.</p>
<p>The FCC&#8217;s ruling comes less than a month after Paramount agreed to pay $16 million to Trump after he sued the company over the editing of a &#8220;60 Minutes&#8221; interview with former Vice President Kamala Harris. It also occurred a week after CBS announced it was canceling &#8220;The Late Show with Stephen Colbert.&#8221;</p>
<p>Colbert had called the settlement a &#8220;big fat bribe&#8221; during one of his monologues last week, referencing the $8.4 billion pending merger between Paramount and Skydance Media, which required the approval of the Trump administration to proceed.</p>
<p>At the time, Paramount and CBS executives released a statement saying the cancellation was &#8220;purely a financial decision against the challenging backdrop in late night.&#8221;</p>
<p>However, the timing of its decision has been called into question by a number of political figures and Hollywood trade groups.</p>
<p>The Writer&#8217;s Guild of America asked New York State Attorney Letitia James to join California and launch an investigation into potential wrongdoing at Paramount.</p>
<p>&#8220;Cancelations are part of the business, but a corporation terminating a show in bad faith due to explicit or implicit political pressure is dangerous and unacceptable in a democratic society,&#8221; the WGA wrote in a statement last week. &#8220;Paramount&#8217;s decision comes against a backdrop of relentless attacks on a free press by President Trump, through lawsuits against CBS and ABC, threatened litigation of media organizations with critical coverage, and the unconscionable defunding of PBS and NPR.&#8221;</p>
<p>Democratic Senators Adam Schiff, of California, and Elizabeth Warren, of Massachusetts, also questioned the deal.</p>
<p>&#8220;Was it a coincidence that CBS canceled Colbert just three days after he spoke out?&#8221; Warren wrote in an op-ed for Variety published Wednesday. &#8220;Are we sure that this wasn&#8217;t part of a wink-wink deal between the president and a giant corporation that needed something from his administration?&#8221;</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fcc-approves-8-billion-paramount-skydance-merger/">FCC approves $8 billion Paramount-Skydance merger</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves Gilead HIV prevention injection lenacapavir</title>
		<link>https://www.ourstoryinsight.com/fda-approves-gilead-hiv-prevention-injection-lenacapavir/</link>
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		<pubDate>Sun, 22 Jun 2025 08:04:26 +0000</pubDate>
				<category><![CDATA[Business]]></category>
		<category><![CDATA[Approves]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Gilead]]></category>
		<category><![CDATA[HIV]]></category>
		<category><![CDATA[injection]]></category>
		<category><![CDATA[lenacapavir]]></category>
		<category><![CDATA[prevention]]></category>
		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=7769</guid>

					<description><![CDATA[<p>The Food and Drug Administration on Wednesday approved Gilead&#8217;s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus.  But the launch of the injectable drug, which will be marketed under the name Yeztugo, [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-gilead-hiv-prevention-injection-lenacapavir/">FDA approves Gilead HIV prevention injection lenacapavir</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>The Food and Drug Administration on Wednesday approved <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Gilead&#8217;<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>s twice-yearly antiviral injection for preventing HIV — a milestone that the company and some experts say could help bring the world closer to ending the decadeslong epidemic caused by the virus. </p>
<p>But the launch of the injectable drug, which will be marketed under the name Yeztugo, faces a set of potential threats, including the Trump administration&#8217;s proposed cuts to federal funding for HIV prevention efforts. </p>
<p>In two groundbreaking clinical trials in 2024, Gilead&#8217;s injection proved to be capable of virtually eliminating new HIV infections when taken every six months. That&#8217;s a less frequent dosage than for all existing HIV prevention medications, including daily pills from Gilead and another injection, from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">GSK<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>, taken every other month. </p>
<p>That makes Yeztugo a valuable and far more convenient tool for addressing an epidemic that led to around 1.3 million new infections and contributed to the deaths of 630,000 people globally in 2023, according to the World Health Organization. </p>
<p>The U.S. alone sees 700 new cases and 100 HIV-related deaths each week, Gilead CEO Daniel O&#8217;Day said in an interview ahead of the approval. HIV continues to have a disproportionate impact on people of color, gay and bisexual men, other men who have sex with men and transgender women.</p>
<p>&#8220;It&#8217;s hard to overstate the importance of this for global public health,&#8221; O&#8217;Day said, adding that the injection &#8220;really will bend the arc of the epidemic as we roll this out across the globe.&#8221;</p>
<p>But the magnitude of its impact will also depend on how easy it is to get, said Jeremiah Johnson, executive director of PrEP4All, an organization focused on expanding access to HIV prevention medications. </p>
<h2 class="ArticleBody-subtitle">Pricing, access, efficacy</h2>
<p>Lenacapavir, the generic name of Yeztugo, has an annual list price of $28,218 in the U.S. before insurance, a Gilead spokesperson said in an email. That is in line with existing branded medications approved for the same use: pre-exposure prophylaxis, or PrEP, which reduces the risk of getting HIV. </p>
<p>A month&#8217;s supply of Truvada and Descovy, Gilead&#8217;s daily pills for PreP, are both around $2,000 without insurance, which amounts to around $24,000 per year. One dose of GSK&#8217;s Apretude, which is taken once monthly for the first two months and then once every other month thereafter, costs roughly $4,000 before insurance.</p>
<p>&#8220;We are working to make Yeztugo accessible for anyone who needs or wants it and expect to see broad insurance coverage,&#8221; the Gilead spokesperson said, adding that there is broad insurance coverage for existing prevention options.</p>
<p>The company said it has a copay savings program for eligible insured patients that may reduce out-of-pocket payments for Yeztugo to as little as zero dollars. Gilead also has a program for eligible uninsured people to receive the injection for free.</p>
<p>Lenacapavir is already approved for treating HIV under the brand name Sunlenca, which has a price tag of more than $42,200 per year. One analysis in 2024 found that the drug could be made for as little as $26 to $40 a year.</p>
<p>Mizuho analysts have estimated that lenacapavir could reach peak sales of around $4 billion globally for both HIV prevention and treatment.</p>
<p>O&#8217;Day said the company is also committed to supplying the drug for that use globally as the virus &#8220;knows no boundaries.&#8221; Gilead in October granted licenses to six generic manufacturers to produce and sell lower-cost versions of the injection in 120 low- and lower-middle-income countries.</p>
<p>Gilead also promised to supply doses for up to 2 million people at no profit before those generic versions come to the market, O&#8217;Day said. </p>
<p>PrEP has been available for a decade in the form of daily pills, but infections have climbed or remained roughly flat in many areas. Pills can be difficult for many people to take consistently for several reasons, including inconvenience and stigma around HIV and PrEP in many communities, particularly outside the demographic of white men who have sex with men.</p>
<p>Black Americans account for 39% of new HIV diagnoses but only 14% of PrEP users, while Hispanic people represent 31% of new diagnoses but just 18% of PrEP users, according to AIDSVu, a public resource for HIV surveillance data from Gilead in partnership with Emory University&#8217;s Rollins School of Public Health.</p>
<p>&#8220;Unfortunately, there&#8217;s still enormous amount of stigma and cultural challenges when it comes to HIV prevention,&#8221; Johanna Mercier, Gilead&#8217;s chief commercial officer, said in an interview. &#8220;Getting a twice-a-year injection really gives you that privacy that people have been looking for.&#8221;</p>
<p>She said Gilead aims to ensure that more people, especially those not currently using PrEP, are aware of that convenience advantage and the efficacy of the company&#8217;s injection.</p>
<p>In one late-stage trial, 99.9% of patients who took Gilead&#8217;s injection did not contract an infection. There were only two cases among more than 2,000 patients, effectively reducing the risk of HIV infection by 96% and proving 89% more effective than Gilead&#8217;s daily pill Truvada. The study enrolled cisgender men, transgender women, transgender men and gender nonbinary individuals who have sex with partners assigned male at birth.</p>
<p>Another trial, on more than 5,000 cisgender women, found that none of the roughly 2,000 participants who received Gilead&#8217;s injection contracted an HIV infection, demonstrating 100% efficacy. </p>
<h2 class="ArticleBody-subtitle">Proposed federal funding cuts pose a threat</h2>
<p>In the U.S., ensuring access to underserved populations will also require broad insurance coverage. Most PrEP users are under commercial plans, according to the HIV+Hepatitis Policy Institute. But the federal Medicaid program is also crucial to reaching lower-income communities.</p>
<p>Medicaid is the largest source of insurance coverage for people who have the virus in the U.S., covering an estimated 40% of nonelderly adults who have HIV, according to health policy research organization KFF. That makes Republicans&#8217; proposed funding cuts to Medicaid a huge potential threat to HIV treatment and prevention access.</p>
<p>Mercier said that, as of now, Gilead believes that Medicaid will continue to cover HIV services and support.</p>
<p>&#8220;There are pretty incredible programs out there, not only Medicaid and other government programs, that really have safety nets to make sure that people who need or want access, both for HIV treatment and prevention, are set up,&#8221; she said, also pointing to Gilead&#8217;s programs for uninsured individuals.</p>
<p>But PrEP4All&#8217;s Johnson said the &#8220;entire foundation for HIV prevention in America is under attack at this moment.&#8221;</p>
<p>Other proposed federal funding cuts could make it harder to get Gilead&#8217;s injection into the hands of physicians and patients, Johnson said. For example, the White House&#8217;s proposed budget for fiscal year 2026 includes deep cuts to several HIV prevention programs, particularly those that are run through the CDC.</p>
<p>While some funding streams are continuing, Johnson said they are doing so &#8220;in a way that would completely destabilize the entire field of HIV prevention.&#8221;</p>
<p>He said if Congress does not push back on the White House&#8217;s proposed cuts, people currently taking PrEP &#8220;could start to slip off&#8221; and HIV infections could rise in many communities. </p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-gilead-hiv-prevention-injection-lenacapavir/">FDA approves Gilead HIV prevention injection lenacapavir</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>Meta approves plan for bigger executives bonuses following 5% layoffs</title>
		<link>https://www.ourstoryinsight.com/meta-approves-plan-for-bigger-executives-bonuses-following-5-layoffs/</link>
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		<pubDate>Fri, 21 Feb 2025 00:02:47 +0000</pubDate>
				<category><![CDATA[Technology]]></category>
		<category><![CDATA[Approves]]></category>
		<category><![CDATA[bigger]]></category>
		<category><![CDATA[bonuses]]></category>
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		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=5416</guid>

					<description><![CDATA[<p>Meta CEO Mark Zuckerberg looks on before the luncheon on the inauguration day of U.S. President Donald Trump&#8217;s second Presidential term in Washington, U.S., Jan. 20, 2025.  Evelyn Hockstein &#124; Reuters Executives at Meta stand to get bigger bonuses this year.  The company said in a corporate filing Thursday that it had approved &#8220;an increase [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/meta-approves-plan-for-bigger-executives-bonuses-following-5-layoffs/">Meta approves plan for bigger executives bonuses following 5% layoffs</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>Meta CEO Mark Zuckerberg looks on before the luncheon on the inauguration day of U.S. President Donald Trump&#8217;s second Presidential term in Washington, U.S., Jan. 20, 2025. </p>
<p>Evelyn Hockstein | Reuters</p>
<p>Executives at <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Meta<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span> stand to get bigger bonuses this year. </p>
<p>The company said in a corporate filing Thursday that it had approved &#8220;an increase in the target bonus percentage&#8221; for its annual bonus plan for executives. Meta&#8217;s named executive officers could earn a bonus of 200% of their base salary under the new plan, up from the 75% they earned previously, according to the filing. </p>
<p>The updated bonus plan doesn&#8217;t apply to Meta CEO Mark Zuckerberg, the filing noted.</p>
<p>A committee for Meta&#8217;s board of directors approved the change after determining that the &#8220;target total cash compensation&#8221; for its executives &#8220;was at or below the 15th percentile of the target total cash compensation of executives holding similar positions&#8221; at peer companies. </p>
<p>&#8220;Following this increase, the target total cash compensation for the named executive officers (other than the CEO) falls at approximately the 50th percentile of the Peer Group Target Cash Compensation,&#8221; the filing said.</p>
<p>The approval of the new executive bonus plan comes a week after Meta began laying off 5% of its overall workforce. The company had previously said this would impact its lowest performers.</p>
<p>Meta also slashed its annual distribution of stock options by about 10% for thousands of employees, according to a report published Thursday by the Financial Times. The report noted that the stock-option reduction may differ based on where the workers live and their position at the company.</p>
<p>Meta shares are up over 47% over the past year and closed Thursday at $694.84, underscoring  investor enthusiasm over the social media company&#8217;s growing sales in the digital advertising market and the potential for its AI investments to eventually generate big returns.</p>
<p>The company said in January that its fourth-quarter revenue grew 21% year over year to $48.39 billion.</p>
<p>Meta did not reply to a request for comment.</p>
<p><strong>Watch</strong>: What&#8217;s driving Meta&#8217;s stock run</p>
<p><span class="InlineVideo-videoButton"/><span/></p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/meta-approves-plan-for-bigger-executives-bonuses-following-5-layoffs/">Meta approves plan for bigger executives bonuses following 5% layoffs</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves Vertex non-opioid painkiller drug Journavx</title>
		<link>https://www.ourstoryinsight.com/fda-approves-vertex-non-opioid-painkiller-drug-journavx/</link>
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		<pubDate>Fri, 31 Jan 2025 07:56:49 +0000</pubDate>
				<category><![CDATA[Business]]></category>
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		<category><![CDATA[Vertex]]></category>
		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=5018</guid>

					<description><![CDATA[<p>A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston. Brian Snyder &#124; Reuters The Food and Drug Administration on Thursday approved Vertex Pharmaceuticals&#8217; non-opioid painkiller pill, a new alternative for pain relief that comes without the risk of addiction.  Vertex is now the first drugmaker in decades to gain U.S. [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-vertex-non-opioid-painkiller-drug-journavx/">FDA approves Vertex non-opioid painkiller drug Journavx</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>A sign hangs in front of the world headquarters of Vertex Pharmaceuticals in Boston.</p>
<p>Brian Snyder | Reuters</p>
<p>The Food and Drug Administration on Thursday approved Vertex Pharmaceuticals&#8217; non-opioid painkiller pill, a new alternative for pain relief that comes without the risk of addiction. </p>
<p>Vertex is now the first drugmaker in decades to gain U.S. approval for a new type of pain medicine. It&#8217;s a milestone after a long history of mostly unsuccessful efforts to develop painkillers without the destructive dependency of cheap and widely available opioids, which have caused a horrific epidemic of abuse and overdose in the U.S.</p>
<p>Vertex&#8217;s drug, Journavx, is specifically approved for the treatment of moderate-to-severe acute pain, which is usually caused by injury, surgery, illness, trauma or painful medical procedures and likely eases with time. Around 80 million patients are prescribed a medicine for their moderate-to-severe acute pain every year in the U.S., according to Vertex. </p>
<p>Almost 10% of patients with acute pain who are treated initially with an opioid will go on to have prolonged opioid use, and roughly 85,000 people will develop opioid use disorder annually, Vertex said in a statement.</p>
<p>&#8220;We have the opportunity to change the paradigm of acute pain management and establish a new standard of care,&#8221; Dr. Reshma Kewalramani, Vertex CEO, said in a statement.</p>
<p>Vertex said Journavx will have a list price of $15.50 per 50-milligram pill. Wall Street analysts have said that the medication could become a blockbuster drug if it wins approval from regulators, estimating its annual sales could exceed $1 billion. </p>
<p>The experience of pain starts in a nerve ending, and the body detects the pressure and sends a signal to the spinal cord and then the brain. Vertex&#8217;s treatment works by blocking pain signals at their origin before they reach the brain. That&#8217;s different from opioids, which act directly on the brain to block pain, triggering the brain&#8217;s rewards centers in a way that can feed addiction.</p>
<p>The approval underscores the &#8220;FDA&#8217;s commitment to approving safe and effective alternatives to opioids for pain management,&#8221; said Dr. Jacqueline Corrigan-Curay, acting director of the FDA&#8217;s Center for Drug Evaluation and Research, in a release.</p>
<p>Vertex&#8217;s painkiller was more effective than placebo at reducing the intensity of pain after 48 hours in two late-stage studies on more than 1,000 patients who had abdominoplasties, also known as &#8220;tummy tucks,&#8221; and roughly another thousand in people who had bunion surgery. Those two procedures are commonly used in studies of people with acute pain.</p>
<p>The painkiller, however, failed to meet the secondary goal in both trials of reducing pain when compared to a combination of the opioid drug hydrocodone, which is frequently abused, and acetaminophen, the basis for popular pain medications such as Tylenol.</p>
<p>In both trials, rates of adverse side effects were lower in those who received Vertex&#8217;s drug compared to people who took a placebo. The most commonly reported adverse events among people who received Journavx were itching, muscle spasms and rash, among others, according to the FDA.</p>
<p>In a separate phase three study, more than 83% of patients said in a survey that the drug was good, very good or excellent at easing pain. Those people had undergone various surgical or non-surgical procedures.</p>
<p>The bigger opportunity for Vertex may be to win FDA approval in chronic pain. That&#8217;s an area where the risk of addiction to prescription opioids can be greater, according to the Centers for Disease Control and Prevention. </p>
<p>In 2023, the company&#8217;s painkiller produced positive results in a mid-stage trial in diabetes patients suffering from a chronic nerve condition.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-vertex-non-opioid-painkiller-drug-journavx/">FDA approves Vertex non-opioid painkiller drug Journavx</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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		<title>FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</title>
		<link>https://www.ourstoryinsight.com/fda-approves-eli-lillys-weight-loss-drug-zepbound-for-sleep-apnea/</link>
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		<pubDate>Sat, 21 Dec 2024 08:17:31 +0000</pubDate>
				<category><![CDATA[Business]]></category>
		<category><![CDATA[apnea]]></category>
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		<guid isPermaLink="false">https://www.ourstoryinsight.com/?p=4219</guid>

					<description><![CDATA[<p>An Eli Lilly &#038; Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024.  Shelby Knowles &#124; Bloomberg &#124; Getty Images The Food and Drug Administration on Friday approved Eli Lilly&#8216;s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding [&#8230;]</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-eli-lillys-weight-loss-drug-zepbound-for-sleep-apnea/">FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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										<content:encoded><![CDATA[<p><span class="HighlightShare-hidden" style="top:0;left:0"/></p>
<p>An Eli Lilly &#038; Co. Zepbound injection pen arranged in the Brooklyn borough of New York, US, on Thursday, March 28, 2024. </p>
<p>Shelby Knowles | Bloomberg | Getty Images</p>
<p>The Food and Drug Administration on Friday approved <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>&#8216;s blockbuster weight loss drug Zepbound for treating patients with the most common sleep-related breathing disorder, expanding its use and possibly its insurance coverage in the U.S.</p>
<p>The weekly injection is now the first drug treatment option cleared for patients with obesity and moderate-to-severe obstructive sleep apnea, or OSA, which refers to breathing interrupted during sleep due to narrowed or blocked airways. Zepbound should be used in combination with a reduced-calorie diet and increased physical activity, the FDA noted in a release. </p>
<p>An estimated 80 million patients in the U.S. experience the disease, according to Eli Lilly. Roughly 20 million of those people have moderate-to-severe forms of the disease, but 85% of cases go undiagnosed, the company told CNBC earlier this year.</p>
<p>&#8220;Too often, OSA is brushed off as &#8216;just snoring&#8217; — but it&#8217;s far more than that,&#8221; said Julie Flygare, president and CEO of Project Sleep, a nonprofit advocating for sleep health and sleep disorders, in a release from Eli Lilly. &#8220;It&#8217;s important to understand OSA symptoms and know that treatments are available, including new options like Zepbound. We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.&#8221; </p>
<p>Eli Lilly expects to launch the drug for OSA at the beginning of next year. It is the first approval beyond obesity treatment for Zepbound, which entered the market late last year and is also being tested for several other obesity-related conditions, such as fatty liver disease. Tirzepatide, the active ingredient in Zepbound, has been sold on the U.S. market for longer as the diabetes drug Mounjaro.</p>
<p>The agency&#8217;s decision could pave the way for Eli Lilly to gain broader insurance coverage for Zepbound, which, like other weight loss drugs, is not covered by many insurance plans. That includes the federal Medicare program, which only covers obesity drugs if they are approved and prescribed for an added health benefit.</p>
<p>The approval also backs up mounting evidence that there could be further health benefits tied to GLP-1s, a class of weight loss and diabetes treatments that have soared in popularity and slipped into shortages over the past year. Notably, Zepbound&#8217;s main rival, the weight loss drug Wegovy from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-6">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><span class="AddToWatchlistButton-addWatchListFromTag"/></span></span></span>, is not approved for OSA.</p>
<p>Zepbound could be a valuable new treatment option for patients with OSA, which can lead to loud snoring and excessive daytime sleepiness, and can contribute to serious complications including stroke and heart failure. Patients with the condition have limited treatment options outside of wearing masks hooked up to cumbersome machines that provide positive airway pressure, or PAP, to allow for normal breathing.</p>
<p>Eli Lilly in April released initial results from the two clinical trials, which showed that Zepbound was more effective than a placebo at reducing the severity of OSA in patients with obesity after a year.</p>
<p>In June, Eli Lilly released additional data from the studies showing that Zepbound helped<br />resolve OSA in almost half of patients. The first study examined the weekly injection in adults with moderate-to-severe OSA and obesity who were not on PAP therapy. The second tested Zepbound in adults with the same conditions, but those participants were on and planned on continuing PAP therapy.</p>
<p>The data showed that 43% of people in the first study and 51.5% of patients in the second trial who took the highest dose of Zepbound achieved &#8220;disease resolution,&#8221; according to the company. That compares with 14.9% and 13.6% of patients who took a placebo in the two trials, respectively.</p>
<p>Researchers came to those conclusions by examining an apnea-hypopnea index, or AHI, which records the number of times per hour a person&#8217;s breathing shows a restricted or completely blocked airway. The index is used to evaluate the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.</p>
<p>Disease resolution for OSA is defined as a patient having fewer than five AHI events per hour, the company said. It is also defined as a person having five to 14 AHI events per hour and scoring a certain number on a standard survey designed to measure excessive daytime sleepiness, according to Eli Lilly.</p>
<p>The post <a rel="nofollow" href="https://www.ourstoryinsight.com/fda-approves-eli-lillys-weight-loss-drug-zepbound-for-sleep-apnea/">FDA approves Eli Lilly&#8217;s weight loss drug Zepbound for sleep apnea</a> appeared first on <a rel="nofollow" href="https://www.ourstoryinsight.com">Our Story Insight</a>.</p>
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