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	<title>Amgen39s &#8211; USA NEWS LIVE</title>
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	<title>Amgen39s &#8211; USA NEWS LIVE</title>
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		<title>Healthy Returns: Wall Street ponders Amgen&#039;s weight-loss drug data</title>
		<link>https://bloggingthree.soflytech.com/2024/12/healthy-returns-wall-street-ponders-amgens-weight-loss-drug-data/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Fri, 06 Dec 2024 23:27:07 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Amgen39s]]></category>
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		<category><![CDATA[drug]]></category>
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		<category><![CDATA[weightloss]]></category>
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					<description><![CDATA[Wall Street is mulling over critical data released last week Amgen&#39;s experimental weight-loss injection – a possible competitor within the blockbuster obesity drug market. Some analysts said the early results of the trial&#39;s mid-stage appear positive overall. However, they noted that there remain questions on the drug&#39;s effectiveness and patient tolerance. We likely won&#39;t get [&#8230;]]]></description>
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<p>Wall Street is mulling over critical data released last week <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-2">Amgen&#39;<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>s experimental weight-loss injection – a possible competitor within the blockbuster obesity drug market. </p>
<p>Some analysts said the early results of the trial&#39;s mid-stage appear positive overall. However, they noted that there remain questions on the drug&#39;s effectiveness and patient tolerance. </p>
<p>We likely won&#39;t get any further answers until the corporate releases the complete data from the study. These include results from a second a part of the study, which examines how long MariTide&#39;s weight reduction lasts. </p>
<p>Investors were initially not blissful. Shares of Amgen plunged greater than 11% on the market open last Tuesday as results appeared to fall barely in need of Wall Street&#39;s high expectations for the drug.</p>
<p>The MariTide injection helped patients with obesity lose as much as 20% of their weight on average after one 12 months without plateauing. Ahead of the information release, several analysts said they wanted MariTide to indicate a minimum of 20% weight reduction within the Phase 2 trial, with some hoping for as much as 25%. </p>
<p>Here is the comparison with the present injections in the marketplace based on recent studies: </p>
<ul>
<li><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-4">Novo Nordisk<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>&#39;s Wegovy showed that it resulted in 15% weight reduction inside 68 weeks </li>
<li><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-5">Eli Lilly<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>&#39;s Zepbound helped patients lose greater than 22% of their weight inside 72 weeks</li>
</ul>
<p>But in a note last week, Evan Seigerman, an analyst at BMO Capital Markets, said last Tuesday&#39;s stock response reflected &#8220;overly high expectations for percentage weight loss without any emphasis on easier dosing&#8221; of the shot. </p>
<p>Specifically, Amgen is testing MariTide as an injection given once a month and even less often, which can be much more convenient for patients to take long-term than Novo Nordisk and Eli Lilly&#39;s weekly injections. </p>
<p>“MariTide data clearly demonstrates that Amgen is a competitor in the obesity and diabetes indications and is today demonstrating compelling weight loss in both indications,” Seigerman said. </p>
<p>In the study, MariTide also helped patients with obesity and sort 2 diabetes lose as much as 17% of their weight after one 12 months.</p>
<p>The drug&#39;s effectiveness could also improve, Jefferies analyst Michael Yee said in a note last week. The 20% weight reduction after a 12 months with no plateau could increase to 25% by 18 months, Yee said. He found that, compared, Zepbound-induced weight reduction largely stagnated for a 12 months. </p>
<p>The most typical uncomfortable side effects of MariTide were gastrointestinal in nature, including nausea, vomiting, and constipation. Nausea and vomiting were predominantly mild and occurred in association with the primary dose of MariTide. </p>
<p>Amgen said the incidence of nausea and vomiting was also significantly reduced by increasing the dose. This involves starting patients on a lower dose of MariTide and regularly increasing it over a time period until they reach the next goal dose. </p>
<p>Approximately 11% of patients within the dose escalation groups discontinued treatment as a consequence of hostile uncomfortable side effects, while lower than 8% discontinued treatment specifically as a consequence of gastrointestinal uncomfortable side effects reminiscent of nausea and vomiting. </p>
<p>Amgen reported that 70% of patients in dose escalation groups experienced nausea and 40% experienced vomiting. </p>
<p>However, Amgen said it conducted one other early-stage study that found that when patients start MariTide, the starting dose was lower, these rates were significantly reduced, leading to about 50% of patients over Nausea and 20% reported vomiting. </p>
<p>This appears to be higher than the degrees of nausea and vomiting seen with Zepbound and Wegovy. Still, Seigerman said the low severity of those uncomfortable side effects and &#8220;the discrete events early in treatment make us confident that they are manageable.&#8221; </p>
<p>He added that he was “encouraged by the reductions observed with dose increases.” </p>
<p>In a research note last week, JPMorgan analyst Chris Schott said Amgen would examine lower starting doses in its Phase 3 trial of MariTide. The company believes that “further improvement in tolerability in the Ph3 trial will be key to potential acceptance of the compound,” he noted. </p>
<p>David Risinger, an analyst at Leerink Partners, outlined in a note last week key questions that may have to be addressed when the study&#39;s full results are released. He said this includes detailed data on how well patients tolerated the drug when no dose escalation was used, in addition to data on weight reduction in non-diabetic patients who received the very best dose of the drug. </p>
<p>You can send suggestions, suggestions, story ideas and data to Annika at <a href="http://nbcuni.com/?__source=newsletter%7Chealthyreturns" target="_blank">annikakim.constantino@nbcuni.com</a>.</p>
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<h2 class="ArticleBody-subtitle"><a id="headline0"></a>The latest in health tech: GE HealthCare acquires Japanese pharmaceutical company </h2>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-7">GE Healthcare<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>    announced Monday that it&#8217;ll fully acquire Japanese radiopharmaceutical company Nihon Medi-Physics (NMP). GE HealthCare has held a 50% stake in the corporate since 2004 and can acquire the remaining half from Sumitomo Chemical, it said in a press release <a href="https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-to-acquire-remaining-50-stake-in-nihon-medi-physics-nmp-a-leading-radiopharmaceutical-company-in-japan-from-sumitomo-chemical" target="_blank">release</a>.</p>
<p>Tokyo-based NMP was founded in 1973. The company makes radiopharmaceuticals, a special style of radioactive medicine that will be used to treat some sorts of cancer and perform imaging tests. NMP operates 13 manufacturing facilities and conducts its own research and development, GE HealthCare said.</p>
<p>Radiopharmaceuticals have gotten an increasingly competitive market as firms prefer it <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-10">Bristol Myers Squibb<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>, <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-11">AstraZeneca<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>Eli Lilly and <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="SpecialReportArticle-QuoteInBody-12">Novartis<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>    Race to develop them. Two Novartis radiopharmaceuticals, Pluvicto and Lutathera, are already available within the United States</p>
<p>According to the press release, NMP generated sales of roughly $183 million last 12 months. Prior to Monday&#39;s announcement, GE HealthCare held three seats on NMP&#39;s board.  </p>
<p>“This will strengthen our precision care strategy in Asia and our existing presence in Japan, where our contrast agents and medical devices are used daily to enable imaging procedures across the country,” said Kevin O&#39;Neill, president and CEO of GE&#39;s Pharmaceutical Diagnostics segment HealthCare, the press release says.</p>
<p>Terms of the deal weren&#8217;t disclosed and shutting is anticipated to shut early next 12 months, in line with the press release. The takeover remains to be subject to official approval. </p>
<p>Solomon Partners advised GE HealthCare on the transaction. </p>
<p>GE HealthCare announced the acquisition in the course of the Radiological Society of North America&#39;s 2024 Annual Meeting in Chicago, where it shared various additional updates. This week the corporate introduced a brand new one <a href="https://www.gehealthcare.com/insights/article/ge-healthcare-unveils-research-on-advanced-3d-mri-foundation-model" target="_blank">3D MRI </a>Research foundation model, a <a href="https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-showcases-aurora-a-new-dual-head-spectct-and-clarify-dl-at-rsna24" target="_blank">recent SPECT/CT</a> solution and a <a href="https://www.gehealthcare.com/about/newsroom/press-releases/ge-healthcare-announces-510k-submission-for-clearecon-dl-technology-designed-to-improve-image-quality-in-the-interventional-suite-with-ai-based-reconstruction" target="_blank">recent template</a> including the US Food and Drug Administration.</p>
<p>Read the complete press release about GE HealthCare&#39;s acquisition of NMP <a href="https://www.gehealthcare.com/" target="_blank">Here</a>.</p>
<p>Feel free to send suggestions, suggestions, story ideas and data to Ashley at ashley.caroot@nbcuni.com.</p>
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<p><em>image credit : www.cnbc.com</em></p>
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		<title>The FDA approves Amgen&#039;s treatment for the deadliest type of lung cancer</title>
		<link>https://bloggingthree.soflytech.com/2024/05/the-fda-approves-amgens-treatment-for-the-deadliest-type-of-lung-cancer/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Fri, 17 May 2024 08:14:42 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Amgen39s]]></category>
		<category><![CDATA[approves]]></category>
		<category><![CDATA[cancer]]></category>
		<category><![CDATA[deadliest]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=3703</guid>

					<description><![CDATA[The Food and Drug Administration approved on Thursday Amgen&#39;s therapy for patients with the deadliest type of Lung cancer. The agency has approved the drug to be marketed under that name Imdelltraas a second or later line of treatment for individuals with advanced small cell lung cancer. This means patients can take the drug if [&#8230;]]]></description>
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<p>The <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761344s000lbl.pdf" target="_blank" rel="noopener">Food and Drug Administration</a> approved on Thursday <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">Amgen<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"></span></button></span></span></span>&#39;s therapy for patients with the deadliest type of <a href="https://www.amgen.com/newsroom/press-releases/2023/10/amgen-presents-new-tarlatamab-data-in-small-cell-lung-cancer" target="_blank" rel="noopener">Lung cancer</a>. </p>
<p>The agency has approved the drug to be marketed under that name<a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener"> Imdelltra</a>as a second or later line of treatment for individuals with <a href="https://www.cancer.gov/news-events/cancer-currents-blog/2023/tarlatamab-previously-treated-sclc" target="_blank" rel="noopener">advanced small cell lung cancer</a>.  This means patients can take the drug if their cancer progresses during or after one other type of treatment, which is often chemotherapy.  Amgen&#39;s drug can be known by the generic name tarlatamab.</p>
<p>Amgen&#39;s drug has been shown to work in clinical trials <a href="https://www.esmo.org/oncology-news/tarlatamab-shows-promise-in-patients-with-previously-treated-small-cell-lung-cancer" target="_blank" rel="noopener">reduce tumor growth</a> and help individuals with small cell lung cancer live significantly longer.</p>
<p>Of the greater than 2.2 million patients diagnosed with lung cancer every year worldwide, small cell lung cancer accounts for 15%, or 330,000 of those cases, Amgen said.  About 80% to 85% of individuals with <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9330463/#B3" target="_blank" rel="noopener">small cell lung cancer</a><strong> </strong>They are diagnosed with advanced stages of the disease, based on a study published within the Journal of Cancer.</p>
<p>There are roughly 35,000 patients with small cell lung cancer within the United States, said Dr.  Jay Bradner, chief scientific officer of Amgen, told CNBC. </p>
<p>Small cell lung cancer normally begins within the airways of the lungs and <a href="https://medlineplus.gov/ency/article/000122.htm" target="_blank" rel="noopener">grows quickly</a>, causing large tumors to form and spread throughout the body.  Symptoms include bloody mucus, cough, chest pain and shortness of breath.</p>
<p>Only <a href="https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html" target="_blank" rel="noopener">3% of patients</a> According to the American Cancer Society, individuals with small cell lung cancer that has spread to other parts of the body live longer than 5 years.  This five-year survival rate is 7% of all patients with this disease, no matter whether the cancer spreads.  Bradner said patients with small cell lung cancer typically have 4 to 5 months to live.</p>
<p>An exception is Lynne Bell, a small cell lung cancer patient from Atlanta, Georgia.  She says she was &#8220;horrified&#8221; and &#8220;in a dark place&#8221; after being diagnosed with a complicated stage of the disease in 2021.</p>
<p>But she began taking Amgens <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a> in an ongoing clinical trial in September after other treatments, including chemotherapy, stopped working.  Since then, Bell said her tumors have shrunk significantly and the cancer scans &#8220;look great.&#8221;  She said she particularly noticed that her pain subsided after taking a second dose of Amgen&#39;s drug.</p>
<p>When asked how long she would proceed <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a>Bell said: “If this medication works and I don’t have any side effects, I’m good to go.  I’m in it to win.”</p>
<p>Maida Mangiameli, a small cell lung cancer <a href="https://podcasts.apple.com/us/podcast/caregiver-lifehacks-there-is-hope-episode-one/id1482032829?i=1000648029253" target="_blank" rel="noopener">advocate</a> and patient mentor from Naperville, Illinois, can be a survivor of the devastating disease.  She was diagnosed with advanced stages of the disease in 2018, but was found to be in remission this 12 months, meaning the treatment she received has reduced the signs and symptoms of the cancer. </p>
<p>Mangiameli has been in remission for five years.  Her treatments included chemotherapy and 28 days of radiation therapy.  She told CNBC that Amgen <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a> could also be “not for me, but it could happen in the future.” </p>
<p>Mangiameli added that she is pleased that there shall be one other treatment option for other patients with small cell lung cancer.  She said the event of recent treatments for the disease has been “on hold” for several years. </p>
<p>Amgen&#39;s Bradner also said treatment options are &#8220;pretty slim.&#8221; </p>
<p>“It&#39;s just one of the most terrible cancers and that&#39;s why we needed a new solution,” he said. </p>
</div>
<div class="group">
<p>Amgen&#39;s drug is named a bispecific T-cell engager, which is designed to redirect the immune system&#39;s T cells to acknowledge and kill cancer cells. </p>
<p>The approval relies on results of a <a href="https://www.esmo.org/oncology-news/tarlatamab-shows-promise-in-patients-with-previously-treated-small-cell-lung-cancer" target="_blank" rel="noopener">Phase 2 study</a> who followed greater than 200 patients with small cell lung cancer. <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Cancer tumors shrank</a> in 40% of individuals given a 10-milligram dose of Imdelltra every two weeks.</p>
<p>Notably, the median time people lived after starting the 10-milligram dose of Amgen&#39;s drug was 14.3 months.  This is comparable to about <a href="https://www.cancer.gov/news-events/cancer-currents-blog/2023/tarlatamab-previously-treated-sclc#:~:text=The%2040%%20response%20rate%20(tumor%20shrinkage)%20seen,Paz%2DAres%20and%20his%20colleagues%20wrote%20in%20NEJM." target="_blank" rel="noopener">six to 12 months</a> with current treatments, based on the National Cancer Institute. </p>
<p>“These patients who would normally only have four to five months are enjoying almost another full year of life,” Bradner told CNBC. </p>
<p>This time could make a giant difference for patients. </p>
<p>Treatment for her small cell lung cancer gave Mangiameli years to spend along with her grandchild, who was born shortly before she was diagnosed with the disease. </p>
<p>“I had the push, the drive to make sure I survived.  … I just had my first grandchild, I have to live long enough for us to be friends,” Mangiameli said. </p>
<p>Meanwhile, Bell said taking it <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a> gave her the time to travel;  She took a visit to San Diego along with her daughter.</p>
<p>“I try to go to as many places as possible,” Bell told CNBC.</p>
<p>Amgen continues to review <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a> in several studies, including some testing the drug as an earlier line of treatment for small cell lung cancer. </p>
<p>This includes one<a href="https://classic.clinicaltrials.gov/ct2/show/NCT05740566" target="_blank" rel="noopener"> Late stage process </a>compare <a href="https://www.amgen.com/newsroom/press-releases/2023/12/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer" target="_blank" rel="noopener">Imdelltra</a> with chemotherapy as second-line treatment for the disease.  Amgen also plans to launch one other one <a href="https://classic.clinicaltrials.gov/ct2/show/NCT06211036" target="_blank" rel="noopener">Third phase study</a> concerning the drug as a first-line treatment for patients with advanced stages of small cell lung cancer. </p>
<p>“What gives us confidence in developing cancer drugs is that if they work in later stages of the disease, they can work even better when moved to first-line therapy,” Bradner said.</p>
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