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	<title>Moderna &#8211; USA NEWS LIVE</title>
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	<description>All About USA NEWS</description>
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		<title>Moderna beats income, but loses greater than expected when it scales the production</title>
		<link>https://bloggingthree.soflytech.com/2025/02/moderna-beats-income-but-loses-greater-than-expected-when-it-scales-the-production/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Sat, 15 Feb 2025 03:52:18 +0000</pubDate>
				<category><![CDATA[Health]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=24594</guid>

					<description><![CDATA[Moderna published on Friday Income within the fourth quarter However, these estimates have lost greater than expected for the period, because the biotech company further reduce the prices and the demand for its covid vaccines. It is one other quarter of growing pain for the corporate, which is for the introduction of recent products and [&#8230;]]]></description>
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<p>Moderna published on Friday <a href="https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" target="_blank">Income within the fourth quarter</a> However, these estimates have lost greater than expected for the period, because the biotech company further reduce the prices and the demand for its covid vaccines. </p>
<p>It is one other quarter of growing pain for the corporate, which is for the introduction of recent products and the recovery of the rapid decline of his once fighting covid business. </p>
<p>Moderna&#39;s shares rose by greater than 3%on Friday. </p>
<p>Moderna recorded a net lack of $ 1.12 billion or $ 2.91 per share for the fourth quarter of 2024. This corresponds to the web results of $ 217 million or 55 cents per share, which was reported for the period from the previous yr.</p>
<p>The company said that the quarterly loss comprises a not quite a few fee of around $ 238 million in reference to the termination of a contract manufacturing contract.</p>
<p>In an interview, the CFO of Moderna, Jamey Mock, said that one of the crucial necessary findings from the outcomes of your complete yr 2024 reduced costs in comparison with 2023 by 27%. By the top of 2025, Moderna expects to scale back the associated fee of 1 USD billions in comparison with 2024.</p>
<p>Moderna confirmed its product sales instructions for the yr 2025 from $ 1.5 to 2.5 billion, most of which is able to happen within the second half of the yr. Moderna expects that in the primary half of the yr attributable to the seasonal demand for respiratory products, which often rise in autumn and winter, only $ 200 million got here for sales of only 200 million dollars. </p>
<p>The company reduced its sales instructions from 2025 in January by around 1 billion US dollars, which reduces its shares. The share has now declined by greater than 20% for the yr. </p>
<p>At that point, Moderna identified increased competition on the Covid market, the vaccination rates, the time of production contracts with a handful of nations and the uncertainty about what the consultants for the control and prevention of diseases for the resumption of syncytial virus &#8211; Shots of the respiratory tract would recommend. </p>
<p>&#8220;If these potential headwinds all hit, this would bring us to the bottom of our instructions,&#8221; Mock told CNBC and added that the corporate hopes to &#8220;combat&#8221; the challenges.</p>
<p>Moderna reported for the fourth quarter that ended on December thirty first<strong> </strong>Compared to the expectations of Wall Street, LSEG is predicated on a survey of LSEG analysts:</p>
<ul>
<li><strong>Loss per share:</strong> USD 2.91 in comparison with an expected lack of $ 2.68</li>
<li><strong>Revenue:</strong> 966 million US dollars are expected in comparison with USD 942.8 million</li>
</ul>
<p>Moderna generated sales with $ 966 million within the fourth quarter, lower than half of the $ 2.8 billion, which it recorded in the identical period a yr ago. </p>
<p>The overwhelming majority of this total amount got here from the Covid shot, which declined 923 million US dollars, which corresponds to a decline of 66% in comparison with the previous yr. This includes sales of US $ 244 million and $ 679 million from international markets. </p>
<p>According to StreetCcount estimates, the analysts had expected sales of 909 million US dollars for the quarter. </p>
<p>Moderna said that the decline was mainly attributable to the sooner introduction of the most recent iteration of his Covid shot last yr, which shifted sales into the third quarter. The US Food and Drug Administration approved the brand new vaccine three weeks sooner than in 2023, so Moderna &#8220;&#8221; encountering demand before the fourth quarter, &#8220;added the corporate. </p>
<p>The sales of Covid vaccines fell back internationally, since in response to Moderna, the corporate continued to perform pre -purchase agreements with certain countries. </p>
<p>The sales with the fourth quarter of the corporate also included $ 15 million for the turnover of its RSV shot in US dollars, which entered seniors in the autumn and winter after winning the approval in May. It is the second approved Moderna product in response to its Covid vaccine. </p>
<p>According to StreetCcount estimates, analysts had expected sales of $ 13 million for the RSV vaccine. Modernas RSV shot is approved within the United States, the USA, the European Union, in Canada, Norway, Iceland and within the Qatar as much as the age of 60. </p>
<p>The company uses a pipeline that&#8217;s positioned around its Messenger RNA platform, namely the technology utilized in each products. Moderna plans to enhance its portfolio with 10 recent product permits over the subsequent three years. </p>
<p>In the fourth quarter, Moderna submitted three MRNA products for regulatory approval, including the subsequent generation Covid shot, the mixture of covid and the flu and RSV vaccine for adults aged 18 to 59. Moderna expects a call from the FDA on the subsequent generation of the subsequent generation in May and a possible approval for the RSV shot in June in June.</p>
<p>Moderna also develops an independent flu vaccination, a customized cancer vaccine with Merck and recordings for latent viruses. Some of those products will start data Lehouts later this yr, says Mock.</p>
<p>The sales costs for the fourth quarter were $ 739 million, which decreased from 20% in comparison with the identical period within the previous yr. Among other things, this includes $ 193 million in spelling of unused doses of the Covid vaccine. </p>
<p>The research and development costs decreased by 20% to 1.1 billion US dollars in comparison with the identical period from 2023. Moderna said that the decline is primarily attributable to lower clinical development and manufacturing costs for the COVID, RSV, flu and combination programs and was partly compensated for by increased expenses on other recent experimental products. </p>
<p>In the meantime, sales, general and administrative costs for the period decreased by 25% to USD 351 million in comparison with the fourth quarter of 2023. SG &#038; A expenditure often includes the prices for the promotion, sale and provision of an organization&#39;s services.</p>
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<p><em>image credit : www.cnbc.com</em></p>
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		<title>Moderna shares plunge nearly 17% after the corporate cut its 2025 revenue forecast by $1 billion</title>
		<link>https://bloggingthree.soflytech.com/2025/01/moderna-shares-plunge-nearly-17-after-the-corporate-cut-its-2025-revenue-forecast-by-1-billion/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Tue, 14 Jan 2025 01:53:23 +0000</pubDate>
				<category><![CDATA[Health]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=22634</guid>

					<description><![CDATA[Modern on Monday lowered its 2025 revenue forecast by about $1 billion on account of some potential headwinds later this 12 months because the biotech company continues to chop costs and expand its portfolio. Moderna now expects sales of between $1.5 billion and $2.5 billion for 2025, most of which is able to occur within [&#8230;]]]></description>
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<div id="RegularArticle-ArticleBody-5" data-module="ArticleBody" data-test="articleBody-2" data-analytics="RegularArticle-articleBody-5-2"><span class="HighlightShare-hidden" style="top:0;left:0"></span></p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    on Monday lowered its 2025 revenue forecast by about $1 billion on account of some potential headwinds later this 12 months because the biotech company continues to chop costs and expand its portfolio.</p>
<p>Moderna now expects sales of between $1.5 billion and $2.5 billion for 2025, most of which is able to occur within the second half of the 12 months. The majority of those sales will come from Moderna&#39;s Covid vaccination and newly launched respiratory syncytial virus vaccine, in response to a press release.</p>
<p>The forecast is below the $2.5 billion to $3.5 billion forecast previously made in September. At the time, the corporate said it expected to interrupt even on an operating money basis in 2028 &#8211; up from 2026 &#8211; with revenue of $6 billion.</p>
<p>Shares of Moderna closed nearly 17% lower on Monday. Other vaccine stocks also fell, with Novavax and BioNTech each closing greater than 7% lower.</p>
<p>“As we head into 2025, there are a handful of uncertainties that we must expect,” Moderna CFO Jamey Mock told CNBC. “From this period onwards we expect that there will be headwinds. It could be a tailwind, but at the moment we see it as a headwind.” </p>
<p>Mock pointed to 4 aspects that would weigh on sales, including increasing competition within the Covid market. He said Moderna&#39;s share of the U.S. retail marketplace for Covid vaccinations fell to 40% at the tip of 2024 from 48% in 2023 and the corporate was preparing for an additional decline this 12 months. </p>
<p>He noted <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-4">Sanofi<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>    is commercialized together <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-5">Novavax<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>Under a brand new agreement, it should be possible to market the Covid vaccine worldwide, which could potentially make this vaccine more competitive. </p>
<p>Mock said the second factor was declining vaccination rates, which fell about 7% overall within the U.S. retail market in fall 2024 in comparison with the identical point in 2023. The final two aspects, he said, are the timing of producing contracts with a handful of nations and uncertainty about what Centers for Disease Control and Prevention advisers will recommend for an RSV revaccination. </p>
<p>However, Mock noted that the corporate expects to cut back money costs by $1 billion in 2025, with one other $500 million in cost reductions planned for 2026. </p>
<p>“We are taking the right amount of costs to preserve our liquidity,” Mock said. “We are excited to invest in and diversify our portfolio.” </p>
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<p>The announcement comes as Moderna charts a path forward following a rapid decline in demand for its Covid vaccine, the one commercially available product until the RSV shot got here onto the market last 12 months. It also comes ahead of Moderna&#39;s presentation on the annual meeting <a href="https://www.jpmorgan.com/about-us/events-conferences/health-care-conference" target="_blank">JPMorgan Healthcare Conference</a>one among the most important gatherings of healthcare executives on this planet and a hotbed of business deals within the industry. </p>
<p>Revenue from Moderna&#39;s two shots was in step with its 2024 forecast and got here in at about $3 billion to $3.1 billion. In November, the corporate said its updated Covid shot had benefited from being approved within the US three weeks sooner than the previous version of the shot in 2023. </p>
<p>Still, those sales represent a big decline from the $6.7 billion that Moderna&#39;s Covid shot brought in in 2023 and the $18 billion it brought in in 2022, as fewer people up the sleeves rolled as much as receive updated vaccinations. </p>
<p>Moderna plans to expand its portfolio with ten recent product approvals over the following three years, including a mix vaccination against Covid and the flu and a “next generation” Covid vaccination. The company said Monday that it could receive three approvals in 2025 alone. </p>
<p>The company is betting on a pipeline based on its messenger RNA platform, the technology utilized in its Covid vaccine and RSV shot.</p>
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<p><em>image credit : www.cnbc.com</em></p>
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		<title>Moderna posts surprise profit as Covid vaccine sales are impressive and price cuts take hold</title>
		<link>https://bloggingthree.soflytech.com/2024/11/moderna-posts-surprise-profit-as-covid-vaccine-sales-are-impressive-and-price-cuts-take-hold/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Sat, 09 Nov 2024 21:46:17 +0000</pubDate>
				<category><![CDATA[Health]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=18854</guid>

					<description><![CDATA[Modern reported a surprise third-quarter profit on Thursday, beating Wall Street estimates, as its cost-cutting efforts took effect and sales of its Covid vaccine got here in higher than expected. The biotech company reported net income of $13 million, or 3 cents per share. That compares with a net lack of $3.63 billion, or 9.53 [&#8230;]]]></description>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    reported a surprise third-quarter profit on Thursday, beating Wall Street estimates, as its cost-cutting efforts took effect and sales of its Covid vaccine got here in higher than expected. </p>
<p>The biotech company reported net income of $13 million, or 3 cents per share. That compares with a net lack of $3.63 billion, or 9.53 cents per share, reported within the year-earlier period.</p>
<p>Moderna shares were flat on Thursday.</p>
<p>Moderna is dramatically cutting expenses and recently announced a goal of $1.1 billion in savings by 2027 because it tries to get better from the rapid decline of its Covid business. It&#39;s the primary quarter that features sales of Moderna&#39;s respiratory syncytial virus (RSV) vaccine, its second ever commercially available product. </p>
<p>Before the top of the yr, the corporate plans to use for approval of its experimental Covid vaccine and the “next generation” combination vaccination against Covid and the flu. Moderna also expects to use for expanded approval of its RSV vaccine this yr, aimed toward high-risk adults ages 18 to 59. </p>
<p>Moderna said on Thursday that its latest Covid vaccine had advantages after it received approval within the US three weeks sooner than the last iteration of the vaccine in 2023, allowing the biotech company to “meet demand more effectively “. The company was able to ship doses to pharmacies and healthcare providers and reach more patients&#39; arms sooner. </p>
<p>“I think the earlier start and a steeper ramp led to much higher sales of the Covid vaccine,” Moderna CEO Stéphane Bancel said in an interview. In the primary week of the vaccine rollout, the corporate shipped twice as many products worldwide because it did in 2023, Bancel noted. </p>
<p>He added: &#8220;This has been a quarter of major cost cutting and we will continue to do so.&#8221; </p>
<p>Here&#39;s something <a href="https://investors.modernatx.com/news/news-details/2024/Moderna-Reports-Third-Quarter-2024-Financial-Results-and-Provides-Business-Updates/default.aspx" target="_blank" rel="noopener">Moderna reported for the third quarter</a> in comparison with Wall Street expectations based on an analyst survey by LSEG:</p>
<ul>
<li><strong>Earnings per share:</strong> 3 cents versus an expected lack of $1.90</li>
<li><strong>Revenue:</strong> $1.86 billion versus expected $1.25 billion</li>
</ul>
<p>Moderna posted third-quarter sales of $1.86 billion, only barely higher than its $1.83 billion in the identical period last yr. The overwhelming majority of that total got here from Covid vaccinations, including $1.2 billion in U.S. sales and about $600 million in international markets. </p>
<p>The company&#39;s third-quarter sales also included $10 million in U.S. sales of its RSV shot, which received approval in May. Moderna said sales of that vaccine were lower than expected since it was not approved and really useful by regulators until later within the contracting season, when many vaccine distributors had already accomplished their orders. </p>
<p>Analysts had expected sales of $132 million for the RSV vaccine, in accordance with StreetAccount estimates. Moderna&#39;s RSV shot is to date approved within the United States, the European Union, Norway, Iceland and Qatar. </p>
<p>The company reiterated its full-year 2024 product sales guidance of roughly $3 billion to $3.5 billion. In probably the most recent quarter, Moderna lowered its guidance as a consequence of lower expected sales in Europe, a &#8220;competitive environment&#8221; for respiratory vaccines within the U.S. and the potential for deferred international revenue into 2025. </p>
<p>Moderna shares have fallen nearly 50% this yr as investors ponder the trail ahead post-Covid. The company is betting on a pipeline based on its messenger RNA platform, the technology utilized in its Covid vaccine and RSV shot. </p>
<p>The biotech company currently has 45 products in development and expects to bring ten of them to market in the subsequent three years. </p>
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<p>Moderna is developing, amongst other things, an independent flu vaccination, a personalised cancer vaccine with Merck and vaccinations against latent viruses.</p>
<p>Third-quarter cost of sales was $514 million, down 77% from the identical period last yr. This includes, amongst other things, write-downs on unused doses of the Covid vaccine of $214 million and charges of $27 million related to the corporate&#39;s efforts to downsize its production site. </p>
<p>Research and development costs fell 2% to $1.1 billion in comparison with the identical period in 2023. Moderna said the decline was primarily as a consequence of lower clinical development and manufacturing spending, citing lower clinical trial spending, amongst other aspects.</p>
<p>Meanwhile, selling, general and administrative expenses fell 36% to $281 million within the period in comparison with the third quarter of 2023. SG&#038;A expenses typically include the prices of promoting, selling, and providing an organization&#39;s services and products.</p>
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		<title>Moderna shares plunge on plans to chop costs by $1.1 billion and launch 10 latest products by 2027</title>
		<link>https://bloggingthree.soflytech.com/2024/09/moderna-shares-plunge-on-plans-to-chop-costs-by-1-1-billion-and-launch-10-latest-products-by-2027/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Thu, 12 Sep 2024 17:01:22 +0000</pubDate>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=14568</guid>

					<description><![CDATA[Modern announced on Thursday that the corporate plans to chop spending by about $1.1 billion by 2027 and seek approvals for several latest products because it seeks to forge a path forward after the rapid decline of its Covid business. The biotechnology company says it expects to have ten latest products approved by 2027. However, [&#8230;]]]></description>
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<div id="RegularArticle-ArticleBody-5" data-module="ArticleBody" data-test="articleBody-2" data-analytics="RegularArticle-articleBody-5-2"><span class="HighlightShare-hidden" style="top:0;left:0"></span></p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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 on Thursday that the corporate plans to chop spending by about $1.1 billion by 2027 and seek approvals for several latest products because it seeks to forge a path forward after the rapid decline of its Covid business. </p>
<p>The biotechnology company says it expects to have ten latest products approved by 2027. However, Moderna announced that it could pause work on some products in its pipeline and abandon others with a view to &#8220;maintain the necessary pace&#8221; of spending on latest research and development. </p>
<p>The company intends to cut back its research and development spending from an expected $4.8 billion at year-end to $3.6 billion to $3.8 billion in 2027, in line with a press release.</p>
<p>&#8220;You&#39;re going to see things taper off because there are some trials that we&#39;re basically shutting down and not going to start again,&#8221; Moderna CEO Stephane Bancel told CNBC, adding that the corporate is putting its latent product portfolio &#8220;on hold,&#8221; a category of viruses that linger in patients&#39; bodies for prolonged periods of time without causing symptoms but can reactivate later in life and cause serious health complications. </p>
<p>Still, Moderna shares fell greater than 15% on Thursday.</p>
<p>Mani Foroohar, an analyst at Leerink Partners, wrote in an email Thursday that the corporate&#39;s updates &#8220;eradicate key elements of the optimistic outlook&#8221; for the stock and &#8220;reflect a deteriorating financial position.&#8221;</p>
<p>&#8220;The research and development cuts are too far in the future to be credible from a management team that, in our view, has repeatedly demonstrated its inability to predict the trajectory of its business,&#8221; Foroohar said.</p>
<p>In a research note Thursday, Jefferies analyst Michael Yee said the majority of the price savings won&#8217;t be achieved until 2027, which &#8220;now delays profitability until 2028.&#8221;</p>
<p>Moderna plans to interrupt even on a money operating cost basis with revenue of $6 billion in 2028. The company had previously stated that it expected to interrupt even and return to growth in 2026. </p>
<p>The company expects sales of $2.5 billion to $3.5 billion in 2025. From 2026 to 2028, Moderna expects a compound annual growth rate of over 25% as latest products are launched. </p>
<p>While Moderna expects some product approvals in 2025, the corporate doesn&#8217;t expect &#8220;significant revenue contributions until the following year,&#8221; Moderna CFO Jamey Mock told investors in the course of the event.</p>
<p>Also on Thursday, Moderna announced positive late-stage testing results for its respiratory syncytial virus vaccine in high-risk patients.<strong> </strong>Adults aged 18 to 59, with an application for approval for this age group expected this yr. Positive data was also announced on an experimental stand-alone flu vaccine for adults aged 65 and over. </p>
<p>The company announced the news on Thursday at its annual Research and Development Day investor event in New York, which is able to cover its product pipeline and long-term business updates. This comes about 4 months after U.S. regulators approved Moderna&#39;s RSV vaccine for seniors, its second commercially available product after the Covid vaccine. </p>
<p>The company said it now has five respiratory vaccines with positive phase three results and expects to submit three of those vaccines for approval later this yr. These include Moderna&#39;s combination Covid and flu vaccine, for which the corporate plans to hunt approval within the US this yr, and a brand new and simpler version of its Covid vaccine. </p>
<p>Moderna also has five non-respiratory products to treat cancer, latent viruses and rare diseases that might be approved by 2027, the corporate&#39;s press release said. </p>
<p>The company expects sales of $2.5 billion to $3.5 billion in 2025. From 2026 to 2028, Moderna expects a compound annual growth rate of over 25% as latest products are launched. </p>
<p>&#8220;This is truly a remarkable achievement that the team has accomplished. We now have many effective drugs, which is why we have to be cautious in our investments in research and development,&#8221; he told CNBC. </p>
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<h2 class="ArticleBody-subtitle"><a id="headline0"></a>What does Moderna have in store?</h2>
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<p>Moderna presented latest data on its RSV vaccine mRESVIA, which is approved within the United States and European Union for adults ages 60 and older. </p>
<p>The company said the vaccine met all key efficacy goals in an ongoing Phase 3 trial in adults ages 18 to 59 who&#8217;re at increased risk of becoming severely sick from the virus. No safety concerns were observed, Moderna added.</p>
<p>There are currently no approved RSV vaccines worldwide for younger, vulnerable adults, resembling those with weakened immune systems or chronic diseases resembling asthma and diabetes. Moderna’s major competitors within the RSV field, <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-5">Pfizer<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>    And <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-6">GSK<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>are also in search of expanded approval for this age group. </p>
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<p>Bancel said the corporate plans to make use of a “Priority Review Voucher” when applying for approval for people ages 18 to 59, which might shorten the time it takes for the Food and Drug Administration to review the product to <a href="https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review" target="_blank" rel="noopener">six months as a substitute of 10 months</a>Moderna hopes that the agency will approve mRESVIA for this age group in time for the 2025 RSV season. </p>
<p>&#8220;Millions of people could benefit from this. &#8230; We are also doing this to be competitive in the market because as a large pharmacy you want the product to be available to all customers who come to one of the pharmacies,&#8221; Bancel said. </p>
<p>However, on account of “new clinical data,” the corporate can be stopping development of its RSV vaccine for infants under two years of age. </p>
<p>Moderna said its experimental stand-alone flu vaccine, mRNA-1010, produced a stronger immune response against the virus than an existing flu shot in a recent Phase 3 trial. The shot also demonstrated &#8220;consistently acceptable safety and tolerability&#8221; in three late-stage studies, the corporate added.</p>
<p>Moderna has since announced that it plans to maneuver its vaccine against norovirus, a highly contagious gastrointestinal virus that causes vomiting and diarrhea, right into a Phase 3 trial &#8220;shortly.&#8221; Bancel expects the corporate could complete the trial inside a yr and, if the outcomes are positive, apply for approval immediately thereafter. </p>
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<p>&#8220;The product could be on the market in two years, which is great because today there are no treatments for norovirus,&#8221; he said. &#8220;Many healthcare workers are infected by their patients.&#8221;</p>
<p>Moderna can be working with <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-8">Merck<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>    to develop a customized cancer vaccine that shall be studied together with Keytruda in patients with different types of the disease. </p>
<p>The firms are testing the vaccine in a Phase 3 trial in patients with fatal skin cancer and are discussing approval with regulators based on data from a mid-stage vaccine trial.</p>
<p>However, Moderna said the FDA &#8220;did not support&#8221; what&#8217;s referred to as accelerated approval of the vaccine based on the available data, a variety of accelerated approval that enables the FDA to approve drugs more quickly in the event that they address an unmet medical need for serious diseases.</p>
<p>Bancel said: “We will continue to have discussions with regulators” and “we are also generating more data.”</p>
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		<title>FDA approves updated Covid vaccines from Pfizer and Moderna amid increasing virus spread; shots expected to be available inside days</title>
		<link>https://bloggingthree.soflytech.com/2024/08/fda-approves-updated-covid-vaccines-from-pfizer-and-moderna-amid-increasing-virus-spread-shots-expected-to-be-available-inside-days/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Thu, 29 Aug 2024 16:00:31 +0000</pubDate>
				<category><![CDATA[Health]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=13316</guid>

					<description><![CDATA[The Food and Drug Administration on Thursday approved updated Covid vaccines from Pfizer And Modernwhich is able to allow the brand new vaccinations to achieve most Americans in the approaching days, amid a Summer boost from the virus. The vaccines goal a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that [&#8230;]]]></description>
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<p>The Food and Drug Administration on Thursday<strong> </strong><a href="https://www.fda.gov/news-events/press-announcements/fda-approves-and-authorizes-updated-mrna-covid-19-vaccines-better-protect-against-currently" target="_blank" rel="noopener">approved</a> updated Covid vaccines from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">Pfizer<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>    And <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-3">Modern<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>which is able to allow the brand new vaccinations to achieve most Americans in the approaching days, amid a <a href="https://www.nbcnews.com/health/health-news/covid-vaccines-fall-will-arrive-combat-surge-rcna166182" target="_blank" rel="noopener">Summer boost</a> from the virus. </p>
<p>The vaccines goal a strain called KP.2, a descendant of the highly contagious omicron subvariant JN.1 that was widespread within the US earlier this 12 months. KP.2 was the dominant Covid strain in May, but now accounts for under <a href="https://covid.cdc.gov/covid-data-tracker/#variant-proportions" target="_blank" rel="noopener">about 3%</a> of all cases within the U.S. through Saturday, in response to the newest data from the Centers for Disease Control and Prevention.</p>
<p>Still, Pfizer and Moderna have said their KP.2 vaccines can elicit stronger immune responses against other circulating subvariants of JN.1, akin to KP.3 and LB.1, than last 12 months&#39;s round of vaccinations against the omicron strain XBB.1.5.<strong>.</strong></p>
<p>&#8220;Given the waning population immunity from previous exposure to the virus and from prior vaccinations, we strongly recommend that eligible individuals get vaccinated with an updated COVID-19 vaccine to provide greater protection against the variants currently circulating,&#8221; said Dr. Peter Marks, director of the FDA&#39;s Center for Biologics Evaluation and Research, in an announcement.</p>
<p>In June, the CDC <a href="https://www.cdc.gov/media/releases/2024/s-t0627-vaccine-recommendations.html" target="_blank" rel="noopener">really helpful</a> that everybody over 6 months of age will receive an updated Covid vaccine and flu shot this 12 months. The recent vaccines from Pfizer and Moderna are specifically approved for people 12 years of age and older and have emergency use authorization for youngsters ages 6 months to 11 years.  </p>
<p>Pfizer will begin shipping its recent vaccine immediately and expects it to be available in pharmacies, hospitals and clinics across the U.S. &#8220;in the coming days,&#8221; the corporate said in an announcement. Moderna also expects its vaccine to be available in an identical timeframe, in response to an announcement.</p>
<p>&#8220;Staying up to date with your COVID-19 vaccination remains one of the best ways for people to protect themselves and prevent severe disease,&#8221; Moderna CEO Stephane Bancel said in an announcement. &#8220;We appreciate the U.S. FDA&#39;s timely review and encourage individuals to talk with their healthcare providers about whether they can receive their updated COVID-19 vaccine this fall in addition to their flu shot.&#8221;</p>
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<p>The FDA approval got here a couple of weeks before last 12 months&#39;s round of vaccinations, which the agency approved on September 11.</p>
<p>The earlier rollout of recent vaccines could provide some reassurance to Americans because the country experiences a comparatively large surge in virus cases this summer. Almost every state is detecting “high” or “very high” levels of Covid in wastewater, in response to <a href="https://www.cdc.gov/nwss/rv/COVID19-currentlevels.html" target="_blank" rel="noopener">CDC data</a>Wastewater monitoring provides insight into the spread of the virus within the United States as other testing methods have waned.</p>
<p>Other virus indicators are rising, but are still well below the degrees seen at the height of the pandemic. <a href="https://www.cdc.gov/ncird/whats-new/kp-3-1-1-is-the-predominant-variant.html" target="_blank" rel="noopener">Positive Covid test</a> According to the CDC, rates rose to 18.3% within the week ending August 10, up from 17.9% the previous week.</p>
<p>Meanwhile, the CDC said that in a given area, about 4 people per 100,000 individuals are hospitalized for Covid. That&#39;s up from about one Covid hospitalization per 100,000 people in May, the bottom level because the pandemic began. </p>
<p>By the time the vaccines reach patients and trigger an immune response against the virus, which often takes two weeks after vaccination, the Covid-19 wave could subside in the summertime. </p>
<p>Still, federal health officials have long warned Americans that Covid shots should be updated annually since the virus is spawning recent strains that may undermine the immunity people have from previous vaccinations or infections &#8211; protection that wanes over time. The same is true of the annual rollout of recent flu vaccines within the U.S. </p>
<p>It is unclear what number of Americans will actually roll up their sleeves to get one other vaccination in the approaching months.</p>
<p>Only about 22.5% of adults within the U.S. received the newest round of vaccinations administered last fall, in response to <a href="https://www.cdc.gov/vaccines/imz-managers/coverage/covidvaxview/interactive/adult-coverage-vaccination.html" target="_blank" rel="noopener">CDC data</a> until the start of May. </p>
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<p>Many Americans who had previously received a Covid vaccine said they didn&#8217;t get the ultimate booster shot because they weren&#8217;t as anxious concerning the virus, in response to a November study. <a href="https://www.kff.org/coronavirus-covid-19/poll-finding/vaccine-monitor-november-2023-with-covid-concerns-lagging-most-people-have-not-gotten-latest-vaccine/" target="_blank" rel="noopener">Survey by the health policy research organization KFF</a>Others said they were too busy to get vaccinated, the survey said.</p>
<p>In June, the FDA initially asked vaccine makers to provide vaccines against JN.1 before telling them to concentrate on KP.2 as an alternative “if possible.”</p>
<p>This shift seemed <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-14">Novavax<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>which applied for approval of a brand new JN.1 vaccine in the identical month, was at an obstacle. The FDA didn&#8217;t approve the biotech company&#39;s vaccine. </p>
<p>In an announcement, Novavax said it&#8217;s working &#8220;productively&#8221; with the FDA because the agency completes its review. Novavax expects its vaccine to be approved in time for peak vaccination season within the U.S.</p>
<p>The company stated that its vaccine provides protection against descendants of JN.1, including KP.2.3, KP.3, KP.3.1.1 and LB.1.</p>
<p>Novavax makes protein-based vaccines that can not be quickly adapted to a unique virus strain. The protein-based technology is a decades-old method utilized in routine vaccinations against hepatitis B and shingles. </p>
<p>The Pfizer and Moderna vaccines use messenger RNA technology, which teaches cells to make proteins that trigger an immune response against Covid. The mRNA vaccines are much easier to develop and update than protein vaccines. </p>
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<p><em>image credit : www.cnbc.com</em></p>
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		<title>Moderna shares fall 20% as company cuts forecast attributable to low EU sales and a difficult US vaccine market</title>
		<link>https://bloggingthree.soflytech.com/2024/08/moderna-shares-fall-20-as-company-cuts-forecast-attributable-to-low-eu-sales-and-a-difficult-us-vaccine-market/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Fri, 02 Aug 2024 14:14:18 +0000</pubDate>
				<category><![CDATA[Health]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=10689</guid>

					<description><![CDATA[Modern The company on Thursday reported second-quarter revenue that beat expectations but cut its full-year revenue forecast, saying lower sales were expected in Europe, there was a &#8220;competitive environment&#8221; for respiratory vaccines within the U.S. and international sales could also be delayed until 2025. The biotechnology company now expects product sales of between $3 billion [&#8230;]]]></description>
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<div id="RegularArticle-ArticleBody-5" data-module="ArticleBody" data-test="articleBody-2" data-analytics="RegularArticle-articleBody-5-2"><span class="HighlightShare-hidden" style="top:0;left:0"></span></p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    The company on Thursday reported second-quarter revenue that beat expectations but cut its full-year revenue forecast, saying lower sales were expected in Europe, there was a &#8220;competitive environment&#8221; for respiratory vaccines within the U.S. and international sales could also be delayed until 2025. </p>
<p>The biotechnology company now expects product sales of between $3 billion and $3.5 billion for 2024, down from its previous forecast of $4 billion. </p>
<p>The company&#39;s shares closed greater than 20% lower on Thursday.</p>
<p>The company has begun shipping its respiratory syncytial virus vaccine, called mRESVIA, within the U.S. after it was approved for older adults in May. It is Moderna&#39;s second commercially available product after the Covid vaccine, demand for which has fallen because the world emerges from the pandemic and relies less on protective shots and coverings.</p>
<p>Stephane Bancel, CEO of Moderna, told CNBC that there was &#8220;greater intensity of competition&#8221; in each RSV and Covid vaccines. He noted that mRESVIA is the third RSV vaccine to hit the market, following the <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-4">Pfizer<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>    And <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-5">GSK<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>the latter dominating the market last yr.</p>
<p>He added that “we have had quite intensive discussions with governments across Europe” to secure supplies of Moderna’s Covid vaccines.</p>
<p>But &#8220;some countries told us just last week that due to very tight budgets, they simply did not have the capacity to buy more vaccine than they needed because they already had another contract,&#8221; Bancel said.</p>
<p>He refers back to the European Union <a href="https://www.politico.eu/article/eu-pfizer-renegotiate-coronavirus-vaccine-contract/" target="_blank" rel="noopener">massive renegotiated supply contract for Covid vaccine</a> with <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-7">Pfizer<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>    and his German partner <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-8">BioNTech<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>He also referred to the continued war in Ukraine, which is putting a strain on state budgets. </p>
<p>Nevertheless, Moderna expects to return to sales growth in 2025 and break even by 2026 with the launch of latest products, Bancel said. </p>
<p>Here&#39;s what Moderna reported for the second quarter, in comparison with Wall Street expectations, based on an LSEG analyst survey:</p>
<ul>
<li><strong>Loss per share: </strong>$3.33 versus an expected lack of $3.39</li>
<li><strong>Revenue:</strong> $241 million versus expected $132 million</li>
</ul>
<p>The company reported second-quarter revenue of $241 million, with product sales of its Covid vaccine falling 37 percent in comparison with the identical period last yr. Moderna reported revenue of $344 million in the identical period last yr. </p>
<p>The company said the sales decline was partly attributable to the expected transition to a seasonal Covid vaccine market, where patients typically receive their shots in the autumn and winter. However, Bancel said Moderna had a &#8220;good spring season&#8221; within the U.S. for seniors who&#8217;re really helpful to receive an extra dose of the newest round of Covid vaccinations.</p>
<p>Moderna reported a net lack of $1.28 billion, or $3.33 per share, within the second quarter. In the identical period last yr, the online loss was $1.38 billion, or $3.62 per share. </p>
<p>Bancel said the corporate&#39;s losses were partly attributable to progress in cost-cutting and that Wall Street had recorded smaller losses than expected. </p>
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<p>Moderna &#8220;made a little more revenue than expected, but also saved a lot more costs than Wall Street expected,&#8221; he said. &#8220;So I&#39;m really pleased with the progress we&#39;re making on both fronts.&#8221;</p>
<p>Selling expenses were $115 million, down 84 percent from the identical period last yr. This included $14 million in write-offs for unused doses of the Covid vaccine and $55 million in costs related to the corporate&#39;s efforts to scale back its manufacturing capability. </p>
<p>Research and development expenses increased 6% to $1.2 billion within the second quarter in comparison with the identical period last yr. The increase was primarily attributable to personnel costs, including a rise within the variety of employees. </p>
<p>At the identical time, selling, general and administrative expenses for the period decreased 19% to $268 million in comparison with the second quarter of 2023. Selling, general and administrative expenses typically include the prices of promoting, selling and delivering an organization&#39;s services.</p>
<p>Moderna has up to now managed to spice up investor sentiment about its post-Covid path forward. The company&#39;s shares have risen nearly 20% this yr as confidence grows in its pipeline and its messenger RNA platform, the technology utilized in its Covid vaccine and RSV shot.</p>
<p>The biotech company currently has 45 products in development, five of that are in advanced testing phases. This includes its combination vaccine against Covid and flu, which may very well be approved as early as 2025.</p>
<p>Moderna can be developing a standalone flu vaccine, a personalised cancer vaccine with <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-9">Merck<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>    and vaccinations against latent viruses, amongst other products.</p>
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		<title>Moderna receives $176 million to speed up development of vaccine against avian flu pandemic</title>
		<link>https://bloggingthree.soflytech.com/2024/07/moderna-receives-176-million-to-speed-up-development-of-vaccine-against-avian-flu-pandemic/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Fri, 05 Jul 2024 13:04:13 +0000</pubDate>
				<category><![CDATA[Technology]]></category>
		<category><![CDATA[accelerate]]></category>
		<category><![CDATA[avian]]></category>
		<category><![CDATA[development]]></category>
		<category><![CDATA[flu]]></category>
		<category><![CDATA[million]]></category>
		<category><![CDATA[Moderna]]></category>
		<category><![CDATA[pandemic]]></category>
		<category><![CDATA[receives]]></category>
		<category><![CDATA[vaccine]]></category>
		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=8206</guid>

					<description><![CDATA[Moderna will receive $176 million to develop a pandemic flu vaccine for humans following a worrying outbreak of bird flu in dairy cows across the country, federal officials announced Tuesday. &#8220;We have successfully leveraged lessons learned during the COVID-19 pandemic to better prepare for future health crises,&#8221; Health Secretary Xavier Becerra said in a press [&#8230;]]]></description>
										<content:encoded><![CDATA[<p><img decoding="async" src="https://www.mercurynews.com/wp-content/uploads/2024/07/Flu_Vaccine_33870.jpg?w=1400px&amp;strip=all" /></p>
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<p>Moderna will receive $176 million to develop a pandemic flu vaccine for humans following a worrying outbreak of bird flu in dairy cows across the country, federal officials announced Tuesday.</p>
<p>&#8220;We have successfully leveraged lessons learned during the COVID-19 pandemic to better prepare for future health crises,&#8221; Health Secretary Xavier Becerra said in a press release on Tuesday. &#8220;As we do so, we continue to develop new vaccines and other tools to fight influenza and strengthen our pandemic response capabilities.&#8221;</p>
<p>The federal funds will go toward late-stage development of an mRNA-based vaccine against influenza that uses similar technology to the COVID-19 vaccine and is meant to hurry up the response to similar future public health threats, Moderna said Tuesday. The company is already working on developing the vaccine, and if early results are positive, development could move into late-stage testing next yr.</p>
<p>Bird flu, an H5N1 variant of the flu, is a highly contagious type of viral infection. An outbreak of the virus was first reported in several states in late March, in keeping with the CDC. This was the primary time that bird flu virus was detected in cows.</p>
<p>The CDC continues to take care of that &#8220;the current risk to the general population from avian influenza viruses is low,&#8221; although the geographic spread of infection in dairy cows &#8220;may create additional opportunities for humans to be exposed to these viruses.&#8221; Mammal-to-mammal transmission of the virus is believed to be rare.</p>
<p>Mammals can change into infected with the disease by “eating infected birds, poultry, or other animals and/or being exposed to an environment contaminated with the virus,” the CDC says.</p>
<p>The federal funding for the vaccine comes from the Department of Health and Human Services&#39; Biomedical Advanced Research and Development Authority (BARDA), a program focused on developing countermeasures to public health threats. The department&#39;s press release said the funds would also help &#8220;support a fair pricing arrangement that continues to ensure equitable access to vaccines on an ongoing basis.&#8221;</p>
<p>The mRNA technology used to develop the COVID-19 vaccine offers &#8220;advantages in terms of efficacy, speed of development, and scalability and reliability of production,&#8221; said Stéphane Bancel, CEO of Moderna, on Tuesday.</p>
<p>The company said it began collecting safety and other data on the vaccine in healthy adults ages 18 and older in 2023. Results are expected in 2024 and can &#8220;feed into Phase 3 development plans,&#8221; Moderna added.</p>
<p>Federal officials stressed that the event of vaccine technology enables a faster response to potential recent threats.</p>
<p>&#8220;Adding this technology to our pandemic influenza toolkit will give us more flexibility and speed to respond to the strains in circulation and their potential variants,&#8221; said Dawn O&#39;Connell, undersecretary of state for preparedness and response.</p>
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<p><em>image credit : www.mercurynews.com</em></p>
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		<title>Moderna and Merck: Vaccine improves survival of patients with fatal skin cancer</title>
		<link>https://bloggingthree.soflytech.com/2024/06/moderna-and-merck-vaccine-improves-survival-of-patients-with-fatal-skin-cancer/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Tue, 04 Jun 2024 09:42:30 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[cancer]]></category>
		<category><![CDATA[fatal]]></category>
		<category><![CDATA[improves]]></category>
		<category><![CDATA[Merck]]></category>
		<category><![CDATA[Moderna]]></category>
		<category><![CDATA[Patients]]></category>
		<category><![CDATA[skin]]></category>
		<category><![CDATA[survival]]></category>
		<category><![CDATA[vaccine]]></category>
		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=5343</guid>

					<description><![CDATA[Modern And Merck publishes more positive Three-year data Monday about their experimental vaccine, which is being given to patients with the deadliest type of skin cancer together with the therapy Keytruda. The vaccine together with Merck’s Keytruda improved survival and showed long-lasting efficacy in an interim study in patients with a deadly type of skin [&#8230;]]]></description>
										<content:encoded><![CDATA[<p></p>
<div>
<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    And <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-2">Merck<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>    publishes more positive <a href="https://investors.modernatx.com/news/news-details/2024/Moderna--Merck-Announce-3-Year-Data-For-mRNA-4157-V940-in-Combination-With-KEYTRUDAR-pembrolizumab-Demonstrated-Sustained-Improvement-in-Recurrence-Free-Survival--Distant-Metastasis-Free-Survival-Versus-KEYTRUDA-in-Patients-With-High-Risk-Stage-IIIIV/default.aspx" target="_blank" rel="noopener">Three-year data</a> Monday about their experimental vaccine, which is being given to patients with the deadliest type of skin cancer together with the therapy Keytruda.</p>
<p>The vaccine together with Merck’s Keytruda improved survival and showed long-lasting efficacy<strong> </strong>in an interim study in patients with a deadly type of skin cancer. Moderna and Merck will present the info on the <a href="https://www.asco.org/" target="_blank" rel="noopener">American Society of Clinical Oncology</a> Annual meeting in Chicago.</p>
<p>The vaccine is a key a part of Moderna&#39;s product pipeline and has helped boost investor sentiment toward the biotech company after a bumpy last 12 months that saw demand for its Covid vaccine, the one product currently commercially available, plummet.</p>
<p>The data includes the primary results that the 2 corporations announced in December.</p>
<p>According to latest data, nearly 75% of patients who took the mixture were alive after 2.5 years, with no signs or symptoms of their cancer returning, compared with just 55.6% of patients who received Keytruda alone. </p>
<p>This profit was seen in several subgroups of patients, no matter whether or not they had tumors with a lot of mutations or whether or not they had sufficient amounts of a protein called PD-L1, which helps keep the body&#39;s immune responses under control. </p>
<p>The data suggested the vaccine could help treat a &#8220;broad spectrum&#8221; of melanoma patients, said Dr. Kyle Holen, head of development, therapeutics and oncology at Moderna, in a press release.</p>
<p>The overall survival rate of patients who received the vaccine together with Keytruda was 96 percent after 2.5 years. By comparison, the survival rate for patients who received Keytruda alone was 90.2 percent.</p>
<p>&#8220;When we look at the three-year updates, I&#39;m really excited about the consistency of these data,&#8221; Marjorie Green, head of world clinical development for oncology at Merck, said in an interview. </p>
<p>As the businesses previously announced, patients with severe types of melanoma who received the mixture were 49 percent less more likely to die or have their cancer return after about three years than patients who took Keytruda alone. The combination also reduced the chance of melanoma spreading to other parts of the body or dying by 62 percent.</p>
<p>The commonest unwanted side effects of the vaccine, in response to the info, were fatigue, pain on the injection site and chills. Most of those unwanted side effects were mild. Immune-related unwanted side effects were barely more common in patients who received the mixture.</p>
<p>The vaccine, which uses the identical mRNA technology as Moderna&#39;s Covid vaccine, is tailored based on an evaluation of a patient&#39;s tumors after they&#8217;ve been surgically removed. The vaccine is designed to coach the immune system to acknowledge and attack certain mutations in cancer cells. </p>
<p>Moderna is looking forward to working to shorten the time between the initial evaluation of a tumor and the administration of the shot to the patient, CEO Stephane Bancel said in an interview with CNBC.</p>
<p>Merck&#39;s Keytruda is approved to treat melanoma and other cancers and is a component of a gaggle of widely used immunotherapies that aim to deactivate a selected protein that helps cancer evade the immune system.</p>
<p>The US Food and Drug Administration announced in February <a href="https://www.merck.com/news/moderna-and-merck-announce-mrna-4157-v940-an-investigational-personalized-mrna-cancer-vaccine-in-combination-with-keytruda-pembrolizumab-was-granted-breakthrough-therapy-designation-by-the/" target="_blank" rel="noopener">Name for groundbreaking therapy</a> for the cancer vaccine to treat melanoma. This designation is meant to speed up the event and testing of treatments for serious and life-threatening diseases.</p>
<p>But Moderna and Merck also wish to apply to the FDA for an expedited approval process, Bancel noted. The process allows for accelerated approval of medicine for serious diseases that fill an unmet medical need.</p>
<p>According to the American Cancer Society, melanoma is answerable for the overwhelming majority of deaths from skin cancer. The variety of melanomas has increased dramatically in recent many years, in response to the organization.</p>
<p>According to the American Cancer Society, about 100,000 people within the United States will likely be diagnosed with melanoma this 12 months and nearly 8,000 persons are expected to die from the disease.</p>
<p>The two pharmaceutical corporations are investigating the mixture as a treatment for late-stage melanoma in a <a href="https://www.reuters.com/business/healthcare-pharmaceuticals/merck-moderna-begin-late-stage-study-mrna-cancer-vaccine-2023-07-26/" target="_blank" rel="noopener">Phase 3 study</a>which began in July. Bancel said the progress of this process to this point is &#8220;beyond our plans&#8221;. </p>
<p>Merck can be conducting one other Phase 3 study of the vaccine in patients with a certain kind of lung cancer. </p>
<p>This 12 months, Merck and Moderna began a two-part mid- to late-stage study of the vaccine and Keytruda in patients with advanced stages of a standard skin cancer. The corporations are also conducting a phase two study in certain patients with a certain kind of kidney cancer and one other study in individuals with a certain kind of bladder cancer.</p>
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<p><em>image credit : www.cnbc.com</em></p>
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		<title>According to Moderna, the FDA has delayed approval of the RSV vaccine until the top of May</title>
		<link>https://bloggingthree.soflytech.com/2024/05/according-to-moderna-the-fda-has-delayed-approval-of-the-rsv-vaccine-until-the-top-of-may/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Sat, 11 May 2024 07:51:33 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[approval]]></category>
		<category><![CDATA[delayed]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Moderna]]></category>
		<category><![CDATA[RSV]]></category>
		<category><![CDATA[vaccine]]></category>
		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=3167</guid>

					<description><![CDATA[Modern said Friday that the Food and Drug Administration has delayed approval of its respiratory syncytial virus vaccine until the top of May on account of &#8220;administrative constraints&#8221; on the agency. The FDA was expected to make a call on the RSV vaccination on Sunday. The agency didn&#8217;t inform Moderna of any issues related to [&#8230;]]]></description>
										<content:encoded><![CDATA[<p></p>
<div id="RegularArticle-ArticleBody-5" data-module="ArticleBody" data-test="articleBody-2" data-analytics="RegularArticle-articleBody-5-2"><span class="HighlightShare-hidden" style="top:0;left:0"></span></p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    said Friday that the Food and Drug Administration has delayed approval of its respiratory syncytial virus vaccine until the top of May on account of &#8220;administrative constraints&#8221; on the agency.</p>
<p>The FDA was expected to make a call on the RSV vaccination on Sunday.  The agency didn&#8217;t inform Moderna of any issues related to the security, effectiveness or quality of the vaccine that will prevent its approval, the biotech company said in a news release.</p>
<p>Investors are closely watching the pending approval as Moderna looks to get better from the rapid decline in its Covid business last 12 months.  If approved, the RSV shot could be the corporate&#39;s second product to hit the U.S. market, following its once-successful Covid vaccine.  It would even be the third RSV vaccine to come back onto the market after vaccinations <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-3">Pfizer<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>    And <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-4">GSK<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>    introduced last 12 months.</p>
<p>Moderna said its RSV vaccine continues to be on course to be reviewed by a Centers for Disease Control and Prevention advisory panel inside a 12 months <a href="https://www.cdc.gov/vaccines/acip/meetings/index.html" target="_blank" rel="noopener">meet</a> on June twenty sixth and twenty seventh.  This panel will vote on recommendations for the usage of the vaccine and the intended population needed before it involves market.</p>
<p>Moderna tested the vaccine in older adults, who&#8217;re more vulnerable to severe RSV cases.  According to CDC data, the virus kills between 6,000 and 10,000 seniors every year and ends in 60,000 to 120,000 hospitalizations.</p>
<p>“Moderna is very grateful to the FDA for their continued efforts and diligence,” said Dr.  Stephen Hoge, president of Moderna, said in a press release.  “We stay up for helping the agency complete its review of our application and stay up for June [advisory] meet.&#8221; </p>
<p>The approval would demonstrate the versatility of Moderna&#39;s messenger RNA platform beyond treating Covid.  The biotech company uses this technology to combat a range of diseases.  These include RSV, cancer and a highly contagious gastrointestinal virus known as norovirus. </p>
<p>Investors have high hopes for the long-term potential of Moderna&#39;s mRNA product pipeline: The company&#39;s shares have risen more than 20% this year after falling nearly 45% in 2023.</p>
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		<title>Moderna loses lower than expected as Covid vaccine sales beat estimates and value cuts take hold</title>
		<link>https://bloggingthree.soflytech.com/2024/05/moderna-loses-lower-than-expected-as-covid-vaccine-sales-beat-estimates-and-value-cuts-take-hold/</link>
		
		<dc:creator><![CDATA[chandankumarsoft]]></dc:creator>
		<pubDate>Sun, 05 May 2024 07:32:35 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[beat]]></category>
		<category><![CDATA[cost]]></category>
		<category><![CDATA[Covid]]></category>
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		<category><![CDATA[loses]]></category>
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		<guid isPermaLink="false">https://bloggingthree.soflytech.com/?p=2596</guid>

					<description><![CDATA[Modern reported a narrower-than-expected first-quarter loss on Thursday as the corporate&#39;s cost-cutting efforts took effect and sales of its Covid vaccine, its only commercially available product, beat estimates. The results come as Moderna gets closer to launching one other product that&#8217;s urgently needed as demand for Covid vaccinations falls worldwide. The biotech company expects U.S. [&#8230;]]]></description>
										<content:encoded><![CDATA[<p></p>
<div id="RegularArticle-ArticleBody-5" data-module="ArticleBody" data-test="articleBody-2" data-analytics="RegularArticle-articleBody-5-2"><span class="HighlightShare-hidden" style="top:0;left:0"></span></p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Modern<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>    reported a narrower-than-expected first-quarter loss on Thursday as the corporate&#39;s cost-cutting efforts took effect and sales of its Covid vaccine, its only commercially available product, beat estimates. </p>
<p>The results come as Moderna gets closer to launching one other product that&#8217;s urgently needed as demand for Covid vaccinations falls worldwide.  The biotech company expects U.S. approval for its respiratory syncytial virus vaccine on May 12.  If approved, vaccination is predicted to occur within the third quarter.</p>
<p>Shares of Moderna closed greater than 12% higher on Thursday following the outcomes.</p>
<p>Here&#39;s what Moderna reported for the primary quarter in comparison with Wall Street&#39;s expectations, based on an analyst survey from LSEG:</p>
<ul>
<li><strong>Loss per share: </strong>$3.07 versus an expected lack of $3.58</li>
<li><strong>Revenue: </strong>$167 million versus expected $97.5 million</li>
</ul>
<p>&#8220;On the [operating expenses] &#8220;On the company side, we&#39;ve made great progress,&#8221; Moderna CEO Stéphane Bancel said of the cost cuts on CNBC&#39;s &#8220;Squawk Box&#8221; on Thursday.  He added that the biotech company&#39;s team &#8220;has done an excellent job in resizing the corporate.&#8221;</p>
<p>Moderna posted first-quarter revenue of $167 million, with Covid vaccination revenue falling about 90% compared to the same period last year.  The company reported revenue of $1.86 billion in the same period last year.</p>
<p>About $100 million came from the U.S., while $67 million came from international markets, primarily in Latin America, Moderna CFO Jamey Mock said in an interview with CNBC. </p>
<p>The company said the decline in sales was partly due to the expected transition to a seasonal Covid vaccine market, where patients typically get their vaccinations in the fall and winter.</p>
<p>Moderna posted a first-quarter net loss of $1.18 billion, or $3.07 per share.  That compares with net income of $79 million, or 19 cents per share, in the year-earlier period.</p>
<p>The company reiterated its full-year 2024 revenue forecast of about $4 billion, including revenue from its RSV vaccine.  Specifically, Moderna expects only $300 million of these sales to occur in the first half of the year, as respiratory virus season is typically in the second half of the year. </p>
<p>The second quarter will include part of the company&#39;s recently announced deal with Brazil to supply 12.5 million Covid vaccines, executives said during a conference call on Wednesday.</p>
<p>Moderna has said it expects to return to revenue growth in 2025 and reach breakeven with new product launches by 2026. </p>
<p>For the first quarter, Mock said the company was &#8220;more encouraged by what we&#39;re seeing from a productivity perspective&#8221; than by the higher sales of its Covid vaccine. </p>
<p>Cost of sales was $96 million in the first quarter, down 88% from the same period last year.  This includes, among other things, $30 million in write-downs on unused doses of the Covid vaccine and $27 million in charges related to the company&#39;s efforts to reduce its manufacturing footprint. </p>
<p>Research and development costs fell 6% to $1.1 billion in the first quarter compared to the same period in 2023.  This decline was primarily due to fewer payments to partners in 2024 and lower clinical development and manufacturing costs, including lower clinical trial expenses for the company&#39;s Covid, RSV and seasonal flu vaccinations. </p>
<p>Meanwhile, selling, general and administrative expenses fell 10% to $274 million in the period compared to the first quarter of 2023.  SG&#038;A expenses typically include the costs of advertising, selling, and providing a company&#39;s products and services.</p>
<p>The company said the decline was partly due to its investments in &#8220;digital business capabilities&#8221; and increased focus on using AI technologies to streamline operations.</p>
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<p>Last month, Moderna <a href="https://investors.modernatx.com/news/news-details/2024/Moderna-and-OpenAI-Collaborate-To-Advance-mRNA-Medicine/default.aspx" goal="_blank" rel="noopener">announced </a>a partnership with artificial intelligence heavyweight OpenAI that aims to automate nearly every business process at the biotech company. </p>
<p>Mock told CNBC that Moderna has been working with OpenAI for a year.  He added that 60 to 70% of the company currently uses an AI chatbot for work. </p>
<p>Moderna has so far managed to boost investor sentiment about its post-Covid approach.  Its shares have risen more than 10% this year as confidence in its pipeline and messenger RNA platform, the technology used in Covid vaccinations, has increased. </p>
<p>The biotech company currently has 45 products in development, some of which are in late-stage testing.  This includes the combination vaccination against Covid and the flu, which could be approved as early as 2025.</p>
<p>Moderna is also developing, among other things, a stand-alone flu vaccination, a personalized cancer vaccine with Merck and vaccinations against latent viruses.</p>
</p>
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