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id="container" class="awakable" data-awake="Presentation" ><div id="articleBrowser"><section id="articles"><article data-parent="54415" id="art_latest_news" data-id="54417" data-title="Latest News" data-name="latest_news" data-thumbnail="/pharma/pharma_mar25/latest_news/1301000/__screenshot.jpg" data-visible="1" data-automatic-seo-enabled="" data-use-as-toc="0"><section data-name="section" data-template="section" data-area-name="latest_news" id="latest_news" class="area area-root area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="page" id="page" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="nav-area" id="nav-area" class="area area-section"><div class="append-here"></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="page-container" id="page-container" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="body" id="body" class="area area-section"><div class="append-here"><div data-template="header" data-name="header" data-area-name="header-1" id="header-1" class="area headline"><h1 data-elkey="headline" data-html-edit="headline">Latest News</h1></div><section data-name="section" data-template="section" data-area-name="container" id="container" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="news-1" id="news-1" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-1" id="text-1" class="area textbox headlinetitle"><section data-elkey="textbox" data-html-edit="textbox">13 February</section></section><div data-template="header-h2" data-name="header-h2" data-area-name="header-h2-32429" id="header-h2-32429" class="area headline headlinetitle"><h2 data-elkey="headline" data-html-edit="headline">US Government actions having a serious impact on global health, WHO chief says</h2></div><section data-name="section" data-template="section" data-bg-width="770" data-bg-height="433" data-bg-mp-width="770" data-bg-mp-height="433" data-bg-sp-width="770" data-bg-sp-height="433" data-bg-pr-width="770" data-bg-pr-height="433" data-area-name="story-image" id="story-image" class="area area-section"><div class="append-here"></div><div class="clear"></div></section><section data-name="text" data-template="text" data-area-name="text-2" id="text-2" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">The US spent $68bn on international aid in 2023, with USAID accounting for around $40bn of that total. Credit: Chip Somodevilla / Getty Images</section></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="news-2" id="news-2" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-6" id="text-6" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">The World Health Organization’s (WHO) director-general Tedros Adhanom Ghebreyesus has asked the US to reconsider its pause on foreign healthcare aid, which he says is causing a serious impact around the world. “There are also actions that the US Government is taking that are unrelated to its intended withdrawal from WHO, but which we are concerned are having a serious impact on global health,” Dr Tedros said whilst speaking at a WHO virtual conference in Geneva on 12 February. After the US stated its intention to withdraw from the WHO last month, the new administration has suspended or curtailed HIV, malaria and tuberculosis treatment services in low-income countries supported by the United States Agency for International Development (USAID). Commenting publicly for the first time about President Trump’s freeze on US aid funding, the WHO chief pointed to the suspension of financial support for the president’s Emergency Plan for AIDS Relief (PEPFAR). The plan has become a major pillar in fighting the global HIV/AIDS response, providing testing services, antiretroviral treatment, and education programmes.</section></section></div><div class="clear"></div></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="container-1" id="container-1" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="news-3" id="news-3" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-3" id="text-3" class="area textbox headlinetitle"><section data-elkey="textbox" data-html-edit="textbox">10 February</section></section><div data-template="header-h2" data-name="header-h2" data-area-name="header-h2-32429-2" id="header-h2-32429-2" class="area headline headlinetitle"><h2 data-elkey="headline" data-html-edit="headline">Super Bowl ad for copycat weight loss drugs stokes pharma power debate</h2></div><section data-name="text" data-template="text" data-area-name="text-8" id="text-8" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">As the Philadelphia Eagles romped to victory against the Kansas City Chiefs in the Super Bowl LIX, the eyes of the pharmaceutical industry were on an advert aired by telehealth company Hims & Hers that once again ignited the debate around the legitimacy of compounded weight loss medications.Controversy has surrounded the commercial, called ‘Sick of the System’, in the lead-up to America’s biggest sporting event. Drug industry bodies and politicians labelled the advert misleading while pharmacy compounding experts backed Hims & Hers’ message.The 60-second advert details obesity in America, what it calls the country’s deadliest epidemic. Hims & Hers says the weight loss system is broken, citing that profit in the pharmaceutical industry is more important than patient health. Glucagon-like peptide-1 receptor agonist (GLP-1RA) injection pens, that resemble Novo Nordisk’s semaglutide products Wegovy and Ozempic, are featured in the advert.</section></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="news-4" id="news-4" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-4" id="text-4" class="area textbox headlinetitle"><section data-elkey="textbox" data-html-edit="textbox">7 February</section></section><div data-template="header-h2" data-name="header-h2" data-area-name="header-h2-32429-3" id="header-h2-32429-3" class="area headline headlinetitle"><h2 data-elkey="headline" data-html-edit="headline">Genentech eyes lupus market for Gazyva with positive Phase III data readout</h2></div><section data-name="text" data-template="text" data-area-name="text-9" id="text-9" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">Roche’s subsidiary Genentech has shared positive Phase III data with the US Food and Drug Administration (FDA) as the company targets the billion-dollar lupus market for its CD20-targeting drug Gazyva (obinutuzumab).The latest Phase III data for Gazyva is important because, if approved, the drug would represent the first CD20-directed therapy for lupus nephritis with regulatory backing.The Phase III REGENCY trial (NCT04221477) – which enrolled 271 patients – demonstrated that 46.4% of patients with lupus nephritis who received Gazyva plus standard therapy achieved complete renal response at 76 weeks, compared to 33.1% in the placebo group. The findings were presented at the World Congress of Nephrology in New Delhi, India, with Genentech confirming that the data has been shared with both the FDA and European Medicines Agency (EMA) for regulatory review.</section></section></div><div class="clear"></div></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="container-2" id="container-2" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="news-5" id="news-5" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-5" id="text-5" class="area textbox headlinetitle"><section data-elkey="textbox" data-html-edit="textbox">6 February</section></section><div data-template="header-h2" data-name="header-h2" data-area-name="header-h2-32429-4" id="header-h2-32429-4" class="area headline headlinetitle"><h2 data-elkey="headline" data-html-edit="headline">Supernus wins FDA approval for Parkinson’s pump on fourth try</h2></div><section data-name="text" data-template="text" data-area-name="text-10" id="text-10" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">Supernus Pharmaceuticals has won US approval for its wearable pump Onapgo (apomorphine hydrochloride) to treat symptoms of Parkinson’s disease.Supernus’ regulatory path for Onapgo has been marked by multiple setbacks over nearly five years, with the Food and Drug Administration (FDA) rejecting three prior applications before securing approval.The company acquired Onapgo, previously known as SPN-830, from US WorldMeds in 2020. Soon after, Supernus submitted its first application for FDA review. However, in 2020, the agency issued a refusal-to-file (RTF) letter, determining that the submission was incomplete and not ready for formal review.Supernus resubmitted the application twice, receiving complete response letters (CRLs) both times. The first 2022 rejection required further analysis of the infusion device and drug product, while the most recent CRL, issued in April 2023, cited product quality concerns and deficiencies in the master file for the proprietary pump.</section></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="news-6" id="news-6" class="area area-section"><div class="append-here"><section data-name="text" data-template="text" data-area-name="text-11" id="text-11" class="area textbox headlinetitle"><section data-elkey="textbox" data-html-edit="textbox">6 February</section></section><div data-template="header-h2" data-name="header-h2" data-area-name="header-h2-32429-5" id="header-h2-32429-5" class="area headline headlinetitle"><h2 data-elkey="headline" data-html-edit="headline">AstraZeneca’s shares rise as it addresses China investigation</h2></div><section data-name="text" data-template="text" data-area-name="text-12" id="text-12" class="area textbox"><section data-elkey="textbox" data-html-edit="textbox">AstraZeneca’s shares rose today (6 February) after the pharma company reported better-than-expected Q4 2024 results. The strong financial performance helped ease investor concerns following ongoing legal issues in China and the company’s recent decision to cancel a planned £450m investment in Merseyside, UK. The UK-based drugmaker reported a 21% increase in annual revenues, reaching £43bn ($54.1bn), driven by strong sales in oncology, respiratory, and immunology treatments. Investors responded positively, with AstraZeneca’s stock climbing 4.6% in before the markets opened and continued to trade a higher price than the previous day.Despite the positive financial results, AstraZeneca’s recent decision to withdraw from its planned expansion in Liverpool, UK, remains a contentious issue. The company had intended to transform its childhood flu vaccine factory in Speke into a major vaccine hub but abandoned the project after failing to come to an agreement with the UK government on state support.</section></section></div><div class="clear"></div></section></div><div class="clear"></div></section></div><div class="clear"></div></section><section data-name="section" data-template="section" data-area-name="footer" id="footer" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-area-name="backtotop-container" id="backtotop-container" class="area area-section"><div class="append-here"><section data-name="section" data-template="section" data-bg-width="36" data-bg-height="36" data-bg-mp-width="36" data-bg-mp-height="36" data-bg-sp-width="36" data-bg-sp-height="36" data-bg-pr-width="36" data-bg-pr-height="36" data-area-name="back-circle" id="back-circle" class="area area-section has-href"><a data-linkblock="yes" 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data-image="/pharma/pharma_mar25/issue_152/1300945/__screenshot.jpg" tabindex="0">Home | Radiopharmaceutical deals drive sector growth despite supply crisis</a></li><li class="nesting-level-1" data-article="editors_letter" data-id="54411"><a href="/pharma_mar25/editors_letter" data-image="/pharma/pharma_mar25/editors_letter/1300953/__screenshot.jpg" tabindex="0">Editor's letter</a></li><li class="nesting-level-1" data-article="contents" data-id="54412"><a href="/pharma_mar25/contents" data-image="/pharma/pharma_mar25/contents/1300961/__screenshot.jpg" tabindex="0">Contents</a></li><li class="nesting-level-1" data-article="mimotopes_company_insight" data-id="54413"><a href="/pharma_mar25/mimotopes_company_insight" data-image="/pharma/pharma_mar25/mimotopes_company_insight/1300980/thumbnail_Mimotopes-CI.jpg" tabindex="0">Mimotopes Company Insight</a></li><li class="nesting-level-1" data-article="mimotopes_advert" data-id="54414"><a href="/pharma_mar25/mimotopes_advert" 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medicines</a></li><li class="nesting-level-2" data-article="eu-reshapes-htas-is-the-industry-ready-for-it" data-id="54425"><a href="/pharma_mar25/eu-reshapes-htas-is-the-industry-ready-for-it" data-image="/pharma/pharma_mar25/eu-reshapes-htas-is-the-industry-ready-for-it/1301051/thumbnail.jpg" tabindex="0">EU reshapes HTAs: is the industry ready for it?</a></li><li class="nesting-level-2" data-article="obesity-market-173-5-billion-2031" data-id="54426"><a href="/pharma_mar25/obesity-market-173-5-billion-2031" data-image="/pharma/pharma_mar25/obesity-market-173-5-billion-2031/1301060/thumbnail.jpg" tabindex="0">Obesity market to reach $173.5bn by 2031</a></li><li class="nesting-level-2" data-article="people-focused-cancer-care-demands-policy-support" data-id="54427"><a href="/pharma_mar25/people-focused-cancer-care-demands-policy-support" data-image="/pharma/pharma_mar25/people-focused-cancer-care-demands-policy-support/1301065/thumbnail.jpg" tabindex="0">People-focused cancer care 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