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	<title>Europe Pharma News | EMA Approvals &amp; Biopharma Trends</title>
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		<title>LogiPharma 2026 Delivers Landmark Edition Marked by Engagement, Innovation and Practical Progress</title>
		<link>https://www.pharmaadvancement.com/press-statements/logipharma-2026-delivers-landmark-edition-marked-by-engagement-innovation-and-practical-progress/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Mon, 04 May 2026 12:13:41 +0000</pubDate>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Packaging & Logistic]]></category>
		<category><![CDATA[Press Statements]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/logipharma-2026-delivers-landmark-edition-marked-by-engagement-innovation-and-practical-progress/</guid>

					<description><![CDATA[<p>LogiPharma 2026 has concluded on a high, bringing together more than 2,300 life sciences supply chain professionals from around the world for three days of insight, innovation and debate at its new home, the Austria Center in Vienna. The move to Vienna and the introduction of refreshed formats proved a resounding success, with record engagement, [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/press-statements/logipharma-2026-delivers-landmark-edition-marked-by-engagement-innovation-and-practical-progress/">LogiPharma 2026 Delivers Landmark Edition Marked by Engagement, Innovation and Practical Progress</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>LogiPharma 2026 has concluded on a high, bringing together more than 2,300 life sciences supply chain professionals from around the world for three days of insight, innovation and debate at its new home, the Austria Center in Vienna.</p>
<p>The move to Vienna and the introduction of refreshed formats proved a resounding success, with record engagement, packed sessions and a strong pipeline of exhibitor announcements signalling continued momentum across the sector.</p>
<p>This year’s edition reflected a maturing conversation within pharmaceutical and biotech supply chains, grounded in practical application, resilience and real-world value. That was evident both on stage and across the exhibition floor, where suppliers showcased solutions designed to address today’s most pressing operational challenges.</p>
<p>The focus on interaction delivered tangible results. Delegates submitted 321 questions via the event app, underlining strong audience participation and the appetite for open, honest discussion. Sessions across both the Supply Chain and Logistics tracks benefited from live polling, audience-led debate and practical peer-to-peer exchange.</p>
<p>Reflecting on the themes that shaped discussions throughout the week, Ben Sharples, Event Director of LogiPharma, highlighted a noticeable shift in how the industry is approaching transformation:</p>
<p>“AI dominated the conversation again this year, but the tone was far more grounded. There’s a growing realism about what the technology can deliver right now, as well as where its limitations still lie.”</p>
<p>According to Sharples, true end‑to‑end visibility emerged as the single most critical capability for supply chains responding to major disruption. Survey data shared during sessions revealed that 50% of respondents felt AI had not helped at all during the recent Middle East crisis, reinforcing the message that technology alone is not a silver bullet.</p>
<p>Other key learnings included the increasing alignment between supply chain and commercial teams, with organisations placing greater emphasis on growth, market share and customer outcomes. Sharples also noted that while AI continues to attract attention, poor data quality remains the root cause of many failed initiatives, often overlooked amid the hype.</p>
<p>Crucially, people and culture continue to define success. “Even the best technology won’t deliver if it’s in the wrong hands,” Sharples added. “Digital transformation is still, at its core, a people and change challenge.”</p>
<p>With major disruption now viewed as inevitable rather than exceptional, the LogiPharma agenda reinforced the need for resilient networks and predictive capabilities. Looking ahead, AI‑enabled control towers were widely cited as a foundational element, increasingly acting as the nervous system of modern supply chains, shifting organisations from reactive recovery to proactive foresight.</p>
<h3><strong>Other highlights from across the conference</strong></h3>
<p>A larger exhibitor zone and wider variety of formats meant that the move to Vienna was also praised by sponsors.</p>
<p><img fetchpriority="high" decoding="async" class="aligncenter size-full wp-image-25850" src="https://www.pharmaadvancement.com/wp-content/uploads/2026/05/LogiPharma-2026-success-sponsors-1.webp" alt="LogiPharma 2026 success sponsors" width="700" height="467" /></p>
<p>“People love the interactive elements of LogiPharma and these extend from plenaries and round-tables, to the experiential activities brought by sponsors, including a F1 simulator and an A.I. photobooth,” confirmed Jake Brown, Commercial Lead at LogiPharma.</p>
<p>“Exhibitors used LogiPharma as a platform to launch and showcase next-generation technologies aimed at improving resilience, reducing risk, balancing cost and sustainability, and strengthening cold chain integrity,” he added.</p>
<p>TransVoyant announced the launch of Risk in Motion, a new solution designed to analyse multiple data sources against disruption threats. The platform enables supply chain teams to act ahead of potential issues, protecting shipments, inventory and temperature-sensitive products in real time.</p>
<p>Cold chain innovation continued with Peli BioThermal’s introduction of a new SmartCap for DV10 dewars, offering enhanced visibility and reliability for high‑value cell and gene therapy shipments.</p>
<p>Visitors to Woolcool were introduced to the LifeGUARDIAN® thermal box system, a fully passive packaging solution designed to protect temperature‑sensitive payloads for up to 120 hours. The system combines a layered design including an outer carton, fleece jacket, thermal core and ice packs to deliver consistent and reliable temperature control without the need for active components.</p>
<p>Innovation from emerging companies was also firmly in the spotlight. Tapp was named Start Up Village Champion, recognised for its progress in developing a simpler and more sustainable way to manage temperature-controlled shipments. The company was selected for its focus on reducing e‑waste and enabling instant data access without the need for additional hardware.</p>
<p>Beyond technology, the event also highlighted the importance of partnership and shared purpose. A standout moment was Yusen Logistics hosting a traditional Japanese Kagami Biraki sake barrel‑opening ceremony, symbolising new beginnings and strengthened collaboration.</p>The post <a href="https://www.pharmaadvancement.com/press-statements/logipharma-2026-delivers-landmark-edition-marked-by-engagement-innovation-and-practical-progress/">LogiPharma 2026 Delivers Landmark Edition Marked by Engagement, Innovation and Practical Progress</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>Samsung Bioepis Starts Direct Commercialization of Byooviz</title>
		<link>https://www.pharmaadvancement.com/pharma-news/samsung-bioepis-starts-direct-commercialization-of-byooviz/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Wed, 07 Jan 2026 13:33:30 +0000</pubDate>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[  Biopharmaceutical Development]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/samsung-bioepis-starts-direct-commercialization-of-byooviz/</guid>

					<description><![CDATA[<p>Samsung Bioepis has begun its direct commercialization of Byooviz, which is a biosimilar to Genentech’s Lucentis &#8211; ranibizumab in Europe. The company has gone ahead and bought the commercial rights for Byooviz from Biogen, and the product is now going to be available as a brand from Samsung Bioepis throughout many European countries as part of the ongoing [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/pharma-news/samsung-bioepis-starts-direct-commercialization-of-byooviz/">Samsung Bioepis Starts Direct Commercialization of Byooviz</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>Samsung Bioepis has begun its direct commercialization of Byooviz, which is a biosimilar to Genentech’s Lucentis &#8211; ranibizumab in Europe.</p>
<p>The company has gone ahead and bought the commercial rights for Byooviz from Biogen, and the product is now going to be available as a brand from Samsung Bioepis throughout many European countries as part of the ongoing expansion plans that it has.</p>
<p>It was in August 2021 that Byooviz went on to receive an approval from the European Commission &#8211; EC as a single-use vial when it comes to intravitreal administration &#8211; 0.5mg/0.05ml.</p>
<p>It is indicated for treatment in terms of visual impairment because of diabetic macular oedema, neovascular &#8211; wet age-related macular degeneration, visual impairment due to choroidal neovascularization, and proliferative diabetic retinopathy, as well as visual impairment because of macular oedema secondary to retinal vein occlusion &#8211; branch or central.</p>
<p>The Committee for Medicinal Products for Human Use &#8211; CHMP of the European Medicines Agency &#8211; EMA issued quite a positive opinion for the Byooviz pre-filled syringe &#8211; PFS in November 2025. The syringe is expected to enter the European market sometime in the second quarter of 2026.</p>
<p>Antonio Rito, the vice-president of Samsung Bioepis said that direct commercialization of Byooviz indeed a major milestone for Samsung Bioepis since the company continues to make its presence across Europe very robust through expanding its portfolio when it comes to directly commercialized products.</p>
<p>He added that making utmost use of the last three years of experience with Epysqli &#8211; eculizumab and the newly launched Obodence &#8211; denosumab along with Xbryk &#8211; denosumab in Europe, they are going to continue with their journey to become a completely integrated biopharmaceutical company having end-to-end capabilities right from development to commercialization.</p>
<p>They are going to work closely along with payers as well as healthcare professionals in order to make sure of a seamless access when it comes to their biosimilar medicines for patients who are in need.</p>
<p>In September 2023, Sandoz went on to collaborate with Samsung Bioepis in order to develop and also market a Stelara &#8211; ustekinumab, a biosimilar in the US, Canada, and Europe.</p>The post <a href="https://www.pharmaadvancement.com/pharma-news/samsung-bioepis-starts-direct-commercialization-of-byooviz/">Samsung Bioepis Starts Direct Commercialization of Byooviz</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>CDMO-CRDO Partner For Requirements of the Biologics Market</title>
		<link>https://www.pharmaadvancement.com/manufacturing/cdmo-crdo-partner-for-requirements-of-the-biologics-market/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Sat, 06 Dec 2025 06:34:22 +0000</pubDate>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[  Biopharmaceutical Development]]></category>
		<category><![CDATA[Biopharma Businesses]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/cdmo-crdo-partner-for-requirements-of-the-biologics-market/</guid>

					<description><![CDATA[<p>A leading global contract development and manufacturing organization &#8211; CDMO for biopharmaceuticals, Rentschler Biopharma, and Coriolis Pharma, which is a globally operating contract research and development organization &#8211; CRDO and also a leader in formulation research and development when it comes to biopharmaceuticals, announced on December 02, 2025, a strategic collaboration. Together, the companies are going to [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/manufacturing/cdmo-crdo-partner-for-requirements-of-the-biologics-market/">CDMO-CRDO Partner For Requirements of the Biologics Market</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>A leading global contract development and manufacturing organization &#8211; CDMO for biopharmaceuticals, Rentschler Biopharma, and Coriolis Pharma, which is a globally operating contract research and development organization &#8211; CRDO and also a leader in formulation research and development when it comes to biopharmaceuticals, announced on December 02, 2025, a strategic collaboration.</p>
<p>Together, the companies are going to offer clients seamless as well as end-to-end solutions right from early formulation to commercial manufacturing, therefore combining their complementary expertise in order to speed up the path to market of the product. This collaboration goes on to respond to the evolving requirements of the biologics market, as the growing complexity in modalities as well as regulatory expectations go on to drive the demand when it comes to integrated and science-driven solutions. Clients are surely going to benefit from a unified interface along with aligned project teams, decreasing the tech transfer risks and also helping with a much faster progression right from an early development to clinical as well as commercial stages.</p>
<p>To cater to the requirements of the biologics market, Coriolis Pharma goes on to bring a very distinct combination of in silico as well as wet lab formulation and also drug product development expertise, scientific depth along with advanced analytical ability to this collaboration. Due to a legacy of scientific excellence along with the commitment to innovation, Coriolis goes on to support every drug development phase, be it R&amp;D or GMP. The collaborative approach, along with the deep scientific expertise of the company, makes them a dependable partner from discovery to commercial manufacturing as well as lifecycle management.</p>
<p>On the other hand, Rentschler Biopharma brings quite an extensive experience within the bioprocess development and manufacturing for multiple biotherapeutics that are backed by a robust track record of dependability as well as quality. Because of a long-standing commitment to client-centric solutions, Rentschler Biopharma offers very strong support from process development to commercial supply. Through focusing on technical excellence, long-term partnerships as well as customised solutions, Rentschler Biopharma makes sure of successful outcomes across each and every stage of the project.</p>
<p>According to the Chief Executive Officer of Coriolis Pharma, Silvia Steyrer-Gruber, at Coriolis, they believe that scientific excellence, client-focused innovation along with robust partnerships are indeed key to advancing the intricate biopharmaceutical programs in an efficient and reliable way. With Rentschler Biopharma, they have a dependable partner whose process development as well as manufacturing expertise ideally complements their deep understanding when it comes to formulation development as well as analytical services. This collaboration is indeed a testament to their Coriolis partnering strategy, which makes use of synergistic relationships throughout the biopharma ecosystem. Together, they can indeed offer clients connected and science-driven solutions that help them move their projects towards success. She added that their teams look forward to working closely along with Rentschler Biopharma on this collab. Apparently, the integrated service offering is going to be available to clients from December 2025. Both the organizations have operations across Germany and the United States, which in a way offer global reach as well as local access for clients in major biopharmaceutical markets.</p>The post <a href="https://www.pharmaadvancement.com/manufacturing/cdmo-crdo-partner-for-requirements-of-the-biologics-market/">CDMO-CRDO Partner For Requirements of the Biologics Market</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>Alvotech and Advanz Pharma Secure EC Approval for Gobivaz</title>
		<link>https://www.pharmaadvancement.com/drug-development/alvotech-and-advanz-pharma-secure-ec-approval-for-gobivaz/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Thu, 27 Nov 2025 11:56:09 +0000</pubDate>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[News]]></category>
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					<description><![CDATA[<p>Key takeaways: EC approval of Gobivaz gives Alvotech and Advanz Pharma a stronger foothold in Europe’s competitive biosimilar segment. The authorisation widens the companies’ reach in immune-mediated therapies by adding a multi-indication biosimilar to their portfolio. Gobivaz’s clinical and pharmacokinetic evidence base reinforces its positioning as a comparable treatment option across several immune-mediated conditions. Alvotech [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/drug-development/alvotech-and-advanz-pharma-secure-ec-approval-for-gobivaz/">Alvotech and Advanz Pharma Secure EC Approval for Gobivaz</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p><strong>Key takeaways:</strong></p>
<ul>
<li><strong>EC approval of Gobivaz gives Alvotech and Advanz Pharma a stronger foothold in Europe’s competitive biosimilar segment.</strong></li>
<li><strong>The authorisation widens the companies’ reach in immune-mediated therapies by adding a multi-indication biosimilar to their portfolio.</strong></li>
<li><strong>Gobivaz’s clinical and pharmacokinetic evidence base reinforces its positioning as a comparable treatment option across several immune-mediated conditions.</strong></li>
</ul>
<p>Alvotech and Advanz Pharma have secured European Commission marketing authorisations for Gobivaz, marking the first approval in the European Economic Area for a biosimilar referencing Simponi (golimumab).</p>
<p>The green light extends to Gobivaz 50 mg/0.5 mL and 100 mg/mL, which will be available in both pre-filled syringe formats equipped with a passive needle safety guard as well as autoinjector. The therapy is cleared for adult patients with rheumatoid arthritis when used with methotrexate, psoriatic arthritis either in combination with or without methotrexate, axial spondyloarthritis, ulcerative colitis, and for children aged two or older with juvenile idiopathic arthritis in combination with methotrexate.</p>
<p>Robert Wessman, Chairman and Chief Executive Officer of Alvotech, said: “This milestone marks the second biosimilar to receive approval through our partnership with Advanz Pharma and further strengthens the commercial presence we are building in Europe. As the first biosimilar to Simponi (golimumab) to gain approval in the European market, we are committed to expanding access to high quality biologic medicines for people living with immune-mediated diseases while providing value to healthcare systems throughout the region.”</p>
<p>Steffen Wagner, Chief Executive Officer of Advanz Pharma, added: “We welcome the EC approval of Gobivaz, an important milestone in our partnership with Alvotech. Expanding access to high-quality biosimilars is central to Advanz Pharma’s mission, and this approval enables us to offer patients across Europe a valuable new treatment option for immune-mediated diseases.”</p>
<p>The collaboration between Alvotech and Advanz outlines a clear division of responsibilities: Alvotech oversees development and commercial supply, while Advanz Pharma manages registration and has exclusive commercialisation rights for the EEA and the UK.</p>
<p>The EC decision rests on a totality of evidence, supported by clinical and pharmacokinetic studies that demonstrated the biosimilar’s comparability. With this authorisation now in place, the two companies are positioned to further scale their biosimilar footprint across Europe’s immune-mediated disease landscape.</p>The post <a href="https://www.pharmaadvancement.com/drug-development/alvotech-and-advanz-pharma-secure-ec-approval-for-gobivaz/">Alvotech and Advanz Pharma Secure EC Approval for Gobivaz</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>Bayer Secures EU Approval for Lynkuet Menopause Treatment</title>
		<link>https://www.pharmaadvancement.com/drug-development/bayer-secures-eu-approval-for-lynkuet-menopause-treatment/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Fri, 21 Nov 2025 10:24:33 +0000</pubDate>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[FDA Approvals]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[FDA]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/bayer-secures-eu-approval-for-lynkuet-menopause-treatment/</guid>

					<description><![CDATA[<p>Bayer has secured regulatory clearance in both the United States and the European Union for Lynkuet, a non-hormonal therapy for vasomotor symptoms (VMS), marking a significant step in the company’s effort to expand its global women’s health portfolio. The back-to-back approvals position Lynkuet as one of Bayer’s most strategically important pipeline assets, reflecting the commercial [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/drug-development/bayer-secures-eu-approval-for-lynkuet-menopause-treatment/">Bayer Secures EU Approval for Lynkuet Menopause Treatment</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>Bayer has secured regulatory clearance in both the United States and the European Union for Lynkuet, a non-hormonal therapy for vasomotor symptoms (VMS), marking a significant step in the company’s effort to expand its global women’s health portfolio.</p>
<p>The back-to-back approvals position Lynkuet as one of Bayer’s most strategically important pipeline assets, reflecting the commercial potential of a product aimed at a rapidly expanding patient base and a therapeutic category undergoing accelerated innovation. With decisions now finalised on both sides of the Atlantic, Bayer is preparing to scale the rollout across major pharmaceutical markets.</p>
<p>The European Commission has authorised Lynkuet menopause treatment (elinzanetant) for moderate to severe VMS linked to menopause or endocrine treatment for breast cancer. This follows the FDA’s approval, granted roughly one month earlier, for the menopause-related VMS indication in the U.S. The drug, an oral neurokinin (NK) 1 and 3 antagonist, enters a competitive field currently led by Astellas’ NK 3 antagonist Veozah/Veoza (fezolinetant), which received its first approval in 2023 for menopause-related VMS.</p>
<p>Market interest in non-hormonal VMS therapies has grown steadily, with Astellas reporting that Veozah/Veoza sales rose nearly 55% in the first six months of the current fiscal year to approximately $146 million. However, updated FDA labeling that includes a warning on rare but serious liver injury has reshaped expectations for the product’s long-term growth. Lynkuet menopause treatment faces related considerations, as its use has been linked to elevated liver enzyme levels requiring regular blood-test monitoring.</p>
<p>Bayer has positioned Lynkuet as its next major pharmaceutical launch, planning commercial availability in the U.S. this month. The therapy has now been approved in the U.S., EU, UK, Australia, Canada, and Switzerland. Demand potential is extensive: an estimated 1.2 billion women worldwide are expected to experience menopause by 2030, while millions receive breast cancer diagnoses each year, with about 70% presenting HR-positive tumours treated with endocrine therapies that commonly induce VMS.</p>
<p>“Menopause symptoms, including hot flashes, can greatly affect women’s quality of life,” said Nick Panay, a gynaecologist at Imperial College London and a principal investigator in one of the supporting clinical trials. “This approval is an important milestone in the area of menopause care as it expands therapeutic options for women experiencing distressing menopause symptoms with a novel targeted hormone-free treatment and facilitates healthcare professionals to achieve more personalised treatment,” he added.</p>
<p>A potential variable for the drug’s commercial trajectory is the FDA’s recent removal of black-box warnings related to breast cancer, cardiovascular disease, and dementia from hormone replacement therapies (HRT), a shift that could renew interest in hormonal treatments and influence uptake of newer non-hormonal options.</p>The post <a href="https://www.pharmaadvancement.com/drug-development/bayer-secures-eu-approval-for-lynkuet-menopause-treatment/">Bayer Secures EU Approval for Lynkuet Menopause Treatment</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>Lilly to Build $3B Manufacturing Facility in Netherlands</title>
		<link>https://www.pharmaadvancement.com/manufacturing/lilly-to-build-3b-manufacturing-facility-in-netherlands/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Thu, 06 Nov 2025 08:32:21 +0000</pubDate>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Facilities & Operation]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[News]]></category>
		<category><![CDATA[Eli Lilly]]></category>
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					<description><![CDATA[<p>Eli Lilly and Company is investing $3 billion to build a new manufacturing facility in Katwijk, the Netherlands, within the Leiden Bio Science Park. Seen as a major milestone in Lilly’s global expansion, the project is designed to expand the company’s capacity for oral medicine production and strengthen the resilience of its supply chain. At [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/manufacturing/lilly-to-build-3b-manufacturing-facility-in-netherlands/">Lilly to Build $3B Manufacturing Facility in Netherlands</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>Eli Lilly and Company is investing $3 billion to build a new manufacturing facility in Katwijk, the Netherlands, within the Leiden Bio Science Park. Seen as a major milestone in Lilly’s global expansion, the project is designed to expand the company’s capacity for oral medicine production and strengthen the resilience of its supply chain.</p>
<p>At the new manufacturing facility, Lilly will manufacture a variety of oral solid medicines spanning key therapeutic areas, including cardiometabolic health, neuroscience, oncology, and immunology. It will also include advanced production systems like dock-to-dock automation, paperless operations, and analytical technologies to enhance efficiency and uphold high manufacturing standards. The site will also use spray-dried dispersion technology to improve the absorption and effectiveness of oral medications. Among its first outputs will be orforglipron, Lilly’s initial oral, small-molecule GLP-1 receptor agonist, which the company intends to submit for global obesity regulatory review by year-end.</p>
<p>“With extensive investments already underway in the U.S., our planned expansion in Europe further strengthens our ability to deliver medicines to patients worldwide. Localized manufacturing ensures we can quickly respond to meet regional demand and accelerate distribution within Europe,” said David A. Ricks, Lilly chair and CEO. “Leiden Bio Science Park offers access to a skilled workforce, reliable infrastructure and proven pharmaceutical manufacturing capabilities. We look forward to working closely with the EU, national and local governments to create a more favorable and predictable policy environment open to fully harnessing innovative medicines to deliver faster access to patients.”</p>
<p>The development is expected to create 500 high-paying positions across engineering, science, operations, and laboratory functions, with an additional 1,500 construction jobs generated during the build phase beginning next year. The investment remains dependent on the completion of government permits and local approvals. “I’m truly proud that Lilly has chosen the Netherlands, Katwijk and the Leiden Bio Science Park after considering many locations across Europe,” said Vincent Karremans, minister of Economic Affairs of the Netherlands. “The arrival of Lilly will not only bring new jobs and investments but also boost collaboration in the field of innovative medicines, helping us work together on solutions that truly improve people&#8217;s health and lives.”</p>
<p>Lilly already operates manufacturing sites in France, Ireland, Italy, and Spain and has revealed plans for three additional European Union facilities since 2020 — in Ireland, Germany, and now the Netherlands. The Netherlands’ strong life sciences business climate, recently ranked among the top globally, aligns with Lilly’s continued investment in regional production. “At Lilly, we are investing in next-generation manufacturing facilities around the world to ensure our medicines are made and distributed closer to the communities and patients we serve,” said Edgardo Hernandez, executive vice president and president of Lilly Manufacturing Operations. “Expanding our capabilities in Europe strengthens our global supply chain and reflects our commitment to getting innovative treatments to patients who need them.” He added that each new facility is designed to achieve carbon neutrality and eliminate waste to landfills.</p>
<p>The company has also disclosed ongoing manufacturing expansion in Puerto Rico and new facility developments in Texas and Virginia, with announcements on two additional U.S. locations expected in the coming months.</p>The post <a href="https://www.pharmaadvancement.com/manufacturing/lilly-to-build-3b-manufacturing-facility-in-netherlands/">Lilly to Build $3B Manufacturing Facility in Netherlands</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>AstraZeneca Secures EU Approval for Koselugo to Treat NF1 PN</title>
		<link>https://www.pharmaadvancement.com/drug-development/astrazeneca-secures-eu-approval-for-koselugo-to-treat-nf1-pn/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Fri, 31 Oct 2025 13:18:48 +0000</pubDate>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/astrazeneca-secures-eu-approval-for-koselugo-to-treat-nf1-pn/</guid>

					<description><![CDATA[<p>Alexion, an AstraZeneca rare disease, has received EU approval for Koselugo (selumetinib), its oral, selective MEK inhibitor, to treat symptomatic, inoperable plexiform neurofibromas (PN) in adult patients diagnosed with neurofibromatosis type 1 (NF1). The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/drug-development/astrazeneca-secures-eu-approval-for-koselugo-to-treat-nf1-pn/">AstraZeneca Secures EU Approval for Koselugo to Treat NF1 PN</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>Alexion, an AstraZeneca rare disease, has received EU approval for Koselugo (selumetinib), its oral, selective MEK inhibitor, to treat symptomatic, inoperable plexiform neurofibromas (PN) in adult patients diagnosed with neurofibromatosis type 1 (NF1). The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient group.</p>
<p>NF1 is a rare genetic disorder that usually appears in early childhood and often carries on into adulthood, affecting several organ systems along the way. As many as half of people with the condition can develop PN, a non-cancerous tumour that forms in the brain, spinal cord, or peripheral nerves. Over time, these growths can enlarge and cause pain, disfigurement, or muscle weakness, along with other complications.</p>
<p>Prof. Pierre Wolkenstein, MD, PhD, Head of Dermatology at Henri Mondor Hospital, APHP, Paris East University (UPEC), and European National Coordinating Investigator of the KOMET trial, said: “The approval of Koselugo for adults with NF1 PN in Europe offers patients and physicians a meaningful approach to close treatment gaps beyond childhood. As demonstrated in the KOMET Phase III trial, the most robust late-stage clinical trial conducted in this patient group to-date, adults administered Koselugo saw significant tumour volume reduction with a safety profile consistent with its established use in paediatric patients, validating the clinical benefits of Koselugo for newly diagnosed adults and those transitioning to adult care.”</p>
<p>Marc Dunoyer, Chief Executive Officer at Alexion, commented: “The European Commission approval extends the life-changing potential of Koselugo to adults with NF1 PN in the region, including continuity of care into adulthood. This milestone, along with our pioneering leadership in NF1 PN treatment landscape, embodies Alexion’s unwavering commitment to addressing the unmet needs in the rare disease community. We look forward to bringing Koselugo to those adults in need across Europe as soon as possible.”</p>
<p>In the primary analysis of KOMET, Koselugo demonstrated a statistically significant objective response rate (ORR) of 20% (n=14/71, 95% CI: 11.2, 30.9) compared with 5% for placebo (n=4/74, 95% CI: 1.5, 13.3; p=0.01) by cycle 16. Following 12 cycles, patients receiving placebo were switched to Koselugo, while those already on Koselugo continued therapy for another 12 cycles. The drug’s safety profile in adults aligned with its established performance in paediatric use.</p>
<p>In addition to EU approval for Koselugo, the drug has also secured approval in Japan and several other markets for the treatment of adult NF1 patients with symptomatic, inoperable PN, based on data from the KOMET Phase III trial, with additional regulatory assessments currently underway.</p>The post <a href="https://www.pharmaadvancement.com/drug-development/astrazeneca-secures-eu-approval-for-koselugo-to-treat-nf1-pn/">AstraZeneca Secures EU Approval for Koselugo to Treat NF1 PN</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>UK Grants Pharma Firms Early Access to Aligned Pathway</title>
		<link>https://www.pharmaadvancement.com/drug-development/uk-grants-pharma-firms-early-access-to-aligned-pathway/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Tue, 14 Oct 2025 07:01:05 +0000</pubDate>
				<category><![CDATA[Drug Development]]></category>
		<category><![CDATA[Europe]]></category>
		<category><![CDATA[Manufacturing]]></category>
		<category><![CDATA[News]]></category>
		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/uk-grants-pharma-firms-early-access-to-aligned-pathway/</guid>

					<description><![CDATA[<p>Pharmaceutical companies producing qualifying medicines can now benefit from an accelerated approvals pathway, gaining access significantly earlier than initially expected. The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are offering early access to the aligned pathway six months ahead of schedule, as initial user research [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/drug-development/uk-grants-pharma-firms-early-access-to-aligned-pathway/">UK Grants Pharma Firms Early Access to Aligned Pathway</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p>Pharmaceutical companies producing qualifying medicines can now benefit from an accelerated approvals pathway, gaining access significantly earlier than initially expected.</p>
<p>The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) are offering early access to the aligned pathway six months ahead of schedule, as initial user research helps shape the programme’s next phase. Manufacturers whose medicines have received early access designation from NICE and the MHRA can now submit applications to the pathway.</p>
<p>Designed to support the government’s Regulatory Action Plan, the 10-Year Health Plan for England, and the Life Sciences Sector Plan, the aligned pathway integrates regulatory processes to speed up patient access and enhance the UK’s global competitiveness in life sciences. The pathway brings together the MHRA’s licensing process and NICE’s value assessment so that decisions come out at the same time, instead of one after the other. This cuts the 90-day gap between marketing authorisation and NICE guidance, giving patients quicker access, helping the NHS, and creating a smoother process for the industry.</p>
<p>A fully integrated joint scientific advice service will launch by April 2026, providing a single entry point for coordinated guidance from both organisations. It is designed to help companies prevent delays, get clarity on evidence requirements early, and keep to the pathway timelines. It also aims to give firms more confidence in their investment decisions.</p>
<p>Pharmaceutical companies are encouraged to register products on UK PharmaScan at least three years before they seek marketing authorisation and to engage early with both the MHRA and NICE. Both organisations remain committed to working closely together to improve efficiency, transparency, and timely access to innovative treatments.</p>
<p>The aligned pathway, which MHRA and NICE announced in July 2025 after the Regulatory Action Plan was published by HMT in March, asks companies to commit globally to its timelines. NICE will prioritise scheduling for medicinal topics on the pathway, so evaluations and regulatory decisions are published at the same time.</p>The post <a href="https://www.pharmaadvancement.com/drug-development/uk-grants-pharma-firms-early-access-to-aligned-pathway/">UK Grants Pharma Firms Early Access to Aligned Pathway</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>ABPI Launches Manifesto to Advance Scottish Pharma Sector</title>
		<link>https://www.pharmaadvancement.com/manufacturing/abpi-launches-manifesto-to-advance-scottish-pharma-sector/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Tue, 23 Sep 2025 08:58:05 +0000</pubDate>
				<category><![CDATA[Europe]]></category>
		<category><![CDATA[Facilities & Operation]]></category>
		<category><![CDATA[Manufacturing]]></category>
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		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/abpi-launches-manifesto-to-advance-scottish-pharma-sector/</guid>

					<description><![CDATA[<p>The Association of the British Pharmaceutical Industry (ABPI) has released its manifesto for the Scottish Government, calling for political leaders to act now and make Scotland a leading partner of choice for life sciences and health innovation.  Titled ABPI Scotland: A Manifesto for Health and Growth, the document was released in advance of the upcoming [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/manufacturing/abpi-launches-manifesto-to-advance-scottish-pharma-sector/">ABPI Launches Manifesto to Advance Scottish Pharma Sector</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p><span style="font-weight: 400;">The Association of the British Pharmaceutical Industry (ABPI) has released its manifesto for the Scottish Government, calling for political leaders to act now and make Scotland a leading partner of choice for life sciences and health innovation. </span></p>
<p><span style="font-weight: 400;">Titled ABPI Scotland: A Manifesto for Health and Growth, the document was released in advance of the upcoming Scottish Parliament elections. It calls on all parties to adopt policies aimed at improving patient outcomes, enhancing NHS delivery, and drawing internationally mobile investment in research, development, and advanced manufacturing. The pharmaceutical sector, the ABPI noted, underpins Scotland’s economy by supporting more than 15,000 high-value jobs and generating over £1.7 billion annually, achievements built on collaboration among the “triple helix” of government (the NHS), academia, and industry.</span></p>
<p><span style="font-weight: 400;">Despite the strengths of Scottish pharma sector, uptake of new medicines remains inconsistent, leaving patients facing what the ABPI described as postcode lotteries and delays. These challenges, it warned, risk deepening inequalities, forcing some to seek private care while others experience worsening health and financial strain. Richard Torbett, Chief Executive of the ABPI, stressed: “Better health and a stronger economy go hand in hand, and Scotland can have both. With the right policy choices, Scotland can become a powerhouse for the discovery, development and delivery of cutting-edge medicines, vaccines and diagnostics. He added: “The next Scottish Parliament offers a critical window to reset industrial and NHS innovation policy to attract investment and benefit patients, but global competition for that investment has never been higher. The opportunity from Scotland’s life sciences sector is real — but unlocking it depends on bold choices that put research, innovation and patient access at the heart of Scotland’s health and industrial strategy.”</span></p>
<p><span style="font-weight: 400;">The manifesto highlights the need to accelerate patient access to new medicines and vaccines, strengthen the Scottish pharma sector in research and innovation, and drive digital transformation through responsible use of health data. Currently, patients wait an average of 374 days for access to licensed medicines, while only 28% of treatments available to European patients are fully accessible in Scotland — compared with 90% in Germany and 37% in England. Torbett emphasized: “Every patient should be able to access Scottish Medicines Consortium (SMC) &#8211; approved treatments quickly, consistently and fairly. Spending on medicines must be recognised as an investment in health as well as NHS efficiency and financial sustainability. By investing in cutting-edge treatments and vaccines, we can drive disease prevention, improve treatable mortality, and generate economic growth for Scotland by reducing economic inactivity.”</span></p>
<p><span style="font-weight: 400;">To address these challenges, the ABPI set out three areas for government focus. </span></p>
<p><span style="font-weight: 400;">First, to guarantee patient access to advanced treatments and vaccines: </span></p>
<ul>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Incentivising rapid adoption by Health Boards</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">ensuring the Scottish Medicines Consortium is properly resourced</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">requiring transparency through adoption reporting</span></li>
</ul>
<p><span style="font-weight: 400;">Second, to establish Scotland as a hub for research and innovation: </span></p>
<ul>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Expanding “triple-helix” collaboration through initiatives such as the CATALYST programme</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Improving transparency in trial income reporting</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">streamlining approvals with </span><span style="font-weight: 400;">“Once for Scotland” approach.</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Reinforcing NHS–industry partnerships. </span></li>
</ul>
<p><span style="font-weight: 400;">Third, to advance the use of health data: </span></p>
<ul>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Implementing a national strategy led by the Health Secretary, </span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Investing in core infrastructure such as disease registries</span></li>
<li style="font-weight: 400;" aria-level="1"><span style="font-weight: 400;">Building public trust through transparent governance and annual progress updates.</span></li>
</ul>The post <a href="https://www.pharmaadvancement.com/manufacturing/abpi-launches-manifesto-to-advance-scottish-pharma-sector/">ABPI Launches Manifesto to Advance Scottish Pharma Sector</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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		<title>Pharmaceutical Tariff Agreed at 15% Under US-EU Trade Deal</title>
		<link>https://www.pharmaadvancement.com/pharma-news/pharmaceutical-tariff-agreed-at-15-under-us-eu-trade-deal/</link>
		
		<dc:creator><![CDATA[API PA]]></dc:creator>
		<pubDate>Tue, 26 Aug 2025 05:52:38 +0000</pubDate>
				<category><![CDATA[Americas]]></category>
		<category><![CDATA[Europe]]></category>
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		<guid isPermaLink="false">https://www.pharmaadvancement.com/uncategorised/pharmaceutical-tariff-agreed-at-15-under-us-eu-trade-deal/</guid>

					<description><![CDATA[<p>Pharmaceutical tariffs between the European Union and the United States will now be limited at 15% under the terms of the latest trade agreement, providing relief for an industry that had faced the possibility of sharp increases. Earlier, US President Donald Trump had indicated that pharmaceuticals would not be covered by the preliminary framework agreed [&#8230;]</p>
The post <a href="https://www.pharmaadvancement.com/pharma-news/pharmaceutical-tariff-agreed-at-15-under-us-eu-trade-deal/">Pharmaceutical Tariff Agreed at 15% Under US-EU Trade Deal</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></description>
										<content:encoded><![CDATA[<p><span style="font-weight: 400;">Pharmaceutical tariffs between the European Union and the United States will now be limited at 15% under the terms of the latest trade agreement, providing relief for an industry that had faced the possibility of sharp increases.</span></p>
<p><span style="font-weight: 400;">Earlier, US President Donald Trump had indicated that pharmaceuticals would not be covered by the preliminary framework agreed upon with the European Commission, a move that would have exposed European drugmakers to pharmaceutical tariff levels as high as 200% or even 250%. This move was in alignment with the president&#8217;s goal to increase domestic production of pharmaceuticals. </span><span style="font-weight: 400;">&#8220;We want pharmaceuticals made in our country,&#8221; President Trump told CNBC.</span></p>
<p><span style="font-weight: 400;">Details released confirmed that pharmaceuticals will be included under the tariff structure, aligning with most other sectors and ensuring a ceiling of 15%. This development reduces the risk of disruptive cost pressures on companies that supply the US market.</span></p>
<p><span style="font-weight: 400;">Ireland, one of the EU’s leading pharmaceutical exporters, had been particularly vulnerable to the proposed higher tariffs. Welcoming the outcome, Ireland’s Deputy Prime Minister and Foreign Minister Simon Harris said, </span><span style="font-weight: 400;">&#8220;This provides an important shield to Irish exporters that could have been subject to much larger tariffs,&#8221; </span></p>
<p><span style="font-weight: 400;">EU Commission President Ursula von der Leyen stressed that the agreement adds predictability for businesses and consumers, describing it as a step toward greater stability in one of the world’s most significant trading partnerships.</span></p>
<p><span style="font-weight: 400;">The decision also safeguards the position of major European drugmakers with strong ties to the US market, including Denmark-based Novo Nordisk, the manufacturer of Ozempic. </span></p>
<p><span style="font-weight: 400;">For the industry, 15% rate represents a crucial safeguard, ensuring that essential supply chains remain steady while broader negotiations between the EU and the US continue.</span></p>The post <a href="https://www.pharmaadvancement.com/pharma-news/pharmaceutical-tariff-agreed-at-15-under-us-eu-trade-deal/">Pharmaceutical Tariff Agreed at 15% Under US-EU Trade Deal</a> appeared first on <a href="https://www.pharmaadvancement.com">Pharma Advancement</a>.]]></content:encoded>
					
		
		
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