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<?xml version="1.0" encoding="UTF-8"?><rss version="2.0" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:wfw="http://wellformedweb.org/CommentAPI/" xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:sy="http://purl.org/rss/1.0/modules/syndication/" xmlns:slash="http://purl.org/rss/1.0/modules/slash/" xmlns:media="http://search.yahoo.com/mrss/" > <channel> <title>International Biopharmaceutical Industry</title> <atom:link href="https://international-biopharma.com/feed/" rel="self" type="application/rss+xml" /> <link>https://international-biopharma.com</link> <description>Supporting Modern Science Through Communication</description> <lastBuildDate>Wed, 07 May 2025 15:08:35 +0000</lastBuildDate> <language>en-GB</language> <sy:updatePeriod> hourly </sy:updatePeriod> <sy:updateFrequency> 1 </sy:updateFrequency> <generator>https://wordpress.org/?v=6.8.1</generator> <image> <url>https://international-biopharma.com/wp-content/uploads/2021/03/IBI-150x150.jpg</url> <title>International Biopharmaceutical Industry</title> <link>https://international-biopharma.com</link> <width>32</width> <height>32</height></image> <item> <title>Rein Therapeutics and Qureight Ltd Announce Planned Integration of Deep-Learning Platform for Phase 2 Trial of LTI-03 in Patients with IPF</title> <link>https://international-biopharma.com/rein-therapeutics-and-qureight-ltd-announce-planned-integration-of-deep-learning-platform-for-phase-2-trial-of-lti-03-in-patients-with-ipf/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Wed, 07 May 2025 15:08:34 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17519</guid> <description><![CDATA[AUSTIN, Texas, May, 2025 (PR Newswire) —Rein Therapeutics (“Rein”) (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, and Qureight Ltd, a Core Imaging Laboratory developing deep-learning image analytics, today announced a collaboration for the integration of Qureight’s deep-learning platform […]]]></description> <content:encoded><![CDATA[<p>AUSTIN, Texas, May, 2025 (PR Newswire) —Rein Therapeutics (“Rein”) (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, and Qureight Ltd, a Core Imaging Laboratory developing deep-learning image analytics, today announced a collaboration for the integration of Qureight’s deep-learning platform into Rein’s planned Phase 2 trial of its lead asset LTI-03, a novel, multi-pathway, Caveolin-1-related peptide, for the treatment of idiopathic pulmonary fibrosis (IPF). </p> <p>Rein previously announced <a href="https://ir.reintx.com/news-releases/news-release-details/aileron-therapeutics-announces-positive-topline-data-cohort-2" target="_blank" rel="noreferrer noopener">positive topline results</a> from Cohort 2 (5 mg BID) of the Phase 1b clinical trial of LTI-03 in IPF, in which a positive trend was observed in seven out of eight biomarkers evaluated, with five biomarkers demonstrating dose-dependent effects and four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set.</p> <p>The Phase 2 clinical trial of LTI-03 will evaluate the safety and tolerability of LTI-03 in patients with IPF, as well as its activity across multiple biomarkers, and measure lung function and the potential for healthy tissue regeneration. In the trial, Qureight will provide full end-to-end imaging core lab services, including site qualification, data handling, quality control and deep-learning AI image analysis. Qureight’s deep-learning platform will be used to analyze lung imaging data and identify potential correlations between any volumetric changes within the lungs of IPF patients and LTI-03’s activity across the biomarkers. Qureight’s AI tools will measure the volume of fibrotic, vascular and airway lung compartments to allow a more detailed examination of LTI-03’s potential ability to simultaneously modulate pro-fibrotic activity and protect critical alveolar epithelial cells. Additionally, Qureight’s technology is designed to improve the efficiency of the clinical trial workflow and significantly reduce the time required for image interpretation, in turn accelerating the trial. </p> <p>“In our Phase 1b clinical trial of LTI-03, we emphasized the importance of biomarkers for measuring progress in patients with IPF treated with LTI-03 as well as for illustrating the dual mechanism of LTI-03 in the body,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Rein Therapeutics. “We are taking the evaluation of biomarkers a step further with the application of cutting-edge deep-learning imaging technology and detailed AI-based data analysis by collaborating with Qureight on this Phase 2 trial. These tools will be critical in gaining a deeper understanding of the potential therapeutic effect of LTI-03.”</p> <p>Dr. Muhunthan Thillai, Chief Executive Officer of Qureight, said, “We’re delighted that our core platform and AI technology will be supporting Rein Therapeutics in advancing its treatment, LTI-03, for patients with IPF. Our AI tools will provide precise, quantitative insights into how LTI-03 affects lung structure and function. This partnership represents another milestone in accelerating fibrotic lung disease treatment, which is so desperately needed for patients.”</p> <p>Rein plans to announce further details on the design of the Phase 2 trial of LTI-03 in IPF in the near term.</p>]]></content:encoded> </item> <item> <title>ELRIG Announces Keynote Speakers for Drug Discovery 2025</title> <link>https://international-biopharma.com/elrig-announces-keynote-speakers-for-drug-discovery-2025/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Wed, 07 May 2025 15:07:24 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17517</guid> <description><![CDATA[·       Prof Heather Pinkett and Dr Dafydd Owen to lead ELRIG’s flagship event ·       Drug Discovery returns to Liverpool, 21–22 October 2025 to celebrate “A Festival of Life Science” ·       Event supported by VisitBritain showcases UK life science sector and extends international reach ELRIG, a not-for-profit, volunteer-led organisation dedicated to the global drug discovery community, has revealed the […]]]></description> <content:encoded><![CDATA[<p>· <em>Prof Heather Pinkett and Dr Dafydd Owen to lead ELRIG’s flagship event</em></p> <p>· <em>Drug Discovery returns to Liverpool, 21–22 October 2025 to celebrate “A Festival of Life Science”</em></p> <p>· <em>Event supported by VisitBritain showcases UK life science sector and extends international reach</em></p> <p>ELRIG, a not-for-profit, volunteer-led organisation dedicated to the global drug discovery community, has revealed the keynote speakers for its flagship event, Drug Discovery 2025. Taking place at the ACC in Liverpool, UK from 21–22 October, the conference will feature presentations from Professor Heather Pinkett (Northwestern University) and Dr Dafydd Owen (Pfizer Medicine Design).<br><br>Held under the theme “<em>A Festival of Life Science</em>”, Drug Discovery 2025 is a celebration that aims to unite scientists from industry and academia working toward the same goal: improving human health through more effective drug discovery. The event offers free access to over 150 talks across 14 scientific tracks, covering topics such as advances in robotics and automation,<em> </em>advanced models for drug discovery, hit-finding approaches in neurodegenerative disease therapeutics, chemical biology and omics, translating ideas into therapies, as well as sustainable drug development. ELRIG is also collaborating with organisations including SLAS, the British Pharmacological Society, the Royal Society of Chemistry, Cancer Research Horizons, The Protein Society, SiLA and Alzheimer’s Research UK to bring a broad range of content. To further its international outreach, <a href="https://elrig.org/elrig-awarded-grant-from-visit-britain/" target="_blank" rel="noreferrer noopener">ELRIG has partnered with VisitBritain</a> to provide the opportunity for global drug discovery researchers to experience the UK life science sector first-hand and contribute their perspectives to the conversation.</p> <p><br>The conference will host 200+ exhibitors, a “<em>Breakthrough Zone</em>” for startups, a Tech Theatre, and dedicated events for early-career professionals (ECPs), including “<em>Network Like a Boss</em>” and “<em>Meet & Greet</em>” sessions. Awards will also recognise innovation, rising stars from the ECP community, and individuals who have made outstanding contributions to both ELRIG and the drug discovery field.<br><br>Prof Heather Pinkett leads research at Northwestern University into the structure, function, and regulation of membrane proteins with a particular emphasis on ATP-binding cassette (ABC) transporters, proteins that use ATP hydrolysis to transport substrates across cellular membranes. She is also the Director of the NIH Molecular Biophysics Training Program at Northwestern, a member of the editorial board of the <em>Journal of Molecular Biology,</em> and President-Elect of The Protein Society. Prof Pinkett will present “<em>Targeting ABC Transporters: Structural Prediction and Computational Strategies Against AMR</em>” on the first day.</p> <p><strong>Prof Heather Pinkett, Associate Professor, Department of Molecular Biosciences at Northwestern University, commented:</strong> “<em>I’m excited to engage with scientists from across academia and industry and to deliver the opening keynote at Drug Discovery 2025</em>.” <br><br>Dr Dafydd Owen is a Senior Scientific Director at Pfizer with 25 years’ experience in medicinal chemistry. He has delivered over 150 invited lectures, is an author on over 80 research papers and patents, and has received several innovation and leadership awards. He serves as a Structural Genomics Consortium board member and was on the <em>Journal of Medicinal Chemistry</em> editorial advisory board until 2022. Dr Owen will discuss “<em>Drug Discovery During the Pandemic: The Discovery of PAXLOVID</em>” during his presentation on the second day.</p> <p><strong>Dr Dafydd Owen, Senior Scientific Director at Pfizer Medicine Design, added:</strong> <em>“It’s an honour to share the science behind PAXLOVID and to celebrate global innovation in drug discovery at ELRIG’s flagship event.”</em><br><br><strong>Dr Del Trezise, Chair of ELRIG, and Strategy Development, Laboratory Products and Services at Sartorius, said:</strong> <em>“We’re thrilled to welcome Prof Pinkett and Dr Owen to Drug Discovery 2025. With over 3,000 delegates expected, this promises to be Europe’s leading event for the drug discovery community.”</em></p> <p><strong>Sanj Kumar, CEO of ELRIG, added:</strong><em> “ELRIG’s partnership with VisitBritain underscores the importance of international collaboration in accelerating scientific and economic progress.”</em><br><br>Learn more and register at: <a href="http://elrig.org/portfolio/drug-discovery-2025" target="_blank" rel="noreferrer noopener">elrig.org/portfolio/drug-discovery-2025</a></p>]]></content:encoded> </item> <item> <title>DFE Pharma achieves ISO 22301 Certification for Business Continuity Management Systems</title> <link>https://international-biopharma.com/dfe-pharma-achieves-iso-22301-certification-for-business-continuity-management-systems/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Wed, 07 May 2025 15:04:28 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17515</guid> <description><![CDATA[This certificate recognizes that DFE Pharma’s head office in Goch, Germany, ensures the continuity of critical business functions and the secure supply of pharmaceutical excipients. DFE Pharma, a global leader in pharma- and nutraceutical excipient solutions, has achieved the ISO 22301 certification for Business Continuity Management Systems (BCMS) at its head office at Goch, Germany. This certification demonstrates […]]]></description> <content:encoded><![CDATA[<p><strong><em>This certificate recognizes that DFE Pharma’s head office in Goch, Germany, ensures the continuity of critical business functions and the secure supply of pharmaceutical excipients.</em></strong></p> <p><a href="https://dfepharma.com/" target="_blank" rel="noreferrer noopener">DFE Pharma</a>, a global leader in pharma- and nutraceutical excipient solutions, has achieved the <a href="https://www.iso.org/obp/ui/en/#iso:std:iso:22301:ed-2:v1:en" target="_blank" rel="noreferrer noopener">ISO 22301</a> certification for Business Continuity Management Systems (BCMS) at its head office at Goch, Germany. This certification demonstrates DFE Pharma’s commitment to ensuring that its critical business functions and infrastructure are prepared to safeguard operations and maintain consistent excipient availability.</p> <p>The ISO 22301 certification is awarded following a rigorous, independent, third-party assessment that evaluates a company’s ability to maintain operations and deliver products and services to its customers in the event of any possible contingencies. DFE Pharma has successfully completed this auditing process, proving its robust preparedness for responding to disruptions and sustaining operations continuity during the most challenging and unexpected circumstances.</p> <p>As a core area of its strategy, DFE Pharma has been developing and implementing its robust BCMS over an extended period. This plan is designed to respond to disruptions, ensuring the company can continue operations during crises; increase resilience levels and recovery capabilities; minimize downtime during incidents, and reduce recovery time.</p> <p><a></a><strong>Sven Abend, Chief Executive Officer (CEO) </strong>at DFE Pharma, stated: <em>“</em><em>For over 125 years, DFE Pharma has been committed to delivering premium-quality excipients and expert solutions through a reliable supply chain. In light of increasing global uncertainties, ensuring business continuity has become more crucial than ever. Our achievement of ISO 22301 certification underscores our proactive and enduring commitment to Business Continuity Management. Our customers can be confident that, regardless of the circumstances, DFE Pharma has established the necessary capabilities to mitigate risks, prevent disruptions, and guarantee the consistent supply of our excipients”.</em></p> <p></p>]]></content:encoded> </item> <item> <title>Almac Discovery and Formosa Pharmaceuticals Announce Global Licensing Agreement for Development and Commercialisation of ALM-401, a First-in-Class EGFRxROR1 Bispecific Antibody-Drug Conjugate</title> <link>https://international-biopharma.com/almac-discovery-and-formosa-pharmaceuticals-announce-global-licensing-agreement-for-development-and-commercialisation-of-alm-401-a-first-in-class-egfrxror1-bispecific-antibody-drug-conjugate/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Wed, 07 May 2025 08:18:10 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17513</guid> <description><![CDATA[Formosa Pharmaceuticals, Inc. (“Formosa”; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery announce a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours. The agreement facilitates the next phases of […]]]></description> <content:encoded><![CDATA[<p>Formosa Pharmaceuticals, Inc. (“Formosa”; 6838.TW ticker-symbol on the Taiwan Stock Exchange) and Almac Discovery announce a global licensing agreement for development and commercialisation of ALM-401, a first-in-class engineered bispecific Antibody-Drug Conjugate (ADC), addressing the high unmet needs of cancer patients worldwide suffering with intractable and aggressive solid tumours.</p> <p>The agreement facilitates the next phases of CMC and drug development by Formosa, including IND submission and early clinical proof-of-concept in international clinical trials.</p> <p>ALM-401 has been the culmination of a multi-year R&D programme at Almac Discovery deploying their proprietary OmniaScape<img src="https://s.w.org/images/core/emoji/15.1.0/72x72/2122.png" alt="™" class="wp-smiley" style="height: 1em; max-height: 1em;" /> informatics platform, protein engineering and medicinal chemistry capabilities.</p> <p>The design of ALM-401 has built upon the recent clinical successes within the ADC field, including selection of a linker-payload matched to potential clinical cancer indications, and the molecule also benefits from being approximately half the size of conventional ADCs, thereby facilitating enhanced solid tumour penetration. The main features of ALM-401 include:</p> <ul class="wp-block-list"><li>Innovative bi-specific target-pairing based on co-expression and functional analysis of specific, aggressive solid tumours</li> <li>Sustained high-efficacy <em>in vivo</em> in PDX models; as presented at the 2025 American Association for Cancer Research (AACR; Chicago) annual meeting</li> <li>Half-the-size of conventional ADCs for enhanced solid tumour penetration and optimised manufacturing.</li></ul> <p>Formosa Pharmaceuticals, Inc. (6838.TW) is a clinical stage biotechnology company with primary focus in the areas of ophthalmology and oncology, with particular CMC and manufacturing expertise for specialist ADC therapeutics. “Formosa Pharma is pleased to have this opportunity to bring ALM-401 into our development pipeline. This novel, next-generation ADC complements our corporate strategy and resources and promises to deliver a differentiated therapy to cancer patients worldwide. We look forward to collaborating closely with Almac Discovery in advancing this exciting program through clinical trials, commercialization, and beyond.” said Dr. Erick Co, President and CEO of Formosa Pharmaceuticals.</p> <p>“We are pleased to have met Formosa’s exacting selection requirements for Next Generation ADC candidates,” said Dr Stephen Barr, President and Managing Director of Almac Discovery. “This agreement allows the seamless progression of the molecule into clinical evaluation, driven by Formosa.”</p> <p>“In addition to an excellent preclinical efficacy profile, high-quality, robust and scalable CMC and manufacturing is a key competitive advantage for ADCs in the fast-moving race for effective cancer therapeutics” commented Dr Graham Cotton, Vice-President of Protein Therapeutics, Almac Discovery.</p>]]></content:encoded> </item> <item> <title>AI and Automation Skills Critical for Future Biopharma Engineers</title> <link>https://international-biopharma.com/ai-and-automation-skills-critical-for-future-biopharma-engineers/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Tue, 06 May 2025 10:51:16 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17503</guid> <description><![CDATA[AI and automation skills will be in demand as biopharma embraces digitization according to Atlantic Technological University expert. The next generation of biopharmaceutical engineers will need hands-on experience with AI and process automation in regulated environments, as well as the adaptability to learn new skills, for a successful career. The prediction comes from Neville McClenaghan, […]]]></description> <content:encoded><![CDATA[<p>AI and automation skills will be in demand as biopharma embraces digitization according to Atlantic Technological University expert.</p> <p>The next generation of biopharmaceutical engineers will need hands-on experience with AI and process automation in regulated environments, as well as the adaptability to learn new skills, for a successful career.</p> <p>The prediction comes from Neville McClenaghan, PhD, professor and head of life sciences at the Atlantic Technological University (ATU) in Sligo, Ireland, who tells <em>GEN</em> that innovation in drug R&D is reshaping industry skills requirements.</p> <p>“The life sciences sector is one of the fastest-growing and evolving of any industry, with new innovations in drugs and therapies coming all the time. Manufacturing these cutting-edge products inherently requires a workforce with enhanced knowledge and skills.</p> <p>“In addition to core engineering skills, employees need to be able to adapt to new technologies,” McClenaghan says, citing automation, digitalization, and AI as examples.</p> <p>McClenaghan shared his thoughts on changing industry skills requirements shortly after the 15<sup>th</sup> anniversary of ATU’s partnership with Ireland’s National Institute for Bioprocessing Research and Training (NIBRT).</p> <p>Together, the organizations provide training courses designed to give student engineers firsthand experience and relevant skills. Examples include degrees in “Bioindustry 4.0” and “validation and digitization technologies.”</p> <p>In addition, ATU and NIBRT recently launched a post-graduate degree in Advanced Therapy Medicinal Product (ATMPs) manufacturing, where the focus is on cell therapy and viral vector production.</p> <h4 class="wp-block-heading"><strong>Key element</strong></h4> <p>McClenaghan says, “A key element of the ATU-NIBRT partnership is its responsiveness to industry needs, ensuring that students gain theoretical knowledge and hands-on experience. Training at NIBRT’s pilot plant simulates the environments that operate in biopharma, equipping learners with real-world practical skills.</p> <p>“As such, these educational experiences offer the opportunity for upskilling and reskilling of staff and new employees in the biopharma sector with a focus on enhancing the employability and impact of our graduates,” he says.</p> <p>To date, more than 5,000 people have completed training courses developed by ATU and NIBRT. In recognition, <a href="https://www.atu.ie/news/minister-lawless-announces-e1m-hea-performance-funding-for-atu-biopharma-industry-and-education-partnership" target="_blank" rel="noopener">earlier</a> this year, Ireland’s Minister of Further and Higher Education, Research, Innovation and Science, James Lawless, awarded a grant to fund expansion of the program.</p> <p>McClenaghan says, “This HEA funding is a clear endorsement of the impact of the partnership over the past 15 years, and the intent is that ATU will use a large part of this funding to extend and deepen the collaboration.”</p> <p>He cites expanding the “bioprocessing core facility” at ATU’s campus in Sligo, as well as taking part in events targeted at alumni and life science stakeholders, as examples.</p> <p>McClenaghan adds, “The partnership demonstrates how by addressing skills gaps, we continue to support the life sciences sector and enhance Ireland’s global reputation in biopharma manufacturing.</p> <p>“Our graduates directly make a difference by helping to bring life-saving medicines and medical technologies to patients around the world,” he says.</p> <p></p>]]></content:encoded> </item> <item> <title>ArriVent BioPharma Appoints New Board Member</title> <link>https://international-biopharma.com/arrivent-biopharma-appoints-new-board-member/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Tue, 06 May 2025 10:39:15 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17501</guid> <description><![CDATA[ArriVent BioPharma, Inc. (NASDAQ: AVBP), a clinical-stage biopharmaceutical company with a market capitalization of approximately $708 million, announced today the addition of Merdad Parsey, M.D., Ph.D., to its Board of Directors. The company maintains a strong financial health score of 2.72, rated as “GOOD” by the platform’s comprehensive analysis system. Dr. Parsey, with a substantial […]]]></description> <content:encoded><![CDATA[<p>ArriVent BioPharma, Inc. (NASDAQ: AVBP), a clinical-stage biopharmaceutical company with a market capitalization of approximately $708 million, announced today the addition of Merdad Parsey, M.D., Ph.D., to its Board of Directors. The company maintains a strong financial health score of 2.72, rated as “GOOD” by the platform’s comprehensive analysis system. Dr. Parsey, with a substantial background in global clinical development, joins ArriVent during a critical phase as the company prepares for the potential registration of its lead development candidate, firmonertinib, and progresses its antibody drug conjugate (ADC) pipeline.</p> <p>Recently serving as Chief Medical Officer and Executive Vice President at Gilead Sciences, Inc., Dr. Parsey’s career spans significant roles at Genentech, Inc., a member of the Roche Group, and CEO positions at 3-V Biosciences, now known as Sagimet Biosciences, Inc. His expertise extends to academic contributions as a former Assistant Professor of Medicine and Director of Critical Care Medicine at New York University School of Medicine.</p> <p>ArriVent’s Chairman and CEO, Bing Yao, expressed enthusiasm over Dr. Parsey’s appointment, citing his extensive experience and leadership in therapeutic innovation. Dr. Parsey also shared his anticipation for contributing to ArriVent’s mission to transform cancer treatment with novel therapeutics.</p> <p>The company’s lead candidate, firmonertinib, is a focus of their clinical programs, aiming to address unmet medical needs in cancer care. ArriVent’s strategy involves leveraging its team’s drug development experience to advance a portfolio of novel therapeutics, including next-generation ADCs, through approval and commercialization. The company maintains a strong liquidity position with a current ratio of 13.14, and notably holds more cash than debt on its balance sheet, providing financial flexibility for its development programs.</p> <p>The press release also contains forward-looking statements regarding ArriVent’s development plans and strategies, clinical programs, and future operations. These statements are subject to risks and uncertainties, including those detailed in ArriVent’s annual report and filings with the Securities and Exchange Commission. Analyst consensus remains optimistic, with price targets ranging from $36 to $45 per share.</p> <p>This news article is based on a press release statement from ArriVent BioPharma, Inc. and does not include independent verification or endorsements of the claims made. The appointment of Dr. Parsey reflects ArriVent’s commitment to strengthening its leadership as it moves towards key milestones in its clinical development programs.</p> <p>In other recent news, ArriVent BioPharma has garnered attention with several significant developments. The company reported a cash reserve of $266.5 million at the end of the year, which Oppenheimer analysts believe will support operations through 2026. ArriVent also announced the appointment of PricewaterhouseCoopers LLP as its new auditor, replacing KPMG LLP, with no disagreements on accounting practices noted. Meanwhile, H.C. Wainwright maintained a Buy rating with a $39 price target, citing promising clinical data for firmonertinib, an investigational treatment for non-small cell lung cancer. The treatment demonstrated notable efficacy and safety in patients with EGFR PACC mutations. Additionally, B.Riley initiated coverage with a Buy rating and a $37 price target, emphasizing the potential market expansion for firmonertinib. The analyst highlighted the drug’s advantages, such as oral administration and improved tolerability. Oppenheimer also reaffirmed its Outperform rating and $39 price target, reflecting confidence in ArriVent’s strategic initiatives and financial stability.</p> <p></p>]]></content:encoded> </item> <item> <title>Be Biopharma to Present at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting</title> <link>https://international-biopharma.com/be-biopharma-to-present-at-the-american-society-of-gene-and-cell-therapy-asgct-28th-annual-meeting/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Tue, 06 May 2025 10:36:12 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17499</guid> <description><![CDATA[Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting being held in New Orleans, May 13-17, 2025. Details regarding the Be Biopharma presentations at the conference are […]]]></description> <content:encoded><![CDATA[<p>Be Biopharma, Inc. (“Be Bio”), a clinical-stage company pioneering the discovery and development of engineered B Cell Medicines (BCMs), today announced that it will present at the American Society of Gene and Cell Therapy (ASGCT) 28<sup>th</sup> Annual Meeting being held in New Orleans, May 13-17, 2025.</p> <p>Details regarding the Be Biopharma presentations at the conference are as follows:</p> <p><strong>Oral Presentation Title: </strong><em>Ex Vivo</em> Gene Editing of Autologous B Cells Produce Sustained Levels of Tissue Nonspecific Alkaline Phosphatase <em>In Vivo</em> for the Potential Treatment of Hypophosphatasia<br><strong>Presenter:</strong> Hanlan Liu, Ph.D., MBA, SVP, Head of Late Research and NCD, Be Biopharma<br><strong>Date: </strong>May 17, 2025<br><strong>Presentation Time: </strong>10:45 – 11:00 AM CT<br><strong>Session Title: </strong>B-Cell and Solid Organ Therapies<br><strong>Session Time: </strong>10:15 AM – 12:00 PM CT<br><strong>Session Room: </strong>278-282</p> <p>The oral presentation will include nonclinical data for Be Biopharma’s BE-102 program, a novel B cell therapy developed as a potential treatment of Hypophosphatasia (HPP). HPP is caused by deficiency of tissue-nonspecific alkaline phosphatase (TNSALP) activity, resulting from pathogenic mutations in the <em>ALPL</em> gene, which leads to multi-systemic clinical complications including deficient bone mineralization. Enzyme replacement therapy (ERT) is the only approved treatment for HPP which requires frequent lifelong injections. ERT is only available for perinatal/infantile- and juvenile-onset forms of HPP and weekly injections are associated with common side effects that can significantly affect a patient’s quality of life. BE-102 was developed to address these limitations. BE-102 is manufactured from primary human B cells by isolating, activating, and precision engineering with CRISPR/Cas9 followed by AAV-mediated delivery of a DNA donor template for the insertion of human <em>ALPL</em> gene into the CCR5 locus (a safe harbor locus). <em>In vitro </em>pharmacology results demonstrate that BE-102 secretes active TNSALP, which is capable of rescuing calcium deposit inhibited by inorganic pyrophosphate (PPi), a substrate which accumulates in people with HPP.<em> In vivo</em> studies were conducted in immune-deficient NOG-hIL6 mice, confirming long-term engraftment and continuous production of active TNSALP <em>in vivo </em>following a single IV administration of BE-102. Be Biopharma’s <em>in vitro</em> and <em>in vivo</em> pharmacology and safety data established nonclinical proof-of-concept that BE-102 has the potential to be a disease-modifying therapy for people with HPP by providing long-lasting active TNSALP, with the flexibility to be titratable and redosable as needed.</p> <p><strong>Poster Title: </strong>Exploration of Allogeneic Shielding Strategies by Precise CRISPR/Cas9 Genome Engineering of Primary Human B Cells to Enable Off-the-shelf B Cell Medicines for Sustained Delivery of <em>in vivo</em> Biologics<br><strong>Presenter:</strong> Xuqing Zhang, Ph.D., Director, Immunology, Be Biopharma<br><strong>Date: </strong>May 13, 2025<br><strong>Time: </strong>6:00 – 7:30 PM CT<br><strong>Session Title: </strong>Tuesday Poster Reception<br><strong>Session Room: </strong>Poster Hall, Hall I2<br><strong>Final Abstract Number:</strong> 777</p> <p>The abstract highlights Be Biopharma’s approach using both <em>in vitro </em>and <em>in vivo</em> assays to determine the potential of B Cell Medicines (BCMs) as an allogeneic off-the-shelf cell therapy without additional engineering and ways to enhance hypoimmunogenicity via CRISPR/Cas9 genome engineering. The data demonstrates BCMs are immunologically stealthy and can be further engineered to evade host immune responses, opening the possibility of exploring them as off-the-shelf cellular therapies without HLA matching for broader patient access.</p>]]></content:encoded> </item> <item> <title>Hansa Biopharma Appoints New Chief Executive Officer</title> <link>https://international-biopharma.com/hansa-biopharma-appoints-new-chief-executive-officer/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Tue, 06 May 2025 10:31:40 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17497</guid> <description><![CDATA[Hansa Biopharma AB, “Hansa” (Nasdaq Stockholm: HNSA) today announced the appointment of Renée Aguiar-Lucander as Chief Executive Officer (CEO), effective immediately. Søren Tulstrup will be stepping down from his position by mutual agreement as CEO after seven years of dedicated service to the Company. “On behalf of the Board of Directors, I would like to […]]]></description> <content:encoded><![CDATA[<p><strong>Hansa Biopharma AB</strong>, “Hansa” (Nasdaq Stockholm: HNSA) today announced the appointment of Renée Aguiar-Lucander as Chief Executive Officer (CEO), effective immediately. Søren Tulstrup will be stepping down from his position by mutual agreement as CEO after seven years of dedicated service to the Company.</p> <p>“On behalf of the Board of Directors, I would like to extend our gratitude to Søren for his leadership and significant contribution to the company during his tenure. Under his guidance, Hansa has evolved from a clinical-stage company into a commercial-stage biopharmaceutical organization, navigating both transformative progress and substantial challenges. We deeply appreciate Søren’s commitment to the Company and wish him every success in his future endeavors,” said Peter Nicklin, Chairman of the Board, Hansa Biopharma. “With the appointment of Renée as CEO, Hansa is entering a new phase of growth and development. Renée brings extensive experience in both the biopharmaceutical and financial sectors, and her proven leadership will be instrumental in advancing the Company’s strategic positioning. The Board is confident that she is the right person to successfully lead Hansa through this next chapter, and we look forward to working closely with her.”</p> <p>Aguiar-Lucander served for seven years as CEO of Calliditas Therapeutics AB where she successfully led the company through a dual listing on NASDAQ in both Sweden and the U.S. During her tenure, the company successfully launched and commercialized the first ever approved drug for immunoglobulin A (IgA) nephropathy in the U.S. and until it was acquired by Asahi Kasei Corporation of Japan in September 2024. Prior to that, Aguiar-Lucander had a long and successful career in the healthcare investment sector, holding senior roles in funds such as Omega Funds and 3i Group.</p> <p>Aguiar-Lucander said, “I am delighted and honored to take up the position of CEO of Hansa during this exciting and challenging times. I hope to bring relevant perspectives from my previous roles, both with regards to capital raising and management, as well as insights regarding regulatory, commercial preparation and launch dynamics. I look forward to working with the team and Board to ensure Hansa’s future success.”</p> <p>In light of these changes, Hansa’s Q1 2025 interim results conference call, scheduled for 14:00 CEST/8:00am EDT later today, will be hosted by Peter Nicklin (Chairman of the Board), Evan Ballantyne (CFO) and Hitto Kaufmann (Chief R&D Officer), and will be joined by Renée Aguiar-Lucander.</p> <p></p>]]></content:encoded> </item> <item> <title>ElevAAte and the Push for East Asian American Leaders in biopharma</title> <link>https://international-biopharma.com/elevaate-and-the-push-for-east-asian-american-leaders-in-biopharma/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Tue, 06 May 2025 10:28:45 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17495</guid> <description><![CDATA[Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry. In this week’s episode of “The Top Line,” Fierce […]]]></description> <content:encoded><![CDATA[<p>Although East Asians make up a significant share of entry-level roles in U.S. biopharma, few have risen to senior leadership positions. That disparity is what inspired the launch of ElevAAte—a new nonprofit founded this year to support and grow East Asian American leadership in the industry.</p> <p>In this week’s episode of “The Top Line,” Fierce Pharma Deputy Editor Angus Liu speaks with two of ElevAAte’s co-founders: Architect Therapeutics CEO Angie You and Candid Therapeutics CEO Ken Song. The veteran biotech leaders discuss why a group like ElevAAte is needed and how East Asian Americans can harness their collective strength to build the next generation of biopharma executives.</p> <p>You and Song—who led Amunix’s $1.2 billion sale to Sanofi and RayzeBio’s $4.1 billion acquisition by Bristol Myers Squibb, respectively—also share insights from their dealmaking careers and offer advice for young professionals entering the field.</p>]]></content:encoded> </item> <item> <title>Almac Diagnostic Services launches PNPLA3 Genotyping Kit for Liver Disease Research</title> <link>https://international-biopharma.com/almac-diagnostic-services-launches-pnpla3-genotyping-kit-for-liver-disease-research/</link> <dc:creator><![CDATA[chloe]]></dc:creator> <pubDate>Fri, 02 May 2025 08:22:24 +0000</pubDate> <category><![CDATA[news]]></category> <guid isPermaLink="false">https://international-biopharma.com/?p=17492</guid> <description><![CDATA[Almac kit will assist researchers with further insights into MASH / MASLD biology Almac Diagnostic Services, a member of the Almac Group, has today announced the launch of a new PNPLA3 genotyping kit for liver disease research. This novel kit provides accurate genotyping of the PNPLA3 gene within a simple workflow, providing researchers with further […]]]></description> <content:encoded><![CDATA[<p><strong>Almac kit will assist researchers with further insights into MASH / MASLD biology</strong></p> <p>Almac Diagnostic Services, a member of the Almac Group, has today announced the launch of a new PNPLA3 genotyping kit for liver disease research.</p> <p>This novel kit provides accurate genotyping of the PNPLA3 gene within a simple workflow, providing researchers with further biological insights into steatotic liver disease (including MASH and MASLD).</p> <p>The Almac qPCR based kit delivers highly repeatable and reproducible results (≥99%) from blood or buccal swab specimens, with hands-on time of less than 30 minutes. It includes three genotyping assay controls to ensure confidence for researchers in allelic assay calls. </p> <p>Metabolic dysfunction-associated steatotic liver disease (MASLD), is one of the most common forms of chronic liver disease, with an estimated prevalence of about 30% across many countries.<sup>1 </sup>The I148M genotype variant of the PNPLA3 gene is linked to liver disease severity and fibrosis progression even in the absence of classical metabolic dysfunction such as obesity.</p> <p>By providing a reliable method to genotype the PNPLA3 gene, Almac is enabling researchers to identify genetic risk factors to understand the underlying genetic predisposition to MASLD better, to investigate how the I148M variant influences disease severity and fibrosis progression, and to develop future targeted therapies through better disease population understanding.</p> <p>Michael Sloan, Global VP of Commercial Development, Almac Diagnostic Services said: <em>“</em>The launch of the Almac PNPLA3 Genotyping Kit represents our commitment to providing researchers with the tools they need to uncover useful biological information to further precision medicine in liver disease.<em>”</em></p>]]></content:encoded> </item> </channel></rss> If you would like to create a banner that links to this page (i.e. this validation result), do the following:
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