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Shareable Insights by Citeline | 28. November 2024 APAC Self-Care Congress: ‘Human Health Without Environmental Health Is Just Not Possible’ •Who should read this? Leaders of consumer health companies, ESG professionals, manufacturing and supply leaders. Government environmental policy makers. •What is it? A report from the APAC Self-Care Congress on discussions around industry initiatives to deal with the global climate crisis. •Why is it important? Many major consumer health companies and industry bodies have signed up to the Global Self-Care Federation’s Charter for Environmentally Sustainable Self-Care launched in 2021. Key priority areas are plastics and packaging, pharmaceuticals in the environment and CO2 footprint. Tackling issues like global recycling requires collaboration with governments.

Shareable Insights by Citeline | 27. November 2024 In The Nick Of Time: Xbrane Picks Up Intas As Global Nivolumab Partner •Who should read this? Biosimilars developers and marketers worldwide. •What is it? A report on a collaboration deal struck between Xbrane and Intas to develop and commercialize globally an Opdivo (nivolumab) biosimilar. •Why is it important? Xbrane was facing severe financial consequences if it failed to strike a partnership deal on one of two lead biosimilar candidates by the end of November. With just days to spare, the firm has secured a development and marketing alliance with Intas/Accord on nivolumab. This article digs into the details of the agreement as well as its strategic significance for both companies.

Shareable Insights by Citeline | 26. November 2024 Q2 Results: What Top Indian Firms Said On China, Deal Appetite, GLP-1s •Who should read this? Competitive intelligence professionals in pharma. •What is it about? Key takeaways from major Indian pharma companies’ latest earnings calls. •Why is it important? It provides a digestible summary of key trends, issues and opportunities. The companies discussed their prospects in the China market, and their strategy around M&A. Meanwhile GLP-1 drugs for diabetes and obesity are generating huge returns for big pharma, and generics players like Dr Reddy’s, Sun Pharma and Cipla are aiming to target the significant Indian market opportunity.

Shareable Insights by Citeline | 25. November 2024 Dose Optimization And Rare Diseases: Doing More With Less •Who should read this? Research, development and regulatory execs in businesses working on rare disease products. •What is it about? The US FDA is encouraging dose optimization for rare diseases, applying some of the same thinking it has in oncology development. •Why is it important? With trial populations especially challenging to recruit in rare diseases, sponsor should focus on gathering more data from each patient.

Europe has the potential to lead the way in biotech innovation, but outdated regulations, lack of financing, and long approval processes are holding us back. We need a clear regulatory framework for new technologies, revising existing laws at both the national and EU levels to support biotech manufacturing and bio-based products. Additionally, legal pathways should be created for European capital-collecting institutions to invest in venture capital (VC), with tax incentives that encourage private investors to engage in this vital sector. It’s time to drive our economy through the power of biology. Learn more at https://lnkd.in/dQ7dj63t Thank you to Marit Hvithamar Rystrøm and Sofie Carsten Nielsen for the initiative.

Digital meeting of the Finance and Taxation Working Group On October 15, the first meeting of the Working Group on Finance & Taxation took place as a digital exchange under the direction of Jens Klein (Insempra) and Holger Reithinger (Forbion). After a round of introductions, in which the two new leaders introduced themselves and their goals and the working group members introduced themselves to each other, the group discussed the draft bill from the Federal Ministry of Finance on the Second Future Financing Act. In principle, the experts assessed the draft positively, as it enables the working group. However, potential for improvement was identified in some areas, so BIO Deutschland is to take a position on these in the coming weeks. The working group also decided to update the financial position paper for the 2025 Bundestag election campaign. To this end, the core demands of the working group's previous paper from the last election campaign were discussed. Task forces were formed for each topic, and in the coming weeks they will examine the extent to which current legislation has sufficiently met the demands or whether there is still a need for demands.

Industrial Cell Technology Symposium in Lübeck At the 2024 Symposium on Industrial Cell Technology, experts from industry and science met to exchange ideas on the latest findings in the field of cell-based biotechnology. The topics ranged from the use of cells for medical applications, bioproduction and nutrition to the use of cell cultures as a basis for research and production of biopharmaceuticals. Major industries in which cell cultures are used include the pharmaceutical and cosmetics industries, the food industry and materials science, for example for the development of bio-based materials. Accordingly, legal frameworks play an important role in the development and application of biotechnological innovations. To this end, the EU is working on risk minimization measures to maintain a leading position in biotechnological innovation while protecting economic security. Viola Bronsema took over the moderation of the panel discussion with representatives from Cellbox Solutions, CellTec Systems and MyriaMeat, who presented their business models and shared their vision of the future with the guests.

Digitales Meeting of the AG Diagnostik The AG Diagnostics met in digital format on October 9. After being welcomed by the AG leader Matthias Probst from QIAGEN, the AG discussed the new cost allowances for in-vitro diagnostics. Those who dialled in agreed that the value of diagnostics was not sufficiently appreciated in the current development. Although diagnostic expenses are low, they determine 60 to 80% of therapy costs. Hortense Deslandesthen presented the company Owkin. She emphasized the importance of decoding complex biology using AI and AI to find the right treatment for each patient. Susanne Albrecht from Thermo Fisher Scientific spoke about the implementation of the AI Act and its significance for diagnostics.

BIO Deutschland at the #financedayleipzig For 18 years, the Finance Day hosted by BIO Deutschland e. V. member Going Public has been dedicated to start-up, growth and capital market financing in the life sciences industry. This year, the event took place in Leipzig for the first time on 24 and 25 October. Andre Hofmann, managing director and CEO of Biosaxony, and Markus Rieger, CEO of Going Public, welcomed the approximately 150 participants to Biocity Leipzig. Presentations, discussion panels and start-up pitches offered insights into the scene. Karin Hofelich, Head of Life Sciences Publishing, invited BIO Deutschland to lead the panel discussion “How to...? Successful locals and beacons from across Germany reveal their secrets of success”. Dr. Anne-Kristin Heninger, Head of Operations, founder and Managing Director of Seamless Therapeutics, Ben Orzelek, Senior Director, Head of Treasury & Investor Relations of ITM Isotope Technologies Munich SE, Jens Ruhe, COO and founder of SciRhom and Marc Struhalla, CEO and founder of c-LEcta GmbH talked about the beginnings of their companies, their financing rounds, their business models and the paths to the future. An entertaining evening event and a tour of the Biocity on the following day rounded off the program. Founded in 1998, GoingPublic Media AG is one of the leading media companies for corporate finance and investment topics. The group operates three cross-media platforms, focusing on the capital market (capital market platform GoingPublic), family businesses/medium-sized companies (platform Unternehmeredition, trade magazine FuS) and life sciences (platform Life Sciences). GoingPublic Media AG (WKN 761210) is listed in the Quotation Board of the Frankfurt Stock Exchange (trading on Xetra) and in M:access, the SME segment of the Munich Stock Exchange.

Visit to State Secretary Judith Pirscher at the Federal Ministry of Education and Research In September, Judith Pirscher, State Secretary at the Federal Ministry of Education and Research (BMBF), invited Oliver Schacht, Chairman of the Board of BIO Deutschland, and Viola Bronsema, the association's Executive Director, to a meeting. The achievements of biotechnology and the opportunities it offers for research and application in a wide range of areas were the subject of the discussion. In particular, Bronsema and Schacht discussed the biotech agenda called for by the association in relation to the recommendations of the German Chancellor's Council for the Future (Zukunftsrat des Bundeskanzlers). Last summer, the Council discussed the economic potential of key technologies for Germany as a business location with the Chancellor. Subsequently, the German Academy of Science and Engineering (acatech) published a dossier entitled “Lost in Translation?” – Approaches to Unleashing the Societal and Economic Potential of Biotechnology. The biotech agenda proposed by BIO Deutschland e. V. reflects the recommendations of the councilors. It envisages the following fields of action: agenda setting, increasing location expertise, setting the regulatory framework, networking and inclusion, cross-value-added and transnational implementation, and better framework conditions for entrepreneurship, a culture of advancement and innovation. The State Secretary explained the measures that have already been initiated and those that are planned by the government, which could also be beneficial for the biotechnology industry. Judith Pirscher has been State Secretary at the Federal Ministry of Education and Research (BMBF) since January 2022. Before moving to Berlin, she was District President of the administrative district of Detmold in North Rhine-Westphalia. From 2011 to November 2019, she served as a state councilor at the Landschaftsverband Westfalen-Lippe for the LWL-Bau- und Liegenschaftsbetrieb and as managing director of the municipal pension funds of Westphalia-Lippe.