Dr. Andreas Friese

Our colleague, Christian Reinhard, is attending this year's #Digestive #Disease #Week® (#DDW2024) together with our US sister company BUHLMANN Diagnostics Corp. He is presenting the latest research from BÜHLMANN Laboratories AG at this important event for  #gastroenterology experts. Join us for insightful discussions! #DDW #DDW2023 #DigestiveDiseaseWeek #gastroenterology #medicalconference #healthcare #medicine #research #immunology

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🌟Exciting News in Breast Cancer Diagnostics! 🌟 We are thrilled to announce the latest update to the German Uniform Evaluation Standard (EBM) catalogue for the third quarter of 2024, which includes the introduction of a groundbreaking new code, 19466. This code represents a significant advancement in the fight against breast cancer. Code 19466 allows for the targeted determination of ESR1 mutations using circulating tumour #DNA. This test is crucial for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer. It provides a targeted treatment pathway for those whose disease has progressed after at least one line of endocrine therapy, including a CDK 4/6 inhibitor. 🧬 Why is this important? This new code covers the detection of activating mutations E380Q, L536H, Y537C/N/S, and D538G, along with up to four additional activating mutations in the ligand binding domain using PCR-based methods. This precision in detecting mutations ensures that patients receive the most effective, tailored treatment possible, enhancing their chances of positive outcomes. 💰 Tariff and Billing: The tariff for this test is set at €250.61 and can be billed twice if the disease persists. This makes the test not only a scientific breakthrough but also a financially viable option for ongoing patient management. 🔬 Manufactured by: This innovative diagnostic test is developed by QuantideX qPCR ESR1 Mutation Kita leader in precision medicine and diagnostic solutions. Their commitment to advancing healthcare and improving patient outcomes is evident in the introduction of this essential diagnostic tool. By integrating Code 19466 into the #EBM catalogue, Germany is taking a decisive step towards enhancing personalised medicine and providing hope to many battling #breastcancer. This development underscores the importance of continued investment in medical research and the swift adaptation of new technologies into clinical practice. #BreastCancerAwareness #MedicalInnovation #Healthcare #Diagnostics #PrecisionMedicine #Oncology #EBMUpdate #Germany #CancerTreatment #PersonalizedMedicine #HealthcareInnovation www.asuragen.com

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⏰#timeisrunning 📣The countdown for #HUPO2024 just started! Will we see you in Dresden two weeks? ➡️ Check all details here: https://2024.hupo.org/ #HUPO2024 #Proteomics #humanproteomics #clinicalproteomics #Microbiome #cellbiology #Bioinformatics #science

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👉 Although an #RCT was submitted for #Abecma, no additional benefit was granted by the German #HTA body.   Abecma (active substance: idecabtagene vicleucel) is a #CAR-T cell therapy and authorized for treatment of patients with multiple myeloma. Initially, Abecma was authorized for treatment after at least 3 prior therapies in August 2021, after extension of indication in March 2024, Abecma can also be used after only 2 prior therapies. Initial marketing authorization is based on the single-arm study KarMMa, the extension of indication is based on the #RCT KarMMa-3, comparing Abecma to “investigator´s choice”. 🔎 Of note: KarMMa-3 is one of the first multi-comparator RCTs for CAR-T cell therapies in multiple myeloma. Abecma is available in Germany   🏆German HTA rating: To date Abecma was assessed in 2️⃣  German HTAs. First HTA rating from June 2022 resulted in a hint for a non-quantifiable additional benefit, only because of the orphan drug status of Abecma.   In June 2023 Abecma exceeded annual sales of € 30 million and reassessment started in March 2024 (📍 see previous post on #orphan drug reassessment). In the same month Abecma was granted the extension of indication. The according HTA started in April 2024. As this HTA covers also patients with 3 prior therapies, the HTA from March 2024 was suspended.    Reassessment and simultaneous assessment of the new indication was based on the RCT KarMMa-3, comparing Abecma versus “investigator´s choice. The HTA rating from September 2024 resulted in no additional benefit, because Abecma did not show significant advantages in overall survival.   💵 Launch price: € 350,000. Abecma is used as a one-time treatment. Reimbursement price: € 240,000 (so far one price reduction, price negotiation after the latest HTA is not completed, yet). Current rebate: 31 %. An arbitration award for Abecma determined the retroactive effect of the reimbursement price and an extended refund period.   📘 Special features of reimbursement: Abecma is reimbursed. Like other CAR-T cell therapies, Abecma is reimbursed via #NUB fees in hospitals, which meet all requirements of the #ATMP Quality Assurance Guideline.   💡 Orphan drug reassessment usually yields the risk of no additional benefit, due to the lack of comparative data. For Abecma direct comparative data was indeed submitted. However, there was no advantage in overall survival and therefore no additional benefit was granted.

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📢 Pentixapharm AG Acquires Target Discovery Business of Glycotope GmbH, effective July 1st.  This strategic acquisition of the Berlin-based biotech company marks a significant milestone in their mission to develop novel targeted radiopharmaceuticals against a broad range of malignancies. 🌟 𝗞𝗲𝘆 𝗛𝗶𝗴𝗵𝗹𝗶𝗴𝗵𝘁𝘀 𝗼𝗳 𝘁𝗵𝗲 𝗔𝗰𝗾𝘂𝗶𝘀𝗶𝘁𝗶𝗼𝗻: • 𝗖𝗼𝗺𝗽𝗿𝗲𝗵𝗲𝗻𝘀𝗶𝘃𝗲 𝗣𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼: The deal includes a portfolio of 𝗽𝗿𝗲𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗮𝗻𝘁𝗶𝗯𝗼𝗱𝗶𝗲𝘀 against multiple oncology targets, 𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗼𝗿𝗶𝗲𝘀, cell banks, a 𝘁𝘂𝗺𝗼𝗿 𝘁𝗮𝗿𝗴𝗲𝘁 𝗱𝗮𝘁𝗮𝗯𝗮𝘀𝗲, and essential equipment.    • 𝗘𝗻𝗵𝗮𝗻𝗰𝗲𝗱 𝗜𝗻𝘁𝗲𝗹𝗹𝗲𝗰𝘁𝘂𝗮𝗹 𝗣𝗿𝗼𝗽𝗲𝗿𝘁𝘆: This acquisition broadens the 𝗜𝗣 𝗽𝗼𝗿𝘁𝗳𝗼𝗹𝗶𝗼 beyond the CXCR4 receptor, 𝗱𝗼𝘂𝗯𝗹𝗶𝗻𝗴 the 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗽𝗶𝗽𝗲𝗹𝗶𝗻𝗲 and expanding business and clinical opportunities.    • 𝗘𝘅𝗽𝗲𝗿𝘁 𝗧𝗲𝗮𝗺: Pentixapharm welcomes an 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗲𝗱 𝘁𝗲𝗮𝗺 𝗼𝗳 𝟰𝟬 seasoned executives, R&D specialists, and administrators from Glycotope.    • 𝗟𝗲𝗮𝗱𝗲𝗿𝘀𝗵𝗶𝗽 𝗘𝘅𝗽𝗮𝗻𝘀𝗶𝗼𝗻: Patrik Kehler, former CSO of Glycotope, will join as Pentixapharm's 𝗖𝗦𝗢, and Henner Kollenberg, former CEO of Glycotope, will become the 𝗖𝗵𝗶𝗲𝗳 𝗕𝘂𝘀𝗶𝗻𝗲𝘀𝘀 𝗢𝗳𝗳𝗶𝗰𝗲𝗿.    💬 𝗜𝗻𝘀𝗶𝗴𝗵𝘁𝘀 𝗳𝗿𝗼𝗺 𝗣𝗲𝗻𝘁𝗶𝘅𝗮𝗽𝗵𝗮𝗿𝗺'𝘀 𝗟𝗲𝗮𝗱𝗲𝗿𝘀: “Glycotope’s pipeline comprises 𝘀𝗲𝘃𝗲𝗿𝗮𝗹 𝗰𝗮𝗻𝗱𝗶𝗱𝗮𝘁𝗲𝘀 that can be 𝘂𝘀𝗲𝗱 𝗶𝗺𝗺𝗲𝗱𝗶𝗮𝘁𝗲𝗹𝘆 for 𝗽𝗿𝗼𝗼𝗳-𝗼𝗳-𝗰𝗼𝗻𝗰𝗲𝗽𝘁 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 as next generation radiopharmaceuticals,” said Dr. Hakim Bouterfa, CEO of Pentixapharm AG. “We look forward to 𝗺𝗮𝘅𝗶𝗺𝗶𝘇𝗶𝗻𝗴 𝘁𝗵𝗲 𝘀𝘆𝗻𝗲𝗿𝗴𝘆 of Pentixapharm’s know-how and Glycotope’s target discovery for the 𝗯𝗲𝗻𝗲𝗳𝗶𝘁 𝗼𝗳 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 in both diagnostics and therapeutic applications.” “The transaction 𝘀𝘁𝗿𝗲𝗻𝗴𝘁𝗵𝗲𝗻𝘀 our 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗽𝗶𝗽𝗲𝗹𝗶𝗻𝗲 and administrative capacities, facilitating a 𝘀𝗲𝗮𝗺𝗹𝗲𝘀𝘀 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 to the 𝗙𝗿𝗮𝗻𝗸𝗳𝘂𝗿𝘁 𝗦𝘁𝗼𝗰𝗸 𝗘𝘅𝗰𝗵𝗮𝗻𝗴𝗲,” noted 𝗗𝗿. 𝗔𝗻𝗱𝗿𝗲𝗮𝘀 𝗘𝗰𝗸𝗲𝗿𝘁, Chairman of the Supervisory Board of both Pentixapharm and Eckert & Ziegler SE. This acquisition positions Pentixapharm to develop 𝗶𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗿𝗮𝗱𝗶𝗼𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹𝘀 by leveraging Glycotope’s 𝘂𝗻𝗶𝗾𝘂𝗲 𝗚𝗹𝘆𝗰𝗼𝗧𝗮𝗿𝗴𝗲𝘁𝘀—tumor-associated 𝗰𝗮𝗿𝗯𝗼𝗵𝘆𝗱𝗿𝗮𝘁𝗲 𝘀𝘁𝗿𝘂𝗰𝘁𝘂𝗿𝗲𝘀 with 𝘀𝘂𝗽𝗲𝗿𝗶𝗼𝗿 𝘁𝘂𝗺𝗼𝗿-𝘀𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗶𝘁𝘆. These advancements have the potential to close the treatment gap for many solid tumors, enhancing both diagnostic and therapeutic applications. 🔗 Learn More: https://lnkd.in/eCXh35Nw #NuclearMedicine #Radiopharmaceuticals #Acquisition #PrecisionMedicine  

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Mainz Biomed NV (NASDAQ: MYNZ), a molecular genetics diagnostic company, is making strides with its flagship product, ColoAlert®, an early detection screening test for colorectal cancer. The company has reported significant clinical successes in U.S. and European trials, with ColoAlert demonstrating sensitivities exceeding 90% for detecting colorectal cancer and over 80% for advanced adenomas. These positive results have positioned Mainz Biomed for upcoming FDA clinical trials in 2025, a crucial step towards entering the U.S. market and unlocking a major revenue growth opportunity. The company has also seen increased demand for its enhanced ColoAlert product, launched in July, with existing and prospective laboratory partners transitioning to the new version. This enhancement simplifies workflow and reduces retest rates, contributing to a 26% reduction in net loss for the first half of 2024 compared to the previous year. Mainz Biomed's efforts have garnered support from brand ambassadors like Petra Smeltzer Starke, a former White House advisor, and Frankie Muniz, an actor and NASCAR driver. Muniz has highlighted the importance of early detection, especially among young people, where colorectal cancer cases have surged 500% in the past twenty-two years. Beyond ColoAlert, Mainz Biomed has a robust pipeline, including PancAlert, a next-generation detection test for pancreatic cancer developed in collaboration with Liquid Biosciences. Mainz Biomed #coloncancerawareness #earlydetection #healthtech

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Veja as fascinantes imagens de microscopia 3D e saiba mais sobre as várias técnicas de criação de esferóides e organóides no seguinte artigo do blogue da ibidi ➡️ https://abrir.link/ttQfO #lifesciences #enzifarma

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ATMP Symposium - Save the Date 🔬 Meet us Thursday, November 28, 2024 at ILB Potsdam “The Product is the Process - Is it?” 🔬Manufacturing and Translation of ATMP (advanced therapy medicinal products) and Tissue-& Cell-based products. 🔬The symposium is organized by #bbb Biotechnologieverbund Berlin Brandenburg in cooperation with the #PaulEhrlichInstitut (PEI), the #CentralOfficeoftheFederalStatesforHealthProtection with regard to Medicinal Products and Medical Devices (#ZLG), the German Stem Cell Network (#GSCN), #HealthCapital - the Cluster Healthcare Industry Berlin Brandenburg and Berlin Partner. 🔬Whether in regenerative medicine, cell or gene therapy - through remarkable research and clinical success, innovative therapy and product concepts for advanced therapies are moving into the focus of general interest. 🔬Several products have now achieved regulatory approval and clinical application, while others are on the verge of doing so. A large number of other product approaches are in the early development phase or clinical trials. Greetings Ursula & Volker #biotechnology #sustainibility #foodscience #foodinnovation #networking #science #plantbased #alternativeproteins #biotech #biopharm #bioreactor #fermenter #projectmanagement #fermentation #precisionfermentation #hmo #glycoBiotech #humanmilkoligo #food #enzymeproduction #foodlovers #foodregulation #enzymeregulation #dietarysupplements #productionscaleup #novelfood #foodtech #foodregulations

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On this World Lung Day, we would like to emphasize the importance of Krebs von den Lungen-6 (#KL-6) as a key biomarker for interstitial pneumonia. KL-6, a high molecular weight glycoprotein, is a reliable serum biomarker for interstitial lung diseases (ILD). It plays a key role in diagnosis, monitoring disease activity, evaluating treatment response, and predicting clinical outcomes. Due to the complexity of ILD, patients are frequently misdiagnosed, which could lead to delays in appropriate management #WorldLungDay #Lung #laboratory #laboratoryequipment #diagnosis

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This is an interesting paper outlining the tolerance and effectiveness of CD-19 targeted CAR-T therapy in Lupus. Impressive work by the teams at the Erlangen University Hospital and Miltenyi Biotec for conducting this case study and changing the life of their 15-year-old patient. https://lnkd.in/eRpM69sV #CART #Lupus #autoimmune #cellandgenetherapy #celltherapy

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🤔 Have you signed up yet? 👇 More details on the upcoming healthbook Live Webinar below

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🌟 From Innovation to Expansion: 25 years AHN Biotechnologie GmbH's Journey in Life Science Excellence 🌟 Join us as we celebrate AHN Biotechnologie GmbH's incredible journey in the life sciences industry! From pioneering innovative biotechnological solutions to expanding our global reach, we remain committed to excellence and advancing scientific research. Our Key Milestones: 🌍 Global Expansion: Reaching new markets and establishing a worldwide presence. 🧬 Innovative Solutions: Developing state-of-the-art biotechnological products. 🏆 Commitment to Quality: Ensuring the highest standards in all our offerings. 🤝 Collaborative Success: Partnering with our customers to achieve scientific breakthroughs together. Stay tuned for more exciting updates and breakthroughs from AHN Biotechnologie GmbH. Together, we're shaping the future of life science! #LifeScience #Biotechnology #Innovation #GlobalExpansion #ScientificExcellence #ResearchAndDevelopment #BiotechSolutions #FutureOfScience #QualityCommitment #ScientificBreakthroughs

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A team from ZHAW Zurich has showcased the transferability of CHO-cell-based mAb production processes from geometrically dissimilar stirred bioreactors for fed-batch and perfusion processes, the team has opened up new possibilities for cost savings and increased yields. Their study found that the high volumetric productivity in the perfusion processes can lead to cost savings, smaller bioreactor sizes, and maintained manufacturing capacity in production plants. Alternatively, yields could be increased by a factor of 2.8 to 3.2 while still using the same bioreactor size. We look forward to seeing how it will impact the future of antibody production. #biotech #antibodyproduction #research https://lnkd.in/eA9992FV

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Systems Medicine - Matthias Prucha and I will join the e:Med Meeting 2024 in Hamburg tomorrow till Saturday representing Olink Proteomics. We are much looking forward to discussing #multivariate #marker screens on clinical or health cohorts with attending researchers, involving the establishment of protein signatures associated to other phenotypic characteristics, such as disease state, drug response, or further mechanistic settings. Also looking into #causal #linkage of genomic variants in form of #pQTLs. Venue: Helmut-Schmidt-Auditorium of the Bucerius Law School https://lnkd.in/ev5e35jX #PrecisionMedicine #TranslationalResearch #SystemsMedicine #Proteomics #Multiomics #Proteogenomics #ProteinSignature

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𝗤𝗨𝗔𝗡𝗧𝗥𝗢 𝗧𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀 𝗿𝗲𝗮𝗰𝗵𝗲𝘀 𝗮 𝗺𝗶𝗹𝗲𝘀𝘁𝗼𝗻𝗲 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 𝘄𝗶𝘁𝗵 𝗕𝗼𝗲𝗵𝗿𝗶𝗻𝗴𝗲𝗿 𝗜𝗻𝗴𝗲𝗹𝗵𝗲𝗶𝗺 𝘁𝗼 𝗱𝗲𝘃𝗲𝗹𝗼𝗽 𝗳𝗶𝗿𝘀𝘁-𝗶𝗻-𝗰𝗹𝗮𝘀𝘀 #𝗰𝗮𝗻𝗰𝗲𝗿 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁𝘀: QUANTRO Therapeutics GmbH, a Spin-out from the research institutes IMBA and IMP in Vienna, announced that the company has reached a key milestone in its joint R&D program with Boehringer Ingelheim. In successfully applying QUANTRO’s proprietary QUANTROseq® Transcriptional Fingerprint technology, all pre-set goals for technical proof-of-concept, cross-validation of HTS screening technology and identification of high-quality hits for a previously undruggable transcription factor were fully accomplished. For many cancer patients there are no or only limited treatment options, which is why cancer remains to be a leading cause of death worldwide, accounting for nearly one in six deaths. Transcription factors have emerged as a promising class of therapeutic targets to address currently undruggable cancers. Transcription factors are central regulators of gene expression that are commonly dysregulated in cancer and have remained largely unamenable to pharmacological intervention. The joint R&D program, which was initiated in 2022, aims at changing the implied status quo via development of transformational, first-in-class cancer treatments. 𝗥𝗲𝗮𝗱 𝗺𝗼𝗿𝗲: https://lnkd.in/ehQ6Nvsb Michael Bauer, Ph.D., Norbert Kraut

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Last week, Harald Kolmar from the Technische Universität Darmstadt talked about the generation and biophysical characterization of bispecific #antibodies in our #webinar series. 🎥 Watch the recording now on YouTube to learn more about different bispecific formats, FACS-assisted yeast surface display screenings, affinity maturation, single-cell Interaction Cytometry and what chicken have to do with all that 🐔 #DiscoverMolecularInteractions #switchSENSE #scIC

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Congratulations to Tubulis GmbH! The company announced that the U.S. Food and Drug Administration has granted Fast Track designation to its lead antibody-drug conjugate (ADC) TUB-040 for the treatment of patients with platinum-resistant ovarian cancer. TUB-040 is a NaPi2b-targeting Exatecan ADC based on Tubulis’ proprietary P5 technology with superior biophysical properties that demonstrated effective and durable responses in a range of preclinical models, including ovarian cancer. The candidate is currently being evaluated in a multicenter Phase I/IIa study (NAPISTAR 1-01, NCT06303505) in patients with platinum-resistant high-grade ovarian cancer or relapsed/refractory adenocarcinoma non-small cell lung cancer, who have exhausted other available treatment options. #mabs https://lnkd.in/ePUNUgkZ

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Join us and special guest speaker Prof. Dr. Nicole Endlich, Dept. of Anatomy and Cell Biology, Universitätsmedizin Greifswald and CEO of NIPOKA GmbH, Germany, for this LIVE webinar. To register ➡️ https://lnkd.in/dr9R5ww9 Prof. Nicole Endlich will give an overview of her research on kidney disease and the development of new diagnostic tools. She will speak on: ○ Developing high-content screening methods based on a zebrafish larvae model for the identification of potential therapeutic agents ○ Combing super resolution-based imaging techniques with multiplex staining and in situ hybridization for the advanced visualization of structure and morphology #diagnostics #drugdevelopment #microscopy

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We're making strong progress! The Freiburg prospective trial is crucial for setting a gold standard for FDA submission. It provides a powerful case for the treatment process when paired with retrospective data from Markus Notter’s 2020 paper (as presented in the September 21 graphical results). The Freiburg trial focuses on key metrics and endpoints outlined in the graphic. Marianne Sarcich #BreastCancerAwareness, #BreastCancerResearch, #BreastCancerTreatment, #ClinicalTrials, #CancerCare, #BreastCancerSupport, #BreastCancerMonth, #CancerInnovation, #PatientCare, #MedicalAdvancements, #OncologyResearch, #FightingCancer, #BreastCancerHope, #BreastCancerWarriors, #BreastCancerSolutions, #LocallyRecurrentBreastCancer, #RecurrentBreastCancer, #LymphangiosisCarcinomatosa, #CancerSpread, #InflammatoryBreastCancer, #IBCawareness, #TripleNegativeBreastCancer, #TNBC, #InvasiveDuctalCarcinoma, #IDCawareness, #InvasiveLobularCarcinoma, #ILCawareness

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