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    medac CDMO Supports UGN-103 Ph3 UTOPIA Trial for LG-IR-NMIBC

    21 Jul 2025

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    A New Chapter for medac CDMO: One Brand, One Vision

    14 Jul 2025

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    Medac Unveils New Methotrexate Data For Arthritis At EULAR 2025

    30 Jun 2025

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    medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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    At medac CDMO, we offer tailored fill & finish services for sterile injectables in pre-filled syringes and cartridges and liquid and lyophilized drugs in vials. We are specialized in complex formulations including biologics and ADCs with over 25 years of aseptic expertise. From clinical to commercial scale, our two European sites deliver flexibility and speed. Our unwavering commitment to foresight, progress, reliability and creative solution thinking makes us - a solution ahead.

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    GMP Certificate 2024

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    CDMO Service Book

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    CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    CDMO Activity Tracker: Veranova, ChemExpress invest in ADC facilities; Cohance to set up oligonucleotide facility in India

    The contract development and manufacturing organization (CDMO) sector has emerged as a key partner in new drug development. This was evident from the strategic investments, partnerships, and expansions witnessed in the third quarter (Q3) of 2025. Several CDMOs, such as Cohance Lifesciences, Fermion Oy, Axplora, AGC Pharma Chemicals invested in new projects. Others, including Veranova, Aenova, and Biosynth, expanded capacities, while Ofichem strengthened its footprint with the acquisition of Avivia BV. CDMOs like Fareva, Evonik, and Samsung Biologics forged strategic partnerships for growth. During Q3, the sector continued to adopt artificial intelligence (AI). This prompted the US Food and Drug Administration (FDA) to issue guidance that recognizes the increasing use of AI and data analytics in drug development.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Cohance, Veranova invest in bioconjugation suites in US; ChemExpress inks ADC deal Earlier this year, Indian drugmaker Suven Pharmaceuticals Limited merged with  leading CDMO Cohance Lifesciences Limited. The merged entity — Cohance Lifesciences — has invested US$ 10 million in a current Good Manufacturing Practice (cGMP) bioconjugation suite at its subsidiary NJ Bio in Princeton, New Jersey.  NJ Bio is executing a major program for an existing innovator client with multiple antibody-drug conjugate (ADC) candidates. Cohance also announced an INR 230 million (approximately US$ 2.58 million) investment in a cGMP oligonucleotide facility at its Hyderabad (India) site. Veranova’s Devens (Massachusetts) site successfully passed a routine FDA cGMP surveillance inspection with a “No Action Indicated” (NAI) classification. Earlier, the company had initiated a US$ 50 million investment to expand its ADC and bioconjugate capabilities at its Devens site. This includes a 9,000-square-foot facility expansion with a new process development lab, two additional cGMP suites, and state-of-the-art bioconjugation development and manufacturing capabilities. These initiatives strengthen the site’s highly potent API (HPAPI) and ADC development and manufacturing capabilities. Biosynth has expanded its Berlin facility with a new GMP bioconjugation suite. The expansion supports the company’s manufacturing capabilities in conjugate vaccines, conjugate drugs, activated polyethylene glycol (PEGs), and polymer-based drug delivery excipients. ChemExpress, Mabwell Bioscience, and Insilico Medicine have entered into a strategic partnership to jointly develop a large ADC compound library and advance next-generation ADC candidates. The collaboration combines Mabwell’s antibody and ADC technology, Insilico’s AI-powered drug design platform, and ChemExpress’s expertise in linker-payload chemistry. Together, they aim to build a complete, AI-driven ADC development model that accelerates discovery, optimization, and commercialization. This partnership is expected to enhance R&D efficiency and deliver safer, more effective cancer treatments.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available) Fermion, Axplora, Aenova increase API manufacturing capacities; ICE Pharma expands India facility Finnish CDMO Fermion Oy has launched a renovation project at its Hanko (Finland) production site to modernize its API manufacturing capabilities. This expansion is part of Fermion's broader strategy to increase production, enhance flexibility in the manufacturing of both existing and future pharmaceutical products, and enable potential contract manufacturing opportunities. German CDMO Axplora has announced a €6.5 million (approximately US$ 7.5 million) investment to expand its API manufacturing capacity at its Vizag site in India. This expansion aims to strengthen both production capabilities and supply chain resilience. India-based Aarti Pharmalabs has inaugurated the first phase of its greenfield manufacturing facility in Gujarat (India). This expansion aims to bolster Aarti's CDMO and contract manufacturing organization (CMO) services, targeting a revenue goal of INR 10 billion (approximately US$ 112 million). Snapdragon Chemistry, which was acquired by Cambrex in 2023, has expanded its Massachusetts facility to better support peptide drug development and manufacturing. With this upgrade, the company can now handle peptide projects from early development through full-scale manufacturing. Italy-headquartered ICE Pharma has expanded its Raichem facility in India. The new facility will enhance the production of ursodeoxycholic acid (UDCA), an API it derives from chicken bile. This expansion increases the site’s raw UDCA output by 120 metric tons annually. Spain-headquartered AGC Pharma Chemicals inaugurated a new advanced manufacturing plant in Barcelona, with an investment of €110 million (approximately US$ 128.3 million). The plant spans 7,500 square meters and integrates cutting-edge technologies to support the entire drug development lifecycle — from R&D to commercial manufacturing. This represents a 30 percent increase in the company’s production capacity and introduces a segment dedicated to HPAPIs. Germany-headquartered Aenova has launched a new hot melt extrusion platform at its Regensburg (Germany) site. This new equipment enables the production of advanced drug formulations, while handling all testing and quality checks in-house. The move strengthens Aenova’s capabilities in developing and manufacturing complex medications. US-based Cytovance Biologics has introduced in-house formulation development services, enhancing its role as a comprehensive partner for biologic drug developers. These services utilize quality-by-design principles to ensure speed, safety, and precision in current and future client programs.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Ofichem acquires Avivia BV; Evonik, Samsung Biologics form strategic collaborations Europe-based CDMO Ofichem Group announced the acquisition of Avivia BV, a formulation development company in the Netherlands. This acquisition is part of Ofichem’s strategy to become a fully integrated provider of development solutions across both drug substance and drug product, with a focus on complex formulations. Ofichem has also acquired Meribel Pharma Solutions’ site in Uppsala (Sweden) to strengthen its support for biotech innovators and expand its presence in the Nordic region.  Simtra BioPharma Solutions has acquired a 65-acre property near its Bloomington, Indiana (US) facility, adding over 300,000 square feet of potential expansion space. With this site, Simtra now has the flexibility to rapidly expand in the US. German specialty chemicals company Evonik is partnering with German biotech Ethris to develop and commercialize a next-generation lipid nanoparticle (LNP) platform for delivering nucleic acid therapies. Evonik will assist in formulation using Ethris’ SNaP LNP technology. The LNP market alone is projected to grow to US$2.3 billion by 2032. Luxembourg-headquartered Fareva has partnered with Zhaoke Ophthalmology to expand its footprint in China’s pharma market. Zhaoke will act as Fareva’s go-to partner for customers seeking pharmaceutical manufacturing in China. Samsung Biologics has signed a 1.8 trillion won (US$ 1.3 billion) manufacturing agreement with an undisclosed US-based drugmaker. And UK-based eXmoor Pharma has partnered with Anthony Nolan to provide end-to-end services for cell therapy developers.  View CDMO Activity Tracker for Q3 2025 (Free Excel Available)  Our view The global CDMO market, valued at around US$ 255 billion in 2025, is projected to grow to over US$ 465 billion by 2032. Significantly, about 60 percent of new drug approvals in the US and over 65 percent in Europe now involve CDMO support. The developments outlined above underscore the increasing role CDMOs are playing today in bringing about growth and innovation in the pharmaceutical industry.  
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    #PharmaFlow by PHARMACOMPASS
    16 Oct 2025
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    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    FDA approvals drop 24% in H1 2025; GSK’s UTI med, Vertex’s non-opioid painkiller lead pack of first-in-class meds

    It has been a turbulent year for the US Food and Drug Administration (FDA), marked by reductions in both staff and budget, shake-ups at the top and a reduction in inspections. This upheaval has clearly impacted the functioning of the agency, with reports of missed deadlines and reduced responsiveness. This disruption resulted in a slowdown in new drug approvals in the first half of 2025 (H1 2025), as opposed to the same period last year. Incidentally, drug approvals in H1 2024 were also down by 19 percent compared to H1 2023. FDA’s Center for Drug Evaluation and Research (CDER) approved 16 novel drugs in H1 2025, down from 21 in H1 2024, a decline of nearly 24 percent. Of these, nine were small molecules and seven were biologics. The period saw eight first-in-class therapies get CDER’s approval, as opposed to 17 in H1 2024. FDA’s Center for Biologics Evaluation and Research (CBER) approved seven biologics in H1 2025, compared to eight in the same period last year. In comparison, both Health Canada and the European Medicines Agency (EMA) reported a strong rebound in approvals and authorizations, respectively. Health Canada approved 20 drugs in H1 2025, as opposed to 10 in H1 2024. Similarly, EMA authorized 19 new therapies in H1 2025, compared to 15 in H1 2024. Notably, EMA’s pending decisions increased to 25 in H1 2025, from 14 in the same period last year, while conditional authorizations remained static at five. This underscores EMA’s active regulatory pipeline, suggesting that more drugs could be approved in Europe soon.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available) Vertex’s non-opioid painkiller, GSK’s antibiotic for UTI, Merck’s RSV antibody bag FDA nods Oncology remained the single largest category in H1 2025 with seven new drugs being approved by the FDA, followed by four rare diseases and disorders and as many infections and infective diseases.  The eight drugs that were designated first-in-class in H1 2025 are: Journavx (Suzetrigine), Imaavy (nipocalimab), Emrelis (telisotuzumab vedotin), Blujepa (gepotidacin mesylate), Qfitlia (fitusiran), Avmapki Fakzynja Co-Pack (avutometinib potassium/defactinib hydrochloride), Tryptyr (acoltremon), and Andembry (garadacimab). In January, a new class of non-opioid pain therapy made a debut — FDA approved Vertex Pharmaceuticals’ Journavx (suzetrigine). This first-in-class oral analgesic could bring in US$ 2.9 billion in sales for Vertex by 2030. The half year also saw a new oral antibiotic — GSK’s Blujepa (gepotidacin) — for treating uncomplicated urinary tract infections (uUTIs) bag FDA approval. This is the first new antibiotic for uUTIs in nearly three decades. It treats infections caused by resistant pathogens such as E. coli and K. pneumoniae. In June, Merck’s Enflonsia (clesrovimab), a long-acting monoclonal antibody, won FDA approval to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants entering their first RSV season. A single 105 mg dose provides protection for about five months, the length of a typical RSV season. Enflonsia could bring in US$844 million in annual sales by 2030.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA approves four meds for rare diseases, including SpringWorks’ Gomekli, Novartis’ Vanrafia In H1 2024, rare genetic diseases had witnessed some significant approvals. The trend continued in H1 2025. In February, Gomekli (mirdametinib), developed by SpringWorks Therapeutics, became the first approved therapy for neurofibromatosis type 1 (a genetic disorder that causes tumors to grow on nerve tissues) in adult and pediatric patients who have symptomatic plexiform neurofibromas (benign, complex nerve tumors) not amenable to complete resection. Analysts expect peak sales of around US$ 0.8 billion by 2030. Post this approval, SpringWorks got acquired by Merck KGaA for approximately US$ 3.9 billion. The same month, Ono Pharma-owned Deciphera’s Romvimza (vimseltinib) became the first oral therapy approved for another rare disease known as symptomatic tenosynovial giant cell tumor. This is a benign but aggressive growth that can be painful. This new drug offers patients an option beyond surgery. In March, Sanofi’s Qfitlia (fitusiran) was approved for routine prophylaxis in hemophilia A or B, with or without inhibitors. And in April, Novartis’ Vanrafia (atrasentan) was granted accelerated approval for IgA nephropathy (a chronic autoimmune kidney disease), which is at the risk of rapid progression. Vanrafia could bring in sales of over US$ 735 million by 2030. Johnson & Johnson secured approval for Imaavy (nipocalimab-aahu) for generalized myasthenia gravis (a chronic autoimmune disease that causes muscle weakness) in adults and adolescents. Imaavy’s sales could cross US$1.17 billion by 2030. Rare diseases continue to attract regulatory attention, with the trend carrying into the current quarter. July witnessed two noteworthy rare-disease approvals — Ekterly (garadacimab), CSL’s once-monthly prophylactic treatment for hereditary angioedema (a genetic disorder that causes recurrent episodes of swellings), and Sephience (pegvaliase-abcx), BioMarin’s new therapy for phenylketonuria (a rare metabolic disorder).   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  FDA greenlights new oncology therapies, including Astra’s Datroway, AbbVie’s Emrelis The field of oncology saw some notable new drug approvals. In January, Datroway (datopotamab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca and Daiichi Sankyo, was granted approval for adults with unresectable or metastatic, hormone receptor-positive, HER2-negative breast cancer. Later, in June, the FDA granted accelerated approval  to AstraZeneca;s Datroway for adults with locally advanced or metastatic, EGFR-mutated non-small cell lung cancer. The drug’s peak annual sales are projected at about US$ 4.2 billion by 2030. In May, Emrelis (telisotuzumab vedotin-tllv), AbbVie’s ADC was granted FDA’s accelerated approval. Emrelis treats locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) characterized by significantly increased levels of the c-Met protein in cancer cells. FDA also approved a companion diagnostic test — Roche's Ventana — in May to determine the c-Met protein biomarker status in order to identify patients eligible for Emrelis.  The same month, FDA also granted accelerated approval to Verastem’s Avmapki Fakzynja Co-pack, a dual oral therapy for adults with KRAS‑mutated recurrent low‑grade serous ovarian cancer (LGSOC). This novel regimen combines two inhibitors — avutometinib and defactinib — to disrupt critical signaling pathways that fuel tumor growth. In ophthalmology, Alcon re-entered the prescription pharmaceutical market with Tryptry (acoltremon), a first-in-class TRPM8 agonist for dry eye disease, which stimulates corneal nerves to increase tear production.   View New Drug Approvals in H1 2025 with Estimated Sales (Free Excel Available)  Our view The changes in the FDA are clearly having a far-reaching impact on the global pharmaceutical industry. There have been reports of drugmakers losing confidence in the FDA, which has been a gold standard for drug regulation. Some American biotechs are shifting early trials outside of the US. With EMA and Health Canada authorizing/approving a larger number of drugs in H1 2025, we do see some changes underway that may eventually reshape drug development.  
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    28 Aug 2025
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    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    US drug shortages reduce 16% YoY in Q1 2025; CNS drugs, antimicrobials face highest scarcities

    The pharmaceutical industry in the United States continued to grapple with drug shortages during the first quarter (Q1) of 2025. According to the American Society of Health‑System Pharmacists (ASHP), the total number of active shortages stood at 270 as of March 31, 2025 — only slightly below the 277 reported in September 2024, but down 16.4 percent from an all‑time high of 323 reported in Q1 2024.These numbers imply that while dramatic surges in drug shortages may have subsided, underlying vulnerabilities in manufacturing, supply chains, and raw‑material sourcing continue to frustrate efforts towards a durable resolution.A deeper analysis of these drug scarcities reveals that 41 percent of the 270 active shortages first emerged in 2022 or earlier. This implies that many of the current disruptions have become chronic in nature and are exerting pressure on pharmacy operations. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available)CNS drugs dominate with 49 meds in short supply; antimicrobials face shortage of 39 drugsClass‑specific analysis reveals that central nervous system (CNS) agents remained the most disrupted category, with 49 distinct CNS drugs having faced scarcities during Q1. This group spans anxiolytics (anti-anxiety drugs) such as clonazepam and flurazepam, sedatives like lorazepam and midazolam, and stimulants such as methylphenidate and lisdexamfetamine. These shortages pose two challenges — controlling seizures and managing sedation in acute care settings. After CNS agents, antimicrobials was the second‑largest category, with shortages affecting 39 drugs. Key antibacterial and anti-fungal agents such as cefotaxime sodium powder for injection, clindamycin phosphate, rifampin, and metronidazole find themselves on ASHP’s active‑shortage roster, threatening both routine hospital protocols and emergency sepsis management.Fluids and electrolytes occupied the third spot, with 29 items facing shortage in Q1 2025. Hormone agents, including insulin analogs, ranked fourth with 24 drugs in short supply.Chemotherapy medications rounded out the top five categories, with 23 antineoplastic agents (a broad class of medications used to treat cancer) flagged as actively constrained in Q1 2025. Notable shortages included azacitidine, carboplatin, methotrexate, and streptozocin. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) US faces 26 new shortages; Pharmacopeia list warns of 100 vulnerable medicationsThe first quarter saw the emergence of 26 new shortage declarations, emphasizing that even drugs previously deemed reliably sourced can fall into scarcity. The US has been facing a shortage of attention deficit hyperactivity disorder (ADHD) drugs since 2022. The new shortages included ADHD transdermal patch methylphenidate, peginterferon alfa‑2a (Pegasys) used in chronic hepatitis B and C, and bacitracin ophthalmic ointment.The fragility of the pharmaceutical supply chains has been particularly evident in the aftermath of natural disasters. Hurricane Helene’s flooding at Baxter’s Marion, North Carolina, facility deeply affected IV‑solution supply lines. Baxter supplies roughly 60 percent of the US’ IV fluids and the ASHP report listed “hurricane” as the reason behind nine percent of drug shortages, as of January 2025.Regulatory and policy interventions continue to evolve. The US Pharmacopeia’s inaugural Vulnerable Medicines List, launched in 2025, identifies 100 drugs at the highest risk of future shortages, with a particular focus on injectables (comprising 71 percent of the list) and essential hospital care.Antibiotics, medications for pain management and oncology are the other drugs on the list. Although 61 percent of these vulnerable medicines were not in active shortage at the time of listing, their inclusion is intended to galvanize manufacturers and purchasing organizations to bolster inventories.Meanwhile, the Government Accountability Office in the US has called on the Department of Health and Human Services (HHS) to establish a formal coordination mechanism, warning that elimination of the HHS supply‑chain coordinator role in May 2025 risks fragmenting federal response efforts. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Global shortages mirror US patterns; Europe launches monitoring platform Globally, we notice comparable trends. For instance, Europe has rolled out the European Shortages Monitoring Platform (ESMP) this year in order to centralize shortage reporting across member states. Critical‑medicine shortages in the EU — in areas such as oncology, ADHD, and critical care analgesics — mirror US patterns. The European Medicines Agency’s shortage list currently holds 37 human drugs.According to Health Canada’s May 12, 2025 update, its Tier 3 list had 18 drug shortages that are considered to have the greatest impact on Canada’s drug supply and health‑care system. Tier 3 designation is based on medical necessity and minimal availability of alternatives.In hematology and oncology, scarcity of essential drugs like Oncaspar for acute lymphoblastic leukemia, idarubicin and lomustine for leukemias and brain tumors, anagrelide for thrombocythemia, and preservative‑free methotrexate for various malignancies underscore the impact these drug shortages can have on treatment. View Our Interactive Dashboard on Drug Shortages So Far in 2025 (Free Excel Available) Our viewThe global pharma supply chain is dealing with a fresh wave of uncertainties, especially with the likelihood of tariffs on drugs imported into the US. Analysts warn that the proposed pharmaceutical tariffs could exacerbate supply issues.Over 50 percent of drugs used in the US are manufactured abroad. Generic sterile injectable drugs — like chemotherapy medications and IV saline — are particularly vulnerable due to their complex manufacturing processes and low profit margins. Generic drugs (which account for 90 percent of prescriptions filled in the US) could face increased pressure, as many rely on raw materials from China and India. This could result in more severe drug shortages in the future. 
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    22 May 2025
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    medac CDMO Supports UGN-103 Ph3 UTOPIA Trial for LG-IR-NMIBC
    medac CDMO Supports UGN-103 Ph3 UTOPIA Trial for LG-IR-NMIBC

    21 Jul 2025

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    https://www.medac-cdmo.com/news-events/newsroom/ugn-103-medac-cdmo

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    21 Jul 2025
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    A New Chapter for medac CDMO: One Brand, One Vision
    A New Chapter for medac CDMO: One Brand, One Vision

    14 Jul 2025

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    https://www.medac-cdmo.com/news-events/newsroom/medac-cdmo-brand

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    14 Jul 2025
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    Medac Unveils New Methotrexate Data For Arthritis At EULAR 2025
    Medac Unveils New Methotrexate Data For Arthritis At EULAR 2025

    30 Jun 2025

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    https://www.medac.de/news/newsroom/eular-2025

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    30 Jun 2025
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    Medac & Clinigen Expand Asia-Pacific Partnership Patient Care
    Medac & Clinigen Expand Asia-Pacific Partnership Patient Care

    16 Jun 2025

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    https://www.medac.de/news/newsroom/medac-und-clinigen-erweitern-kooperation

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    16 Jun 2025
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    Shaping the future of HSCT – with medac’s educational support
    Shaping the future of HSCT – with medac’s educational support

    12 Jun 2025

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    https://www.medac-group.com/news/newsroom/medscape-symposium-recording

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    12 Jun 2025
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    Innovative nutrition meets pharmaceutical expertise
    Innovative nutrition meets pharmaceutical expertise

    11 Mar 2025

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    https://www.medac.de/news/newsroom/kooperation-mit-dr.-schaer

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    11 Mar 2025
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    Drugs in Development

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    Virtual Boothmedac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

    Treosulfan Vs Melphalan Conditioning + PTCy In AML/MDS Allogeneic Transplant

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    Treosulfan is a Cytotoxic Drug drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.


    Lead Product(s): Treosulfan,Fludarabine Phosphate

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Cytotoxic Drug

    Recipient: Technische Universität Dresden

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 18, 2025

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    Lead Product(s) : Treosulfan,Fludarabine Phosphate

    Therapeutic Area : Oncology

    Highest Development Status : Phase II

    Recipient : Technische Universität Dresden

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Treosulfan Vs Melphalan Conditioning + PTCy In AML/MDS Allogeneic Transplant

    Details : Treosulfan is a Cytotoxic Drug drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Leukemia, Myeloid, Acute.

    Product Name : Undisclosed

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    June 18, 2025

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    Strategic cornerstone: FDA approves treosulfan for alloHSCT

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    Grafapex (treosulfan) is now approved by FDA for the treatment of adult and pediatric patients aged 1 year and older with acute myeloid leukemia.


    Lead Product(s): Treosulfan,Fludarabine Phosphate

    Therapeutic Area: Oncology Brand Name: Grafapex

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 23, 2025

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    Lead Product(s) : Treosulfan,Fludarabine Phosphate

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Strategic cornerstone: FDA approves treosulfan for alloHSCT

    Details : Grafapex (treosulfan) is now approved by FDA for the treatment of adult and pediatric patients aged 1 year and older with acute myeloid leukemia.

    Product Name : Grafapex

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    January 23, 2025

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    Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bladder Cancer

    Details:

    Mitomycin C is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Non-Muscle Invasive Bladder Neoplasms.


    Lead Product(s): Mitomycin,Inapplicable

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Jakob Kristian Jakobsen

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable January 17, 2025

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    03

    medac

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    Lead Product(s) : Mitomycin,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Jakob Kristian Jakobsen

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Chemoablation or Bladder Resection with Adjuvant Chemotherapy in Recurrent Non-Muscle Invasive Bla...

    Details : Mitomycin C is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Non-Muscle Invasive Bladder Neoplasms.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    January 17, 2025

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    Medexus and medac Conclude Negotiations to Amend US Treosulfan Agreement

    Details:

    The fourth amendment adjusts the unpaid regulatory milestone payments upon an FDA approval of Grafapex (treosulfan).


    Lead Product(s): Treosulfan,Inapplicable

    Therapeutic Area: Oncology Brand Name: Grafapex

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Sponsor: Medexus Pharmaceuticals

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement December 02, 2024

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    medac

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    Lead Product(s) : Treosulfan,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Medexus Pharmaceuticals

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    Medexus and medac Conclude Negotiations to Amend US Treosulfan Agreement

    Details : The fourth amendment adjusts the unpaid regulatory milestone payments upon an FDA approval of Grafapex (treosulfan).

    Product Name : Grafapex

    Product Type : Cytotoxic Drug

    Upfront Cash : Undisclosed

    December 02, 2024

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    Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.

    Details:

    Methotrexate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dermatitis, Atopic.


    Lead Product(s): Methotrexate,Inapplicable

    Therapeutic Area: Dermatology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Cytotoxic Drug

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable February 02, 2024

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    medac

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    Lead Product(s) : Methotrexate,Inapplicable

    Therapeutic Area : Dermatology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Efficacy and Safety of Methotrexate Versus Placebo in Adults With Atopic Dermatitis.

    Details : Methotrexate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Dermatitis, Atopic.

    Product Name : Undisclosed

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    February 02, 2024

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    UroGen gets Medac License to Develop Novel Mitomycin Formulation for Urothelial Cancers

    Details:

    Under the agreement, UroGen will develop a next-generation novel mitomycin-based formulation, UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, for urothelial cancers.


    Lead Product(s): Mitomycin,Inapplicable

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Antibiotic

    Sponsor: UroGen Pharma

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Licensing Agreement January 17, 2024

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    medac

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    Lead Product(s) : Mitomycin,Inapplicable

    Therapeutic Area : Oncology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : UroGen Pharma

    Deal Size : Undisclosed

    Deal Type : Licensing Agreement

    DEALS_DEV arrow-down

    UroGen gets Medac License to Develop Novel Mitomycin Formulation for Urothelial Cancers

    Details : Under the agreement, UroGen will develop a next-generation novel mitomycin-based formulation, UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, for urothelial cancers.

    Product Name : Undisclosed

    Product Type : Antibiotic

    Upfront Cash : Undisclosed

    January 17, 2024

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    Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-Refractory Acute Graft Versus Host Disease

    Details:

    MC0518 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Graft vs Host Disease.


    Lead Product(s): MC0518,Inapplicable

    Therapeutic Area: Immunology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Undisclosed

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 10, 2023

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    07

    medac

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    Lead Product(s) : MC0518,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Trial of Efficacy and Safety of MC0518 Versus Best Available Therapy in Participants With Steroid-...

    Details : MC0518 is a drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Graft vs Host Disease.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Inapplicable

    October 10, 2023

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    Metoject® Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthritis

    Details:

    Primary endpoint of ACR20 response* at 12 weeks was 59.6% in Metoject (Methotrexate) group versus 51.0% in oral MTX group, indicating comparable efficacy. Adverse drug reaction incidence rates in this trial were 25.0% in the Metoject group and 34.0% in the oral MTX group.


    Lead Product(s): Methotrexate,Inapplicable

    Therapeutic Area: Immunology Brand Name: Metoject

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Sponsor: Eisai

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 26, 2022

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    medac

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    Lead Product(s) : Methotrexate,Inapplicable

    Therapeutic Area : Immunology

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Eisai

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Metoject® Subcutaneous Injection Syringe (Methotrexate) Approved in Japan for Rheumatoid Arthriti...

    Details : Primary endpoint of ACR20 response* at 12 weeks was 59.6% in Metoject (Methotrexate) group versus 51.0% in oral MTX group, indicating comparable efficacy. Adverse drug reaction incidence rates in this trial were 25.0% in the Metoject group and 34.0% in t...

    Product Name : Metoject

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    September 26, 2022

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    Medexus Provides Update on Treosulfan NDA Resubmission and Provides Business Update

    Details:

    Trecondyv (treosulfan) is used to prepare patients for blood stem cell transplant. Trecondyv destroys bone marrow cells. This allows for the transplant of new blood stem cells from a donor which leads to the production of healthy blood cells.


    Lead Product(s): Treosulfan,Fludarabine Phosphate

    Therapeutic Area: Oncology Brand Name: Trecondyv

    Study Phase: Approved FDFProduct Type: Cytotoxic Drug

    Recipient: Medexus Pharmaceuticals

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 19, 2022

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    09

    medac

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    Lead Product(s) : Treosulfan,Fludarabine Phosphate

    Therapeutic Area : Oncology

    Highest Development Status : Approved FDF

    Recipient : Medexus Pharmaceuticals

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Medexus Provides Update on Treosulfan NDA Resubmission and Provides Business Update

    Details : Trecondyv (treosulfan) is used to prepare patients for blood stem cell transplant. Trecondyv destroys bone marrow cells. This allows for the transplant of new blood stem cells from a donor which leads to the production of healthy blood cells.

    Product Name : Trecondyv

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    September 19, 2022

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    Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

    Details:

    Treosulfan is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.


    Lead Product(s): Treosulfan,Fludarabine Phosphate

    Therapeutic Area: Oncology Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Cytotoxic Drug

    Sponsor: Syneos Health

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 09, 2022

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    medac

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    Lead Product(s) : Treosulfan,Fludarabine Phosphate

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Syneos Health

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Effect of Moderate Renal Impairment and Race/Ethnicity on Treosulfan Pharmacokinetics

    Details : Treosulfan is a Cytotoxic Drug drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Leukemia, Myeloid, Acute.

    Product Name : Undisclosed

    Product Type : Cytotoxic Drug

    Upfront Cash : Inapplicable

    September 09, 2022

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