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Hemispherian Receives FDA Orphan Drug Status for GLIX1 for the Treatment of Malignant Glioma

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Oslo, Norway, July 1, 2025 – Norwegian biotech company Hemispherian AS has reached a significant milestone: The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the active substance GLIX1 for the treatment of malignant glioma, a group of serious brain tumors including glioblastoma. This status underscores GLIX1's potential to offer significant clinical benefit over existing therapies and addresses the urgent medical need in this rare, life-threatening disease. "The FDA's recognition confirms our scientific approach and our mission to develop innovative solutions for oncological challenges," explained Zeno Albisser, CEO of Hemispherian. "GLIX1 is a novel small molecule drug with a unique mechanism of action. The support from US and EU regulatory authorities strengthens our goal of offering a new treatment option for patients with malignant glioma." Details of the Orphan Drug Award The FDA grants ODD in accordance with Section 526 of the Federal Food,...

BfArM Warns of Health Risks from Kratom

Bonn, July 1, 2025 – The Federal Institute for Drugs and Medical Devices (BfArM) has issued an urgent warning against the use of kratom for medical purposes. Kratom, derived from the leaves of the Southeast Asian kratom tree, is not approved as a medicinal product in Germany and is advertised on the internet as a herbal remedy for pain, inflammation, anxiety, depression, and other ailments. The BfArM emphasizes that neither the safety nor the efficacy of kratom has been sufficiently tested. For approval as a medicinal product, efficacy, safety, and quality must be proven, and a positive benefit-risk ratio must be confirmed – criteria that kratom does not meet. Studies indicate serious risks, including neurological damage, addiction, withdrawal syndromes, and possible liver and kidney damage. Reports of deaths associated with kratom are currently being scientifically investigated, although the exact causes are still unclear. The BfArM is working closely with state authorities that monitor the drug trade… 

University Medicine Network starts new funding phase: From crisis management to the medicine of the future

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Dresden, July 1, 2025 – The University Medicine Network (NUM), an association of all 37 German university hospitals, is beginning its third funding phase today, which will be supported by the Federal Ministry for Research, Technology and Space (BMFTR) until December 31, 2030. Founded in April 2020 in response to fragmented research during the COVID-19 pandemic, the NUM has developed into a central platform for coordinated, cross-site clinical research in Germany. The goal is to create a unified study and data space and to improve patient care through practice-oriented research results. The NUM brings together scientists in interdisciplinary projects and offers nationwide research and data infrastructures. “Excellent medical research requires digital transformation and collaboration across institutions. The funding from the BMFTR enables us to continue our pioneering projects,” emphasizes Prof. Esther Troost, Dean of the Medical Faculty of TU Dresden. Strong role of University Medicine Dresden The University Medicine Dresden (HSMD),… 

New Milestone in Stem Cell Research: Robert Koch Institute Optimizes Stem Cell Register

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Berlin, July 1, 2025 – The Robert Koch Institute (RKI) has announced the further development of its stem cell registry, which is a central component of research with human embryonic stem cells (hESCs) in Germany. Via the registry's search platform, accessible at the RKI's URL, scientists and research institutions can retrieve specific information on approved research projects under the Stem Cell Act (StZG). This registry supports transparent and ethically monitored research, regulated by the Central Ethics Committee for Stem Cell Research (ZES) at the RKI. The RKI's stem cell registry serves as a public database documenting all research projects approved under § 11 StZG. It enables an extended search for projects utilizing human embryonic stem cells or induced pluripotent stem cells (hiPSCs) and provides insights into the respective scientific questions. One example is the 68th approval from 2011, which dealt with the investigation of genomic changes in hESCs under long-term cultivation in order to...

Soligenix Reports Successful Manufacturing of Synthetic Hypericin in the USA

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Princeton, New Jersey, July 1, 2025 – Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with high unmet medical need, today announced a significant advancement. In collaboration with Sterling Pharma Solutions, the manufacturing of the active pharmaceutical ingredient synthetic hypericin has been successfully transferred from Europe to the United States. The optimized production process enables commercially viable and scalable manufacturing of the API, which is used in the topical drug products HyBryte™ and SGX302 for the treatment of cutaneous T-cell lymphoma (CTCL) and psoriasis. Synthetic hypericin is a potent photosensitizer applied to skin lesions and activated by visible light. The partnership with Sterling has enabled manufacturing to cGMP standards (current good manufacturing practice) for clinical studies, with the goal of establishing a long-term commercial collaboration. “We are pleased to be able to produce larger quantities of cGMP-compliant synthetic… 

Abortion in Germany: Laws, Debates, and Perspectives

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In Germany, over 100,000 women decide each year against continuing their pregnancy. Abortion is regulated under Paragraph 218 of the Criminal Code, which generally classifies abortions as unlawful but allows them to be free of punishment under certain conditions. This regulation has far-reaching effects on affected women and medical personnel, as reported by the current issue of the health magazine "Apotheken Umschau" (July A-Edition 2025). Over 80 percent of the population reject the current regulations, and the German Medical Assembly called for decriminalization at the end of May. Nevertheless, the political will for reform is lacking, as emphasized by Prof. Dr. Christiane Woopen, a member of the Bundestag commission on abortions. Dr. Alicia Baier from Doctors for Choice sees potential for minor improvements, but the coalition agreement prioritizes the protection of unborn life and further restricts abortions. However, it promises better access to medically safe care, expanded cost coverage by health insurance companies, and stronger… 

AvenCell Japan receives $40 million in funding for innovative CAR-T therapy

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AvenCell Japan, a wholly-owned subsidiary of AvenCell Therapeutics, has received up to $40 million in funding from the Japan Agency for Medical Research and Development (AMED). The non-dilutive capital supports the global development of the AVC203 candidate, an IND-phase allogeneic CAR-T therapy targeting CD19 and CD20 antigens, being developed for the treatment of B-cell lymphomas. AvenCell's proprietary technology uses multi-stage gene editing to prevent rejection of donor cells by the patient's immune system without compromising T-cell efficacy. Early clinical data from the AVC201 program for patients with relapsed and refractory acute myeloid leukemia (AML) show that the allogeneic cells expand robustly and remain active beyond the usual one-month rejection limit – a breakthrough compared to previous allogeneic approaches. The funding underscores the significance of AvenCell's approach in an area of high medical… 

Dental Gold Scandals: Organized Crime in Germany's Crematoria?

Cremation has long been the standard in Germany: over 50 percent of deceased individuals are cremated, and the number is rising. But behind the quiet work of the approximately 200 crematoria, an issue rarely comes to light is simmering: What happens to the dental gold and other precious metals left behind after cremation? Estimates suggest up to one ton of gold, worth millions of euros, is generated annually – a treasure hidden in the furnaces of crematoria. While some facilities claim to donate the proceeds to charitable causes, reports of abuse, embezzlement, and lack of transparency are increasing. Private crematoria, such as the one in Braunschweig, are particularly coming under fire. This investigative report sheds light on the questionable practices in the industry, the unclear legal situation, and possible parallels to organized crime, which could range from systematic theft to illegal networks. A million-dollar business in the shadow of the… 

ESTEVE Acquires Rights to Caprelsa® and Strengthens Rare Disease Portfolio

The Spanish pharmaceutical company ESTEVE has entered into an agreement with Sanofi to acquire the rights to Caprelsa® (vandetanib) in over 50 countries. The drug is used to treat aggressive and symptomatic medullary thyroid cancer in adults and children over five years of age. Medullary thyroid carcinoma, a rare neuroendocrine tumor, originates in calcitonin-producing cells of the thyroid gland. Caprelsa®, a tyrosine kinase inhibitor, blocks enzymes, reduces blood supply to cancer cells, and thus slows tumor growth. The acquisition marks another step in ESTEVE's international growth strategy, focusing on highly specialized therapies for rare diseases. In April 2024, ESTEVE already acquired a company specializing in endocrinology and onco-endocrinology, expanding its portfolio to include three drugs for endogenous Cushing's syndrome and adrenocortical carcinoma. Furthermore, ESTEVE recently secured a license for a biological product for the treatment of children and adolescents with severe primary deficiency of insulin-like… 

Medical Report: Electrolyte Solutions as an Essential Measure During a 40-Degree Heatwave

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June 30, 2025 – The ongoing heatwave with temperatures exceeding 40 degrees Celsius presents a significant health challenge. Dehydration and electrolyte imbalances, in particular, threaten vulnerable populations. This report highlights the medical importance of electrolyte solutions, their physiological basis, and practical application under extreme heat conditions. Physiological Role of Electrolytes Electrolytes – particularly sodium, potassium, chloride, magnesium, and calcium – are central regulators of fluid balance, osmotic balance, and neuromuscular function. They enable nerve signal transmission, muscle contraction, and the maintenance of acid-base balance. In heat, the body loses large amounts of water and electrolytes through excessive sweating, altering plasma concentrations of these ions. An imbalanced electrolyte state leads to symptoms such as muscle cramps, hypotension, arrhythmias, or, in extreme cases, heatstroke with multiple organ failure. Pathophysiology of Heat Stress High ambient temperatures increase the body's heat production and impair thermoregulation. Sweat loss can be substantial under intense heat…