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Astellas Receives Approval from the European Commission for VYLOY™

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission (EC) has approved VYLOY™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. The European Medicines Agency has recommended that zolbetuximab’s designation as an orphan medicinal product be maintained in recognition of the poor survival outcomes associated with gastric and GEJ cancers. Zolbetuximab is currently the first and only approved monoclonal antibody specifically designed to target gastric tumor cells that express the biomarker CLDN18.2, offering a more personalized approach to cancer treatment. In the zolbetuximab Phase 3 clinical trials, approximately 38% of adult patients with advanced and metastatic gastric and GEJ… 

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Elanco Announces FDA Approval and Launch of Zenrelia™

U.S. Food and Drug Administration approves Zenrelia, a once-daily oral JAK inhibitor for dogs with allergic and atopic dermatitisElanco enters the estimated $1.7 billion global canine dermatology market, highly accretive to existing portfolioIn a head-to-head study, Zenrelia was shown to be at least as effective as the market incumbent JAK inhibitor at the primary end point, with an additional endpoint at which Zenrelia got 77% of dogs to clinical remission of itch, compared to 53% of dogs treated with Apoquel® (oclacitinib tablet)1*Zenrelia launch begins in U.S. with Elanco now taking orders; product expected to ship in coming days

Navident EVO receives FDA Clearance for Guided Endodontics

Navident EVO will apply its dynamic navigation technology to provide minimally invasive access to tooth structures requiring endodontic treatment. The dual advantage of preserving tooth structure and making the procedure more efficient significantly benefits the dentist and the patient. The advantages are clear: Less invasive access of calcified and hidden canalsPreserved tooth structureSaved time in locating and accessing canals.

Rakuten Medical Presented Research Results

Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox™ platform, today announces that the research results of the preclinical studies for PD-L1-targeted photoimmunotherapy were presented at the 83rd Annual Meeting of the Japanese Cancer Association (JCA2024) in Fukuoka, Japan on September 20, 2024 (JST). The key findings presented at JCA2024 Abstract Title: PD-L1 photoimmunotherapy kills immunosuppressive myeloid cells to activate local and systemic antitumor immunity Presenter: Amy H. Thorne, Ph.D. (Rakuten Medical, Inc.) Abstract Number: 30050 It has been observed in in vitro studies that this photoimmunotherapy has a dual mechanism of action (MoA): depletion of PD-L1 expressing tumor cells and depletion of PD-L1 expressing immunosuppressive cells such as tumor-associated macrophages (TAMs) and myeloid-derived suppressor cells (MDSCs). In addition to this dual MoA, the potential for systemic immune checkpoint inhibition was… 

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Results from the Phase 3 SIERRA Trial of Iomab-B

Iomab-B is the first CD45 targeted radiotherapy for conditioning in development to enable potentially curative bone marrow transplant and represents an alternative to chemotherapy-based approachesSIERRA achieved durable Complete Remission primary endpoint and Event-Free Survival secondary endpoint with high statistical significanceIomab-B was well tolerated in the older, heavily pretreated relapsed/refractory AML patients with active disease enrolled in the SIERRA trialActinium to seek strategic partner for Iomab-B for further development in the U.S. following completion of interactions with FDA for additional head-to-head clinical trial to demonstrate overall survival benefit

Kangpu Completed Bridging Clinical Study of KPG-818 in China

Kangpu Biopharmaceuticals, a clinical-stage company based in Hefei, China, announced today that the Company has successfully completed a bridging clinical study of KPG-818 in healthy subjects in China. The randomized, double-blind, placebo-controlled, and food effects (FE) study aimed to assess the safety and tolerability of multiple oral doses of KPG-818 in male and female healthy participants over a treatment period of 14 days and a follow-up period of 4 weeks, to characterize the single and multiple oral dose pharmacokinetics (PK) of KPG-818, and to select dosing regimens of KPG-818 for future clinical trials. A total of 30 participants were randomized to three escalating cohorts (n=10 each; 8 KPG-818, 2 placebo) receiving 0.15 mg, 0.6 mg, 2 mg or placebo once daily. In the FE cohort, 12 participants received single dose of 0.6 mg KPG-818 with and without food. KPG-818 is… 

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Next-Generation Tumor-Infiltrating Lymphocyte (TIL) Technology Debuts on ESMO 2024

The highly anticipated 2024 European Society for Medical Oncology (ESMO) Annual Congress has taken place from September 13 to 17 in Barcelona, Spain. As one of the most influential annual gatherings in oncology, this congress brings together leading cancer experts and researchers from around the globe, showcasing the latest advancements in the field and providing high-quality educational and networking opportunities for oncology professionals. Biosyngen, an innovative biotechnology company specializing in immune cell therapies, has showcased its groundbreaking technology on gene-modified, functionally enhanced tumor-infiltrating lymphocytes (TILs) derived from liver cancer biopsy samples. BioSyngen has secured ten clinical trial approvals in China and the U.S. for its innovative fourth-generation oncology therapies. Currently, our leading pipeline product, BRG01, is in the pivotal Phase II clinical trial stage for solid tumors. Additionally, the first patients have been enrolled in the Phase I trials for… 

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Laboratory Medicine Made in Germany

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The Importance of Laboratory Medicine in Germany. Laboratory medicine plays a central role in the German healthcare system. Approximately two-thirds of all diagnoses are based on or confirmed by laboratory tests[1][4]. Hundreds of thousands of patients are served daily through laboratory tests, both in outpatient and inpatient settings[1]. Structure and Care In Germany, there are currently over 200 medical laboratories with more than 1,000 specialists, around 500 natural scientists, and approximately 25,000 qualified employees[7]. The industry is characterized by several large corporate groups, each operating numerous laboratories. The largest laboratory groups include: – Limbach Gruppe (31 locations, over 300 specialists, over 5,000 employees)– Sonic Healthcare Germany (13 locations)– Amedes (18 laboratory locations)– LADR (17 specialist laboratories, approx. 3,400 employees)– Synlab (40 human medicine laboratories in Germany)[3] Specialists and Training On January 1, 2001, 1,223 specialists in laboratory medicine were registered in Germany[2]. The training to become a… 

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Microplastics are a global threat

According to a new report, science has provided more than enough evidence to develop a collective and global approach to curb the further spread of plastic pollution. An international group of experts writes in the journal Science that the need for global measures to combat all forms of plastic and microplastic waste has never been more urgent. It is clear that existing national legislation alone is not sufficient to tackle the challenge, they say, and the UN plastic pollution treaty – which is undergoing its fifth round of consultations in November 2024 – offers a "tangible opportunity" for joint international action. However, for such a treaty to be truly effective, it must commit to an overall reduction in plastic production while also taking measures to reduce the emission and release of microplastic particles throughout the entire plastic lifecycle. Otherwise, the researchers add, there is...

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Cambrex Announces New Manufacturing Technology for Liquid-Phase Peptide Synthesis

Cambrex, a global leader in contract development and manufacturing organization (CDMO), today announced that Snapdragon Chemistry, a Cambrex company, has successfully developed a new liquid-phase peptide synthesis (LPPS) technology that utilizes conventional pharmaceutical active ingredient batch reactors and continuous flow, eliminating the need for specialized solid-phase reactors. The new LPPS technology significantly reduces solvent requirements and the need for excess reagents compared to traditional solid-phase peptide synthesis methods. The LPPS technology supports peptides up to 12 amino acid residues in length, while larger peptides are subsequently assembled in the liquid phase using a convergent fragment coupling approach. Processes developed with Cambrex's LPPS technology are scalable in the same way as conventional small molecules. In addition to LPPS, Cambrex has also developed unique peptide and protein crystallization capabilities, including a crystallization screening platform specifically for the discovery of crystalline forms of peptides...

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