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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer
These approvals signify that GeneseeqPrime™ and GeneseeqPrime™ HRD are suitable for solid tumor genomic profiling, while Hemasalus™ DNA/Hemarna™ RNA is cleared for hematological cancer genomic profiling. In addition to the CE-Marked GENESEEQ multi-cancer minimal residual disease detection (Shielding™ ULTRA MRD) and GENESEEQ multi-cancer early detection (CanScan™ MCED) kits introduced earlier this year, Geneseeq currently offers five CE-marked cancer genetic testing kits tailored for various clinical situations.
AI Therapeutics Announces Investigator Initiated Phase 2 Trial at UCSF to Study LAM-001 in Patients With Bronchiolitis Obliterans Syndrome (BOS) Post-Lung Transplant
LAM-001 is a proprietary, investigational, inhaled formulation of sirolimus, also known as rapamycin.
3Z and biotx.ai Forge Partnership to Advance ADHD Drug Development Using AI Modelling
The partnership between 3Z and biotx.ai aims to establish a robust bridge from animal discovery studies to human clinical trials. By utilizing comprehensive AI-powered human genetics-based modelling, the involvement of the lead therapeutic targets in ADHD will be thoroughly explored.
Aegle Therapeutics Corp. Announces First Patient Dosed in Phase 1/2a Clinical Trial Administering a Novel Extracellular Vesicle Therapy
AGLE-102 is an investigational product comprised of native extracellular vesicles isolated from allogeneic stem cells using Aegle's proprietary and patented methods. The product is a composite of cell-derived nanoparticles that contain active biomolecules including proteins and nucleic acids with tissue regeneration, immunomodulation, and anti-inflammation properties.
10xBio Announces the Completion of Enrollment In Phase 2b Clinical Trial of Novel Drug For Submental Body Contouring
"I have been involved in the study of polidocanol for vein sclerotherapy for more than 40 years and am proud to lead the scientific and clinical effort to study this novel formulation of it for a new indication," said Mitchel P. Goldman, M.D., a dermatologic surgeon and medical director of Platinum and West Dermatology. "I believe that 10XB101 can achieve superior efficacy and tolerability than the currently marketed body contouring drug, deoxycholate, which I have more than 10 years of experience with. I look forward to seeing the results of this trial."
SSI Strategy and NDA Group Combine to Form Best-in-Class Global Life Sciences Consultancy
“NDA Group is regarded as the premier regulatory consultancy for Life Sciences companies across the U.S. and Europe, and we’re delighted to build upon our longstanding partnership with this combination,” said Doug Locke, Chief Executive Officer of SSI Strategy.
New Study Demonstrates Ropeginterferon Alfa-2b-njft Is a Cost-Effective Treatment Option for a Broad Range of Patients with Polycythemia Vera
Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2
Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy
First and only AFib ablation products to receive approval for use in a workflow without fluoroscopy from the U.S. Food and Drug Administration. Enables workflows with zero fluoroscopy during catheter ablation procedures. The approval is based on data from REAL AF Registry, demonstrating value of real-world evidence
First-Ever BioMech Clinical Motion Lab Opens in Atlanta to Accelerate Traumatically Injured Patients’ Recovery Using AI-driven Motion Science Technology in Clinic and at Home
“Our technology’s capability to monitor a patient's function in office and then at the patient’s home over a period of time is a catalyst for change in healthcare – signifying cost savings for patients and payers,” says Carter Brown, CEO, BioMech Health. “Because BioMech Lab can set baselines in the office and then monitor a patient’s progress at home, physicians can actively ascertain patient progress without having to incur the inconvenience and costs of an office visit.”