Category:

BIOTECHNOLOGY

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.”

Metrion Biosciences Launches Good Laboratory Practice hERG Screening Service

Dr Andrew Southan, Chief Executive of Metrion Biosciences, said: “The launch of our GLP hERG screening capability adds further depth to our ion channel drug discovery services and complements our existing cardiac safety service portfolio. Our team is pleased to be able to offer GLP quality services to new and existing clients globally as we continue to develop Metrion as a leading ion channel focused CRO.”

TG Therapeutics and Neuraxpharm Announce Ex-US Commercialization Agreement for BRIUMVI® (ublituximab-xiiy)

BRIUMVI is the first and only anti-CD20 monoclonal antibody approved in the United States (US) and European Union (EU) for adult patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion, twice a year, following the starting dose. Neuraxpharm is backed by funds advised by the global private equity firm, Permira.

PureTech Awarded up to $11.4 Million from U.S. Department of Defense to Advance LYT-300 (Oral Allopregnanolone) for Fragile X-associated Tremor/Ataxia Syndrome

LYT-300, an oral prodrug of allopregnanolone, is PureTech’s wholly-owned therapeutic candidate for the potential treatment of anxiety disorders, postpartum depression, FXTAS and other neurological and neuropsychiatric indications. LYT-300 was developed using PureTech’s GlyphTM platform, which harnesses the body’s natural lipid absorption and transport process to enable the oral administration of certain therapeutics that otherwise cannot be administered orally.

ALTB-268: Phase 1 Topline Data of Novel Immune Checkpoint Enhancer for the treatment of Ulcerative Colitis

ALTB-268 was well tolerated with no serious adverse events across all subject cohorts. In addition, ALTB-268 demonstrated substantially greater biological activity than first ICE molecule, ALTB-168, enabling subcutaneous administration.
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