Friday, September 29, 2023

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Biotechnology News Magazine

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iSpecimen Expands Biospecimen Provider Network

These new suppliers will allow iSpecimen to improve global access to vital biospecimens and data needed to help advance research in oncology, autoimmune diseases, infectious diseases, cardiovascular diseases and more.

TransCure bioServices Offers BioVolume 3D Imaging for Insightful Preclinical Oncology Research

BioVolume reconstructs tumors from 3D, RGB, and thermal imaging. The solution is non-invasive, using a machine learning algorithm to automatically calculate subcutaneous tumor length, height, and width.

Center for Medicare Services Established National Pricing of VENDAJETM in All MAC regions

Prior to this milestone, reimbursement for VENDAJETM was restricted to certain MAC regions. Now VENDAJETM can be offered to all Medicare providers across the United States.

Alvotech and Bioventure Announce Approval of AVT02 (adalimumab) as Simlandi in Saudi Arabia

AVT02 as Simlandi™ is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure

PolyPid Provides Positive Regulatory Update for D-PLEX₁₀₀ for the Prevention of Surgical Site Infections in Abdominal Colorectal Surgery

PolyPid provided to the FDA currently available data from the SHIELD I study evaluating D-PLEX₁₀₀ for the prevention of abdominal colorectal SSIs. Based on the data, particularly the 54% reduction observed in the primary endpoint in complex surgeries in a pre-specified subgroup analysis of patients with large incisions (>20 cm) (p=0.0032, n=423) compared to standard of care, the FDA acknowledged that the SHIELD I results may provide supportive evidence on this population and recommended that the Company conduct an additional study to support a potential NDA submission.

BriSTAR Immunotech To Present its Novel Cell Therapy for Acute Myeloid Leukemia at the AACR Special Conference on AML and MDS

"The data shows that our LILRB4 STAR-T cell therapy exhibits potent anti-tumor activity against AML in preclinical models," said Dr. James Pan, CEO at BriSTAR Immunotech. "These findings support our strategy to maximize the potential of our unique STAR-T technology platform."