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BIOTECHNOLOGY
Medical Device News Magazine reports breaking biotechnology news in addition to medical device news.
PCI Pharma Services In Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection
The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI Pharma Services to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections.
Partillion Bioscience Announces Early Access Program for Nanovial Multicell Assays to Enable the Study of Cell-to-Cell Interactions
"Our Nanovial Multicell Assays are a game-changer, opening up new possibilities in research areas where the precise colocalization of cells is essential for studying complex cell-to-cell interactions or screening for therapeutic molecules released by one cell that act on another" said Joe de Rutte, Co-founder and CEO of Partillion. "By enabling these complex screens, all using standard life science instrumentation, we're enabling scientists to scale studies of how cells interact with other cells, whether it's better understanding tumors in the context of immune cells in their microenvironment, host-pathogen interactions or developing the next-generation therapies."
International Consortium to Revolutionize Viral Vector Manufacturing | Reports VVector Bio
"This project represents a paradigm shift towards improving viral vector manufacturing yields," remarked Alina Venereo Sanchez, CEO of VVector Bio. "By integrating genomics, epigenomics, transcriptomics, metabolomics and new ways of directly integrating analytics into production, we're poised to unlock unprecedented production capabilities."
Qubit Pharmaceuticals nominated for “Best start-up 2024” award by Prix Galien USA
Qubit Pharmaceuticals has been nominated for the 2024 edition of the prestigious Prix Galien USA, in the "Best Startup" category, out of a field of 41 companies, including 15 French contenders.
TEPKINLY (epcoritamab) Receives Second European Commission Approval for the Treatment of Adults with Relapsed/Refractory Follicular Lymphoma
TEPKINLY is the first and only subcutaneous bispecific antibody approved as a monotherapy in the European Union to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Hoth Therapeutics and Aronnax Inc. Enter Master Services Agreement For HT-KIT Cancer Therapeutic
HT-KIT cancer therapeutic is an antisense oligonucleotide that targets the proto-oncogene cKIT being developed for the treatment of mast cell-derived cancers and anaphylaxis and previously received Orphan Drug Designation from FDA.
NEC Bio Therapeutics and AGC Biologics Announce Collaboration to Manufacture Personalized Cancer Vaccines
NEC Bio Therapeutics, a Mannheim based German company focused on clinical development of innovative drugs by using proprietary AI, is developing NECVAX-NEO1, a personalized cancer vaccine that uses cutting-edge AI/machine learning technology to target specific tumor neoantigens that are unique to each patient. NECVAX-NEO1 relies on powerful and flexible plug and play bacteria-based platform technology and is convenient for patients due to its oral delivery. Unlike traditional treatments, NECVAX-NEO1 requires tailored manufacturing capacities and is produced by cost-efficient microbial fermentation at a small scale and with a quick turnaround time.
Top Scientists Shaping the Biopharma Industry
This article highlights some of the top scientists shaping the biopharma industry and their contributions to the field.
Rejuvenate Biomed and SAS Tap AI to Develop Disease-agnostic Drug Repurposing Discovery Tools
"Our partnership with SAS amplifies the core strengths of both our R&D teams," Dr. Ann Beliën, Founder and Chief Executive Officer of Rejuvenate Biomed. "By embracing this partnership and leveraging the capabilities of SAS Viya, we expect to meaningfully de-risk and accelerate the development of our internal portfolio while enhancing our discovery platform and partnering capabilities."