Ribobay Pharma, a leading Chinese biopharmaceutical contract research, development, and manufacturing organization (CRDMO) and a spin-off company of General Biol (Anhui) Co., Ltd, will provide cGMP-level oligonucleotide (oligo) CRDMO services to the world using Cytiva’s first FlexFactory platform for oligo manufacturing.
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have announced a strategic partnership in the burgeoning field of oligonucleotide therapeutics.
Elena Zakharova Wins Cancer Drug Discovery Research Award
Intellegens, a company applying machine learning (ML) to accelerate R&D, has secured a £1.6 million grant from Innovate UK to apply ML in the emerging field of oligonucleotide therapies. In collaboration with the Centre for Process Innovation (CPI), the two-year project will augment and validate the company’s ML technology, Alchemite, as a tool to enhance productivity and yields of oligonucleotide therapeutic manufacture through performance prediction and optimization of quality control strategies.
EUROAPI to acquire BianoGMP to strengthen its CDMO expertise in the high-growth oligonucleotide market
AntiClastic™ Antisense Oligonucleotide (AntiClastic ASO) is a proprietary platform available exclusively through partnerships with Alloy.
PepGen’s plans to get a second oligonucleotide therapy into the clinic have hit a regulatory roadblock courtesy of a clinical hold notice from the FDA.
BOSTON, May 30, 2023 (GLOBE NEWSWIRE) -- PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today announced that the Company received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding their Investigational New Drug Application (IND) to initiate a Phase 1 study of PGN-EDODM1 in patients with Myotonic Dystrophy Type 1 (DM1). The FDA indicated its intention to provide an official clinical hold letter to PepGen stating the reasons for the clinical hold within 30 days.
Purification – A Bottleneck For Large-Scale Manufacturing Oligonucleotide API
SAN DIEGO, Feb. 14, 2023 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to AOC 1020 for the treatment of facioscapulohumeral muscular dystrophy (FSHD). FSHD is a serious, rare, hereditary muscle-weakening condition marked by life-long, progressive loss of muscle function that causes significant pain, fatigue, and disability.