Charles River offers ready-to-use rep/cap plasmids that aim to streamline gene therapy supply chains. During Advanced Therapies Week, held Jan. 16–19, 2024 in Miami Beach, Fla., Charles River Laboratories International unveiled its new off-the-shelf replication/capsid (rep/cap) plasmids. These plasmids are designed to simplify the manufacturing process
The safety committee of the European Medicines Agency has highlighted a possible link between the use of valproate in men and the occurrence of neurodevelopment disorders in their children. On Jan. 12, 2024, the European Medicines Agency (EMA) made an announcement regarding the use of valproate medicines in male patients.
Regulators from various countries will convene in Washington, D.C. in April 2024 to contribute to the development of the mRNA and RNA therapeutics field The Alliance for mRNA Medicines (AMM) has announced that a meeting of global regulatory leaders will take place in Washington, D.C from April 4–
GSK is looking to acquire Aiolos Bio in a deal worth up to $1.4 billion. This acquisition will provide GSK with a broader range of biologic-based respiratory therapeutic candidates. On Jan. 9, 2024, GSK and Aiolos Bio, a clinical-stage biopharmaceutical company focused on respiratory and inflammatory conditions, revealed their
The expansion will increase the total reactor volume of solid-phase WuXi AppTec recently shared exciting news about its plans to expand its manufacturing facilities. The company will be adding two new peptide manufacturing plants, one at its Changzhou facility and another at its Taixing site in China. This expansion is
MediWound has received an extra $6.7 million from the DoD to further develop NexoBrid as a non-surgical field care solution for the US military On Dec. 28, 2023, MediWound, an Israel-based biopharmaceutical company, shared that they have received an additional $6.7 million from the US Department of Defense.
Boehringer Ingelheim and Ribo have joined forces to create RNA-based therapeutics for the treatment of NASH/MASH. Boehringer Ingelheim recently shared exciting news about their collaboration with Suzhou Ribo Life Science and Ribocure Pharmaceuticals. Together, they will be working on developing innovative RNA-based treatments for nonalcoholic or metabolic dysfunction-associated steatohepatitis
A clinical-stage autologous cell therapy that focuses on treating hematologic malignancies and autoimmune diseases, along with a unique manufacturing platform AstraZeneca has announced its plans to acquire Gracell Biotechnologies, a clinical-stage biopharmaceutical company that focuses on developing cell therapies for cancer and autoimmune diseases. The deal, valued at around $1.
Andelyn Biosciences has been chosen by Ultragenyx to produce UX111, the gene therapy for Sanfilippo Syndrome Andelyn Biosciences, a contract development and manufacturing organization, recently shared that Ultragenyx has chosen them to carry out late-stage process performance qualification (PPQ) manufacturing of UX111. This gene therapy is being developed by Ultragenyx
Depixus, a company specializing in interactomics, has partnered with Daiichi Sankyo to help speed up their RNA-targeted drug discovery program. They will be using Depixus' innovative MAGNA™ technology for this collaboration MAGNA is a special technology that uses magnetic force spectroscopy. It can analyze dynamic biomolecular interactions in real
The Guidance is an update to the 2021 draft guidance. It provides information about products used under an Emergency Use Authorization and the use of patient-level data from third parties. The 21st Century Cures Act, which became law on December 13, 2016, was created to make medical product development faster
