All News

Synthego has opened its new GMP-compliant RNA manufacturing facility in Redwood City, Calif., for CRISPR-enabled genomics therapeutics.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

The first CleanCap analog was launched in 2017, and since then, the capping technology has been incorporated in one of the first commercially approved COVID-19 vaccines.

Forge will provide adeno-associated virus (AAV) process development, toxicology, cGMP manufacturing, and analytical services to Life Bio, which will occur at Forge’s gene therapy facility in Columbus, Ohio called the Hearth.

This approach is defined as being used to express transcription factor combinations to reprogram human induced pluripotent stem cells (iPSCs).

In a deal potentially worth more than $530 million, Amgen will use TScan Therapeutics’ target discovery platform to home in on novel targets for Crohn’s disease treatment.

Congress have initiated a range of legislative proposals to further manage PBMs and the pharma market.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

The objective of the partnership is to automate portions of ScaleReady’s CGT manufacturing workflow by using Cellular Origin’s robotic system for sterile liquid transfer.

Further, the guidance is to provide information on compliance with applicable regulatory requirements and recommendations.

EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.

GSK’s Alexvy vaccine is the first to receive FDA approval for respiratory syncytial virus.

Private investors from Advent International and Warburg Pincus will operate the assets as an independent CDMO.

According to a press release, SGS has doubled its capacity for nitrosamine testing for North American customers.

The new portfolio from the acquisition will include contract research organization solutions, contract development and manufacturing organization solutions, and KSM/API solutions.

The new agreement is based off the Master Services Agreement that both companies entered in 2021 for the development, manufacture, and supply of rhenium (186Re) obisbemeda, according to a press release.

FDA’s Division of Applied Regulatory Science’s (DARS) computational toxicology and pharmacology research has been focused on the development of highly curated data sets and QSAR models for endpoints of regulatory interest.

The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Presspart will still be responsible for the manufacturing of the Sunriser device.

mRNA therapeutics are being researched to support the fight against rare diseases, infectious viruses, and cancers.

This specific guidance refers to a DCT as a clinical trial where some or all the trial-related activities occur at locations other than traditional clinical trial sites.

The new research and development capacities set the stage for completion of product development for LEON’s manufacturing devices and will be used to showcase the devices and provide process development services to clients using LEON’s equipment.

The acquisition was completed through the merger of a wholly owned subsidiary of Sanofi with and into Provention Bio.

New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.

JP Bornholdt, director of modular operations, CRB, discusses continuous and modular manufacturing.

Wood CEO Ken Gilmartin gives his insight on what's currently in demand in terms of new bio/pharma manufacturing facilities.

The event, cosponsored by FDA and USP, hosted regulators and industry leaders to discuss the challenges in strengthening the medical product supply chain.

Bas Trietsch, chief technology officer, MIMETAS, discusses the successes he's encountered so far using organ on a chip technology in bio/pharmaceutical research.

clonoSEQ Assay is authorized by FDA for MRD assessment in lymphoid malignancies and is highly accurate, sensitive, and standardized compared to other technologies used for disease burden assessment.

Yaakov Nahmias, founder and chief scientific officer of Tissue Dynamics, discusses the barriers in implementing organ on a chip technology.