Jill Murphy

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.

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.

Aspect Biosystems and Novo Nordisk A/S have announced a collaboration, development, and license agreement to develop bioprinted tissue therapeutics.

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

The decision was issued in a joint statement by the FDA Commissioner and Chief Scientist, and effective on April 11.

The BalanCD CHO media portfolio is designed to ensure maximized growth, viability, and productivity of CHO cell lines.

Downstream processing will continue to see shifts with the incorporation of modern, efficient technologies.

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

The combined solutions are currently available on the market.

The services are based on the company’s PurePrep EasyClean (PEC) orthogonal peptide purification technology.

The decision was based on results from the PROpel Phase III trial.

This approval makes the drug the first and only targeted medicine indicated to treat this population of children in Europe and the United States.

Additionally, the MSG discussed plans to mitigate shortages of antibiotics for the next autumn and winter season.

Pharmaceutical companies have shifted their approach to development of vaccines as a result of the COVID-19 pandemic.

Any patients who have received the identified lots or have any questions regarding the recall should contact their pharmacy or immediately contact a health provider in terms of medical advice.

The guidance is intended to build on the existing International Council for Harmonisation (ICH) quality guidance.

CMO growth is focused on analytical testing, toxicity testing, and fill/finish operations.