Jill Murphy

The guidance describes the CDER formal dispute resolution (FDR) procedures for eligible requestors or sponsors that wish to appeal a scientific and/or medical issue related to a final order.

The transaction is expected to close in the third quarter of 2023.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

The bioreactor scaler tool helps scaling between development and manufacturing and to de-risk scaling activities and ensure product quality.

The integration of the binders into a routine lateral flow test will support the clinical and commercial development of rapid diagnostics for Alzheimer’s disease through nasal sampling.

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

The merger agreement states that Novartis will acquire all the shares of Chinook through a subsidiary for a price of $40 per share in cash at closing.

This will allow industry leaders to make and sell the product, in addition to providing more choice to pharma and biotech companies.

The document builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies.

Adamis Pharmaceuticals announced the closing of its merger with DMK Pharmaceuticals on May 25, 2023.

Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Hope is on the horizon as novel solutions and improvements aimed at benefitting the drug development process with the right framework are coming to the fore.

Through the acquisition, Avacta gains Coris’ product portfolio consisting of diagnostic tests for respiratory, gastroenteric, and blood-borne pathogens as well as for the detection of antibiotic resistance markers.

Contract testing services demonstrate a major increase in the speed and efficiency of testing using new testing methods and technologies.

Under the new MTA and Option License Agreement, Adcendo can nominate ADCs against two novel ADC targets, according to the press release.

The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB and gathers engaged stakeholders to move the initiative forward.

This agreement is intended to be executed and see the impact of any financial transfers by the fiscal year ending March 31, 2024.

The new CGMP facility is expected to contribute to the development of mRNA therapeutics, with a building designed for the CGMP manufacture of mRNA-based in-vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.

The facility is based on a state-of-the-art design concept that allows maximum flexibility for a multi-product, multi-platform offering.

The current lack of standardization within the industry can be attributed to the recent rapid growth of the cell therapy market and the associated drive to improve the efficiency and cost-effectiveness of production.

The pin-point system is completely modular, allowing for different components to be selected for optimal performance specific to the gene targets.

The new partnership hopes to increase funding and awareness of global health security challenges and highlight the role of the pharmaceutical industry in increasing access to medicines and improving health worldwide.

The new method was developed to isolate tissue-specific EVs from the blood in addition to using a workflow to analyze their diverse multi-omics content.

This deal would help the companies merge to work on future projects and conduct research together.

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).

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.

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