Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.

EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

The announcement comes after the company saw growth and performance in Asia and decided to continue the expansion of biopharmaceutical manufacturing in the region.

The expansion will feature added capabilities for formulation development via the upgrade of drug product development laboratories and the addition of Gerteis roller compaction equipment for dry granulation processing.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.

The guidance was published in connection with a safety monitoring plan for COVID-19 vaccines.

The expansion will be designed to meet the growing demand for small molecule drug substance development and manufacturing.

The event will be rescheduled for Oct. 19–21, 2021 at the Javits Center in New York City.

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

Moderna CEO Stéphane Bancel says the company will submit EUA data for its vaccine candidate, mRNA-1273, which has shown efficacy of 94.5% in the first analysis of Phase III clinical test results.

The new facility, which is expected to be operational by mid-2026, will utilize cell-based technology to produce influenza vaccines for influenza pandemics and seasonal vaccination programs, both in Australia and globally.

The companies will work together on research activities through to the selection of a preclinical candidate, after which Roche will handle further development and global commercialization.

The 110,000 ft2 site, which is set to be operational by the second half of 2021, will feature new technology including 2000-L scale bioreactors and additional fill-finish capabilities.

The first public announcement from the Biden-Harris transition team was to name members of a COVID-19 advisory board charged with initiating policies and actions to combat the fast-rising infection rate in the United States

Apeiron Biologics has selected Domainex to advance the development of inhibitors for the E3 ubiquitin ligase Cbl-b.

AstraZeneca has received approval for Calquence (acalabrutinib) to be used as a treatment of chronic lymphocytic leukemia (CLL) in adults within the European Union (EU).

PhoreMost and Oxford Biomedica have entered into a discovery collaboration for the development of next-generation chimeric antigen receptor T-cell therapies.

Analysis from the CPhI Annual Report has revealed that the global contract services sector is benefitting from a switch toward COVID-19 manufacturing and clinical-stage contracts; however, mega-cap pharma innovation is slowing outsourcing.

Vifor Pharma and Angion Biomedica have signed a license agreement that will see the commercialization of late-stage product, ANG-3777.

Optibrium has entered into a cheminformatics collaboration with MSD (known as Merck & Co. in the United States).

Construction on the workshop is currently underway with plans for it to be fully operational by the end of 2021.

Clarity from regulators, prior work on other vaccines, and closer collaboration with contract partners and suppliers have allowed Moderna and J&J to slash timeframes. Moderna may be on track to deliver initial doses to the highest risk patient populations before January 2021.

The program will consist of 10 University of Cambridge researchers and a group of PhD students who will work together to develop AI and machine learning technologies for clinical trials, personalized medicine, and biomedical discovery.

The companies will initially develop and design process technologies, single-use systems, and automation, with plans to eventually focus on an expanding process and digital technologies to optimize a continuous manufacturing process.

ISPE announced its 2020–2021 International Board of Directors during the virtual 2020 ISPE Annual Meeting & Expo on Nov. 6, 2020.