BioPharm International Editors

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

The guidelines are part of the independent control of pandemic COVID-19 vaccine batches.

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

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

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 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 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.

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.

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

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.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

The agreement provides Novo Nordisk with full access to Emisphere’s Eligen SNAC technology, which will boost Novo Nordisk’s portfolio of oral therapeutics.

Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.

Lonza has inaugurated its first ADC payload manufacturing suite at the Visp, Switzerland site.

Through the acquisition, Merck will gain access to VelosBio’s lead investigational candidate, VLS-101, an antibody-drug conjugate that targets receptor tyrosine kinase-like orphan receptor 1.

ProteoNic has licensed its protein expression technology, 2G UNic, to Gilead Sciences.

Experts examine the role technology can play in quality programs at the 2020 Bio/Pharma Virtual Congress.

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance.

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.

The company is investing $64.5 million to open new facilities in Germany and Japan to expand its overall capacity.

Through the acquisition, Sanofi will have access to Kiadis’ proprietary platform, which uses natural killer cells from a healthy donor to make products for a wide range of patients across several indications.

PerkinElmer will have the opportunity to strengthen its portfolio of automated life sciences discovery and applied genomics solutions by including Horizon’s gene editing and gene modulation tools.