News

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

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.

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

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.

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.

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.

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

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.

Sanofi’s Digitally Enabled Integrated Continuous Biomanufacturing Facility in Framingham, MA was named the Overall Award winner at the ISPE virtual annual meeting.

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.

FDA, US Customs and Border Protection, and the US Immigration and Customs Enforcement, Homeland Security Investigations signed a Memorandum of Understanding to prevent illegal drug imports from entering the US through International Mail Facilities.

As part of the administration’s campaign to reduce the United States’ reliance on an increasingly global pharmaceutical supply chain and to minimize potential shortages for critical drugs, FDA has published a list of those drugs and medical products considered critical for addressing public health emergencies.

Pierre-Alain Ruffieux has been named Lonza’s new CEO, taking over for Albert Baehny who has been serving as CEO ad interim since November 2019.

A virtual ribbon cutting, tour, and panel discussions were hosted on Oct. 29, 2020 to announce the opening of BioCentriq on the campus of the New Jersey Institute of Technology in Newark, NJ.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.