Pharmaceutical Technology Editors

The VerderFlex Vantage 5000 peristaltic pump is suitable for low to medium flow at low to medium pressures.

The US government will pay $1.95 billion for the additional 100 million doses, bringing the total number of doses supplied by the companies up to 300 million.

The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.

MTEM will handle research activities for the discovery of the next generation of engineered toxin bodies using its ETB platform, while Bristol Myers Squibb will obtain a license to develop and commercialize the ETBs.

4D pharma has signed a clinical trial collaboration and supply agreement with Merck and Pfizer for Bavencio (avelumab).

Rentschler Biopharma will establish its manufacturing capability for advanced therapy medicinal products at the CGT Catapult site in Stevenage, UK.

Optibrium, software developer for drug discovery, has raised investment from Kester Capital, a private equity firm, for the development of its business.

Nanoform and Herantis have signed a biologics proof of concept agreement for formulation proof of concept projects aimed at improving nasal drug delivery to the brain.

The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.

Exscientia has formed a partnership with the ARUK-ODDI for the development of medicines targeting neuroinflammation to treat Alzheimer’s disease.

The new business services site will house the company’s North American human resource operations, along with certain finance and information technology teams.

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

EMA has clarified its position on the European approval process of the Sputnik V vaccine.

Evonik has revealed plans for investment in the short-term expansion of its specialty lipids production, which are used with mRNA-based COVID-19 vaccines.

The recently formed scientific advisory board of Europital anticipates that a deficit in the clinical knowledge of smaller biotechs may lead to slow development in 2021.

The cell therapy will be manufactured for each individual patient at BMS’ immunotherapy manufacturing facility in Bothell, WA, and will be launched across a network of treatment centers.

Lessons learned from the pandemic can advance future biologic drug development and manufacturing.

FDA sent a warning letter to Allay Pharmaceuticals for inadequate written procedures; inadequate out-of-specification testing; inadequate stability testing; and inadequate quality control oversight.

The importance of characterizing excipients, supply chain security, and the role of novel excipients are explored.

Representatives of industry organizations discuss crucial business, regulatory, science-based issues facing the industry.

The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.

How can artificial intelligence and machine learning be used to gather and process real-time manufacturing data?

Through the agreement, AbbVie will use Caribou’s next-generation Cas12a CRISPR hybrid RNA–DNA genome editing and cell therapy technologies to develop two new CAR-T cell therapies.

The company has divested its specialty ingredients business and operations to Bain Capital and Cinven, two private equity firms.

FDA considers regulatory flexibility to allow the agency and sponsors to adapt and pivot to changes in coronavirus.

Through the agreement, Catalent will manufacture Trizell’s Phase I cell therapy for the treatment of micro- and macroangiopathies at its Belgium facility.

The study found that more than 90% of packages and cases scanned at three companies met all of the labeling requirements, with three years remaining until the final DSCSA deadline in 2023.

FDA’s Vaccines and Related Biological Products Advisory Committee will meet on Feb. 26, 2021 to discuss the request for emergency use authorization for Janssen Biotech’s COVID-19 vaccine candidate.

The company recently installed a fully validated visual inspection system that uses artificial intelligence in an automated inspection machine.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.