Pharmaceutical Technology Editors

The agency is advising healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine for potential side effects.

The agency sent a warning letter to Chloroquineonline.com for selling unapproved products for the treatment of COVID-19.

The Gavi advance market commitment for COVID-19 vaccines is a new financing instrument aimed at incentivizing vaccine manufacturers to produce sufficient and affordable quantities of COVID-19 vaccines.

The program will invest up to $500 million in biotechnology companies to provide funding and access to Pfizer’s scientific capabilities to continue the biotechnology companies’ clinical development programs.

The medicine is the first outcome of the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19.

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

The acquisition gives Novovax an annual operating capacity of more that one billion doses of COVID-19 vaccine antigen.

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

The new filters extend column life and reduce contamination while simplifying sample preparation.

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

The company announced that it has been issued a task order under a present contract with BARDA to use its contract development and manufacturing capabilities and knowledge to assist in the US government’s efforts to deliver COVID-19 vaccines.

Incyte and MorphoSys have revealed that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for tafasitamab, an anti-CD19 antibody.

Developer and supplier of film coating systems and excipients, Colorcon, has launched a new platform of on-dose technologies and detection services for the authentication of medications.

SeraNovo and Carna Biosciences have announced a second license agreement that will expand the existing partnership to include joint development of an oral formulation of Carna’s kinase inhibitor.

Virpax Pharmaceuticals, which specializes in developing pharmaceutical products for pain management using novel drug delivery systems, has announced the successful completion of a pre-investigational new drug (IND) application meeting with the US FDA.

The UK BioIndustry Association has stated its support of a government led funding initiative, Future Fund, which will support innovative companies in the United Kingdom that will help to ensure the country’s leading position in science, innovation, and technology.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

The Health Products Regulatory Authority (HPRA) has granted Wasdell Group an Investigational Medicinal Product (IMP) license for its European headquarters based in Dundalk, Ireland.

Global pharmaceutical company, Advanz Pharma, has closed its acquisition of specialty pharmaceutical company, Correvio Pharma.

Merck will use Themis’s vector platform to develop a vaccine to prevent COVID-19.

Merck will acquire Themis Bioscience and collaborate with IAVI and Ridgeback Bio on COVID-19 vaccines and therapies.

The company has received a $288,000 grant from the COVID-19 Therapeutics Accelerator, part of the Bill & Melinda Gates Foundation, to support a clinical study in Sub-Saharan Africa to find a treatment for COVID-19.

The new facility in County Mayo includes an ISO class 7 cleanroom for the manufacturing of single-use systems.

CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.

Advent manufactured the vaccine doses for the Phase 2/3 clinical trial.

The 60,000-ft2 facility will work in conjunction with the company’s Kakegawa, Japan, clinical supply facility to serve local and global biotech and pharmaceutical companies.

The companies have entered into a partnership worth more than $231 million to provide GSK with added capacity to manufacture and supply its biopharmaceutical therapies.

The company announced that participants have enrolled in a Phase 1/2 clinical trial of its COVID-19 vaccine candidate, NVX‑CoV2373, a prefusion protein made using Novavax’s proprietary nanoparticle technology.

All ReFIBE wipes are laser-cut with heatsealed edges and cleanroom laundered to lessen the amount of releasable particles and fibers.

Funding from the US government could lead to 300 million coronavirus vaccine doses by October 2020.