Manufacturing

Articles

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

Rita Peters is the former editorial director of 

Pharmaceutical Technology, Pharmaceutical Technology Europe

Achieving herd immunity will require testing, data, a vaccine, and public support. 

Are We All In This Together?

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

Advent Delivers Doses of COVID-19 Vaccine Candidate for University of Oxford Clinical Trial

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

HCATS, apceth Biopharma Form Strategic Manufacturing Agreements with bluebird bio

Trial begins in the US for the Pfizer-BioNTech mRNA COVID-19 vaccine; manufacturing plans announced.

Initial US Patients Dosed in mRNA Vaccine Trial

The companies have entered into a manufacturing agreement to supply leronlimab, an investigational new drug currently being used in clinical trial protocols for COVID-19.

Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

Studies Report Effectiveness of Remdesivir

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

NIAID Plan Describes COVID-19 Research Priorities

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

FDA Updates Clinical Research Policy to Reflect COVID-19 Disruptions

The guidance details considerations FDA has set in place to assure the safety of participants while maintaining compliance with good clinical practices and minimizing risks to trial integrity.

Clinical Trial Materials