Drug Development

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Articles

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

The COVID-19 Vaccine Blind Spot

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

Moderna Files for FDA EUA for mRNA-1273

Behzad Mahdavi, PhD, will join a team of experts in the company’s Science and Technology Group to fast-track the adoption of new development and drug delivery technologies and manufacturing processes and techniques.



Catalent Appoints New Vice President of Open Innovation, Biologics, Cell and Gene Therapy

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

CureVac and Wacker Sign Manufacturing Contract for COVID-19 Vaccine Candidate

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

EC Approves Sanofi’s Meningococcal Meningitis Vaccine 

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

HMA and EMA Release Joint Statement on the Approval of Vaccines

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

AstraZeneca Vaccine Candidate ‘Highly-Effective’ in Preventing COVID-19

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review. 

FDA Schedules COVID-19 Vaccine Review for Dec. 10. 2020

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

Johnson & Johnson Starts Second Global Phase III Clinical Trial of Janssen COVID-19 Vaccine

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Formulation and Drug Delivery