The United States Grants $628 Million Contract with Emergent for COVID-19
The Department of Health and Human Services granted Emergent BioSolutions a $628 million contract under the Biomedical Advanced Research and Development Authority (BARDA), a U.S. federal agency that funds disease-fighting technology in efforts to increase the...
FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis
The FDA announced on Wednesday (5/27) new guidances via a Q&A format for how COVID-19 is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video...
Interviewing CSOFT Health Sciences Strategy Advisor, VP Region Head Medical Amgen, Professor Victoria Elegant
CSOFT Health Sciences and Professor Victoria Elegant convened for another conversation after her previous Women’s day interview (here). She has been actively involved in managing the COVID-19 pandemic situation with her staff. She recently was a panelist on a MAPS...
EMA Strengthens ENCePP Madate Due to COVID-19
The European Medical Association (EMA) has strengthened the mandate for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Currently, the mandate works to strengthen how the risks and benefits of medicinal products...
Remote Devices: A New Age of Patient Centricity
A new age of patient centricity has dawned, and the need for remote patient engagement has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote technology helps...
Moderna Notes Early Signs of Success in COVID-19 Vaccine
Today (5/18) Moderna announced that its clinical trial in the United States has started to see protective antibodies in data from 8 healthy individuals, chosen at random from a 45-person study. The study, which began in March, and found that the...
Potential for COVID-19 Vaccine to be Approved Within a Year, According to EMA Official
Marco Cavaleri, the European Medicines Agency’s (EMA) top official overseeing anti-infectives and vaccines, acknowledged the potential for a vaccine for COVID-19 to be ready by Spring 2021 during a virtual conference last Thursday (5/8). He says that while...
FDA Approves Eli Lilly’s Retevmo, the First Treatment for Patients with a Certain Genetic Mutation for Lung and Thyroid Cancers
The FDA announced on Friday (5/8) of its approval for Retevmo, a drug capsule created by Eli Lilly for patients diagnosed with a specific RET gene mutation for three kinds of tumors: non-small cell lung cancer, medullary thyroid cancer and other types of thyroid...
