Health

CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.

FDA Releases Guidance on Formal Meetings Amid COVID-19 Crisis

May 28, 2020 | News

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

May 28, 2020 | Health

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

May 26, 2020 | Medical Translation

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

May 21, 2020 | Health

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

May 18, 2020 | News

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

May 14, 2020 | News

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

May 11, 2020 | News

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...

How Real-World Data and Real-World Evidence Are Revealing the Patient’s Untold Story

May 7, 2020 | Health

As our world is constantly changing, the healthcare industry is adapting to better serve patients and improve lives around the world. While healthcare is shifting to become more patient-centric, additional data from the patient’s day-to-day life is needed to enhance...

Authoring a Clinical Study Protocol – I

May 7, 2020 | Medical Writing

Continuing her interview series, Dr. Nimita Limaye further answers questions from our guest audience members surrounding medical writing practices for clinical study protocols. She focuses on the role a medical writer plays in the process of writing these strategic...

Moderna Moves into Phase 2 of COVID-19 Vaccine

May 7, 2020 | News

In their business update, Moderna announced they received FDA clearance to move into Phase 2 of their study for the COVID-19 vaccine. In their press release, they also reported additional funding from Biomedical Advanced Research and Development Authority (BARDA) as...