Gilead More than Doubles Original Courses Expectation for Remdesivir to Fight Covid
Gilead announced today (6/22) that its expectation for supply of remdesivir to fight Covid increased from 1 million to exceed 2 million by the end of 2020. Remdesivir is on the forefront of fighting the pandemic, helping shorten the length of hospital recovery times...
The Doctor Will See You Now: Delivering Telehealth Solutions Across Language Barriers
As a global crisis, the COVID-19 pandemic has called on interpreters and translators to step forward and contribute their linguistic expertise to worldwide aid efforts on numerous fronts, including telehealth. As well as supporting clinical trials, the past several...
Dexamethasone and COVID-19: The Breakthrough Steroid Saving Severely Ill Patients
Dexamethasone, a cheap and widely used steroid used to reduce inflammation for patients afflicted with arthritis, asthma, some skin conditions, and more, has been recognized as a breakthrough treatment from severely ill COVID-19 patients. When in use, it has shown to...
Medical Writing: Authoring a Clinical Study Protocol – II
Dr. Nimita Limaye returns to continue answering our guest audience questions in regards to medical writing and authoring a clinical study protocol! This week, she explains the importance of protocol synopsis and ensuring the completeness of the protocol, as well as...
The Need for Culturally Sensitive Medical Interpreters During Covid
Medical interpreters play several important roles in a clinical setting where multiple languages are spoken. Beyond real-time translation, medical interpreters are culturally aware and can communicate important concepts, as well as extract crucial information...
Johnson & Johnson to Begin Human Trials of Covid Vaccine in July
Johnson & Johnson announced today (6/10) that they will be initiating human trials in the second half of July for the Covid vaccine. The trials are expected to last over the course of two months in both the United States as well as Belgium, and will be...
WHO Prequalifies Rituximab Biosimilar for Cancer Treatment
The World Health Organization (WHO) has prequalified a biosimilar of version of rituximab, which is used to treat certain cancers and autoimmune diseases, created by Celltrion. This drug therapy is the second to achieve prequalification status under the...
Key Factors Driving Medical Writing Outsourcing Strategy – II
CSOFT Health Sciences SVP Dr. Nimita Limaye joins us once again to continue her interview on Key Factors Driving Medical Writing Outsourcing Strategy. This time, she focuses on the importance of alignment in terms of business operations, business models and...
Interviewing Dr. George King, Chief Scientific Officer and the Founder / Director of Asian American Diabetes Initiative (AADI) at the Joslin Diabetes Center, affiliated with Harvard Medical School
CSOFT Health Sciences is interviewing Dr. George King, MD at Harvard Medical School’s Joslin Diabetes Center. As the Chief Scientific Officer, a Senior Vice President, and the Founder and Director of the Asian American Diabetes Initiative (AADI), Dr. King is well...
FDA Releases MyStudies App for Patient Informed Consent
The FDA released the app FDA MyStudies, which can be found in app stores as COVID MyStudies, for patients to provide informed consent for traditional clinical trials, real-world trials, observational studies, and registries. The app is free, as...
The United States Grants $628 Million Contract with Emergent for Covid
Due to the Covid pandemic, 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...
FDA Releases Guidance on Formal Meetings Amid Covid Crisis
The FDA announced on Wednesday (5/27) new guidelines via a Q&A format for how Covid is impacting formal meetings, effective immediately. The guidance outlines that all meetings with the FDA will be held remotely, either through teleconference or video conference....
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 interviewing her for Women’s day (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 Mandate Due to Covid
Due to Covid, 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 and remote devices has become more crucial than ever. From being able to remotely visit COVID-19 patients, to continuously tracking patients participating in clinical trials, remote...
Moderna Notes Early Signs of Success in Covid Vaccine
Today (5/18) Moderna announced that its Covid vaccine 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 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 Covid vaccine to be ready by Spring 2021 during a virtual conference last Thursday (5/8). He says that while there may be...
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 Eli Lily's Retevmo, a drug which treats three kinds of tumors associated with lung and thyroid cancer: non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers. This comes as the...
Clinical Trials: How Real-World Data and Real-World Evidence Are Revealing the Patient’s Untold Story
As our world is constantly changing, the healthcare industry, especially clinical trials, are 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...
Medical Writing: Authoring a Clinical Study Protocol – I
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...