Linguistic Validation: What You Need to Know
Linguistic validation is a technique of reviewing and validating the accuracy, reliability, and equivalency for measurements of patient-reported outcomes (PROs). These outcomes, directly reported by patients, help determine the usefulness and efficacy of various...
Russia Announces Approval of COVID-19 Vaccine
Vladimir Putin announced on yesterday (8/11) of Russia’s approval for COVID-19 vaccine, “Sputnik V”. The approval comes before the vaccine has completed its final stages in the clinical trials, causing worry from both inside and outside the country. The first round of...
FDA Provides New Guidance for Drug-Drug Interaction Studies of Therapeutic Proteins
The US Federal Drug Administration (FDA) with the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) has provided guidance today (8/10) for drug-drug interaction studies of therapeutic proteins. The guidance...
How Technology is Enabling Patients’ Voices to be Heard in Clinical Research
COVID-19 has forced most of the world to work remotely, causing a major disruption in clinical research and the drug development process. As a result, the need for centralized and advanced patient engagement technology to better healthcare for all parties involved,...
Pfizer Signs Multiyear Agreement to Make Gilead’s Covid Treatment Remdesivir
Pfizer announced today (8/7) that it has signed a multiyear agreement for Gilead’s remdesivir, a treatment for Covid. With Gilead aiming to produce enough remdesivir to treat more than 2 million patients by the end of the year, and agreeing to send almost the entirety...
FDA Issues EUA for Vela Diagnostics Covid PCR Test
The FDA issued yesterday (8/5) Emergency Use Authorization for Vela Diagnostics for the manual version of their Covid PCR test. The manual version of the test enables flexible sample processing, facilitating widespread use of the test throughout the United States. Sam...
FDA Approves of RedHill Pharma Phase 3 Study for NTM Infection
The FDA approved today (7/31) RedHill Biopharma’s investigational new drug (IND) application for phase 3 of RHB-204 for pulmonary NTM infection in adults. NTM (nontuberculous mycobacteria) is a chronic lung disease caused by environmental bacteria typically near...
Augmented Reality and Virtual Reality in Healthcare: Opening New Possibilities for Efficient Care Delivery
Across industries, including healthcare, professional translation and localization services are essential to bringing innovative products to consumers across linguistic and national borders. For the healthcare industry, however, the stakes are often much higher, as...
US House of Representatives Approves $3.2 Billion for FDA Budget
The US House of Representatives approved of a $3.2 billion budget for the FDA for the 2021 fiscal year, a $40.8 million increase from the 2020 fiscal year. The additional funding is meant to support new initiatives for greater collaboration across departments within...
Adapting Medical Communications in Japan
Japan has one of the world’s largest and most successful medical markets, with leading pharmaceutical companies including Eisai, Takeda, and Daiichi Sankyo, and medical device manufacturers like Terumo, NIPRO, and Hitachi Medico. As a founding member of the...
US Government to Pay Pharmaceutical Leader Pfizer and BioNTech Almost $2 Billion
The US government will pay American pharmaceutical leader Pfizer and German biotech BioNTech $1.95 billion USD to buy enough COVID-19 vaccines for approximately 50 million people. Pfizer and BioNTech will not receive payment until their...
Novartis Receives Approval For Asthma Medicine Enzair Breezhaler
The European Commission (EC) has granted approval for Novartis’ Enzair Breezhaler, a medicine for uncontrolled asthma. The drug therapy is utilized as a maintenance treatment for adults with asthma. “Novartis is working to reimagine medicine for people with...
How Culture Affects Genetics: Understanding the Importance of Patients’ Diverse Backgrounds
The relationship between genetics and the diversity of cultures around the world is complex. While our genetics play an important part in who we are, the culture we live in also has a direct and large influence on our overall health. The widely accepted theory that...
US House Committee on Appropriation Approves Fiscal Year 2021 FDA Funding Bill
The US House Committee on Appropriation approved a $3.212 billion budget for the 2021 fiscal year. Part of the funding bill also gives the Food and Drug Administration authority to recall unsafe prescription and over-the-counter drugs. The proposed budget also...
United States Sets One-Day Record: Over 65,500 New Confirmed Cases of Covid
The United States on Thursday (7/10) reported across states, according to a Reuter’s tally, more than 60,500 new cases of Covid, setting the new record for the number of those confirmed to be infected in one day. As the cases are steadily on the rise in 41 out of the...
Interviewing Dr. Nimita Limaye on the Challenges and Opportunities of Medical Communications in India
We’re here this week with Dr. Nimita Limaye to discuss challenges and opportunities around medical communications in India. Dr. Limaye a distinguished leader in the international medical writing community and a recent addition to CSOFT Health Sciences’ growing team in...
Considerations When Planning for Spanish Translation
When someone thinks of Spanish translation, it seems like a relatively easy task. After all, Spanish is spoken all over the world, we even see it on a daily basis as an alternative-to-English translation in marketing schemes within the United States. The reality,...
Covid Potential for Brain Damage, According to Scientists
A study conducted by researchers at University College London (UCL) reported 43 cases of patients diagnosed with Covid experiencing temporary brain damage. The scientists warned that new evidence suggests potential issues of severe neurological complications, like...
Over 200 Scientists Claim Covid Is Airborne According to NYT
239 scientists from 32 countries have submitted an open letter with mounting evidence to the WHO that the Covid can be spread through the air. The WHO has stated that only after medical procedures that produce aerosols, or droplets smaller than 5 microns is the virus...
A Quicker Transition to Digitalizing Healthcare in the European Union
European Union Nations agree to accelerate their digital transformation as an ‘essential component of the EU’s response to the economic crisis generated by the COVID-19 pandemic.’ The impact of Covid on the European Union’s diverse healthcare systems has led EU...