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...
Moderna Moves into Phase 2 of Covid Vaccine
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...
Exploring the World of Vaccinations
Explore the world of vaccinations with Professor K in understanding what they are, how they work, and the challenges they face in development and implementation, especially for COVID-19.
Key Factors Driving Medical Writing Outsourcing Strategy – I
CSOFT Health Sciences SVP Dr. Nimita Limaye has taken the time to answer some questions from our guest audience about the medical writing industry. In her first interview, she focuses on key factors that cause businesses to outsource their medical writing needs. Jane:...
FDA Amends Policy for Covid Tests
The FDA announced that it would strengthen its oversight for companies marketing the Covid serology tests. After questions came to light in regards to the accuracy of some of the testing kits, the FDA is now requiring commercial manufacturers to submit an emergency...
FDA Grants EUA for Covid Treatment Remdesivir from Gilead
The FDA announced today (5/1) that it would grant EUA for Gilead for their antiviral drug remdesivir for treatment in early response to suspected or confirmed patients with Covid. This authorization will allow the distribution of the drug all over the US, as well as...
FDA Announces Exemptions and Exclusions from Certain Requirements in the Drug Supply Chain Security Act
Yesterday (4/30) the FDA lifted some of the security requirements in the Drug Supply Chain Security Act to help expedite adequate distribution of prescription drugs due to COVID-19. These exemptions and exclusions apply to...
Amazing Cooperation Between Companies to Meet Global Demands in Global Supply Chains for Pandemic-Response Equipment
There has been amazing cooperation by companies with global supply chains to come together during Covid and produce surplus PPE and ventilators for domestic and international markets. Communicating effectively across multi-lingual global supply chains is more...
FDA Gives Guidance on Bioequivalence Studies for Submission Amidst Covid
The FDA released guidance on Tuesday (4/28) for bioequivalence studies intended for submission in Abbreviated New Drug Applications (ANDAs). Due to Covid, many clinical trial studies have been negatively impacted due to travel limitations, site closures, etc. With...
EU Gives Five New Guidances for Medical Devices
The European Commission's Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
EU Unanimously Votes to Delay EU MDR by 1 Year
In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...
Covid, Ebola, and Typhoid, Oh My!: A Tale of Global Pandemics
This article is part 1 of a mini-series focusing on the progression of global pandemics. This instalment explores the history of past pandemics and how they relate to the current COVID-19 situation. While it may seem that our current Covid self-quarantine has brought...
The Effects of Cabin Fever
Staying at home for extended periods of time, also known as "cabin fever", can feel like entrapment. Especially true for those accustomed to a hyper-connected lifestyle, quarantining can be detrimental to one’s well-being. Not being able to attend a dance class in...
FDA Authorizes First At-Home Covid Testing Kits
Yesterday (4/21) the FDA announced EUA for at-home Covid testing kits from LabCorp. These nasal swab tests were previously authorized in mid-March by the FDA, however only for medical professionals to use. Stephen Hahn, FDA Commissioner, released in a statement that...