First FDA-Approved Ebola Treatment Produced by Regeneron Pharmaceuticals
Regeneron has yet again added to their arsenal of extremely influential U.S. Food and Drug Administration (FDA) approvals with their Inmazeb antibody, a treatment for children, adults, and newborns with mothers who have tested positive for Ebola, a deadly virus that...
GE Healthcare Introduces Edison HealthLink
Today (10/14), GE announced its new technological innovation to healthcare data collection and safeguarding called Edison HealthLink. It will give clinicians multiple points of access to the Edison ecosystem, enabling them to make fast decisions when needed by...
Russia Approves Trial for COVID-19 Vaccine
Russia’s Health Ministry approved the usage of the “Sputnik” COVID-19 trial vaccine on 110 60+ year-olds today (10/13) in the wake of the deadly virus. Alongside this test will be a larger scale test being carried out in Moscow on 40,000 volunteers as part of a third...
FDA Advisory Committee Passes Alkermes’ Schizophrenia Drug
The U.S. Food and Drug Administration (FDA) Advisory Committee voted 16-1 in favor of passing Alkermes’ schizophrenia and bipolar disorder treatment drug (AKMS 3831). FDA members voiced concern about the potentially addictive qualities of the drug, as it contains an...
NDMA Detected in Dangerous Amounts in Metformin by FDA
Marksans Pharma and Sun Biopharmaceuticals Industries are facilitating recalls through the FDA of their drug Metformin as a result of high NDMA (N-nitrosodimethylamine) it contains. The FDA released a comprehensive list of Metformin products being recalled. It is...
Chinese COVID-19 Trial Approaching End
A United Arab Emirates company, Group42 or G42, is nearing the end of phase 3 clinical trials for a Chinese COVID-19 vaccine. They are hoping to start producing in the masses next year. This potential vaccine was a product of the partnership between G42, an Abu-Dhabi...
COVID-19 Testing System Disrupted Resulting from Roche’s Supply Chain Glitch
Roche, a Swiss pharmaceutical company, was hit today (10/7) with a glitch that disrupted one of its warehouses. This interruption caused one of their main receivers, Britain’s National Health Service, to delay the reporting of nearly 16,000 positive COVID-19 tests....
COVID-19 Antibody Treatment Expansion Following Safety Clearance
GlaxoSmithKline (GSK) and Vir Biotechnology are partnering to conduct trials on an antibody for COVID-19 treatment. The clinical trial will include 1,300 patients globally and a control group receiving a placebo. Various other companies, Regeneron for instance, have...
Nvidia Building Britain’s Most Powerful Supercomputer to Combat COVID-19
Nvidia, a chip industry giant from the U.S., announced today (10/5) that they will be building a supercomputer called Cambridge-1 which will channel artificial intelligence technologies to help researchers find solutions to urgent medical challenges such as COVID-19....
Despite Advisory Committee’s Approval, FDA Rejects Mesoblast’s Ryoncil
Today (10/2) the U.S. Food and Drug Administration (FDA) announced the rejection of Ryoncil, a treatment for steroid-refractory acute graft versus host disease (SR-aGVHD) in pediatric patients. For patients with the most aggressive form of SR-aGVHD, the mortality rate...
Safety Report Review Calls for More Thorough Adverse Event Reporting by FDA
According to an analysis published in JAMA Internal Medicine, almost half of the Medical Device Reports (MDRs) were directly from the Medical Device Safety Communications (MDSC) sent by the U.S. Food and Drug Administration (FDA). From this report, it was more clear...
What’s So Special About Life Science Translation?
The life science industries are highly regulated for good reason. Without proper guidelines and control mechanisms to ensure safety and quality, dangerous products could be marketed to unassuming customers, making life science translation a necessity for global...
Premier Holographic Cardiac Ablation System by SentiAR Cleared by FDA
Today (9/30) the U.S. Food and Drug Administration (FDA) granted clearance for leading visualizations for surgical procedures provider, SentiAr’s holographic cardiac ablation system Command EP. This will be the first holographic guidance system to be used in an...
CMS Issues Guidance to Expedite COVID-19 Testing Certification
On Friday (9/25), the Centers for Medicare & Medicaid Services (CMS) published a revised guide to expedite the process in which laboratories receive approval for COVID-19 testing. To aid in combatting the novel virus, the CMS program’s goal is to eliminate the lag...
Hologic Receives FDA Emergency Use Approval for COVID-19 Test
Today (9/28), Hologic received emergency use authorization (EUA) from the FDA for their testing kit for individuals with no symptoms of COVID-19. The CDC recently rescinded their statement saying that asymptomatic people did not need to be tested for COVID-19 and...
Pre-Market Testing Guidance Pilot Program Released by FDA
The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
FDA Grants EUA for Point-of-Care COVID-19 Antibody Test
Amidst the COVID-19 public health crisis, many companies have worked tirelessly to perfect testing technology. Assure Tech, a Chinese company based in Hangzhao, has prevailed with an antibody test with emergency use authorization. This is the first time that the FDA...
Paraxel Announces Resource for EU Clinical Trials Information System Regulation
With the incoming implementation of the EU Clinical Trial Regulation 536/2014 in December 2021, Parexel, an end-to-end innovative therapeutics solutions provider, has announced the launch of their Regulatory Submissions Hub Service for their life science and...
Resurgence of COVID-19 Cases in European Cities Causes New Restrictions
In the most recent report from the UK this past week, cases of COVID-19 have doubled to about 6,000 per day. While infections have been on a slow and steady increase in Europe over the last two months, especially in Spain and France, governmental bodies are...
Translating Lay Summaries – Driving Transparency
A study participant participates in a clinical trial, contributing invaluable data to understanding the safety and efficacy profile of a drug. Yet, patients, despite risking their lives by participating in a clinical trial, don’t usually get to know the outcome of the...