Acute Viral Pneumonia Treatment LungFit Approved by Beyond Air to Enter Clinical Study
In November 2020, the clinical study for treatment of acute viral pneumonia, facilitated by Beyond Air, a medical device and pharmaceutical company, is scheduled to commence. The study will consider enrollment for anyone infected with COVID-19 and pneumonia caused by...
Non-Opioid Pain Management Treatment in Phase One of Clinical Trial
Today (10/20) AmacaThera was granted approval from Health Canada to send their post-operative long-term anesthetic into phase one of clinical trial. This is the first drug they have sent through the clinical trial phase a milestone for the company. AmacaThera was...
At-Home COVID-19 Test Approved by FDA
Today (10/19), the U.S. Food and Drug Administration (FDA) approved Eurofins U.S Clinical Diagnostics at-home COVID-19 test which provides test result within 24 hours and is minimally invasive. This is the first FDA approved self-administered test in circulation from...
Dealing with Data Challenges Associated with COVID-19 Clinical Trials
COVID-19 has disrupted the clinical trial landscape today. The situation has caused many patients not wanting to visit sites, resulting in multiple missed patient visits. The availability of sites and investigators themselves have been limited, since sites have been...
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...