Brilanta by AstraZeneca Approved to Reduce Risk of Stroke
Brilanta was approved by the U.S. Food and Drug Administration (FDA) for its efficacy in reducing the risk of stroke in patients with acute-ischemic stroke based on the Phase 3 THALES Trial. Compared to aspirin alone, when taken with Brilanta there was a clinically...
Merck Acquires Velosbio for $2.75 Billion for Promising Cancer Therapy
Today (11/5) Merck announced their all-cash acquisition of San Diego’s VelosBio following the release of Phase 1 data of ROR1 targeting VLS-101. VLS-101 is a drug for treatment of hematologic malignancies, and exited clinical trial Phase 1 with results showing...
Biogen is Hopeful for First Alzheimer’s Drug in 20 Years to be Approved by FDA
Biogen’s aducanumab has been praised before a final approval meeting by the U.S. Food and Drug Administration (FDA) to treat the disease that is the sixth leading case of death among 65+, Alzheimer’s. Biogen is expecting “blockbuster” sales of over $1 billion from the...
First-of-its-Kind HIV Self-Test Approved by Health Canada
BioLytical Laboratories has been approved for the commercial use of their at-home HIV self-test kit that yields 99% accuracy and takes about one minute to produce results to combat the rising HIV cases in Canada. The INSTI HIV Self-Test kit is BioLytical’s newest...
FDA Approved Boston Scientific’s Ranger Balloon
The Ranger Drug-Coated Balloon was approved today (10/2) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with peripheral artery disease, a disease that affects 200 million people. The disease is characterized by a plaque build up in the...
Johnson & Johnson Informs CDC of Plans to Experiment Vaccine Candidate on 12-18-Year-olds
In late September, Johnson & Johnson commenced a clinical study for their COVID-19 vaccine candidate on 60,000 adults. A company executive declared that they would start experimenting as soon as possible, and depending on results, and other factors would continue...
Planning for Translations – Where to Start?
For life science companies, understanding their business needs for translations is critical for finding the right solution. With so many different options for translation, including employing freelance translators, full-service language service providers (LSP), and...
Moderna’s Late Stage COVID-19 Vaccine on Track to Release Data Next Month
Today, (10/29) Moderna said that will release data on its experimental COVID-19 vaccine that will give insight on its efficacy. The company says they will produce 20 million doses by the end of the year. Pfizer and BioNTech are using similar technology to create their...
World Health Organization Backed by COVAX to Deliver 200 Million COVID-19 Vaccines
The COVAX initiative, worth $18 billion, is planning to administer COVID-19 vaccines to two-thirds of the world’s population by 2021. Sanofi and GalxoSmithKline have agreed to supply 2 million doses to the World Health Organization (WHO) of a vaccine they have been...
FDA Grants Clearance to Abiomed’s Launch of their Artificial Lung
Abiomed’s cardiopulmonary bypass system was cleared by the U.S. Food and Drug Administration (FDA) today (10/27) proceeding their April acquisition of Breethe. The effects of COVID-19 have created an increased need for heart recovery in cardiogenic shock patients....
Moderna Inc. Agrees with Qatar Ministry of Public Health for COVID-19 Vaccine Candidate
Today (10/26), Moderna, a top Biopharmaceutical employer, agreed to supply Qatar with their candidate COVID-19 vaccine, which has not yet been approved by any regulatory body. Moderna is currently scaling up their global manufacturing capabilities to be able to...
Europe Runs Low on Pneumonia Vaccine as Demand Grows
With the spike in COVID-19 cases worldwide, there is an increasing amount of people who are seeking precautionary vaccines for respiratory issues in preparation for the winter. Merck’s Pneumovax 23, more specifically, has hit record high sale volumes worldwide in the...
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...