With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more
With a rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in the biopharma and medical devices sectors. In our inaugural biopharma and medical devices briefing, we highlight a...more
As vaccination rates drop to an all-time low in the United States, the CDC is preparing new guidance on measuring the severity of outbreaks in our communities. Meanwhile, a study on the impact of hospitalization on the mental...more
Major developments in vaccine authorizations and mandates continue in the U.S., while the surge in Europe has prompted one country to implement a lockdown — and also declare a national vaccine mandate.
mRNA COVID-19...more
Efforts to continue to promote and expand access to COVID-19 vaccines reached major milestones this week, as the holiday season draws near.
OSHA Vaccination Mandate -
In early September, President Biden released a...more
This week’s newsletter details the latest developments in the process of approving COVID-19 vaccines for children ages 5-11, a vaccine that produced promising clinical results, and new studies revealing insights about...more
The COVID-19 vaccine approval process reached a major milestone, but the fourth U.S. wave of the COVID-19 virus has prompted some sobering projections about the future of the pandemic.
COVID-19 Vaccine Receives Full FDA...more
Vaccine news dominated the COVID-19 headlines this week, as the ongoing vaccine roll-out hit a snag and leaders contemplated the potential for annual COVID-19 booster shots....more
With his initial goal of 100 million vaccine doses behind us, President Biden announces plans to double that number by his 100th day in office. As a new study brings promising results for vaccinated mothers, U.S. and...more
Why Do Clinical Trials?
Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more
The daily number of new positive COVID-19 cases in the U.S. has exceeded 100,000 twice in the past week, prompting some states to issue more restrictive safety measures and guidance. Amid these heightened concerns, the most...more
As a second COVID-19 wave hits Europe, many countries are implementing lockdown restrictions to flatten the curve. The second wave coincides with a pause in two vaccine clinical trials and the emergence of some documented...more
Recently, public attention has been captured by the progress of medical treatments and vaccines against COVID-19, which are currently going through clinical trials (categorized into phases 1, 2 and 3)....more