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Biopharma & Medical Device Briefing: PFAS Reporting Requirements; ECHA Substances of Very High Concern List; and MicroRNA...

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

Recent Developments in Medical Devices and Biopharma You Should Know

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

COVID-19 Weekly Newsletter: New Guidance on Measuring Severity Anticipated

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

COVID-19 Weekly Newsletter: Full FDA Approval

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

COVID-19 Weekly Newsletter: White House Unveils New Vaccine Allocation Strategy

The Biden administration unveiled a new vaccine allocation strategy designed to address vaccine hesitancy and access issues. This new strategy coincides with a number of studies on COVID-19 variants that underscore the need...more

COVID-19 Weekly Newsletter: An Annual COVID-19 Booster?

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

COVID-19 Weekly Newsletter: New Vaccines on the Horizon as COVID-19 Variants Pose Continued Challenges

As we approach the one-year mark of COVID-19’s widespread presence in the United States, vaccines are being distributed, manufacturing is increased to meet demand and news of new vaccines all looks promising. While the world...more

COVID-19 Weekly Newsletter: Vaccine Progress Report

As countries in the Western Hemisphere prepare for the first shipments of vaccines, researchers continue to release new COVID-19 findings. Vaccine News Galore! U.K. Approves COVID-19 Vaccine, Ahead in the Western World:...more

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

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

COVID-19 Weekly Newsletter: New Cases Climb in the U.S.

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

COVID-19 Weekly Newsletter: Second Wave Hits Europe, Reinfection Cases Emerge

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

COVID-19 Weekly Newsletter: Vaccine Development Progresses as Cases Spike in the U.S.

There are an average of 45,000 new COVID-19 cases in the United States daily, an increase of 8% from the previous week. States that were already on an upward trajectory are getting worse and hospitalizations are on the rise,...more

COVID-19 Weekly Newsletter: Pharma Companies Sign Vaccine Pledge, Relief Package Stalls

AstraZeneca’s Phase 3 vaccine clinical trials came to a halt this week as the pharmaceutical company works to identify the underlying cause of a case of transverse myelitis emerging in a volunteer. The pause coincided with...more

Tracking the International Effort to Keep Clinical Trials for Non-COVID-19 Treatments Moving

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

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