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
Our latest briefing dives into the Senate’s exploration of transparency and accountability to prevent bias in algorithmic decision systems, new guidance from the U.S. Copyright Office regarding works including content...more
Updates on vaccines for young children and a massive study on the efficacy of mask-wearing in schools headline this week’s COVID-19 news....more
As the number of cases throughout the nation drops, states are starting to lift mask mandates and COVID-19 restrictions. However, some leaders have cautioned against easing practices that mitigate spread. Meanwhile, recent...more
This week, early findings of an NIH-backed study were released — showing that a combination of doses from any authorized vaccines is safe and effective. Meanwhile, the Department of Labor shifts focus to a traditional...more
This week, the Biden administration formed a new task force to plan for future variants and made COVID-19 tests available for free through the mail, while medical leaders continue to sound the alarm about increasingly dire...more
The Biden administration signaled new plans to make tests and masks available for free, in the same week that the Supreme Court blocked the federal government from enforcing its “vaccine or test” mandate for private...more
In our final newsletter of 2021, we share updates on the federal government’s latest vaccine recommendations, the spread of the Omicron variant, and what the preliminary findings tell us about the need for booster shots to...more
As the holiday season continues, the Omicron variant has prompted an exceptional level of research activity and information-sharing. The early evidence on the Omicron variant is a mixture of encouraging news and more...more
The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of...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
Booster Shot Endorsements -
Last week, the U.S. Food and Drug Administration (FDA) advisory committee endorsed one of the mRNA COVID-19 vaccines and the single-dose vaccine to be used as a booster shot. This week, FDA...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
Vaccinated Individuals Infected With Delta Variant May Carry as Much Virus as Unvaccinated -
The U.S. Centers for Disease Control and Prevention (CDC) updated their mask guidance on July 27, 2021, recommending that...more
As the Delta variant becomes more prevalent — and its severity better understood — public health authorities look to apply lessons from earlier waves of the COVID-19 pandemic to help curb the recent rise in cases. The latest...more
Restrictions put in place to halt the spread of COVID-19 are disappearing across the U.S. as states reach vaccination goals, while the search for effective COVID-19 therapeutics to treat the disease and prevent future...more
While actively launching new initiatives and incentives to boost the vaccination rate within its own population, the U.S. government this week announced its plans to share portions of its vaccine stockpile...more
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
It was a largely encouraging week in the U.S. COVID-19 response, where the vaccination rollout continues to outpace initial goals. Elsewhere, the World Health Organization (WHO) weighed in on the idea of requiring...more
Addressing new variants, coordinating vaccine shipments and the continued progress of a third vaccine highlighted this week in the COVID-19 response.
Vaccine Manufacturers Tackle New Variant -
Manufacturers of COVID-19...more
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
With Inauguration Day rapidly approaching, President-elect Biden has announced an ambitious vaccination plan, and the federal government has signaled a change to its vaccine distribution process, among other COVID-19...more
Positive news is emerging on the vaccine front in the fight against COVID-19, as one vaccine candidate is reported to have prevented more than 90% of symptomatic infections in clinical trials, and another was granted a Fast...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
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