Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
In response to the COVID-19 pandemic, pharmaceutical companies like Pfizer worked diligently to develop safe and effective vaccines. Following the FDA’s approval of these vaccines, many state governments and private...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more
I recently wrote about the patent infringement lawsuit filed by Moderna against Pfizer/BioNTech over the COVID-19 vaccine. In its complaint filed in federal district court in Boston last August, Moderna alleged that...more
Substantial patent litigation activity occurred in the mRNA space in 2022, involving nearly all of the major mRNA and lipid nanoparticle (LNP) pioneers. Since this is the most significant happening in this space with respect...more
One of the most amazing accomplishments in the field of biotechnology has been the development and distribution of a vaccine against SARS-CoV-2 (COVID 19). The numbers tell the story. The time from when the coronavirus’...more
Moderna has sued Pfizer and BioNTech in Massachusetts and Germany (where the defendants are based), claiming that the companies violated three of its patents related to mRNA technology used to develop COVID-19 vaccines....more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
If you are divorcing with children, there are two primary issues that the court must decide as it relates to your kids. The first is a residential schedule which addresses when your children will physically be with you and...more
The Food and Drug Administration (FDA) has recently undertaken a number of notable actions with respect to vaccines in response to the ongoing COVID-19 pandemic....more
For those of you who know me, I like to have fun with my Zoom backgrounds – choosing photos of interesting scenery or changing them mid-call to reflect my mood or negotiating strategy. Sitting in front of my computer this...more
In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
Even as the coronavirus batters parts of the country, notably the Mountain West, public health officials are pointing to key ways in which Americans could safely and effectively further quell the pandemic that has claimed...more
The Pfizer-BioNTech COVID-19 vaccine has been authorized by the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) for administration to children aged 5-11 years old. ...more
Upcoming Hearings/Markups - November 2 - House Veterans’ Affairs Committee, Subcommittee on Technology Modernization Hearing: “Next Steps: Examining Plans for the Continuation of the Department of Veterans Affairs...more
Don’t doubt the central role that vaccines are playing in the battle against the coronavirus pandemic. Federal officials - even as the Delta-variant surge is easing - have dominated the news by approving yet more...more
As the summer’s deadly Delta variant surge slowly seems to be receding, questions are rising anew as to what further harms the coronavirus pandemic may inflict on a nation that already has suffered greatly. The infection...more
This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more
The battle against the coronavirus pandemic is further splintering Americans into brittle groups, segments familiar because they long have been components of the inequitable U.S. health care system - let’s call them the have...more
In a continued effort to ensure cost is not a barrier to vaccine access, on September 24, 2021, CMS announced that it will pay for Medicare beneficiaries’ COVID-19 booster doses without any cost sharing. Medicare...more
Pfizer is saying its COVID-19 vaccine works in kids ages 5-11. You’re divorced and have two children in that age group; both live primarily with you, but they spend a few nights of the week with their other parent. Like most...more
Upcoming Hearings/Markups - September 27 - House Rules Committee Meeting: to discuss H.R. 3110 — PUMP for Nursing Mothers Act, H.R. 3992 — Protect Older Job Applicants (POJA) Act and H.R. 2119 — Family Violence Prevention...more
Following days of lengthy debates, 3rd doses of the Pfizer-BioNTech COVID-19 vaccine or “boosters” can now be officially administered to certain individuals in the U.S., as endorsed by the U.S. Food and Drug Administration...more
The coronavirus keeps ripping through the country with a fourth, Delta-variant fueled surge that also is producing confounding, confused behaviors that only add to the pandemic’s considerable gloom. The pandemic, which...more
Now that the federal Food and Drug Administration (FDA) has issued its formal approval of the Pfizer-BioNTech COVID-19 vaccine, many employers are beginning to implement vaccine requirements for employees. This article...more