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
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
The DOJ announced charges against 21 people across nine federal districts for their alleged role in pandemic-related fraud schemes resulting in over $149 million in false billings to federal programs. This is the largest...more
Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more
In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively...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
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
On Monday, the Food and Drug Administration gave permanent approval to Pfizer’s COVID-19 vaccine. Similar approval of the Moderna vaccine may be forthcoming, with eventual approval of the Johnson & Johnson one-shot...more
Following the successful development (and financial success) of its mRNA vaccine, biotech company Moderna is now looking to expand into the gene editing field. During a second-quarter earnings call on August 5, 2021, Moderna...more
On July 27, 2021, the Centers for Disease Control and Prevention (CDC) released new recommendations applicable to non-healthcare settings for fully vaccinated individuals as well as a report regarding masks and other COVID-19...more
Nine months ago, we discussed several issues that had been raised by COVID-19 face mask-related litigation. Soon after, COVID-19 infection rates spiked to unprecedented levels. But with the emergency use authorization of...more
In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...more
The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. In Thursday's Report: Moderna...more
In Washington: Senate Parliamentarian Elizabeth MacDonough has ruled that the Senate can only discharge one more automatic budget reconciliation this year, upending Democrat’s strategy to sidestep Republicans in advancing...more
New Jersey Gov. Phil Murphy will lift many of the state’s most prevalent COVID-19 safety restrictions, including mask mandates, social distancing requirements and capacity limitations. These changes will allow many companies...more
The CDC has lifted mask requirements for vaccinated individuals, what does that mean for employers? Earlier this month, the CDC issued new guidance that Fully Vaccinated individuals can resume activities without wearing...more
The good news is that the COVID19 pandemic appears to be on the wane. The bad news is that there is a ton of confusion and risk right now in the employment setting around masks, for employees and customers, and around...more
In Washington: The Centers for Disease Control and Prevention (CDC) said Thursday that fully vaccinated individuals don’t need to wear masks. The new guidance says people who have waited for two weeks after receiving their...more
We have seen biopharmaceutical companies around the world working to tackle COVID-19 in vaccine development, treatment development, and diagnostics, including the creation of world-class vaccines in record time, rapid tests...more