Private Equity's Inversion Excursion: Pepper Hamilton Talks Tax With the Deal
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
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
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more
FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an...more
On January 9, 2023, the U.S. Supreme Court denied Pfizer Inc.’s petition for a writ of certiorari. The denial brought the pharmaceutical company’s lawsuit challenging the breadth of the federal Anti-Kickback Statute (AKS) to...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
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
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
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 this week's Report: U.S....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
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
Since the introduction of COVID-19 vaccinations, employers have considered whether vaccine mandates are right for their workplaces. One hurdle has been several lawsuits claiming that because the COVID vaccinations did not...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
On Monday, August 23, 2021, the Food and Drug Administration (“FDA”) formally approved the Pfizer-BioNTech COVID-19 Vaccine for individuals 16 years of age and older. With this new and much-anticipated approval from the FDA,...more
The U.S. Food and Drug Administration's ("FDA") approval of the Pfizer vaccine under a new brand name, Comirnaty, created a cascade of legal and regulatory issues for prescribers, pharmacies, and other vaccine administrators....more