News & Analysis as of August 29, 2025

Pharmaceutical Industry

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Read guidance, analysis, and updates on the myriad issues arising from the global response to the COVID-19 pandemic. Updated hourly every day, the insights published here are written by leading lawyers and law firms helping to make sense of insurance, employment, tax, securities, M&A, risk management, and every other consideration touched by this crisis. Follow the channel for a daily email brief of the latest and best updates. less -

UK Court of Appeal Upholds Moderna mRNA Patent Against Pfizer/BioNTech

Goodwin on 8/15/2025

On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

Goodwin on 8/5/2025

On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...more

mRNA/LNP Patent Litigation Update (Q1 2025)

Rothwell, Figg, Ernst & Manbeck, P.C. on 4/9/2025

As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...more

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on 9/3/2024

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

[Webinar] The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape - September 27th, 2:00 pm ET

Rothwell, Figg, Ernst & Manbeck, P.C. on 8/22/2023

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

DOJ Civil Division's Consumer Protection Branch Features FDA Enforcement Actions in its First-Ever Annual "Recent Highlights"...

Wilson Sonsini Goodrich & Rosati on 4/26/2022

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

FDA Authorizes Two Oral COVID-19 Drugs – Medical Products Supply Chain Week in Review

Alston & Bird on 12/24/2021

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

Kids now can get Covid shots. Will they? And what about the new anti-Covid pills?

Patrick Malone & Associates P.C. | DC Injury... on 11/9/2021

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

Washington Healthcare Update - November 2021 #1

McGuireWoods Consulting on 11/2/2021

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

As Delta surge eases, what’s next with this pandemic?

Patrick Malone & Associates P.C. | DC Injury... on 10/19/2021

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

Washington Healthcare Update - October 2021 #2

McGuireWoods Consulting on 10/12/2021

This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....more

Permanent Approval of the Pfizer COVID-19 Vaccine May Prompt Employers to Mandate Vaccinations

Parker Poe Adams & Bernstein LLP on 8/30/2021

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

FDA Approval of Pfizer Vaccine – Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask

Quarles & Brady LLP on 8/27/2021

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

FDA full approval of Pfizer vaccine should reduce risk of employer mandates

Bricker Graydon LLP on 8/25/2021

On August 23, 2021, the U.S. Food and Drug Administration (FDA) fully approved the Pfizer vaccine for those 16 and older - the first full approval of the three COVID-19 vaccines available in the U.S. The Moderna and Johnson &...more

FDA’s Full Stamp of Vaccine Approval Delivers Progress, but Issues With Vaccine Passports and Policies Are Looming

Ogletree, Deakins, Nash, Smoak & Stewart,... on 8/24/2021

On August 23, 2021, the U.S. Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine. Moderna’s expedited application for full approval is still pending, and Johnson & Johnson plans to submit its...more

FDA Grants Full Approval to the Pfizer Vaccine

Seyfarth Shaw LLP on 8/24/2021

Seyfarth Synopsis: Today the FDA approved Comirnaty (COVID-19 Vaccine, mRNA), previously known as Pfizer-BioNTech COVID-19 Vaccine, to prevent COVID-19 disease in individuals 16 and older. This could be big news for those on...more

Coronavirus: The Hill and the Headlines, June 2021 - Final Issue

Hogan Lovells on 6/7/2021

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

Pfizer Requests Full Approval of its COVID-19 Vaccine

Ballard Spahr LLP on 5/12/2021

On Friday, May 7, Pfizer and its partner BioNTech filed an application seeking full approval from the United States Food and Drug Administration (FDA) for its COVID-19 vaccine for patients age 16 and up. Pfizer is the first...more

Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver

McDonnell Boehnen Hulbert & Berghoff LLP on 5/11/2021

On Friday, Dr. Albert Bourla, the Chairman and Chief Executive Officer of Pfizer, sent an open letter to Pfizer employees regarding the U.S. Trade Representative's announcement last week that the Biden-Harris Administration...more

Coronavirus: The Hill and the Headlines, May 2021 # 4

Hogan Lovells on 5/11/2021

In Washington: The Food and Drug Administration (FDA) has authorized the use of the Pfizer vaccine for 12 - 15 years old. An advisory committee of the Centers for Disease Control and Prevention is expected to meet shortly to...more

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on 5/4/2021

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 Tuesday's Report: FDA revokes...more

Coronavirus: The Hill and the Headlines, April 2021 # 4

Hogan Lovells on 4/20/2021

In Washington: The Consumer Financial Protection Bureau (CFPB) on Monday proposed a rule ordering debt collectors to inform tenants about their rights under a federal eviction ban if they’ve been unable to pay rent during the...more

Coronavirus: The Hill and the Headlines, April 2021 # 3

Hogan Lovells on 4/19/2021

In Washington: An independent advisory panel for the Centers for Disease Control and Prevention (CDC) will meet again on April 23 to resume deliberating about the use of Johnson & Johnson's coronavirus vaccine, agency...more

Pfizer And BioNTech Claim Immunity From COVID-19 Vaccine Testing IP Claim

Weintraub Tobin on 4/19/2021

Pfizer and BioNTech recently asked the Southern District of California to dismiss a patent infringement claim from Allele Biotechnology related to Pfizer and BioNTech’s Covid-19 vaccine. Allele holds a patent for a...more

Privacy Tip #277 – Beware of Vaccine Surveys

Robinson+Cole Data Privacy + Security Insider on 3/26/2021

Criminals use current events to launch new schemes designed to prey on victims’ vulnerabilities or fears. Throughout the pandemic, criminals have used fear of COVID-19, or the anticipation of a cure or a vaccine, to lure...more

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