Podcast - Betty... embargaron Ecomoda
Consumer Finance Monitor Podcast Episode: The Impact of the Election on the FTC
Consumer Finance Monitor Podcast Episode: A Deep Dive Into Judge Jackson’s Preliminary Injunction Order Against CFPB Acting Director Vought
Consumer Finance Monitor Podcast Episode: Prominent Journalist, David Dayen, Describes his Reporting on the Efforts of Trump 2.0 to Curb CFPB
Bar Exam Toolbox Podcast Episode 303: Listen and Learn -- Injunctions and Restraining Orders (Civ Pro)
False Claims Act Insights - Can DE&I Initiatives Lead to Potential False Claims Act Liability?
SCOTUS Limits Availability of Injunctions in NLRB Unfair Labor Practice Cases - Employment Law This Week®
Post-Injunction Enforcement — Highway to NIL Podcast
The NCAA's Response to the NIL Recruitment Injunction — Highway to NIL Podcast
NIL Recruitment Injunction — Highway to NIL Podcast
Injunctions for All – Speaking of Litigation Podcast
Podcast: The Briefing by the IP Law Blog - Jack Nicklaus Companies Landed Hole-In-One With Court’s Recent Injunction
The Briefing by the IP Law Blog: Jack Nicklaus Companies Landed Hole-In-One With Court’s Recent Injunction
#WorkforceWednesday: Employee Privacy and COVID-19, CMS Vaccine Mandate on Hold, Independent Contractor Classification - Employment Law This Week®
Bar Exam Toolbox Podcast Episode 86: Tackling a California Bar Exam Essay: Remedies
#WorkforceWednesday: Component 2 Pay Data Shutdown, CDC Coronavirus Guidance, and California Employers Fight Back - Employment Law This Week®
E18: ICANN Loses First GDPR Court Ruling in Germany
A recent federal court decision highlights the delicate balance between U.S. Food and Drug Administration (FDA) guidance and trade dress protections for drugs administered in a tablet or capsule form. Last month, a district...more
On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more
On March 5, 2025, the U.S. District Court for the Northern District of Texas denied the Outsourcing Facilities Association’s motion for a preliminary injunction to prevent the U.S. Food and Drug Administration (FDA) from...more
Entresto® (valsartan/sacubitril) - Case Name: Novartis Pharms. Corp. v. MSN Pharms., Inc., Nos. 2024-2211, 2024-2212, 2024 WL 4969281 (Fed. Cir. Dec. 4, 2024) (Circuit Judges Lourie, Prost, and Reyna presiding; Opinion by...more
As we previously reported, on September 24, 2024, the District Court for the Northern District of West Virginia denied Regeneron’s motion seeking a preliminary injunction preventing Amgen from launching its FDA-approved...more
Although the press was permitted to attend the hearing, news coverage has been limited and without significant detail of the back-and-forth between the judge and the parties. Nevertheless, the judge’s questions, as reported...more
The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...more
The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more
Pharmaceutical industry and constitutional buffs have been closely watching Amarin Pharma Inc. v. U.S. Food and Drug Administration. The case presented the (not wholly novel) question whether the First Amendment protects...more
The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more
Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
On July 21, the Federal Circuit interpreted the patent litigation procedures and requirements of the Biologics Price Competition and Innovation Act (BPCIA), including whether a company submitting an abbreviated BLA (“k...more
On March 6, 2015, the U.S. FDA announced that it had approved Zarxio, making Sandoz the first company ever to obtain approval of a biosimilar product in the U.S. The FDA deemed Zarxio to be biosimilar to Amgen’s Neupogen...more
The Supreme Court on Monday declined to grant certiorari in Momenta Pharmaceuticals v. Amphastar Pharmaceuticals, a case involving a split in authority that has arisen among Federal Circuit judges regarding the scope of the...more