On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests (“LDTs”) under the Federal
On May 31, 2024, the CFPB announced that it had filed suit against a Pennsylvania-based student loan servicer for engaging in allegedly unfair, deceptive and abusive acts or practices in violation of the CFPA, 12 U.S.C. §§ 5531, 5536(a)(1)(B), and for
In newly released Draft Guidance from the U.S. Food and Drug Administration (FDA) entitled, Platform Technology Designation Program for Drug Development, the FDA addresses its new designation program for platform technologies, which is intended to bring efficiencies to drug development, manufacturing,
On May 16, 2024, the U.S. Supreme Court issued a significant opinion in Consumer Financial Protection Bureau v. Community Financial Services Association of America, Ltd., upholding the funding structure of the Consumer Financial Protection Bureau (CFPB). 601 U.S. 416
On May 22, 2024, the Massachusetts Attorney General (MA AG) announced it entered into an Assurance of Discontinuance (AOD) with a California-based financing company resolving allegations of violations of the Massachusetts Consumer Protection Act.
The MA AG alleged that the company engaged
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor; “Chamberlain”). The Chamberlain decision provides some clarity on the
On May 6, 2024, following more than a decade of discourse with interested stakeholders on potential approaches to regulation of laboratory developed tests (LDTs), the U.S. Food and Drug Administration (FDA) published its final rule setting forth its framework for
Earlier this month, FDA approved Boehringer Ingelheim’s high-concentration (100 mg/mL), citrate-free formulation, CYLTEZO (adalimumab-adbm), a biosimilar to Humira (adalimumab). CYLTEZO was first approved in the US in 2017 and later approved in the US as an interchangeable biosimilar to Humira
On May 20, 2024, the Consumer Financial Protection Bureau (CFPB) announced that it had entered into a consent order with a California-based telemarketer that offered student loan debt relief services resolving allegations that the company charged illegal advance fees and misled student
On May 17, 2024, the Federal Deposit Insurance Corporation (FDIC) announced a settlement with an Arkansas bank and nine of its employees, resolving allegations that the bank and the employees violated Section 5 of the Federal Trade Commission Act (FTC Act), Section
