Last week, FDA released a draft guidance, “Labeling for Biosimilar and Interchangeable Biosimilar Products” that—when finalized—will revise and replace its July 2018 final guidance, “Labeling for Biosimilar Products.” FDA noted that this 2023 Draft Guidance reflects
We previously reported on patent infringement litigations between Alnylam and Moderna. Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna.
First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc.,
On October 26, 2022, the U.S. Securities and Exchange Commission (the “SEC”) adopted regulations implementing Section 10D of the Securities Exchange Act of 1934 (the “Exchange Act”), which was added by the Dodd-Frank Wall Street Reform and Consumer Protection Act
On September 8, 2023, the United States District Court of the Eastern District of Texas granted plaintiff U.S. Chamber of Commerce’s (the “Chamber”) motion for summary judgment invalidating the Consumer Finance Protection Bureau’s (“CFPB”) Exam Manual changes from March 2022
On September 6, 2023, the US Food and Drug Administration (FDA) released a trio of draft guidances in its efforts to “strengthen and modernize” the 510(k) Program and provide for more “predictability, consistency, and transparency” for the 510(k) premarket review
On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar medicines. Notably, the U.S. healthcare system, including patients, employers and taxpayers,
Background
Earlier this year, the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), announced that a new International Recognition Procedure (IRP) will be put in place for the approval of new medicines from 1 January 2024. On
Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested
On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar Tyruko® (natalizumab-sztn), developed by Polpharma Biologics. Tyruko® injection is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). Tyruko® is also indicated for
