Topic
FDA Approval
200 published works
Drug & Device Law
The FDA and Feasible Alternative Designs
By Bexis
In updating chapter three of his book, on non-informational causes of action, Bexis had the opportunity to add the last several years of “alternative design” opinions. Quite a few states,…
Health Industry Washington Watch
Health Provisions of the Consolidated Appropriations Act, 2023: Part 2 The PIE Act
By Rebecca Jones McKnight, Nancy Halstead, Sarah Thompson Schick, Tamra Harris, Matthew Loughran
[Note, this is Part 2 in an ongoing series of posts exploring substantive aspects of the Consolidated Appropriations Act, 2023 (P.L. 117-328) (referred to hereafter as 2023 CAA). Part 1,…
Healthcare Law Blog
FDA Approval Mifepristone REMS Program Modification Expands Patient Access to Abortion Care
By Justine Lei
The Food and Drug Administration (the “FDA”) has approved a modification to the Mifepristone Risk Evaluation and Mitigation Strategy (“REMS”) Program, increasing the accessibility of mifepristone for patients with a…
Big Molecule Watch
Chinese Market Biosimilar Update
This week, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) has approved BAT1806, a biosimilar of ACTEMRA (tocilizumab). BAT1806 is approved for the treatment of rheumatoid arthritis…
Wills, Trusts & Estates Prof Blog
Alzheimer’s Drug From Eisai, Biogen Gets FDA Accelerated Approval
Late last week, the U.S. Food and Drug Administration gave accelerated approval to the Alzheimer’s drug lecanemab, developed by Eisai Co. and Biogen Inc. The drug will be sold under…
Life Sciences Perspectives
Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to Payors, Formularies, & Similar Entities
By Life Sciences FDA Group|Healthcare Group
The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 (“PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation…
Big Molecule Watch
Fresenius Kabi Announces FDA Approval of Adalimumab Biosimilar
Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic…
Big Molecule Watch
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe
On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s…
Big Molecule Watch
EMA Adopts Positive Opinion for STADA and Xbrane’s Ranibuzumab Biosimilar Candidate XIMLUCI®
By Yoko Bian
On Sep 16, 2022, Partners STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (publ) (“Xbrane”) announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP)…
Big Molecule Watch
Biosimilar Regulatory Approval Updates
By Yoko Bian|Kevin DeJong|James Xu
Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic partnership…