Topic
FDA Approval
200 published works
Big Molecule Watch
European Biologics Regulatory Updates
Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency…
Big Molecule Watch
Fresenius Kabi Launches TYENNE, The First Approved Tocilizumab Biosimilar In The European Union
On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union. TYENNE is the first tocilizumab biosimilar available in Europe…
Napoli Shkolnik Blog
Most Regenerative Medicine Therapies on the Market Are Not FDA Approved
Dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures, The New York Times reported. The…
BioSlice Blog
New UK International Recognition Framework for Medicines
By Arnold & Porter, Sofia Wilson
We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby…
Life Sciences Perspectives
UK’s Medicines Regulator Announces Guidance on the New International Recognition Procedure for the Approval of New Medicines from 1 January 2024
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…
Big Molecule Watch
Sandoz Receives FDA Approval for Tyruko® (natalizumab-sztn), the First and Only FDA-Approved Biosimilar for Relapsing Forms of Multiple Sclerosis
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…
ANDVA Advisor Blog
IRS Treatment of Litigation Costs in ANDA Cases Affirmed
The Third Circuit Court of Appeals affirmed on July 27, 2023, that infringement-suit defense costs for ANDA filers who file Paragraph IV certifications are deductible legal expenses, not capital expenditures…
Wills, Trusts & Estates Prof Blog
FDA approves first drug to slow Alzheimer’s progression
Earlier this month, the Food and Drug Administration granted full approval to an experimental Alzheimer's drug, lecanemab, after giving accelerated approval in January. Now begins the process, which could expand…
Big Molecule Watch
Regeneron Received FDA Complete Response Letter For Its Higher Dose Aflibercept Injection BLA
Last week, Regeneron published a press release stating that the FDA had issued a Complete Response Letter (“CRL”) for its aflibercept 8 mg BLA for the treatment of patients with…
Big Molecule Watch
Formycon and Celltrion Announce FDA Submission of aBLAs Seeking Approval to Market Aflibercept Biosimilars
On June 29 and 30, 2023, respectively, Formycon AG (“Formycon”) and Celltrion Inc. (“Celltrion”) announced submission to the FDA of aBLAs for their aflibercept biosimilar candidates. Formycon and Celltrion are…