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May 6, 2024
We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, "Moderna") against BioNTech SE, BioNTech Manufacturing GmbH...
March 11, 2024
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed
January 23, 2024
As we settle into 2024, we reflect on the significant legal developments of 2023 that hold potential impact on the biologics and biosimilars market. The following is a recap of...
January 5, 2024
According to PWC, "2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels."
December 29, 2023
According to PWC, “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a...
April 19, 2023
The BLA submission included results from different studies comparing the structural and functional similarities between HLX02 and reference trastuzumab.
February 28, 2023
On Feb 12, 2023, Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its Biologics License Application (BLA) for its biosimilar referencing AVASTIN (bevacizumab)
January 3, 2023
In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several initiatives...
September 8, 2022
On August 31, 2022, the PTAB instituted two inter partes reviews of Chugai and Roche's tocilizumab patents challenged by Celltrion, adding to the growing list of IPRs instituted against the tocilizumab patent estate.