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Hyman, Phelps, & McNamara
Our last post on small business certification requests described how small medical device manufacturers, defined as those with gross receipts of less than $100 million in gross receipts...
Goodwin Procter LLP
This annual recap highlights Goodwin's continued determination and agility as a full-service, integrated global practice. Committed to being a global destination life cycle law firm...
Hyman, Phelps, & McNamara
The trio of CDER, CBER, and CDRH released a new draft guidance titled "Use of Data Monitoring Committees in Clinical Trials" that revises the 2006 guidance...
Goodwin Procter LLP
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson ("J&J") regarding Bmab 1200, Biocon's proposed biosimilar to STELARA.
Goodwin Procter LLP
On March 4, Biocon Biologics Ltd. announced it has signed a settlement agreement with Bayer Inc. and Regeneron Pharmaceuticals, Inc. regarding YESAFILI, Biocon's proposed biosimilar to EYLEA.
Hyman, Phelps, & McNamara
The American Conference Institute ("ACI") will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes.
Mintz
The American public knows that 2024 is a critical election year, with the next race for the presidency in November expected to be another face-off between President Biden and former President Trump.
Goodwin Procter LLP
Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate.
Hyman, Phelps, & McNamara
On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.
Axinn Veltrop & Harkrider
Jason Murata joins Richard Hsu on the Hsu Untied podcast to discuss his background in biochemistry and biotechnology...
Mayer Brown
Join BioUtah president & CEO Kelvyn Cullimore and Mayer Brown's Vera Nackovic in a discussion about current trends and issues in the life sciences industry.
Goodwin Procter LLP
On February 23rd, 2024, Alvotech and Teva announced FDA's approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira...
Arnold & Porter
In recent years, the California legislature has considered several bills seeking to regulate or prohibit intentionally added perfluoroalkyl and polyfluoroalkyl substances ...
Winston & Strawn LLP
"[The] sin was methodological inconsistency[.]" The Sixth Circuit recently affirmed an MDL court's exclusion of the plaintiffs' only general causation expert and subsequent grant of summary...
Ropes & Gray LLP
A bill introduced by a bipartisan group of Select Committee Members in the Senate and the House could severely impact U.S. companies' ability and desire to contract with biotechnology...
Goodwin Procter LLP
Appeals from and redacted memorandum and opinion in support of judgment in Regeneron v. Mylan (aflibercept) BPCIA case filed
Venable LLP
On February 23, 2024, the FDA approved Alvotech and Teva's Simlandi® (adalimumab-ryvk) as biosimilar to and interchangeable with AbbVie's Humira® (adalimumab). Simlandi® is the tenth Humira...
Ropes & Gray LLP
In honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance...
Global Advertising Lawyers Alliance (GALA)
Join us over the next few months as we spotlight select chapters of Venable's popular Advertising Law Tool Kit, which helps marketing teams navigate their organization's legal risk.
Hyman, Phelps, & McNamara
The most recent version of the BIOSECURE Act (the "Act") was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024.
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