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Mintz
Tom said, "Who knows how the court could decide. But I think it's important to note that they're trying to
essentially prevent total enforcement of the rule as a whole."
Goodwin Procter LLP
On April 16, Alvotech and Teva announced the FDA approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Johnson and Johnson's STELERA® (ustekinumab).
Goodwin Procter LLP
As we previously reported, trial in Regeneron Pharmaceutical, Inc.'s BPCIA case against Mylan Pharmaceuticals Inc. and Biocon Biologics, Inc. (collectively, "the Biocon Defendants")...
Goodwin Procter LLP
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.
Exponent
On March 15, the Food and Drug Administration issued new draft guidance that impacts premarket submissions for all medical devices that produce temperature changes in patient tissues...
Exponent
On Nov. 17, the Food and Drug Administration released the final guidance for assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.
Jones Day
In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts.
Akin Gump Strauss Hauer & Feld LLP
A divided panel of the Federal Circuit affirmed a district court's grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval based on the particular facts of this case.
Exponent
Four questions for developing inclusive digital solutions by identifying women-specific requirements and endpoints
Goodwin Procter LLP
Genentech, Hoffmann-La Roche, and Biogen have settled their BPCIA litigation against Dr. Reddy's Laboratories ("DRL") and Fresenius Kabi.
Farrell Fritz, P.C.
We live in an age of scientific miracles. We have an unprecedented ability to identify the causes of disease, and we have access to treatments, and even cures, we could not imagine only a few decades ago.
Exponent
Final rule requires a 90% reduction in ethylene oxide emissions from commercial medical device sterilization facilities...
Mintz
Of Counsel Benjamin Zegarelli and Associate Pat Ouellete discussed the health care regulations governing medical devices and software and shared how to stay informed and navigate the evolving landscape of health care regulations.
Exponent
The agency has published new draft guidance to support manufacturer compliance with special controls...
WilmerHale
Partner Sarah Hogan has contributed to American Health Law Association's second edition of Health Care Contracts: A Clause-by-Clause Guide to Drafting and Negotiation...
Buchanan Ingersoll & Rooney PC
Last week, the Federal Circuit held an oral argument that may have future implications for Section viii Carve-Outs in Amarin Pharmaceuticals, Inc. v. Hikma Pharmaceuticals...
Axinn Veltrop & Harkrider
Among the most established standards in patent law is that obviousness requires a motivation to combine the prior art with "a reasonable expectation of success."
Diaz Trade Law
Last week, FDA's Center for Tobacco Products (CTP) announced the release of its Searchable Tobacco Products Database.
Goodwin Procter LLP
On April 4, 2024, Bristol Myers Squibb ("BMS") and 2seventy bio, Inc. announced that the FDA has approved ABECMA (idecabtagene vicleucel) for the treatment of adult patients with relapsed ...
Dickinson Wright PLLC
The Food and Drug Administration regulates foods and beverages, drugs and medical devices, biologics, dietary supplements, tobacco products, veterinary products, and cosmetics.
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