Structural Biology > Nova Content
On July 18, 2018, the FDA released a Biosimilar Action Plan[1] that is aimed at promoting competition and affordability across the market for biologics and... Read More »
Federal Circuit Summary
En Banc (excl. Chen), Opinion for the court filed by Stoll, joined by Newman, Lourie, Moore, O’Malley, Wallach, and Taranto. ... Read More »
Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will ... Read More »
In recent years, market interest in meat substitutes has aligned with advances in cell culture techniques to support the emergence of lab-grown meat or... Read More »
In Ex parte Galloway, Appeal No. 2017-004696 (PTAB, May 24, 2018), the Board reversed the examiner’s rejections of claims to a method of diagnosing bladder... Read More »
On May 14, 2018, several important revisions to regulations of the Bayh-Dole Act (University and Small Business Patent Procedure Act of 1980, codified as 35 U.S.C... Read More »
In vitro gametogenesis (IVG) is a recent development in reproductive technology, and has been used for creating mouse embryos in vitro. IVG includes obtaining cells... Read More »
A new infertility technique, mitochondrial replacement therapy (MRT), has been used to create so called “three-parent” babies. MRT is used in cases when... Read More »
Lundbeck Pharmaceutical Company, headquartered in Denmark, recently announced the acquisition of Prexton Therapeutics B.V. for $1.1 billion (U.S.)(1). Lundbeck... Read More »
On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a... Read More »
The PTAB held that all of Genentech’s challenged antibody purification claims were unpatentable as being anticipated, obvious, or both, in an IPR filed by... Read More »
On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the... Read More »
Throughout the past year, substantial investment continued to pour into digital health and personalized medicine. Personalized medicine involves the discovery... Read More »
On December 19, 2017, a seven-judge expanded PTAB panel ruled that the University of Minnesota (UM) waived its Eleventh Amendment immunity defense when it filed a... Read More »
In a recent development with the ongoing complex litigation involving Janssen Biotech’s arthritis biologic medicine Remicade (infliximab) and Celltrion’s... Read More »
In an effort to lay the groundwork for generic entry and reduced drug prices, the non-profit group Initiative for Medicines, Access and Knowledge, Inc. (I-MAK), with... Read More »
Written by Daniel A. Kamkar and Michael L. Fuller
On October 9, 2017, California Governor Jerry Brown signed the new drug price transparency bill SB 17.[1] ... Read More »
Written by Robert J. Hilton, Ph.D. and Jing Liu, Ph.D.
On September 14, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval of Aliqopa... Read More »
Written by Caleb A. Bates, Ph.D. and Michael L. Fuller
In March 2014, Regeneron Pharmaceuticals, Inc. sued Merus B.V. for allegedly infringing U.S. Patent No... Read More »
Written by Daniel K. Yarbrough, Ph.D. and Brenden S. Gingrich, Ph.D.
On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled... Read More »