Chemical Engineering > Nova Content
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 Scott Siera, Ph.D. and Eric Furman, Ph.D.
Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S... 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On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled...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 »
Written by Daniel A. Kamkar and Agnes Juang, Ph.D.
On August 2, 2017, the U.S. Food and Drug Administration approved the use of Imbruvica® (ibrutinib) for the ... Read More »
Written by Robert J. Hilton and Eric Furman, Ph.D.
Before Prost, O’Malley, and Wallach. Appeal from the District of Connecticut (nonprecedential).
On... Read More »
Written by Jane Xia and Jing Liu, Ph.D.
MILLENNIUM PHARMACEUTICALS, INC. v. SANDOZ INC
(Fed. Cir. July 17, 2017) (NEWMAN, Mayer, O’Malley)
This case ... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jason Jardine
On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic... Read More »
Written by Scott Siera, Ph.D. and Michael L. Fuller
Stanford University v. The Chinese University of Hong Kong. Federal Circuit Appeal No. 2015-2011. Decided June ... Read More »
Written by Jeffrey C. Wu, Ph.D. and Brenden S. Gingrich, Ph.D.
New York City took a step toward its goal of becoming a life sciences hub with a $5 million grant... Read More »
Written by Daniel A. Kamkar and Agnes Juang, Ph.D.
Janssen Biotech Inc. and Celltrion Healthcare have taken the next step over Janssen’s blockbuster... Read More »
Written by Caleb A. Bates, Ph.D. and Agnes Juang, Ph.D.
On June 19, 2017, the U.S. Food and Drug Administration approved the use of the fluoroquinolone... Read More »
Written by Robert J. Hilton, Ph.D. and Jason J. Jardine
On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™... Read More »
Written by Jane Xia and Michael L. Fuller
The U.S. Food and Drug Administration (FDA) recently approved Keytruda (pembrolizumab) for treatment of patients whose... Read More »
Written by Marc Chatenay-Lapointe, Ph.D. and Jing Liu, Ph.D.
On May 17, 2017, Vertex Pharmaceuticals small molecule drug Kalydeco® (ivacaftor) was approved by ... Read More »
Written by Scott Siera, Ph.D. and Eric Furman, Ph.D.
The sale of a product prior to filing a patent application, or “on-sale bar,” has long been a... Read More »
Written by Jeffrey C. Wu, Ph.D. and Jing Liu, Ph.D.
An MIT group consisting of the CRISPR pioneer Feng Zhang and 18 of his colleagues recently published a paper... Read More »