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Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology by Jennifer Chheda ordered by Published Date Descending.
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Supreme Court: Biosimilar Applicants May Provide Commercial Marketing Notice Before FDA Approval
Intended to provide a faster route to approval for generic biologics, the Biologics Price Competition and Innovation Act, was the basis for a decision rendered by the U.S. Supreme Court in Sandoz Inc. v. Amgen Inc.
United States
26 Jun 2017
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Supreme Court Hears Oral Arguments In Sandoz Inc. v. Amgen
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting...
United States
12 May 2017
3
PTAB Denies Institution of IPR Proceedings Against Bayer's Patent Covering STIVARGA®
On February 8, 2017, the PTAB denied Fustibal LLC's ("Fustibal") petition to institute inter partes review of U.S. Patent 8,637,553 B2 ("the '553 patent") owned by Bayer HealthCare LLC ("Bayer") (IPR2016-01490).
United States
14 Mar 2017
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Regulatory Developments Life Sciences Companies Should Expect In The New Presidential Administration
Essential to implementation of the incoming President's agenda is the appointment of senior leaders in the executive departments and administrative agencies responsible for implementing the agenda.
United States
24 Jan 2017
5
Changes Being Effected To Drug Labeling Regime: FDA Releases Proposed Pathway For Generic Safety Updates
On November 13, the U.S. Food and Drug Administration ("FDA") published a proposed rule concerning "procedures for application holders of an approved drug or biological product to change the product labeling to reflect certain types of newly acquired information prior to FDA's review of the change" that would, specifically, allow abbreviated new drug application ("ANDA") holders to update product labeling for their "generic" drug products in advance of its reference listed drug ("RLD"; i.e., the
United States
13 Dec 2013
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