09/30/2015

Texas Pharmacists to Substitute Biosimilars - Board of Pharmacy Releases New Rules

Alert

On September 25, 2015, the Texas Board of Pharmacy issued proposed rules that will allow pharmacists to substitute interchangeable biological products for brand name drugs.

08/25/2015

FDA's Focus On Drug Appearance May Cause Ugly Problems

Publication

The U.S. Food and Drug Administration recently issued final guidance regarding the size, shape and other physical characteristics of generic-manufactured tablet and capsule dosage forms.

08/03/2015

The IP Beacon, August 2015

Alert

The IP Beacon is a Haynes and Boone Newsletter highlighting current issues in Intellectual Property Law.

08/03/2015

Pretty Pills, Please - The FDA's Focus on Generic Drug Appearance Creates Other Concerns

Alert

The FDA recently issued final guidance regarding the size, shape, and other physical characteristics of generic-manufactured tablet and capsule dosage forms. The guidance noted that differences in phy...

07/09/2015

Haynes and Boone Adds Pharmaceutical Patent Practitioners Whitney Remily and John Bateman to Washington, D.C. Office

Press Release

The Washington, D.C. office of Haynes and Boone, LLP proudly announces the expansion of its Hatch-Waxman/ANDA Practice Group with the addition of Whitney Remily and 

03/23/2015

SEC Enforcement Director Emphasizes Need for a “Robust FCPA Compliance Program” for Pharmaceutical Companies

Alert

In recent remarks to a compliance conference for the pharmaceutical industry, the SEC’s Director of Enforcement, Andrew Ceresney, addressed FCPA issues that commonly arise in the industry.

12/15/2014

Compliance Risks in China

Alert

This alert aims to provide a general introduction to both Chinese laws and the FCPA’s practice relating to American entities that do business in China. 

12/01/2014

INTA Conducts Second Annual Training Seminar at IMPI

Publication

Report by Jeff Becker, the Team Leader for INTA’s Government Officials Education and Training Committee.

10/16/2014

Kyle Musgrove in Law360: High Court Appears Split On Claim Construction Deference

Article

The U.S. Supreme Court appeared divided Wednesday over whether the Federal Circuit should give more deference to claim construction decisions by lower courts, with some justices saying trial judges...

10/15/2014

Haynes and Boone Houston Adds Veteran IP Practitioner John Demarco

Press Release

HOUSTON – Haynes and Boone, LLP Houston has welcomed U.S. patent lawyer John Demarco as a partner in the firm’s Intellectual Property Transactional Section.

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