Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

Executive Summary

This past week in US regulatory, legislative, legal and political news affecting the biopharmaceutical industry included the disclosure by Valeant Pharmaceuticals International Inc. in its long-awaited 10-K of new government investigations into the firm's pricing and business practices and an expression of regret at a Senate hearing by exiting CEO Michael Pearson and board member Bill Ackman about the price hikes of some of the Canadian firm's drugs and a pledge for changes at the embattled company; an agreement by Pfizer Inc. to pay $784.6m to settle a False Claims Act lawsuit in which its subsidiary Wyeth Pharmaceuticals was accused of reporting false and fraudulent prices to the US Medicaid program; a lawsuit filed by the consumer watchdog Pubic Citizen asserting the FDA's practice of blacking out certain information about its advisory committee members in their curricula vitae and keeping it hidden from public view is unlawful; oral arguments at the US Supreme Court in a case involving the Patent Trial and Appeal Board's use of the broadest reasonable interpretation standard to determine the validity of patents under the increasingly popular inter partes review process; and a negative recommendation by an FDA advisory committee for Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy drug eteplirsen, which angered a crowd of patients, family members and advocates at the close of a grueling nearly 12-hour meeting; plus other Washington news.

Advertisement

Related Content

US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News
US Capitol Capsule: Regulatory, Legislative, Legal and Political Biopharma News

Topics

Advertisement
UsernamePublicRestriction

Register

SC065091

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel