Council Members in this Study Group: 711
This study group may include professors, attorneys, former regulatory officers, and consultants knowledgeable on topics such as law and litigation issues, lobbying, policy and government, elections, antitrust, immigration, intellectual property, and legislation, among others.
Leading institutions connect with members of this Study Group through GLG
Paul EqualePresident
EQUALE AND ASSOCIATES![]()
Paul Equale leads Equale & Associates, where he consults on legislative, regulatory and headline risk associated with business, legal and financial services issues in Washington DC. His specialty areas include financial services legislative and regulatory...
Principal
Tarplin Strategies, LLC![]()
Richard Tarplin is the founder of Tarplin Strategies in Washington, DC, where he provides strategic advice and lobbying services to clients in the financial services and health care sectors. He served for almost 20 years in the US House of Representatives...
Jeff StierAssociate Director
American Council on Science and Health![]()
Jeff Stier is an Associate Director at the American Council on Science and Health, a public health and consumer advocacy organization dedicated to promoting sound science in public health. In this position, he is responsible for government relations,...
Deborah OutlawPrincipal
THE OUTLAW GROUP![]()
Deborah Outlaw is the Principal of The Outlaw Group in Washington, DC, where she provides legislative and regulatory services to physician specialty groups, allied health providers, medical device manufacturers, and non-profit organizations interested...
Partner
CLARK HILL PLC![]()
Robert A.W. Strong is Partner at Clark Hill in Birmingham, Michigan, where he has represented industrial clients in all areas of energy and utility law, including contracting, rate negotiation, ratemaking, environmental permitting, energy pricing and...
Opinions and analyses expressed in GLG News are solely those of the author. See the Terms of Use for details.
Black Box Warnings: Not Blacklist Warnings
August 6, 2009
UPDATE: FDA: Requires Stronger Warnings For TNF Blocker Drugs | online.wsj.com
The risk highlighted by this new bold warning was a known risk. The questions are: How should physicians and patients respond to a new warning rather than new risks? What are the risks of black box warnings?What are the implications for Johnson & Johnson (JNJ), which makes Remicade and Simponi, Abbott (ABT), maker of Humira and Amgen (AMGN) and Wyeth (WYE), co-marketers of Enbrel, as well as UCB SA's (UCB.BT) maker of Cimzia?
FDA Warning On E-Cigs is Tone Deaf
July 22, 2009
FDA Questions Safety, Quality of Electronic Cigarettes | blogs.wsj.com
Even major tobacco companies are now considering E-cigarettes, but the FDA is dead set against them. This is a harbinger of how FDA will use their new authority to regulate tobacco.
Swine Flu Presents Opportunities for Vaccine Makers And Others
July 21, 2009
Financial Times FT.com | www.ft.com
A relatively small group of pharmaceutical companies includingGlaxoSmithKline, Roche and Sanofi-Aventis which make vaccines have the market cornered when it comes to the front lines of the global fight against swine flu. But well positioned smaller companies could benefit
Sometimes, Breast Cancer Legislation Could Do More Harm Than Good
July 14, 2009
Detecting a Bad Breast Cancer Bill | www.rollcall.com
New legislation calls for more widespread genetic testing for breast cancer as well as other types of breast cancer screening.
Potential Good News for Biosimilars
July 14, 2009
US Senate panel backs 12-year biotech drug shelter | www.reuters.com
This is good news for Amgen Inc (AMGN.O) and Roche Holding AG (ROG.VX) as longer exclusivity passes a major Senate hurdle. While some are calling this a defeat for "generic" (biosimilar) makers such as Teva Pharmaceutical Industries Ltd (TEVA.TA) and Mylan Inc (MYL.O), it isn't all bad news.
September 20, 2006 | Boston
GLGi: CMS Reimbursements: Medical DevicesSeptember 19, 2006 | New York City
GLGi: CMS Reimbursements: Medical DevicesDecember 6, 2005 | New York
GLGi: Terrorism Risk Insurance ActLeading Experts in Political Experts (outside Washington DC) have not participated in any GLG webcasts.
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