GLG News by Mr. Jeff Stier, Associate Director
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
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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?
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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.
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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
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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.
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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.
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Key Issues As House Considers 19% Increase in FDA Budget
July 1, 2009
Obama healthcare budget includes FDA reform | www.reuters.com
The FDA budget has important implications for the food, drug, and drug device industries.
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House Vote Only The First Hurdle
March 31, 2009
House to Vote Wednesday on Tobacco Bill - NYTimes.com | www.nytimes.com
Wednesday's vote is important, but you need to understand the legislative process if you own tobacco stocks.
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Don't Assume We Can Predict What Will Happen In Post-Engle Cases
March 27, 2009
Third Time's the Charm for Defense in Fla. Smoker Suits | www.law.com
We just don't know whether tobacco companies are going to be hit hard by the post-Engle cases. They might. They might not. Or "post-Engle" may not mean what we think it means.
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Food Safety Reform-- Can We Learn from Product Safety Reform?
March 26, 2009
Groups urge FDA changes to boost U.S. food safety | news.yahoo.com
The food industry rightly realizes we need food safety reform-- but they would be wise to learn from recent safety reform history. Otherwise, major trouble for both industry and consumers is around the corner.
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Pay Attention to Legislation on Medical Device Preemption
February 20, 2009
Lawmakers Seek to Return Right to Sue Device Makers | www.nytimes.com
Some members of Congress are seeking to allow patients allegedly injured by medical devices to sue, despite the product having been approved by the FDA. The New York Times analysis presents one point of view but fails to explain the downside -- to consumers-- of the proposed legislation.
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July 4, 2008
Rhode Island top court overturns lead paint ruling | uk.reuters.com
Paint companies are off the hook- but should others beware?
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CBO Data On Follow-on Biologics Is More Interesting Than It Sounds.
July 1, 2008
Follow-On Biologics Legislation Could Save Billions of Dollars, According to CBO | www.kaisernetwork.org
The report explains that creating a pathway to allow for follow-on biologics will save billions of dollars over the next 10 years. The report will be used to press for quick passage of the House and Senate versions of the legislation.
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Drug Companies (Partially) Give In To Congressional Pressure on Advertising Restrictions
June 19, 2008
Lawmakers Call On Companies to Curb Dug Ads | news.yahoo.com
Drug Companies including Pfizer, Merck, and Johnson & Johnson have agreed not to advertise newly approved drugs for their first six months. Key members of congress say this is not enough and want a two year wait. This will not only hurt pharmaceutical and advertising interests but it is bad for consumers as well.
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Food Crisis, Oil Prices, and US Policy May Help Spur Acceptance of Biotechnology
June 17, 2008
US wants biotech to help solve global food crisis | news.yahoo.com
Secretary Negroponte's statements suggest a more aggressive U.S. policy favoring biotechnology as one way of addressing global food inflation. The policy recognizes the necessity of widespread acceptance of the technology. Will the presidential candidates agree?
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The Cloud Over Tomatoes. Is There a Silver Lining?
June 13, 2008
Repelling the attack of the tainted tomatoes | www.chicagotribune.com
With increased focus on the need for safer produce, industry will be forced to invest more in safety technology. The environment is ripe with opportunities.
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Bar On Genetic "Bias" Could Harm Consumers
May 20, 2008
Congress Passes Bill to Bar Bias Based on Genes | www.nytimes.com
This bill would limit innovative health insurance products which could actually lower rates for consumers.
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Not Involved in Lead Paint Companies? Ignore This Case At Your Peril
May 20, 2008
High-stakes lead paint case to R.I. Supreme Court | www.boston.com
The outcome of this case has liability implications for industries beyond those potentially on the hook for lead paint. Invested in the energy sector? Pharmaceuticals? Biotech? Nanotech? Tech? This case is worth your attention.
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Food Waste Awareness Creates Market Opportunities
May 19, 2008
One Countrys Table Scraps, Another Countrys Meal | www.nytimes.com
As reports of the food crisis reaches fever pitch, will there be new opportunities?
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Will The New Push To Limit DTC Advertising Advance?
May 8, 2008
New Rules on Drug Ads Sought | online.wsj.com
Billions of dollars in pharmaceutical revenue, a large chunk of the advertising industry, and public health implications are at stake as Congress once again considers stricter limits on direct to consumer (DTC) advertising.
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Generic Biologics Won't Get A Free Ride
April 30, 2008
Don't compromise the safety of biotech drugs | www.latimes.com
Allowing "generic" versions of biotech drugs to market without full safety testing would endanger consumers
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