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September 5, 2008
 
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Windhover Information - Pharmaceutical Strategic Alliances Conference

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From THIS WEEK'S ISSUE of www.thepinksheet.com
The Pink Sheet
FDA Mandates New Boxed Warning For TNF Inhibitors
Four TNF-alpha blocker marketers asked to add Medication Guides and strengthen education programs to increase awareness of risk of fungal infections. read more
Acucela, Otsuka Enter Deals For Eye Drugs
Early stage and late stage pacts add proof of Japan’s growing interest in the U.S. read more
Human Genome Sciences Reports First Phase II Findings For TRAIL Receptor Agonist Mapatumumab
Phase II results termed “unimpressive,” though firm says potential partners show interest. read more
BioCryst Compound Ineffective Against Psoriasis In Phase II Dosing Trial
Data show potential against T-cell and B-cell mediated disease, however. read more
Medicare Drug Price Debate May Reemerge After Election, BIO Fears
The biotech association is comfortable with both presidential candidates, but concerned that they appear to support a heavier government hand in the Part D benefit. read more
FDA Nano Meeting Just the Beginning Of Supplement, OTC Questions
Sept. 8 open meeting to address need for nano-regulations, no small undertaking. read more
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Business & Finance 

CEO of CVS confident in prospects of takeover bid for Longs
CVS Caremark CEO Tom Ryan said the company is optimistic that it will get two-thirds of Longs Drug Stores' shareholders to vote in favor of CVS' $2.9 billion acquisition offer despite pressure from some stockholders to ask for a higher bid. The statement came when hedge funds and union-sponsored pension funds are concerned that the offer does not reflect the value of Longs' real-estate assets in Hawaii, Nevada and California. MarketWatch (9/4)

Roche to shut down California research lab
Roche Holding announced plans to close its 1,000-worker research laboratory in Palo Alto, Calif., as it seeks to take over Genentech. The facility's inflammation-research division will be relocated to Roche's U.S. headquarters in Nutley, N.J. The virology unit is expected to move to Genentech's campus in South San Francisco, Calif., but it would operate independently from the biotech firm. International Herald Tribune/Associated Press (9/5)

Government & Legal News 

FDA orders new warnings on four drugs tied to fungal infection
The FDA called for stronger warnings on the labels of Johnson & Johnson's Remicade, Abbott Laboratories' Humira, Amgen and Wyeth's Enbrel and UCB's Cimzia to inform patients about the risk of developing histoplasmosis, a harmful fungal infection. The drugs, also known as tumor necrosis factor blockers, are approved in the U.S. for treating rheumatoid arthritis and Crohn's disease. The drugmakers are cooperating with the FDA for compliance, an agency official said. The Wall Street Journal (subscription required) (9/5) , The New York Times/Associated Press (9/4)

Pfizer's bone drug may cause deaths, FDA analysis reports
Women who got low doses of Pfizer's Fablyn -- a drug candidate for osteoporosis -- were more likely to die within five years compared with those who received placebo, according to an analysis from FDA staff. Reviewers said the once-daily pill is effective for averting fractures in postmenopausal women with osteoporosis, but they are concerned that patients on Fablyn had more than twice the risk of developing blood clots. A panel independent advisers is scheduled Monday to review the drug's safety. The Washington Post/Reuters (9/4)

Report: Most drug-plan marketing tools violate Medicare rules
Federal auditors found that approximately 85% of marketing products used by private insurers to promote their prescription-drug plans fail to meet Medicare requirements. The CMS started implementing measures to ensure that marketing materials are consistently evaluated to prevent these violations, Acting Administrator Kerry Weems said. The Wall Street Journal/Associated Press (subscription required) (9/5)

Celgene's Amrubican obtains fast-track status from FDA
The FDA granted fast-track designation to Celgene's Amrubican, an experimental treatment for small-cell lung cancer after chemotherapy. The expedited review "further validates the considerable scientific data being presented at major medical meetings for this critical disease," a Celgene official said. NJBIZ (New Jersey) (9/4) , RTT News (9/4)

CDC reports majority of children are vaccinated
A CDC report for 2007 states that 77.4% of children were fully inoculated with recommended vaccines, indicating that vaccination rates have stayed at or are close to record levels. Such data from the agency's annual survey is good news because "this is the age group that historically over the past two decades has been hard to raise immunization levels," a public health expert said. HealthDay News (9/4)

BioMS' multiple sclerosis drug gets on FDA's fast track
Dirucotide, an experimental treatment for multiple sclerosis from BioMS Medical, received fast-track status from the FDA. The Canadian firm's drug is being tested in late-stage studies for use in secondary progressive MS patients. The Edmonton Journal (Canada) (9/4)

Pipeline/R&D News 

Philanthropists to give $400M more to gene-research institute
The Broad Institute of Harvard University and the Massachusetts Institute of Technology, a gene-research center, secured a $400 million endowment from founding donors Eli and Edythe Broad. The permanent endowment allows the center to sustain operations, giving it "the ability to think for the long term," the institute's director said. The Wall Street Journal (subscription required) (9/5) , American City Business Journals/Boston (9/4)

Studies: Cancer scientists should explore beyond mutations
Studies aimed at discovering cancer drugs should not focus only on specific genetic mutations but also actions of tumor genes linked to cancer growth, researchers said. The recommendation came at a time when drugmakers, particularly biotech firms, concentrate on developing single-target therapies for diseases such as brain and pancreatic cancers. Three studies published this week demonstrate the use of gene-sequencing machines that could help link genetic mutations to specific types of cancers. Bloomberg (9/4) , The Wall Street Journal (subscription required) (9/5)

BioCryst unveils data from clinical trial of autoimmune drug
BioCryst Pharmaceuticals said BCX-4208, an experimental autoimmune drug, failed to show efficacy in treating patients with moderate to severe psoriasis during a midstage clinical trial. The drug was able to meet its primary safety and tolerability objectives and warrants further development, BioCryst's chief medical officer said. American City Business Journals/Birmingham, Ala. (9/4) , The Birmingham News (Ala.) (9/4)

Researchers find earliest cell changes in Down syndrome
An extra copy of chromosome 21 triggers the earliest developmental changes that lead to Down syndrome, an international team of scientists reported. They found that the presence of trisomy 21 in genetically engineered mice disrupts the function of a gene called REST, which in turn disturbs other genes that regulate normal growth at the embryonic stem cell stage. The findings could be used to develop molecule-based treatments that could mitigate effects of the condition, a molecular biology professor said. BBC (9/5)


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Press Releases provided by PR Newswire
Campbell Alliance Sales Practice to Present at CBI's Leadership Summit on Evolving the Pharma Sales Model
(Campbell Alliance) Fri 08:30 GMT

Huifeng Bio-Pharmaceutical (HFGB) Enters into Letter of Intent with Xi'an Qinba Xintong Medical Ltd.
(Huifeng Bio-Pharmaceutical Technology, Inc.) Fri 08:30 GMT

Somanetics Corporation to Release Third Quarter 2008 Financial Results and Host Conference Call September 17, 2008
(Somanetics Corporation) Fri 08:00 GMT

Expression Genetics' EGEN-001 Named One of 10 Most Promising Oncology Products by Windhover
(Expression Genetics, Inc.) Fri 08:00 GMT

American Academy of Nurse Practitioners Executive Director Dr. Judith Dempster Announces Retirement
(American Academy of Nurse Practitioners) Fri 08:00 GMT

Immigrants From India, Pakistan Face U.S. Prostate, Breast Cancer Risks
(West Virginia University Health Sciences Center) Fri 08:00 GMT

Hooper Holmes Health and Wellness to Present at the 2008 Integrated Care Summit
(Hooper Holmes) Fri 08:00 GMT

BioSpecifics Technologies Corp. Buys Down Royalties for Peyronie's Disease
(BioSpecifics Technologies Corp.) Fri 08:00 GMT

Pierre Fabre Donates the Majority Equity Interest in his Company to his Foundation and Appoints Jean-Pierre Garnier General Manager of Pierre Fabre SA
(Pierre Fabre SA) Fri 08:00 GMT

National Dairy Council Makes $250 Million, Five-Year Commitment to the Health of America's Youth by Teaming Up With the National Football League
(National Dairy Council) Fri 07:59 GMT




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