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From THIS WEEK'S ISSUE of www.thepinksheet.com
The Pink Sheet
Sanofi Pasteur Nets Flu Vaccine Via Acambis Purchase
Early C. difficile program comes along with $550 million deal. read more
EpiCept AML Drug Gets “Exceptional Circumstances” Stamp From EU Regulators
Remission maintenance drug should receive formal EC approval within 67 days; new U.S. filing planned for 2009. read more
Genentech Sticks To Script When Responding to Roche
Roche’s next line will likely involve a sweeter offer. read more
J&J/Omrix’s Evicel Wins CHMP Recommendation
Human fibrogen/thrombin product would be indicated for supportive treatment in surgery. read more
FDA Plans Further Audits Of Telavancin Study Sites; No Major Problems To Date
Firm says FDA and company audits of telavancin clinical trial data are progressing well; no predictions on how long process may take. read more
FDA Calls Roche’s Arthritis Drug Actemra Effective Ahead Of Panel Meeting
First-in-class interleukin-6 receptor inhibitor may sidestep safety concerns seen with anti-TNFs. read more
GSK Inks “Transformational” Licensing Agreement With Onco Therapies To Extend Reach In Emerging Markets
Deal also extends GSK’s interest in branded generics. read more
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Business & Finance 

GSK, Harvard University enter stem cell deal worth $25M
GlaxoSmithKline agreed to invest $25 million in Harvard University's Stem Cell Institute as part of a five-year deal to develop drug-screening techniques. Stem cell research "has great potential to aid the discovery of new medicines by improving the screening, identification and development of new compounds," a GSK official said. American City Business Journals/Raleigh/Durham, N.C. (7/24) , MIT Technology Review (7/24) , The Boston Globe (7/25)

Genentech assigns panel to assess Roche's buyout bid
Genentech announced that it formed a special three-member team to review Roche Holding's takeover offer of $89 a share. The members are not Roche employees. "The outcome of this process has not been predetermined, and there can be no assurance that the special committee will approve any transaction" with the Swiss drugmaker, the panel's chairman said. San Francisco Chronicle (7/25) , The Wall Street Journal (subscription required) (7/25)

Horizon Therapeutics chooses biotech veteran as CEO
Horizon Therapeutics appointed Timothy P. Walbert as its new president and CEO. Walbert's long experience in the pharmaceutical and biotech industries will help the company launch HZT-501 -- a single-pill combination of famotidine and a proprietary formulation of ibuprofen, Horizon founder Dr. George Tidmarsh said. American City Business Journals/San Jose, Calif. (7/24)

Spanish biotech firm seeks partnerships with Big Pharma
Cellerix, a Spanish firm that develops treatments based on stem cells, is having early discussions with major drugmakers about a possible partnership or takeover, CEO Eduardo Bravo said. Many companies expressed interest in Cellerix, but they had the attitude of "wait and see" because the market for stem cell therapy remains unproven, Bravo said. The Guardian (London)/Reuters (7/24)

Government & Legal News 

Research of HIV vaccine must be revamped, scientists say
Researchers aiming to discover a vaccine that prevents HIV infection need to take "enormous intellectual leaps beyond present-day knowledge," a team of scientists wrote in the journal Science. The statement came in the wake of a failed trial of a vaccine candidate and amid budget constraints that limit NIH development efforts. The Wall Street Journal (free content)/Associated Press (7/24)

CDC: Illegal pain drug tied to rise in fatal overdoses
An illegal version of the painkiller fentanyl caused at least 1,013 fatal drug overdoses in the U.S. between 2005 and 2007, according to a CDC report. Deaths linked to the powder version -- said to be more potent than heroin -- were identified in areas including Camden, N.J., and Chicago. The Wall Street Journal (free content) (7/25)

Report: U.S. drugmakers profited from shift to Part D
The first two years of Medicare's Part D program resulted in a $3.7 billion windfall for U.S. drugmakers that had products used by eligible beneficiaries who shifted from Medicaid, according to a report from Democratic congressional staff. Sales of Risperdal, Johnson & Johnson's anti-psychotic drug, reached more than $500 million, while anti-clotting medicine Plavix racked up $200 million for Bristol-Myers Squibb and Co. Yahoo!/Reuters (7/24)

House committee approves bill for electronic records
The House Energy and Commerce Committee voted unanimously in favor of a bill aimed at promoting the adoption of electronic health records by 2014. The legislation would also offer $560 million in loans and grants for medical providers to acquire a system for such records. The bill -- known as the Protecting Records, Optimizing Treatment and Easing Communication Through Healthcare Technology Act of 2008 -- was amended to include some changes, including one to bolster the implementation of protections under the HIPAA of 1996. HealthImaging.com (7/24)

FDA extends J&J's market exclusivity for Topamax
The FDA cleared the use of Johnson & Johnson's Topamax in patients ages 1 month to 24 months, extending the patent on the epilepsy medication to March. The patent, which was approved to treat patients age 10 and older, was supposed to expire in September. Forbes/Associated Press (7/24)

Pipeline/R&D News 

Researchers: HIV drug combos extended lives by 13 years
Early treatment with drug cocktails known as highly active anti-retroviral therapy helped HIV patients live an average of 13 years longer, according to an analysis of 14 studies involving patients in the U.S., Canada and some European countries. The finding underscores the need for improved access to HIV treatments, the researchers said. Reuters (7/25)

Plavix maker plays down rival drug from Lilly
Bristol-Myers Squibb and Co., manufacturer of anti-clotting drug Plavix, said Effient, a rival drug from Eli Lilly and Co., may become a "niche" product if it wins approval because it failed to benefit patients in a large clinical trial. According to the study, which Lilly sponsored, Effient was 19% more effective than Plavix in preventing heart attacks among patients who received stents but also caused a 32% higher incidence of serious bleeding. Yahoo!/Reuters (7/24)

Studies: Longevity-related protein ties internal clock, metabolism
SIRT1, a protein linked to genes that affect longevity, was found to interconnect mammalian circadian rhythms and metabolism by regulating the activity of genes involved in the two mechanisms, two studies found. The findings may prove useful in drug development, one of the researchers said. Yahoo!/HealthDay News (7/24)


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Arbitration Panel Issues Ruling in Distribution Dispute
(Inverness Medical Innovations, Inc.) Fri 22:11 GMT

Nu Skin Recognized for Corporate Social Responsibility at International Business Awards
(Nu Skin Enterprises, Inc.) Fri 21:00 GMT

Eisai Receives Action Letter on Fospropofol Disodium Injection for Sedation in Diagnostic or Therapeutic Procedures
(Eisai Corporation of North America) Fri 20:00 GMT

Klafter & Olsen LLP Announces That It Has Filed a Class Action Lawsuit Against ArthroCare Corporation on Behalf of Common Stock Holders and Certain Traders in ArthroCare Options
(Klafter & Olsen LLP) Fri 20:00 GMT

BioTrends Releases Quarterly TreatmentTrends(TM): Nephrology Report Highlighting Market Trends for Renal Anemia, Hyperphosphatemia, and Secondary Hyperparathyroidism
(BioTrends Research Group, Inc.) Fri 19:59 GMT

Immucor, Inc. Adds Board Members
(Immucor, Inc.) Fri 19:24 GMT

The Lustgarten Foundation for Pancreatic Cancer Research Mourns Loss of Dr. Randy Pausch
(The Lustgarten Foundation for Pancreatic Cancer Research) Fri 18:54 GMT

Conference to Turn Scientists of Color into PA-Based Entrepreneurs Set for November
(Pittsburgh Life Sciences Greenhouse) Fri 17:10 GMT

Jan Gray Joins Resverlogix Board of Directors
(Resverlogix Corp.) Fri 17:00 GMT

Alternative Warm-Up Program Reduces Risk of ACL Injuries for Female College Soccer Players
(Centers for Disease Control and Prevention) Fri 16:32 GMT




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