Shire seeks Replagal approval; Novartis CEO stands up to activists;

> Shire has submitted a BLA with the FDA for Replagal (agalsidase alfa), its enzyme replacement therapy for Fabry disease. Replagal first received marketing authorization in the European Union in 2001, and is approved for the treatment of Fabry disease in 45 countries. Shire release

> NicOx today announced that an application for naproxcinod has been submitted to the European Medicines Agency through the centralized procedure, seeking approval for an indication for the relief of the signs and symptoms of osteoarthritis. NicOx Release

> Senthil Saravanamuthu studies eye biology at the National Institutes of Health. But in a classroom one night last week, squeezed between a tray of carrots and a whiteboard 10 miles from his Bethesda lab, he was there to listen. Academics and state and local officials had gathered Thursday at the Montgomery County campus of Johns Hopkins University to try to recruit biotech entrepreneurs, and Saravanamuthu was gathering data the way he tackles questions about lens development and blinding diseases. Report

> PDL BioPharma has entered into a non-exclusive license agreement with Eli Lilly under PDL's Queen et al., patents with respect to teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next generation anti-CD3 molecules. PDL Release

> Shares in U.K. drug group ARK Therapeutics nosedived on Friday as investors shrank back on news that European advisors have adopted a negative opinion on its flagship brain therapy Cerepro. Story

>  The biotechnology industry in Connecticut has been hit with major setbacks this year, including the sale and dismantling of two drug development companies that were once bright lights--but another biotech firm, 454 Life Sciences Corp. in Branford, is expanding. Story

Pharma News

> Don't be skeptical of the U.S. government's recent spate of off-label marketing claims against drugmakers. That's what AstraZeneca chief (and current chair of the trade group PhRMA) David Brennan (photo) told the Wall Street Journal in an interview. Those fines are actually working, Brennan says. Report

> Let's say you're a Big Pharma CEO who needs a new leader for your vaccines unit. Who are you gonna call? Gerberding. Yep, Julie Gerberding, former top dog at the CDC. She has plenty of experience overseeing the selection of recommended immunizations. And she steered the CDC ship through more than a few public health crises. Story

> On the heels of yesterday's story about India reaping the benefits of pharma contract manufacturing, we ran across this statistic: Contract drug production is expected to grow at a rate of 11 percent per year. And it's expected to hit $299 billion globally by 2014, up from $177 billion this year, according to a report from BCC Research. Report

> You all know that Germany's Ratiopharm is currently on the block, with a sale planned for early next year. What you might not know is that the company is set to beat its own goals for 2009 profits. Report

> Illinois advocacy groups are calling for an overhaul of antipsychotic drug use in nursing home residents. They want Gov. Pat Quinn's nursing home task force to recommend tough new rules for the use of those drugs, including restrictions on doctors who prescribe them. Story

Biotech Research News

> Most of the heads of Big Pharma and Big Biotech companies alike would duck and cover if attacked by animal rights activists--but not Novartis CEO Daniel Vasella (photo). Story

> Speedier, low-cost genomic sequencing and profiling may help clinicians diagnose patients' susceptibility to disease and tolerance of selected drugs more quickly. But engineers need to find a way to increase the sensitivity of sensors used to detect the DNA molecules that define the human genome--something that could be achieved by reducing the number of target DNA molecule copies needed to obtain an accurate read. Report

> One of the most perplexing challenges presented by the swine flu pandemic centered on the question of why some people were killed by a virus that had only a mild impact on the vast majority of its victims. Now a Harvard researcher says it appears that the answer to that question may lie in IFITM proteins. Report

Manufacturing News

> Improved safety monitoring, cooperation with international partners, and enhanced transparency are roadmap objectives of which major government organization? If you guessed the European Medicines Agency... you're right! Maybe that cross-pond cooperation isn't as difficult as it seems. Story

> Serious tools are becoming available for manufacturers serious about sustainability. Applications and software to help measure sustainability are now offered by SAP, which has launched a sustainability-tracking application using its previously launched BusinessObjects sustainability performance management application. Report

> A short circuit is suspected as the cause of a fire at a drug-making plant in Indian that has killed two. Eight others were injured; four of them critically. Story

> What accounts for the low antigen level of the Sanofi-Aventis H1N1 vaccine for kids? The recalled 800,000 doses, in 0.25-mL pre-filled syringes intended for 6- to 35-month olds, have been found to be safe. They're apparently just a little less robust than they ought to be. Report

And Finally... A new stem cell therapy has been used to restore sight in a mutilated eye. A medical team in the U.K. extracted stem cells from the healthy eye of Russell Turnbull and then used the cells to seed a patch of amniotic tissue, which is used to treat burn victims. Story

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