MedImmune wins $61M swine flu contract; Xarelto response may take until early 2010

> MedImmune has won a $61 million contract to test its nasal spray vaccine technology on swine flu. Report

> Bayer and Johnson & Johnson say they may need until early 2010 to respond to the FDA's complete response letter regarding Xarelto, an experimental blood-clotting pill. The agency declined to provide an approval last May, but the developers noted that the FDA did not demand any new clinical trials. Report

> Shares of Sequenom were buoyed by the news that a study demonstrated that its new test for human papillomavirus was able to detect the virus in half of the women who tested negative using standard technology. Story

> India is setting up a new regulatory agency for the country's biotech drugs. "Biologics cannot be treated as traditional chemical-based drugs and regulated under the same norms meant for such drugs," said a government official. Story

> The new version of Wyeth's Prevnar won its first regulatory approval in Chile. Report

Pharma News

> Some disturbing news on the flu front: Another study has found the H1N1 pandemic strain to be more virulent than seasonal flu, with greater ability to replicate within patients' throats and lungs and the ability to cause more lung damage. That's a pattern seen in the 1918 pandemic virus. Report

> Just as the U.S. Mint redesigned currency to foil counterfeiters, the FDA is advising drugmakers on how to redesign their pills. Report

> Pfizer is saying that it's planning a big-time land grab, aiming to grow its oncology sales tenfold by 2018--and become the third-largest purveyor of cancer meds, up from seventh now. Report

> U.K. science and health ministers Paul Drayson and Ara Darzi propose allowing some "innovative" new drugs to be used by the NHS while the National Institute for Health and Clinical Excellence performs its review. This "Innovation Pass" idea would allow NICE to pick meds eligible for three-year, fast-track access. Report

> The new FDA is stepping into the debate over antibiotics in livestock. Deputy Commissioner Joshua Sharfstein (photo) wrote to the House Rules Committee, supporting restrictions on use of the drugs. It should be verboten to feed antibiotics to farm animals that aren't sick, Sharfstein wrote. Report

Research News

> Developers studying new stem cell therapies for orthopedic injuries could learn a lot from the researchers working in the veterinarian field. Report

> The non-profit Institute for OneWorld Health has forged a research pact with Novartis that will tap years of lab work on cystic fibrosis in an effort to find new therapies to treat secretory diarrhea, a condition that kills some 1.6 million children in the developing world every year. Report

> The general public is rarely all that interested in preclinical research. And why should it be? In most cases, the science is years and years from arriving at patients' bedsides. But resveratrol is the exception to the rule. Report

> Tiny Fate Therapeutics appears to have taken an early lead in the race with pharma giant Novartis to create a new stem cell therapy that can pump up the body's supply of blood-generating stem cells and rebuild immune systems. Report

And Finally... In recent years the culture wars have been a central theme in American biomedical research circles. Christian conservatives have banded together to protest, often successfully, new work on embryonic stem cells. Scientific groups have argued loudly that religious beliefs have no place in the lab. And then comes Francis Collins, a world-renowned geneticist and devout Christian. Report

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