BioWorld Today

Osiris Therapeutics Inc. won a double victory today with the first ever marketing approval for a manufactured stem cell product and the first therapy for graft-vs.-host disease (GvHD). Health Canada issued marketing authorization for Osiris's stem cell therapy Prochymal (remestemcel-L) for GvHD in children.

WASHINGTON – The first PDUFA clouds are forming as a revised version of the user fee package heads to the Senate floor this week for possible amendments and a vote.

Having the ApoE4 gene variant is one of the strongest risk factors for developing late-onset Alzheimer's disease. Now, scientists have found out why. ApoE4 is less able to control production of the inflammatory cytokine cyclophilin A than other variants of the ApoE gene, and high levels of cyclophilin A set off inflammatory processes that ultimately damage the blood-brain barrier and the brain vasculature.

Five years after its founding and 15 years after work started on its lead compound, Oncolix Inc. is finally reaching out to venture capitalists for funding. The Houston-based start-up has thus far managed without big-money backers because the academics and contractors who've come into contact with its prolactin antagonist Prolanta (G129R) have been eager to lend their support.

• Kleiner Perkins Caufield & Byers, of Menlo Park, closed KPCB 15, a $525 million venture capital fund focusing on investments in early stage digital consumer and enterprise, green tech and life sciences companies.

• Emergent BioSolutions Inc., of Rockville, Md., said the FDA approved its supplemental biologics license application to change the administration schedule of BioThrax (anthrax vaccine adsorbed) to a three-dose primary series of intramuscular injections at zero, one month and six months.

• NovaBay Pharmaceuticals Inc., of Emeryville, Calif., said it enrolled the first patients in its Phase IIb study, named BAYnovation, to test lead compound NVC-422 in adenoviral conjunctivitis.

Researchers from Weill Cornell Medical College reported this week that methylation of messenger RNA is widespread. It has only recently been recognized that messenger RNA, which was once thought to be a straightforward translational device between DNA and proteins, is methylated at all.