Celtic Pharma raises $100M for fund; Centocor receives FDA response on ustekinumab;

> The private equity firm Celtic Pharma has raised $100 million (£67m) for a new fund that will invest in drug and diagnostic development companies. Report

> Centocor, a Johnson & Johnson company, said the FDA has issued a Complete Response letter for its BLA for ustekinumab, a biologic which treats chronic moderate to severe plaque psoriasis. The agency wants additional information, including a proposal to manage the risks of the drug. However, the FDA will not require any additional trials. Release

> AstraZeneca and MAP Pharma announced an exclusive worldwide agreement to develop and commercialise Unit Dose Budesonide, or UDB, a potential treatment for asthma currently in Phase III clinical development. Release

> Cornerstone Pharmaceuticals, a drug development company focused on cancer bioenergetics, has raised $6 million in new angel funding. It has offices in both Stony Brook, NY and Cranbury, NJ. Report

> Novocell is expected to announce this morning that it has signed a two-year collaboration with Pfizer giving the drug-making giant access to the tiny biotech's expertise at turning human embryonic stem cells into insulin-producing pancreas cells. Report

> An outbreak of bird flu at a Hong Kong poultry farm is raising concerns as some of the birds that died had been vaccinated against the virus. Report

> A U.S. and Swiss biotech company have formed a research collaboration to focus on new therapeutic cancer vaccines. Worcester, MA-based Generex and Switzerland's Pevion Biotech plan to initially concentrate their work on oncogenes over-expressed in breast, ovarian, prostate, stomach and colon cancer, as well as other malignancies. Report

> A research team at the University of Maryland has developed a universal flu vaccine that can also protect birds and mammals from avian flu. Report

> Researchers have finally figured out why a respiratory syncytial virus vaccine used in 1966 to innoculate children against the infection failed and caused severe respiratory disease. Report

> The International AIDS Vaccine Initiative is offering a $150,000 reward to researchers willing to tackle a key challenge in their R&D work. And the right answer could be worth a bonus of more than a million dollars along with a fresh supply of research funds. Report

> Cutting drug prices to consumers is not enough to encourage greater compliance by patients on chronic medication, a new US study has reported. Report

> Auxilium Pharmaceuticals has scored a rich partnership pact with Pfizer for Xiaflex, a late-stage drug for the treatment of Dupuytren's contracture and Peyronie's disease. Malvern, PA-based Auxilium nets $75 million upfront, $410 million in potential development, regulatory and sales milestones. Report

> Developers with experimental diabetes drugs in the pipeline will have to go an extra mile in R&D to win an FDA approval. In a move sure to add a significant amount of expense to the development process, the FDA is mandating more screening of potential heart risks. Report

> Wyeth Pharmaceuticals has acquired the U.K.-based biotech company Thiakis Limited for an upfront payment of $30 million. Report

> San Diego-based Ligand Pharmaceuticals will pocket a $5 million upfront fee and up to $158 million in development and commercial milestones under a new pact it signed with GlaxoSmithKline covering its experimental platelet-booster and other thrombopoietin-related molecules. Report

And Finally... The National Venture Capital Association polled 400 venture capitalists about what they expected from the 2009 investment environment. If 2008 was a rough year for venture capital, 2009 could be even worse. Report

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.