FDA holds off on expanding use of Rituxan; Bayer tests new search-ad format for Yaz;

> Genentech and partner Biogen Idec said the FDA is withholding a decision to expand approval of Rituxan as a leukemia treatment, pending further discussion. Release

> Bayer is trying out a paid search format for Yaz similar to that proposed by Google for products carrying black-box warnings at last week's FDA hearing on Internet marketing. Report

> A former Vermont assistant attorney general who spearheaded efforts to rein in pharma marketing has been nominated as one of five Federal Trade Commission commissioners. Report

> The chair of the European Alliance for Access to Safe Medicines slammed the idea of allowing drug reimportation in the U.S., citing worries about counterfeiting. Report

> The United Nations will pay 19 percent less next year for a vaccine against five deadly childhood diseases than in 2009, because of competition among four companies that now make the shots. Report

> The National Institutes of Health Awarded $8.5 million for studies of drugs and other medical products for children. Report

> An FDA advisory panel recommended against pediatric approval for Roche and Novartis's asthma drug in children ages 6 through 11. Report

> Organon launched its Nuvaring contraceptive product in India. Report

> Dainippon Sumitomo Pharma shares gained the most in five months after Citigroup raised its rating on the Japanese pharmaceutical maker. Report

Biotech News:

> The FDA's Vaccines and Related Biological Products Advisory Committee today will determine whether Protein Sciences' flu vaccine FluBlok, which can be produced in less than two months by inserting flu genes into an insect virus and growing it in caterpillar ovary cells, warrants approval. Report

> AstraZeneca today announced it has submitted an NDA to the FDA for ticagrelor, an investigational oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndrome (ACS). The proposed trade name for ticagrelor is Brilinta, pending approval from the FDA. Report

> ImmuPharma's shares dropped 19 percent following the announcement that a Phase II study of the potential lupus treatment Lupuzor did not reach statistical significance. But CEO Dimitri Dimitriou claims that the market has misinterpreted the study results, and that the subset of patients ImmuPharma intended to test did respond to the drug. Report

> The new Pfizer-Wyeth got good news Wednesday after an FDA panel determined that the company's updated version of childhood vaccine Prevnar--called Prevnar-13--is safe and effective. Report

Vaccine News:

> The GAVI Alliance--a Geneva-based public-private partnership aimed at improving health in the world's poorest countries--touted the news this week that millions of more children would be able to receive vaccines next year thanks to increased competition among drugmakers that produce five-in-one shots, known as the pentavalent vaccine. Report

> With one segment of British society fearful of the potential side effects of a new swine flu vaccine and another large group shrugging off the pandemic as much ado about nothing, more than half of the island's population is saying no to the shot. And it's not solely a British phenomenon. A new poll from CNN/Opinion Research reveals that 55 percent of American adults will shun the vaccine. Report

> A NASA space shuttle is carrying a series of experiments being conducted by Astrogenetix to discover vaccines against a number of diseases--including those caused by methicillin-resistant Staphylococcus aureus microbes--by using the microgravity environment in space. Report

And Finally... More bad news for Genzyme: The company said it has scrapped development plans for a stronger version of its Renvela kidney-failure product. 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.