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FDA Issues Complete Response Letter For INTUNIV™ (guanfacine) Extended Release For The Treatment Of ADHD In Children And Adolescents
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter for INTUNIV TM (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.
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Flu Shot Not Effective In Preventing Flu-Related Hospitalizations In Asthmatic Children
The inactivated flu vaccine does not appear to be effective in preventing influenza-related hospitalizations in children, especially the ones with asthma. In fact, children who get the flu vaccine are more at risk for hospitalization than their peers who do not get the vaccine, according to new research that will be presented on Tuesday, May 19, at the 105th International Conference of the American Thoracic Society in San Diego.
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International Diabetes Federation Kicks Off World Diabetes Day Campaign
The International Diabetes Federation (IDF) launched its World Diabetes Day campaign under the slogan "Understand diabetes and take control."
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Pluristem Therapeutics Announces First Patient Enrollment In Phase I Clinical Trial For Treatment Of Peripheral Artery Disease With PLX-PAD

Pluristem Therapeutics Inc. (NasdaqCM:PSTI) (DAX:PJT), a bio-therapeutics company dedicated to the commercialization of unrelated donor-patient (allogeneic) cell therapy products for a variety of disorders, announced today that the first patient has been enrolled in a Phase I clinical trial of the Company"s allogeneic placental-derived adherent stromal cell product, termed PLX-PAD. PLX-PAD is being used in patients afflicted with critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD). The first patient was enrolled at the Franziskus-Krankenhaus Hospital, Berlin. The initiation of this study follows the recent approval of the Company"s Clinical Trial Application (CTA) to begin clinical trials with PLX-PAD by the Paul Ehrlich Institute (PEI), the German competent authority in the European Union. The Phase I study is designed to evaluate the safety of PLX-PAD in patients with CLI. A total of up to fifteen adults with the disease will be included in the trial which is being conducted at the Franziskus-Krankenhaus Hospital and Charitç© - Universitç¤tsmedizin Hospital, Berlin. Zami Aberman, Chairman, President and CEO of Pluristem stated, "We are proud to begin clinical trials with PLX-PAD, a cellular therapeutic product derived from the placenta, the organ intimately involved in the miracle of birth and a ubiquitous of adult stromal cells that are easily obtained without harm to the mother or baby. Additionally, our proprietary three-dimensional mass manufacturing technology allows us to grow cells significantly more efficiently and cost-effectively than cells grown via the labor intensive two-dimensional method which is the industry norm." Pluristem Therapeutics Inc.


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