The CHMP Delivers a Positive Opinion Recommending Grant of Marketing Authorization for ADASUVE® (Staccato® Loxapine) in the European Union

Alexza Pharmaceuticals, Inc. (ALXA) and Grupo Ferrer Internacional, S.A., today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending that ADASUVE (Staccato loxapine) be granted European Union (EU) centralized marketing authorization.  The CHMP recommends that ADASUVE be authorized in the EU for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.  Patients should receive regular treatment immediately after control of acute agitation symptoms.  The recommendation by the CHMP is that ADASUVE should be administered only in a hospital setting under the supervision of a healthcare professional.  Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects, such as bronchospasm.

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AstraZeneca Announces Top-Line Results of OSKIRA-4 Phase IIb Study of Fostamatinib as a Monotherapy for Rheumatoid Arthritis

AstraZeneca today announced top-line results of OSKIRA-4, a Phase IIb monotherapy study of fostamatinib, the first kinase inhibitor with selectivity for SYK (spleen tyrosine kinase) in development as an oral treatment for rheumatoid arthritis (RA).

OSKIRA-4 was a six month study evaluating improvements in signs and symptoms of RA in 280 patients who had never previously used a disease-modifying anti-rheumatic drug (DMARD), were DMARD intolerant or had an inadequate response to DMARDs and were randomised to receive fostamatinib as a monotherapy, adalimumab as a monotherapy, or placebo.  Three dose regimens of fostamatinib were evaluated in OSKIRA-4: 100mg twice daily, 100mg twice daily for a month followed by 150mg once daily, and 100mg twice daily for a month followed by 100mg once daily.

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Telik Announces Telintra® Clinical Publication at the 54th Annual Meeting of the American Society of Hematology

Telik, Inc. (TELK) announced today the publication of a clinical trial abstract in the proceedings of the 54th Annual Meeting of the American Society of Hematology in Atlanta, Georgia.  The abstract, "Oral Ezatiostat HCl (Telintra), a Glutathione Analog Prodrug GSTP1-1 Inhibitor, for Treatment of Patients with Myeloid Growth Factor-Resistant Idiopathic Chronic Neutropenia (ICN)," by Roger M. Lyons, MD; Sharon T. Wilks, MD; and of David J. Friedman MD, PhD, of Cancer Care Centers of South Texas, US Oncology in San Antonio, Texas; and Shelby A. Young, RN, BSN, and Gail L. Brown, MD, of Telik, Inc., in Palo Alto, California, is available online at Blood (ASH Annual Meeting Abstracts) 2012 120: Abstract 4394.

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Oncolytics Biotech Inc. Announces Positive Top Line REOLYSIN® Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers

Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (TSX:ONC.TO - News) (NASDAQ:ONCY - News) today announced initial positive top line data from the first endpoint in its double-blinded randomized Phase III clinical study examining REOLYSIN in combination with carboplatin and paclitaxel in second-line patients with platinum-refractory, taxane-naïve head and neck cancers (REO 018).

The endpoint examines initial percentage tumour changes between the pre-treatment and first post-treatment scans (typically performed at six weeks post-first treatment) of all patients enrolled in the study. The analysis was designed to assess early differences in response between loco-regional tumours and metastatic tumours, as classified and observed by the investigators. This is the first, and to this point only, endpoint to be un-blinded for this study.

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Gilead Sciences to Acquire YM Biosciences

- Adds Selective JAK Inhibitor to Growing Oncology and Inflammation Pipeline -

Gilead Sciences, Inc. (Nasdaq:GILD - News) and YM BioSciences Inc. (NYSE MKT: YMI, TSX: YM) announced today that the companies have signed a definitive agreement under which Gilead will acquire YM for U.S.$2.95 per share in cash.  The transaction has received the unanimous approval of YM's Board of Directors, and values YM at approximately U.S.$510 million, with YM reporting C$125.5 million in cash and cash equivalents as of September 30, 2012. Gilead plans to fund the acquisition with cash on hand.  The transaction is expected to close in the first quarter of 2013.

Read more: YM BioSciences Inc ( YM / YMI )