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12:00 AM
Oct 05, 2009
 |  BioCentury  |  Finance

3Q Approvals/3Q Setbacks

3Q Approvals/3Q Setbacks

Company Approval
Allos Therapeutics Inc. (NASDAQ:ALTH) FDA grants accelerated approval of Folotyn pralatrexate to treat relapsed or refractory peripheral T cell lymphoma (PTCL)
Anika Therapeutics Inc. (NASDAQ:ANIK) Canada approves Monovisc to treat osteoarthritis (OA) of the knee
AstraZeneca plc (LSE:AZN; NYSE:AZN) EC approves Iressa gefitinib to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients with activating mutations of EGFR
AstraZeneca plc (LSE:AZN; NYSE:AZN)/ Bristol-Myers Squibb Co. (NYSE:BMY) FDA approves Onglyza saxagliptin to treat Type II diabetes
BioDelivery Sciences International Inc. (NASDAQ:BDSI)/Meda AB (SSE:MEDAA) FDA approves Onsolis fentanyl buccal soluble film to treat breakthrough cancer pain in opioid- tolerant adults
Cerus Corp. (NASDAQ:CERS) Swissmedic approves the use of platelet components treated with the company's Intercept Blood System
CSL Ltd. (ASX:CSL) FDA approves vaccine against swine influenza A (H1N1)
Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568)/Eli Lilly and Co. (NYSE:LLY) FDA approves Effient prasugrel to reduce thrombotic cardiovascular events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI)
Eurand N.V. (NASDAQ:EURX) FDA approves Zenpep pancrelipase delayed-release capsules to treat exocrine pancreatic insufficiency in patients with cystic fibrosis (CF) or other conditions
Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) FDA approves Avastin bevacizumab for use in combination with interferon alpha to treat metastatic renal cell carcinoma (RCC)
Genzyme Corp. (NASDAQ:GENZ) EC approves Mozobil plerixafor in combination with G-CSF to enhance mobilization of stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with lymphoma or multiple myeloma (MM)
Gilead Sciences Inc. (NASDAQ:GILD) EC grants conditional approval of Cayston aztreonam lysine to treat chronic pulmonary infections due to Pseudomonas aeruginosa in adults with CF
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) FDA grants accelerated approval of Hiberix Haemophilus influenzae type B (Hib) vaccine as a booster dose for children 15 months to four years old
GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) EC approves Pandemrix swine influenza A (H1N1) adjuvanted vaccine...

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