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Wednesday, 21 September 2011 00:27 |
 Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved two new indications for Prolia® (denosumab) as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer.
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Tuesday, 20 September 2011 00:31 |
 Life Technologies Corporation (NASDAQ: LIFE) applauds the signing by President Barack Obama of "The Leahy-Smith America Invents Act" (H.R. 1249). President Obama will sign the bill today at Thomas Jefferson High School for Science and Technology in Alexandria, Virginia.
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Tuesday, 20 September 2011 00:27 |
 GlaxoSmithKline has turned to the engineering expertise of Formula 1 racing team McLaren in an innovative alliance designed to transform its manufacturing, R&D and consumer health divisions.
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Monday, 19 September 2011 00:09 |
 Biotech firm Vertex, fresh off the introduction of Incivek for hepatitis C, is busying itself with launch preparations once again. The firm said it's hiring across the company to support the anticipated debut of cystic fibrosis (CF) drug VX-770.
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Saturday, 17 September 2011 00:58 |
 Lupin Pharmaceuticals, Inc. (LPI) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market a generic version of UCB's KEPPRA XR tablets. Commercial shipment of the product has commenced.
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Saturday, 17 September 2011 00:36 |
 Allergan Inc (AGN.N) is not worried about over-reliance on sales of its flagship Botox drug, the company's chief said, citing extensive safety data and supply reserves of the injectable medicine.
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Friday, 16 September 2011 00:29 |
 Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") earlier today, presented positive final Phase 2 efficacy and safety data for its targeted cytotoxic luteinizing hormone releasing hormone (LHRH) analog, AEZS-108, in advanced endometrial cancer.
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Thursday, 15 September 2011 00:58 |
 The Gates Foundation, belonging to Microsoft founder Bill Gates and his wife Melinda, could poach Novartis's head of global development, a Swiss newspaper reported on Sunday, citing two sources.
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Thursday, 15 September 2011 00:00 |
 BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX), today announced successful completion of its principal LibiGel (testosterone gel) pharmacokinetic (PK) study. The top-line results indicate that LibiGel increases levels of free testosterone, bioavailable testosterone and total testosterone in the serum of postmenopausal women to within the normal ranges for younger, premenopausal women.
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Wednesday, 14 September 2011 00:49 |
 GlaxoSmithKline PLC said it will stop administering breast cancer drug Tykerb alone to patients in a clinical trial, after an independent committee decided the medicine would probably produce worse results than Roche Holding AG's (ROG.VX) rival product Herceptin.
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Wednesday, 21 September 2011 00:22 |
 A Sioux Falls-based biotechnology firm says it has laid off 18 employees in response to changing needs of its parent company.
Hematech CEO Eddie Sullivan tells the Argus Leader (http://bit.ly/nGDhrh) that the layoffs included researchers, technicians and support staff.
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Tuesday, 20 September 2011 00:29 |
 Qualitest Pharmaceuticals today issued a voluntary, nationwide, retail-level recall of multiple lots of oral contraceptives. The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date no longer visible.
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Monday, 19 September 2011 00:16 |
 U.S. health regulators said they are reviewing the safety of GlaxoSmithKline's anti-nausea drug Zofran to ascertain whether there is a potential risk of abnormal heart rhythm.
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Monday, 19 September 2011 00:02 |
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 The world’s biggest pharmaceutical firm Pfizer is cutting more than 500 jobs in Germany – around one in eight of the work places in the country, according to insiders who have spoken to the Handelsblatt newspaper.
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Saturday, 17 September 2011 00:55 |
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 Pfizer Inc. (PFE) is delaying a sale of its infant-nutrition business to give it more time to explore whether a tax-free spinoff will get more value for investors, said people with direct knowledge of the plans.
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Friday, 16 September 2011 00:34 |
 Yet another unit of Daiichi Sankyo has elicited the wrath of the FDA. The agency issued a warning letter to its Luitpold Pharmaceuticals subsidiary for “significant” and repeated violations at a Long Island, New York, manufacturing plant.
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Friday, 16 September 2011 00:18 |
 Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received notice today from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011Intermezzo® Complete Response Letter.
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Thursday, 15 September 2011 00:56 |
 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company has submitted a New Drug Application for vismodegib to the U.S. Food and Drug Administration (FDA) for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.
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Wednesday, 14 September 2011 00:51 |
 U.S. health advisers declined to suggest how long women should take a class of drugs used by millions to prevent bone fractures, but agreed the labels should be changed to reflect uncertainty about the risks and benefits of long-term use.
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Wednesday, 14 September 2011 00:46 |
 Gilead Sciences Inc's (GILD.O) experimental four-drug HIV pill may need to do more than simply match the safety and effectiveness of existing therapies to meet its lofty sales expectations.
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