US Department of Health and Human Services awards Novartis USD 486 million contract
The US Department of Health and Human Services, Biomedical Advanced Research and Development Authority (HHS, BARDA) has awarded Novartis Vaccines a contract for up to USD 486 million over eight years to support the design, construction, validation, and licensing of U.S. cell-based influenza vaccine manufacturing facilities in Holly Springs, North Carolina, to provide a pre-pandemic supply of influenza vaccine and to provide the capacity to manufacture 150 million doses of pandemic vaccine within six months of declaration of an influenza pandemic.
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Lilly Resolves Investigations of Past Zyprexa Marketing and Promotional Practices
Eli Lilly and Company (NYSE: LLY) today announced that it has reached resolution with the United States Attorney for the Eastern District of Pennsylvania (EDPA) and the Office of Consumer Litigation of the Department of Justice regarding the previously-reported government investigation into the company's past U.S. marketing and promotional practices for the antipsychotic medication Zyprexa(R) (olanzapine).
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Nycomed strengthens its osteoporosis portfolio
Nycomed and EffRx have announced a licensing agreement on EffRx' drug EX101 (effervescent alendronate) for the treatment of osteoporosis. Under the agreement, Nycomed will receive the exclusive rights to develop, manufacture and commercialise the effervescent formulation of alendronate for the treatment of osteoporosis in a large number of countries worldwide. EX101 presents a significant enhancement to Nycomed's osteoporosis portfolio.
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U.S. FDA Issues Complete Response Letter for SAPHRIS(TM)
Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS(TM) (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.
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Abbott Introduces RealTime Molecular Assay in Europe for Detection of HPV Infection
European clinicians will have a new weapon to combat cervical cancer with the introduction of Abbott Molecular's real-time polymerase chain reaction (PCR) based diagnostic test for human papillomavirus (HPV). The CE-marked assay can identify patients infected with specific viral genotypes known to pose the highest risk for progression to cervical cancer.
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Genzyme and Isis Begin New Clinical Trials of Mipomersen
Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) have begun two new studies of mipomersen, a novel lipid-lowering drug in late-stage development, and a third is currently screening patients. These three trials will provide additional data on mipomersen in high-risk patient populations.
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GlaxoSmithKline successfully completes tender offer for shares of Genelabs Technologies, Inc.
GlaxoSmithKline plc [LSE/NYSE: GSK] has announced the successful completion of the tender offer by its wholly-owned subsidiary Gemstone Acquisition Corporation for shares of common stock of Genelabs Technologies, Inc. [Nasdaq: GNLB].
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