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December 7, 2007
Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State, and Austria, Fin…
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December 7, 2007
Seattle Genetics has begun a Phase IIb trial of SGN-40 in combination with Rituxan plus chemotherapy for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Under the terms of the company's collaboration agreement with Genente…
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December 6, 2007
Urigen Pharmaceuticals has established a partnerships with Hyaluron Contract Manufacturing (HCM) to develop URG101, Urigen's proprietary fixed dose combination of FDA-approved drugs targeting painful bladder syndrome (PBS).
"Urigen's de…
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December 6, 2007
Bristol-Myers Squibb has publicized the details of its restructuring initiative as it works to become a "next-generation BioPharma company." With the aim of generating $1.5 billion in annual pre-tax savings by 2010 (the year that top-seller…
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December 6, 2007
Pharmetics, Inc. has entered into an agreement to acquire the Niagara-Burlington commercial manufacturing business of Patheon for approximately $5.75 million. Pharmetics will acquire the assets -- including equipment, facilities and land -- at Patheo…
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December 5, 2007
Edward J. Schutter has been appointed to president and chief operating officer of Sciele Pharma. In his new position, Mr. Schutter will continue to report directly to chief exeutive officer Patrick Fourteau and will be responsible for day-to-day oper…
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December 5, 2007
Pfizer and Adolor Corp. have signed an exclusive collaboration to develop and commercialize novel compounds, ADL5859 and ADL5747, for the treatment of pain. Both compounds are proprietary Delta opioid receptor agonist candidates with the potential to…
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December 5, 2007
Avid Bioservices has signed a manufacturing supply and technology transfer agreement with Arius Research. The agreement covers Arius' lead cancer stem cell antibody, which targets a novel epitope of CD44 found in breast, colon and prostate cancers. A…
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December 4, 2007
Quest Pharmaceutical Services, LLC, a GLP-compliant CRO providing testing services to support preclinical and clinical research and development, has formally changed its name to QPS, LLC.
The company commissioned independent market research to eva…
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December 4, 2007
Two Johnson & Johnson subsidiaries, Centocor, Inc. and Janssen-Cilag International NV, have submitted marketing approval applications for ustekinumab (CNTO 1275) in the U.S. and Europe for the treatment of adult patients with chronic moderate to…
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December 4, 2007
CMC Biopharmaceuticals A/S has reached an agreement with Lilly to buy the biologics development and manufacturing operation of ICOS Corp., which Lilly bought on in January 2007. CMC, a Copenhagen, Denmark-based bio-CMO, will purchase the biologics fa…
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December 3, 2007
David A. Dodd has been named president, chief executive officer and chairman at BioReliance Corp. From 2000 through 2006, Mr. Dodd served as president and chief executive officer of Serologicals Corp., a publicly traded company that was sold to Milli…
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December 3, 2007
Novartis and MorphoSys AG have formed a comprehensive, 10-year, $600 million strategic alliance for the discovery and development of biopharmaceuticals. The deal is aimed at establishing a pipeline of innovative drugs, and establishes Novartis as Mor…
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December 3, 2007
Aptuit, Inc. has completed the acquisition of Evotec's Chemical and Pharmaceutical Development (CPD) business. The move allows Aptuit to integrate an API facility in Oxford, England and a recently expanded parenteral fill/finish facility in Glasgow,…
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November 30, 2007
AstraZeneca has completed enrollment of patients in the ZEST (Zactima Efficacy Study versus Tarceva) study, the first of four Phase III trials for the investigational once-daily oral anti-cancer drug vandetanib. Data from the study is expected in 200…
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