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September 10, 2008
Charles River Laboratories has completed the acquisition of privately held NewLab BioQuality AG, a Dusseldorf, Germany-based provider of safety and quality control services to biopharmaceutical clients. NewLab joins Charles River Biopharmaceutical Se…
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September 9, 2008
Pfizer will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. NDA and the European MAA.
Following feedback from regulatory…
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September 9, 2008
Bilcare Global Clinical Supplies has enhanced its global Phase III capabilities. The company has upgraded its Kalish large-scale bottling line at its U.S. facility and invested in new Pentapack blistering technology for expanded packaging capabilitie…
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September 9, 2008
West has completed expansion work at its Kinston, NC manufacturing facility. The expanded plant provides additional compounding and custom manufacturing capabilities and will bring more than 150 new jobs to Kinston and surrounding communities. The fa…
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September 9, 2008
Thierry Amat has been appointed chief financial officer of Aptuit, Inc. Mr. Amat will oversee the financial and information technology departments. He has more than 20 years of financial management experience in publicly traded companies as well as k…
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September 8, 2008
The FDA has granted supplemental NDA approval for Akorn, Inc.'s IC-Green for Injection, USP. This approval is Akorn’s first lyophilized product approval for manufacture in its Decatur, IL production facility.
The company h…
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September 8, 2008
Bosch's Packaging Technology Division plans to acquire Paal Verpackungsmaschinen GmbH & Co. KG, based in Remshalden near Stuttgart. The purchase price was not disclosed.
Paal is a packaging and automation specialist t…
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September 8, 2008
The FDA has accepted data submitted from Bridge Laboratories' Beijing facility on behalf of a U.S. biotech client. The GLP nonhuman primate toxicology study data was generated and submitted as part of an IND package to the FDA. Bridge’s Beijing…
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September 5, 2008
Cirrus Pharmaceuticals, Inc. has expanded its current capacity for stability storage with the addition of 3 LUWA walk-in stability chambers. The company will add three large capacity, cGMP compliant chambers, each with 1,100 cubic feet of storage spa…
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September 5, 2008
WellSpring Pharmaceutical Corp. has expanded its consumer health care product line with the acquisition of several OTC products from McNeil Consumer Healthcare Division. In an all-cash transaction, WellSpring has purchased U.S. rights to Micatin (ant…
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September 5, 2008
Patheon
3Q Revenues: $195.0 million (+18%)
3Q Loss: $14.7 million (loss of $63.1 million in 3Q07)
YTD Revenues: $545.1 million (+15%)
YTD Loss: $38.3 million (loss of $87.1 million YTD07)
Comments: Commercial Manufacturing revenues w…
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September 5, 2008
Metrics, Inc. is now offering microbiology-testing services to the pharmaceutical industry following its recent $18-million, 47,000-sq.-ft. expansion, which doubled the size of its facility and expanded its service capabilities.
…
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September 4, 2008
Merck Serono has entered into an agreement with Ablynx to discover and develop Nanobodies against two targets in oncology and immunology. The agreement includes an upfront cash payment to Ablynx of $14.5 million.
Nanobodie…
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September 4, 2008
SAFC Pharma, a member of the Sigma-Aldrich Group, plans a $30 million expansion to its Madison, WI facility to increase its capacity to produce commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs). The investment includes the purc…
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September 4, 2008
Steven R. Hagen, Ph.D. has been promoted to vice president of pharmaceutical development and manufacturing, AMRI. He will report to chairman, president and chief executive officer, Thomas E. D’Ambra, Ph.D. Luckner G. Ulysse, Jr., Ph.D. has been…
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