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January 25, 2010
Acorda Therapeutics, Inc. received approval from the FDA for Ampyra (dalfampridine) to improve walking in patients with multiple sclerosis (MS).
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January 25, 2010
Sinobiopharma’s production facility for solid dosage Perindopril has passed Chinese State Food and Drug Administration (SFDA) inspection and is now approved for production and marketing.
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January 22, 2010
Johnson & Johnson has withdrawn an EMEA filing for Comfyde (carisbamate), its investigational drug being developed for the adjunctive treatment of partial onset seizures with or without secondary generalization in patients aged 16 or older.
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January 22, 2010
Genzyme’s BLA for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale, has received a June 17, 2010 PDUFA date from the FDA.
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January 22, 2010
Ray Russo has been appointed vice president, Primary Care Business Unit, at Shionogi Pharma, Inc.
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January 21, 2010
Patheon began construction of a new pharmaceutical development center at its existing manufacturing facility in Bourgoin-Jallieu, France.
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January 21, 2010
Merck’s HIV treatment vicriviroc did not meet the primary efficacy endpoint in two Phase III studies involving patients previously treated with other HIV medicines.
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January 21, 2010
AlphaRx Inc.’s licensee, Gaia BioPharma Ltd., has signed an agreement with a CMO to manufacture GAI-122 for use in Phase I and II trials.
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January 21, 2010
NextPharma Technologies’ expansion of its Cold Chain and Logistics (CLS) business in Austria has received full regulatory approval and has been granted a Distributors-Manufacturers License by the Austrian Federal Office for Safety in Healthcare.
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January 21, 2010
Transposagen Biopharmaceuticals, a provider of genetically modified laboratory rats, has entered into a global marketing and distribution agreement with Taconic, an animal model and service provider, in which Taconic will market and distribute Transposage
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January 20, 2010
Wacker Chemie and MorphoSys have expanded their existing collaboration for the use of Wacker’s Esetec bacterial secretion technology.
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January 20, 2010
Ricerca Biosciences has validated and implemented Watson Laboratory Information Management System (LIMS) for its bioanalysis division.
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January 20, 2010
Paula Brown Stafford, executive vice president, Integrated Clinical Services at Quintiles, has been appointed chair-elect of the board of directors of the Clinical Data Interchange Standards Consortium (CDISC), a global organization dedicated to the devel
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January 19, 2010
AMRI has received certification of its high potency research labs and GMP-manufacturing facilities in Rensselaer, NY for the safe handling of potent APIs by SafeBridge Consultants, Inc.
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January 19, 2010
Maxygen, Inc.’s majority-owned subsidiary, Perseid Therapeutics LLC, has achieved a preclinical milestone under its collaboration with Astellas Pharma, triggering a $5 million payment to Perseid.
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