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June 15, 2011
Dr. Reddy’s chemical manufacturing facility in Cuernavaca, Mexico has received a four-item Warning Letter from the FDA.   Read More »
June 15, 2011
Bayer HealthCare Pharmaceuticals has submitted an IND application for the TAP compound, BAY 94-9343, triggering a $2 million milestone payment to ImmunoGen.  Read More »
June 15, 2011
Covance is launching Xcellerate, a new methodology designed to help optimize clinical trial performance in order to improve quality, reduce waste and decrease trial timelines.   Read More »
June 15, 2011
Abbott received approval from the FDA for an infant-specific dose of Creon (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).   Read More »
Gil Roth
June 14, 2011
Second site added to WHO lab list  Read More »
June 14, 2011
Array BioPharma will restructure in an effort to extend its financial resources to focus on the development of key clinical programs: ARRY-520, a KSP inhibitor for multiple myeloma, ARRY-614, a p38 / Tie-2 inhibitor for myelodysplastic syndrome, and MEK162, a MEK inhibitor for cancer in co-development with Novartis.  Read More »
June 14, 2011
Arecor and GlaxoSmithKline have entered into a license agreement to develop advanced formulations of vaccines combining Arecor’s formulation technologies with GSK’s proprietary vaccines.   Read More »
June 14, 2011
Roquette has completed its new injectable carbohydrate plant at its Lestrem facility.   Read More »
June 14, 2011
IntraLinks has provided the results of its Global Investigator Site Survey, examining what methods are currently used for clinical trial document exchange and the effectiveness of those methods.  Read More »
June 14, 2011
Sartorius Stedim Biotech (SSB) and Südpack Medica AG have signed an exclusive 10-year agreement for the development, manufacture and supply of polymer plastic films for the biopharmaceutical market.   Read More »
June 13, 2011
Kareus Therapeutics SA has entered a broad strategic alliance with Quintiles to progress the development of two of Kareus’ preclinical programs through clinical trials.   Read More »
June 13, 2011
Merck and Hanwha Chemical Corp. have entered into an exclusive global agreement to develop and commercialize HD203, Hanwha’s biosimilar form of Enbrel. Hanwha, through its Bio Business Unit, and Merck, through a subsidiary, will work to develop and commercialize HD203.   Read More »
June 13, 2011
Valeant Pharmaceuticals International and GlaxoSmithKline have received FDA approval for Potiga (ezogabine) Tablets, a potassium channel opener, as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.  Read More »
June 13, 2011
Dr. David Roblin has been appointed to Xceleron’s board of directors in a non-executive capacity and Dr. Stuart Best has been named senior director of operations.  Read More »
June 10, 2011
Revenues from commercial manufacturing operations were $138.5 million (-3%) in the quarter.   Read More »



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