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Last Updated Thursday, June 20 2013
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March 30, 2010
Roche’s Xeloda (capecitabine) in combination with oxaliplatin (a combination known as XELOX) has been approved by the EMEA for the adjuvant treatment of patients with early colon cancer.   Read More »
March 30, 2010
GlaxoSmithKline has re-submitted its sNDA for Avodart (dutasteride) to the FDA for prostate cancer risk reduction in men at increased risk of developing the disease.   Read More »
March 25, 2010
Dainippon Sumitomo Pharma America, Inc.’s NDA for lurasidone for the treatment of acute schizophrenia has been accepted for review by the FDA.   Read More »
March 23, 2010
Merck Serono has temporarily suspended the worldwide clinical development program for Stimuvax (BLP25 liposomal vaccine) due to an unexpected serious adverse reaction in a patient with multiple myeloma.   Read More »
March 17, 2010
New indication for RA biologic   Read More »
March 16, 2010
Savient Pharmaceuticals has resubmitted its BLA for Krystexxa after a CRL in July 2009   Read More »
March 15, 2010
Amylin Pharmaceuticals, Lilly and Alkermes received a complete response letter from the FDA for their NDA for Bydureon (exenatide extended-release injectable suspension).   Read More »
March 15, 2010
Portola Pharmaceuticals and Merck achieved positive results from EXPLORE-Xa, a Phase II dose finding study of investigational oral direct Factor Xa inhibitor betrixaban.   Read More »
March 12, 2010
Pfizer has discontinued the Phase III trial A4021018 (ADVIGO 1018), which examined the investigational compound figitumumab (CP-751,871) in combination with erlotinib as a second/third-line treatment in patients with previously treated advanced non-adenoc   Read More »
March 12, 2010
Baxter and DynPort Vaccine Co. (DVC), achieved positive results from a Phase III study measuring the clinical efficacy for Preflucel, a trivalent seasonal flu vaccine.   Read More »
March 11, 2010
Bayer HealthCare Pharmaceuticals was granted an orphan drug designation by the FDA for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients.   Read More »
March 11, 2010
The FDA has accepted for review Dainippon Sumitomo Pharma America’s lurasidone NDA for the treatment of acute schizophrenia.   Read More »
March 5, 2010
Pfizer and Bristol-Myers Squibb's oral anticoagulant apixaban achieved positive results in the late-stage Advance-2 study.   Read More »
March 3, 2010
Dimebon fails in CONNECTION trial   Read More »
February 25, 2010
Pfizer received approval from the FDA for Prevnar 13, a 13-valent pneumococcal conjugate vaccine.   Read More »
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