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February 25, 2010
Genentech’s Phase III study of Avastin (bevacizumab) plus chemotherapy, followed by maintenance use of Avastin alone, increased progression-free survival (PFS) in women with previously untreated advanced ovarian cancer, compared to chemotherapy alon
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February 24, 2010
Ocera Therapeutics has completed enrollment for its Phase IIb ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy).
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February 22, 2010
Novartis received approval from the FDA for Menveo, a quadrivalent meningococcal conjugate vaccine to prevent invasive meningococcal disease.
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February 19, 2010
Genentech and Biogen Idec received FDA approval of Rituxan in combination with fludarabine and cyclophosphamide (FC) for people with previously treated/untreated CD20-positive chronic lymphocytic leukemia (CLL).
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February 18, 2010
GlaxoSmithKline and XenoPort, Inc. received a Complete Response letter from the FDA regarding the NDA for Horizant (gabapentin enacarbil) Extended-Release Tablets for the treatment of Restless Legs Syndrome (RLS).
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February 12, 2010
Abbott received approval from the FDA for a new tablet formulation of antiretroviral drug Norvir (ritonavir).
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February 12, 2010
3SBio Inc. has submitted its application for a Phase I trial for NuPIAO to the Chinese State Food and Drug Administration (SFDA).
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February 11, 2010
Daiichi Sankyo, Inc. received approval from the FDA for its hypertension treatment Benicar (olmesartan medoxomil) for use in children and adolescents 6 to 16 years of age.
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February 11, 2010
Shire achieved positive results from its first Phase III study (TKT032) evaluating the safety and efficacy of velaglucerase alfa, an investigational enzyme replacement therapy for the treatment of Type 1 Gaucher disease.
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February 8, 2010
Talecris Biotherapeutics’ aerosol formulation of Alpha1-Proteinase Inhibitor (Human, A1PI) to treat congenital alpha1-antitrypsin (AAT) deficiency, was granted orphan drug designation by the FDA.
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February 3, 2010
Auxilium Pharmaceuticals has received marketing approval from the FDA for Xiaflex (collagenase clostridium histolyticum), a first in class, orphan-designated, biologic for the treatment of adult Dupuytren's contracture patients with a palpable cord.
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February 1, 2010
GlaxoSmithKline received accelerated approval from the FDA for a new combination regimen using Tykerb (lapatinib) as a first-line, oral treatment for women with metastatic breast cancer.
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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 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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