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Abbott Seeks FDA Approval For Lupron Depot 45-mg Six Month Formulation

Abott has reported that the FDA has accepted review of the supplemental new drug application (sNDA) of a new six-month 45-mg formulation of Lupron Depot (leuprolide acetate for depot suspension) for use in the palliative treatment of advanced prostate cancer.

Published: 12-Mar-2010

FDA Gives Nod To Five-Day Dosing Regimen Of Dacogen To Treat MDS Patients

Eisai, a US-based pharma company, has received approval from US FDA for a five-day dosing regimen for Dacogen (decitabine) for Injection to treat patients with myelodysplastic syndromes (MDS), a group of bone marrow diseases that alter the production of functional blood cells.

Published: 11-Mar-2010

NeoPharm Files ODA For IL13-PE38QQR

NeoPharm has filed an orphan drug application (ODA) with the Office of Orphan Products Development of the FDA to have orphan drug designation granted to IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

Published: 11-Mar-2010

IntelGenx Receives Bupropion Patent

IntelGenx Corp (IntelGenx) has reported that the US Patent and Trademark Office (USPTO) issued patent number 7,674,479 for a key patent application protecting its CPI-300, a high strength formulation of bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL.

Published: 11-Mar-2010

Cytokinetics Gets ODA Status For Skeletal Muscle Troponin Activator

Cytokinetics, a clinical-stage biopharma company focused on the discovery and development of small molecule therapeutics, has said its fast skeletal muscle troponin activator CK-2017357 has been granted orphan-drug designation by the US FDA for the potential treatment of amyotrophic lateral sclerosis (ALS), which is also known as lou gehrig's disease.

Published: 10-Mar-2010

FDA Approves Allegan's Botox

FDA has approved Allergan's Botox (onabotulinumtoxinA) for the treatment of increased muscle stiffness in the elbow, wrist and fingers in adults with upper limb spasticity.

Published: 10-Mar-2010

FDA Grants Orphan Drug Designation To ImmunoGen IMGN901 Compound

ImmunoGen, a biotechnology company that develops targeted anticancer products using its antibody expertise and targeted antibody payload (TAP) technology, said that the US FDA (FDA) has granted orphan drug designation to its IMGN901 compound when used for the treatment of Merkel cell carcinoma (MCC).

Published: 09-Mar-2010

AstraZeneca Sues Sun Pharma For Patent Infringement

AstraZeneca has filed a patent infringement complaint against India-based Sun Pharma for planning to market a generic formulation of its intravenous acid reflux disease treatment Nexium IV.

Published: 09-Mar-2010

Precision BioSciences Gets Second ACP For Cellectis Core Technology

Precision BioSciences (Precision) has said that the US PTO has issued non-final actions closing prosecution in the reexamination proceedings for US Pat. Nos. 6,833,252 (the ‘252 patent) and 7,214,536 (the ‘536 patent) that are owned by the Institut Pasteur and the Universite Pierre et Marie Cure (UPMC), and licensed to Cellectis (ALCLS).

Published: 08-Mar-2010

Rexahn Pharma Receives Japanese Patent For Archexin

Rexahn Pharmaceuticals (Rexahn), a clinical stage pharmaceutical company commercialising potential oncology and CNS therapeutics, has received patent from the Japanese Patent Office for its novel anti-cancer compound Archexin.

Published: 08-Mar-2010

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