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January 9, 2009
GlaxoSmithKline and development partner XenoPort have resubmitted the NDA to the FDA requesting approval of Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).
The FDA requested that…
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January 5, 2009
DOR BioPharma, Inc. has reached agreement with the FDA on the design of a confirmatory Phase III trial for its lead product orBec for the treatment of acute gastrointestinal Graft-versus-Host Disease (GI GVHD). The agreement was made under the FDA's…
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December 30, 2008
King Pharmaceuticals has initiated the Phase II trial evaluating the efficacy and safety of T-62, an investigational drug for the treatment of neuropathic pain.
Dr. Eric Carter, chief science officer of King, remarked, “T-62, a new chemical…
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December 30, 2008
The FDA has accepted Savient Pharmaceuticals' BLA for pegloticase, a novel biological drug for treatment-failure gout (TFG) patients. The FDA also granted Savient's BLA a priority review status which accelerates the review period to six months. This…
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December 22, 2008
Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking approval for treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and pr…
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December 16, 2008
The FDA has approved Abbott's Trilipix delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approv…
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December 15, 2008
The FDA has granted Schering-Plough marketing approval for PEGintron and Rebetol combination therapy for use in previously untreated patients three years of age and older with chronic hepatitis C. This represents the first and only approved peginterf…
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December 9, 2008
Merck Serono, a division of Merck KGaA, has received marketing authorization from the European Commission for Kuvan for the treatment of hyperphenylalaninemia (HPA) in phenylketonuria (PKU) or BH4 deficient patients. Kuvan, which had previously recei…
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December 4, 2008
MedImmune has initiated a Phase II clinical trial in patients with chronic asthma to determine the safety of subcutaneous dosing of MEDI-563 a humanized monoclonal antibody (MAb) that targets the interleukin-5 receptor (IL-5R). Preclinical data sugge…
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December 1, 2008
Lilly has withdrawn its sNDA from FDA for Cymbalta for the management of chronic pain. Lilly plans to resubmit the application in 1H09, adding recent positive data from a study in chronic osteoarthritis pain of the knee.
Lilly s…
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November 26, 2008
The FDA has granted Pfizer's Selzentry (maraviroc) full approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. Selzentry was originally granted accelerated conditional approval in August 200…
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November 21, 2008
GlaxoSmithKline received approval from the FDA for Promacta (eltrombopag) for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immu…
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November 17, 2008
The FDA plans an Accelerated Approval for Genzyme's Myozyme drug, produced at the 2000 L bioreactor scale for the treatment of Late Onset Pompe disease. According to a Genzyme statement, the two parties need to agree on the design of a post-approval…
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November 10, 2008
GlaxoSmithKline and XenoPort, Inc. withdrew the NDA for Solzira Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has requested that the data in a single study be reformatted. GSK will cond…
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November 6, 2008
Pfizer is discontinuing the Phase III development program for its investigational compound (CP-945,598) for weight management. CP-945,598 is a selective antagonist of the cannabinoid type 1 (CB1) receptor. The company has decided to discontinue the d…
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