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July 14, 2006
CuraGen Corp. and TopoTarget A/S have started a Phase I/II clinical trial evaluating the safety and potential efficacy of PXD101, a small molecule histone deacetylase (HDAC) inhibitor, for the treatment of inoperable hepatocellular (liver) cancer. Th…
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July 13, 2006
Bristol-Myers Squibb and Gilead Sciences received approval from the FDA for Atripla for the treatment of HIV-1 infection in adults. Atripla is the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combi…
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July 11, 2006
Merck received approval from the FDA for Emend for the prevention of postoperative nausea and vomiting (PONV), one of the most common side effects associated with surgical procedures. The recommended dose of Emend for PONV is a single, oral 40 mg dos…
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July 11, 2006
GlaxoSmithKline received approval from the FDA for Avandamet for use as initial treatment of type 2 diabetes, as an adjunct to diet and exercise. Avandamet was previously approved as a second-line therapy for use in patients who were uncontrolled on…
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July 10, 2006
Serono received approval from the European Commission for an update of the Summary of Product Characteristics (SmPC) of Rebif, in order to align it with current medical practice. In the EU, Rebif can now be prescribed after the diagnosis of multiple…
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July 5, 2006
Genentech has received FDA approval of Lucentis for the treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved Lucentis after a six-month Priority Review and will ship the product immediately.
The Phase III trial…
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June 30, 2006
Par Pharmaceutical Co.'s wholly-owned subsidiary, Kali Laboratories, Inc., received final approval from the FDA for its aNDA for tranylcypromine sulfate tablets, 10 mg. Tranylcypromine is the generic version of GlaxoSmithKline's Parnate and is used…
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June 29, 2006
Bristol-Myers Squibb was granted accelerated approval by the FDA for Sprycel, an oral inhibitor of multiple tyrosine kinases for the treatment of adults in all phases of chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy,…
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June 27, 2006
Wyeth submitted two NDAs to the FDA, one for bazedoxifene, a Selective Estrogen Receptor Modulator (SERM) investigated for the prevention of postmenopausal osteoporosis, and one for desvenlafaxine succinate, a non-hormonal agent studied for the treat…
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June 22, 2006
MGI Pharma received approval from the FDA for Dacogen for the treatment of adult patients with myelodysplastic syndromes (MDS). This new drug to combat MDS is the first high potency new chemical entity (NCE) which was developed and produced by fee-fo…
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June 22, 2006
La Jolla Pharmaceutical's Marketing Authorization Application (MAA) has been accepted for review by the EMEA for potential approval to market Riquent, its drug candidate for lupus renal disease, in the EU.
If approved, Riquent will receive marke…
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June 21, 2006
Genentech has received FDA approval for Avastin in combination with intravenous 5-fluorouracil (5-FU)-based chemotherapy for second-line metastatic colorectal cancer. Avastin is also approved as a first-line treatment of metastatic colorectal cancer…
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June 15, 2006
GlaxoSmithKline received approval from the FDA for Hycamtin in combination with cisplatin for the treatment of stage IV-B, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation the…
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June 13, 2006
Amgen's BLA for panitumumab, an investigational fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), has been granted Priority Review by the FDA. The BLA was submitted for the treatment of metastatic colorectal ca…
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June 12, 2006
GlaxoSmithKline has enrolled the first patient in a Phase IIb clinical program with Theravance's compound 642444 ('444), an investigational long-acting beta2 agonist (LABA), in patients with mild to moderate asthma. The collaboration now has two comp…
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