Trials & Filings
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May 24, 2007
Novartis and Nordic Biosciences have begun a Phase III clinical program of oral salmon calcitonin (SMC021) for the treatment of osteoarthritis, a chronic, irreversible and degenerative condition. SMC021 is a new drug candidate with potential to be th…
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May 24, 2007
Exelixis has submitted an IND application to the FDA for XL019. In preclinical studies, the compound has shown to be a potent, selective and orally available small molecule inhibitor of the cytoplasmic tyrosine kinase JAK2, according to the company.…
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May 18, 2007
AstraZeneca received approval from the FDA for Seroquel XR Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients. The Seroquel XR development program was based on the need for a wider choice of medicines…
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May 17, 2007
Millennium Pharmaceuticals has initiated patient dosing in a clinical program designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MLN0002 derived from a newly engineered, commercially scaleable cell line. MLN0002 i…
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May 4, 2007
Array BioPharma, Inc. has initiated dosing in a Phase I trial with ARRY-520, a targeted small molecule anticancer drug. ARRY-520 is a potent Kinesin Spindle Protein (KSP) inhibitor that caused marked tumor regression in preclinical models of human ca…
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May 2, 2007
CuraGen Corp. and TopoTarget initiated a Phase I/II open-label, multi-center trial evaluating the efficacy and safety of intravenous belinostat (PXD101), an HDAC inhibitor, in combination with doxorubicin for the treatment of Soft Tissue Sarcomas (ST…
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April 30, 2007
The FDA voted not to approve Merck's NDA for Arcoxia for the symptomatic treatment of osteoarthritis (OA). Arcoxia has been under review by the FDA as an investigational selective COX-2 inhibitor since December 2003 for a 60 mg once-daily dose along…
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April 23, 2007
Abbott submitted a NDA to the FDA for a fixed-dose combination of Niaspan (extended-release niacin) and simvastatin (the generic version of Zocor). The combination targets multiple lipid parameters in a single pill.
Niaspan and simvastatin are t…
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April 18, 2007
Avanir Pharmaceuticals achieved positive results from its Phase III trial evaluating Zenvia, an NMDA antagonist and sigma-1 agonist, in diabetic neuropathic pain.
The primary endpoint of the trial was based on the daily diary entries for the Pai…
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April 18, 2007
The FDA has licensed Sanofi Pasteur's H5N1 vaccine, the first avian flu vaccine for humans. Sanofi Pasteur, in collaboration with the National Institutes of Health, submitted a BLA to the FDA for the vaccine. The licensure is the first step in achiev…
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April 17, 2007
Merck has submitted a sBLA for Gardasil to the FDA to update the labeling to include efficacy data showing protection against additional cervical cancer causing HPV types responsible for more than 10% of cervical cancers, vaginal and vulvar, and data…
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April 13, 2007
The FDA Arthritis Advisory Committee voted 20-to-1 against recommending approval of Merck's Arcoxia for the symptomatic treatment of osteoarthritis. The drug has been under review by the FDA as an investigational selective COX-2 inhibitor since the N…
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April 9, 2007
Cangene Corp. received approval from the FDA for HepaGam B for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive patients. HepaGam B is Cangene's Hepatitis B Immune Globulin Intra…
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April 4, 2007
Genzyme Corp. and Bayer HealthCare have submitted a sBLA to the FDA to expand the current product label for Campath to include first-line treatment of B-cell chronic lymphocytic leukemia (B-CLL). Campath is currently approved for the treatment of B-C…
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March 30, 2007
GlaxoSmithKline has submitted a BLA to the FDA for Cervarix (human papillomavirus vaccine, AS04 adjuvant-adsorbed), its cervical cancer vaccine. If licensed, the vaccine will be indicated for the prevention of cervical cancer and precancerous lesions…
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