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U.S. Court awards Teva favorable decision for generic Celebrex

U.S. Court awards Teva favorable decision for generic Celebrex

Teva Pharmaceutical Industries Ltd. announced that the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day "first-to-file" exclusivity for generic Celebrex® (celecoxib) 100, 200 and 400 mg capsules. [More]
Actavis' subsidiary files lawsuit against FDA over Celebrex decision

Actavis' subsidiary files lawsuit against FDA over Celebrex decision

Actavis plc today announced that its subsidiary, Watson Laboratories, Inc., has filed suit against the U.S. Food and Drug Administration challenging the Agency's decision regarding its entitlement to shared 180-day marketing exclusivity for its generic version of Celebrex (celecoxib) 50 mg, 100 mg, 200 mg and 400 mg capsules. [More]
Mylan challenges FDA's decision regarding generic drug marketing exclusivity on Celecoxib Capsules

Mylan challenges FDA's decision regarding generic drug marketing exclusivity on Celecoxib Capsules

Mylan Inc. today announced that it has filed suit against the U.S. Food and Drug Administration, challenging the agency's decision regarding generic drug marketing exclusivity on Celecoxib Capsules, the generic version of Pfizer's Celebrex. [More]
Aspirin can lower colon cancer risk among people with high levels of specific gene

Aspirin can lower colon cancer risk among people with high levels of specific gene

The humble aspirin may have just added another beneficial effect beyond its ability to ameliorate headaches and reduce the risk of heart attacks: lowering colon cancer risk among people with high levels of a specific type of gene. [More]
Penn study clarifies action of potential new class of pain relievers that may benefit and not hurt heart

Penn study clarifies action of potential new class of pain relievers that may benefit and not hurt heart

Nonsteroidal antinflamatory drugs (NSAIDs) that block an enzyme called COX-2 relieve pain and inflammation but can cause heart attacks, stroke, heart failure, and even sudden cardiac death. [More]
Effective strategy for noninvasive detection of cancer

Effective strategy for noninvasive detection of cancer

Molecules that bind and illuminate proteins specific to tumor cells are key to detecting cancer as early as possible. The cyclooxygenase-2 enzyme is just such a protein, as the concentration of COX-2 is greater in cancer cells than in adjacent normal tissues. [More]
Scientists create polymer additives that enhance orally administered drugs to reach bloodstream

Scientists create polymer additives that enhance orally administered drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed - a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness. [More]
New polymer additives enhance ability of oral drugs to reach bloodstream

New polymer additives enhance ability of oral drugs to reach bloodstream

All too often, when a person takes a pill full of a potent and effective drug, the drug passes straight through the body, not reaching the organ where it is needed — a waste of money and inconvenient if it is a cold medicine, but potentially dire if it is a treatment for a serious illness. [More]
FDA takes action against websites that illegally sell dangerous medicines

FDA takes action against websites that illegally sell dangerous medicines

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, took action this week against more than 9,600 websites that illegally sell potentially dangerous, unapproved prescription medicines to consumers. [More]
Research findings could lead to new treatments for lung disorders in premature babies

Research findings could lead to new treatments for lung disorders in premature babies

Researchers at Yale School of Medicine have made major discoveries that could lead to new treatments for lung disorders in premature babies. In a mouse study, the team located key molecules that switch on stress pathways in preterm lung disorders, and also found that when parts of these pathways were blocked with a pain drug, lung damage was prevented or reversed. [More]
COX-2 inhibitor extends sunitinib activity in renal cell carcinoma

COX-2 inhibitor extends sunitinib activity in renal cell carcinoma

The effectiveness of sunitinib for the treatment of renal cell carcinoma could be enhanced with the addition of a cyclooxygenase-2 inhibitor, study findings show. [More]
High diclofenac use questioned

High diclofenac use questioned

Diclofenac remains one of the most widely recommended and regularly used non-steroidal anti-inflammatory drugs globally, despite its known association with increased cardiovascular risk, warn researchers who argue it should be removed from Essential Medicines Lists. [More]
Indian medicines ‘promising’ for osteoarthritis care

Indian medicines ‘promising’ for osteoarthritis care

Ayurvedic medicine may offer osteoarthritis relief, say Indian researchers who found traditional formulations to be equal to conventional drugs for the improvement of pain and knee function. [More]

Iroko’s submicron indomethacin Phase 3 study on post-surgical acute pain meets primary endpoint

Iroko Pharmaceuticals, LLC today announced that the Phase 3 study evaluating the company's investigational, lower dose submicron indomethacin in post-surgical acute pain met its primary endpoint of demonstrating significant pain relief compared with placebo. [More]
Duration of ibuprofen use may reduce risk of bladder cancer in northern New England patients

Duration of ibuprofen use may reduce risk of bladder cancer in northern New England patients

Dartmouth researchers have found that duration of ibuprofen use was associated with a reduced risk of bladder cancer in patients in northern New England, which has a high mortality rate of this disease. In a 2012 collaborative project with the National Cancer Institute, Margaret Karagas, PhD, co-director, Cancer Epidemiology & Chemoprevention program at Norris Cotton Cancer Center, and Professor of Community and Family Medicine at the Geisel School of Medicine at Dartmouth, and Richard Waddell, D.Sc, Research Assistant Professor of Medicine at the Geisel School of Medicine, looked for connections between ibuprofen use and bladder cancer. [More]
Results from Biodesix VeriStrat phase II advanced lung cancer trials

Results from Biodesix VeriStrat phase II advanced lung cancer trials

Biodesix today announced that VeriStrat results from two phase II advanced lung cancer trials will be presented at the upcoming 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology. [More]
New Gateway-funded phase II ADAPT study for metastatic colorectal cancer

New Gateway-funded phase II ADAPT study for metastatic colorectal cancer

The Gateway for Cancer Research announces an exciting new Gateway-funded phase II study using ADAPT therapy for treatment of metastatic colorectal cancer based on a 2010 AACR presentation by Dr. Lin and his collaborators. [More]
Iroko announces results from diclofenac Phase 3 study on post-surgical pain

Iroko announces results from diclofenac Phase 3 study on post-surgical pain

Iroko Pharmaceuticals, LLC today announced Phase 3 study results that showed patients treated with the company's novel, submicron particle, lower-dose diclofenac (18mg and 35mg), a non-steroidal anti-inflammatory drug (NSAID), experienced significant pain relief post surgery compared with placebo>0.01 and P<0.001 respectively). [More]
Lead 8A analog can treat osteosarcoma in children

Lead 8A analog can treat osteosarcoma in children

Jiayuh Lin, PhD, and colleagues at Nationwide Children's Hospital have developed a drug to target the most common cancerous bone tumor in children, osteosarcoma, using a version of the FDA-approved drug, Celebrex. The team will soon begin testing the drug using human and canine tumor cell lines thanks to a two-year, $200,000 grant from Alex's Lemonade Stand Foundation for Childhood Cancer. [More]
Positive results from CrystalGenomics’ CG100649 Phase 2b OA study

Positive results from CrystalGenomics’ CG100649 Phase 2b OA study

CrystalGenomics, Inc., a biopharmaceutical company headquartered in Korea, has just announced positive results from the Phase 2b osteoarthritis (OA) study of the CG100649, CrystalGenomics' next-generation NSAID candidate. [More]