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Indigestion, known as ''upset stomach'' or ''dyspepsia'', meaning hard or difficult digestion, is a medical condition characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating. It can be accompanied by bloating, belching, nausea, or heartburn.

Prevalence of celiac disease on the rise among children with irritable bowel syndrome

There appears to be an increased prevalence of celiac disease among children with irritable bowel syndrome (IBS). [More]
Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Pradaxa receives FDA approval for treatment and reduction of risk of recurrence of DVT and PE

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Pradaxa® (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. DVT and PE are collectively referred to as venous thromboembolism (VTE). [More]
Antares Pharma announces launch of OTREXUP to Dermatologists

Antares Pharma announces launch of OTREXUP to Dermatologists

Antares Pharma, Inc. today announced LEO Pharma's launch of OTREXUP to Dermatologists, the first U.S. Food and Drug Administration approved subcutaneous (SC) methotrexate (MTX) product for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. [More]

Merck reports results from Phase 2b study of investigational house dust mite sublingual immunotherapy tablet

Merck, known as MSD outside the United States and Canada, today announced results from a Phase 2b study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237). The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego. [More]
FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

FDA approves Iroko Pharmaceuticals’ TIVORBEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved TIVORBEX™ (indomethacin) capsules, a nonsteroidal anti-inflammatory drug (NSAID), at 20 mg and 40 mg doses for the treatment of mild to moderate acute pain in adults. [More]
Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt announces commercial launch of PENNSAID

Mallinckrodt today announced the commercial launch of PENNSAID (diclofenac sodium topical solution) 2% w/w (PENNSAID 2%). PENNSAID 2% is a topical non-steroidal anti-inflammatory drug (NSAID) approved for use in the treatment of the pain of osteoarthritis of the knees. [More]
Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Erosive GERD treatments: an interview with Professor Joaquim Moraes-Filho, University of São Paulo Medical School

Gastroesophageal Reflux Disease (GERD) is a condition that develops when the reflux of stomach contents causes troublesome symptoms and/or complications. [More]

FDA approves New Drug Application for PENNSA 2%

Mallinckrodt today announced that the U.S. Food and Drug Administration has approved the New Drug Application for PENNSAID (diclofenac sodium topical solution) 2% w/w. PENNSAID 2% is a topical non-steroidal anti-inflammatory drug approved for use in the treatment of the pain of osteoarthritis of the knee(s). [More]

FDA accepts Iroko Pharmaceuticals' ZORVOLEX sNDA for review

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced that the U.S. Food and Drug Administration has accepted for review the Supplemental New Drug Application for ZORVOLEX (diclofenac), a lower dose nonsteroidal anti-inflammatory drug, for the proposed indication of treatment of osteoarthritis pain in adults. ZORVOLEX was approved by FDA in October 2013 for the treatment of mild to moderate acute pain in adults. [More]
Genotyping strategy could boost celiac screening efficacy

Genotyping strategy could boost celiac screening efficacy

Genotyping for human leukocyte antigen followed by biopsy is a sensitive strategy for detecting histopathologic lesions in the close relatives of people with celiac disease, research indicates. [More]
BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

BioLineRx enrolls first patient in BL-7010 Phase 1/2 trial for treatment of celiac disease

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today enrollment of the first patient in a Phase 1/2 trial of BL-7010, for the treatment of celiac disease. The first patient was enrolled at Tampere Hospital in Finland, a world-leading site for celiac disease research. Results are expected in mid-2014. [More]

BioLineRx obtains regulatory approval to initiate BL-7010 Phase 1/2 trial for celiac disease

BioLineRx, a biopharmaceutical development company, announced today that it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. [More]

FDA approves Cubist Pharmaceuticals' sNDA for ENTEREG

Cubist Pharmaceuticals, Inc. today announced the approval of its supplemental new drug application (sNDA) by the U.S. Food and Drug Administration for ENTEREG (alvimopan). [More]

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, today announced that the U.S. Food and Drug Administration (FDA) has approved ZORVOLEX™ (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the treatment of mild to moderate acute pain in adults. ZORVOLEX was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. [More]
FDA approves OTREXUP injection for adults with RA, children with active pJIA

FDA approves OTREXUP injection for adults with RA, children with active pJIA

Antares Pharma, Inc. today announced the approval of OTREXUP (methotrexate) injection by the U.S. Food and Drug Administration. OTREXUP is the first FDA approved subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector. [More]

Adempas drug gets FDA approval for treatment of pulmonary hypertension

The U.S. Food and Drug Administration today approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension. Pulmonary hypertension is caused by abnormally high blood pressure in the arteries of the lungs. [More]

Bayer HealthCare receives FDA approval for Adempas tablets

Bayer HealthCare announced today that the United States Food and Drug Administration has approved Adempas (riociguat) tablets for: (i) the treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; and (ii) the treatment of adults with pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening. [More]

BioLineRx announces regulatory submissions to commence Phase 1/2 trial for treatment of celiac disease

BioLineRx, a biopharmaceutical development company, announced today that it has filed the necessary regulatory submissions to commence a Phase 1/2 trial for BL-7010 - for the treatment of celiac disease - with the Finnish National Supervisory Authority for Welfare and Health (Valvira). The relevant ethics committee has already approved commencement of the study. [More]
Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo: FDA accepts to review New Drug Application for PENNSAID 2%

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products for the topical treatment of pain and the development of its immune modulating drug candidate WF10 today announced that its U.S. licensee for PENNSAID (diclofenac sodium topical solution) 1.5% w/w and PENNSAID 2% (diclofenac sodium topical solution) 2% w/w, Mallinckrodt has advised that the U.S. Food and Drug Administration has accepted for filing and review the New Drug Application for PENNSAID 2% submitted by Mallinckrodt on August 7, 2013. [More]

Boehringer signs agreement with Brigham to conduct long-term study program on oral anticoagulants

Boehringer Ingelheim, a research-based, global pharmaceutical company, today announced a multi-year agreement with Brigham and Women's Hospital, an internationally recognized teaching affiliate of Harvard Medical School known for its excellence in patient care, medical research and training of outstanding young health professionals. [More]