Dyspepsia News and Research

RSS

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.

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).

17 Jan 2014

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.

15 Jan 2014

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.

24 Dec 2013

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.

18 Dec 2013

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.

4 Nov 2013

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).

21 Oct 2013

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.

19 Oct 2013

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.

14 Oct 2013

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.

10 Oct 2013

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.

9 Oct 2013

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.

24 Sep 2013

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.

22 Aug 2013

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.

17 Aug 2013

European authorisation of Aegerion Pharmaceuticals' Lojuxta brings hope for HoFH patients

Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialisation of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, announced today that the European Commission has authorised Lojuxta (lomitapide) hard capsules as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein apheresis in adult patients with homozygous familial hypercholesterolaemia.

3 Aug 2013

Research highlights benefits of vitamin D, diet changes in patients with Crohn's disease

Research presented at Digestive Disease Week explores new methods for managing digestive health through diet and lifestyle.

20 May 2013

Schizophrenia cardiovascular risk under-recognized in primary care

UK researchers have found that despite being a major contributor to premature deaths among patients with schizophrenia, cardiovascular disease is less likely to be recorded on their primary care records than those of people without schizophrenia.

30 Apr 2013

Schizophrenia cardiovascular risk under-recognized in primary care

25 Apr 2013

Abstracts on Bristol-Myers Squibb's research in liver disease accepted for presentation

Bristol-Myers Squibb Company announced today that 14 abstracts on the Company's research in liver disease have been accepted for presentation at The International Liver CongressTM 2013, the 48th annual meeting of the European Association for the Study of the Liver, in Amsterdam, April 24 - 28.

8 Apr 2013

POZEN announces submission of NDA for marketing approval of PA32540/PA8140

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced the submission of a New Drug Application to the U.S. Food and Drug Administration for the marketing approval of PA32540/PA8140.

27 Mar 2013

Dabigatran decreases risk of recurrent venous thromboembolism

New findings from two double-blind, randomized trials, RE-MEDY and RE-SONATE, show that dabigatran 150 mg twice daily reduces the risk of recurrent venous thromboembolism (VTE).

21 Feb 2013