Dyspepsia News and Research

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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.

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

Positive data from POZEN's PA32540 Phase 3 studies presented at AHA 2013 stroke conference

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, presented data today from the combined results of two Phase 3 studies of PA32540, an antiplatelet therapy of enteric-coated (EC) and immediate-release omeprazole, in patients with previous cerebrovascular disease.

10 Feb 2013

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that it has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting approval for the use of ENTEREG® (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease.

21 Dec 2012

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. prescribing information for Pradaxa (dabigatran etexilate mesylate) capsules was updated to include a contraindication related to use in patients with mechanical prosthetic heart valve replacement.

21 Dec 2012

Selective targeting of neurotransmitters may allow for new medication therapies for GI conditions

Selective targeting of the neurotransmitter that differentially affects brain cells that control the two distinct functions of the pancreas may allow for new medication therapies for conditions like diabetes, dyspepsia and gastro-esophageal reflux, according to Penn State College of Medicine researchers.

5 Dec 2012

Novartis to highlight key data from extensive oncology portfolio at SABCS and ASH meeting

Novartis will highlight more than 140 presentations on key data from its extensive oncology portfolio at the leading year-end scientific meetings devoted to hematology and breast cancer, demonstrating continued innovation in research and development efforts to advance the care of patients with cancer and rare diseases.

30 Nov 2012

UCB to sponsor key sets of VIMPAT C-V data at 66th American Epilepsy Society annual meeting

UCB, a global biopharmaceutical company focusing on CNS and immunology treatment and research, is sponsoring key sets of VIMPAT® (lacosamide) C-V data at the 66th Annual Meeting of the American Epilepsy Society (AES) in San Diego, Calif., November 30 - December 4.

29 Nov 2012

Dyspepsia News and Research

Further Reading

FDA approves Iroko Pharmaceuticals’ ZORVOLEX capsules

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

Adempas drug gets FDA approval for treatment of pulmonary hypertension

Bayer HealthCare receives FDA approval for Adempas tablets

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

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

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

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

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

Schizophrenia cardiovascular risk under-recognized in primary care

Schizophrenia cardiovascular risk under-recognized in primary care

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

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

Dabigatran decreases risk of recurrent venous thromboembolism

Positive data from POZEN's PA32540 Phase 3 studies presented at AHA 2013 stroke conference

Cubist seeks FDA sNDA approval for ENTEREG to accelerate GI recovery

Updated U.S. prescribing information for Boehringer Ingelheim’s Pradaxa

Selective targeting of neurotransmitters may allow for new medication therapies for GI conditions

Novartis to highlight key data from extensive oncology portfolio at SABCS and ASH meeting

UCB to sponsor key sets of VIMPAT C-V data at 66th American Epilepsy Society annual meeting

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