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.

Astellas seeks regulatory approval for mirabegron to treat overactive bladder in the U.S., Europe

Astellas Pharma Inc. today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency.

29 Aug 2011

BIPI to launch dabigatran etexilate Phase II trial in patients with mechanical heart valves

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced plans to launch RE-ALIGN, a global, Phase II trial evaluating the safety and pharmacokinetics of dabigatran etexilate in 400 patients who have mechanical heart valves.

26 Aug 2011

Santarus, Depomed enter new commercialization agreement for GLUMETZA

Santarus, Inc. and Depomed, Inc. today announced that they have entered into a new commercialization agreement for GLUMETZA (metformin hydrochloride extended release tablets) under which Santarus will assume broad commercial, manufacturing and regulatory responsibilities to replace a promotion agreement that the companies entered into in July 2008.

23 Aug 2011

Acorda Therapeutics receives U.S. patent allowance for aminopyridine compositions

Acorda Therapeutics, Inc. today announced that the United States Patent and Trademark Office (USPTO) has allowed U.S. Patent Application No. 11/102,559 entitled "Method of Using Sustained Release Aminopyridine Compositions."

10 Aug 2011

CJ, RaQualia sign license agreement to develop and commercialize RQ-00000010 Partial Agonist

RaQualia Pharma Inc. today announced the signing of a license agreement with CJ CheilJedang Co. (CJ), granting CJ exclusive rights to develop, manufacture and commercialize RaQualia's 5-HT4 Partial Agonist in Korea, China, Taiwan, India and Southeast Asia.

30 Jul 2011

PENNSAID Viscous Solution Phase 2 clinical trial for osteoarthritis pain meets primary endpoint

Nuvo Research Inc., a specialty pharmaceutical company dedicated to building a portfolio of products primarily for the treatment of pain, today announced receipt from Mallinckrodt Inc., a Covidien company (Covidien), of top-line results from a Phase 2 study conducted by Covidien, of twice-daily administration of PENNSAID Viscous Solution (topical diclofenac sodium viscous solution) 2% w/w, previously referred to as PENNSAID Gel.

30 Jun 2011

AMPYRA ER Tablets improve walking ability in patients with multiple sclerosis

Acorda Therapeutics, Inc. today announced an analysis of pooled clinical trial results showed patients who were responders to AMPYRA (dalfampridine) Extended Release Tablets, 10 mg demonstrated clinically relevant improvements in walking ability as measured by patient self-report on the 12-Item Multiple Sclerosis Walking Scale (MSWS-12), regardless of either their baseline Expanded Disability Status Scale (EDSS) score or baseline walking speed.

7 Jun 2011

ZYTIGA clinical study data on prostate cancer to be presented at ASCO 2011

Data related to ZYTIGA (abiraterone acetate) will be presented at the 2011 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

3 Jun 2011

NEJM publishes ZYTIGA plus prednisone Phase 3 trial data in metastatic castration-resistant prostate cancer

A study titled "Abiraterone and Increased Survival in Metastatic Prostate Cancer," published in the May 26 issue of NEJM, found that patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel showed a significant improvement in overall survival when treated with ZYTIGA plus prednisone compared to patients treated with prednisone plus placebo.

26 May 2011

FDA approves SUTENT for treatment of pancreatic NET

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT® (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.

21 May 2011

EMA CHMP recommends conditional marketing authorization of FAMPYRA

The Committee for Medicinal Products for Human Use of the European Medicine Agency has recommended conditional marketing authorization of FAMPYRA (prolonged-release fampridine 10 mg tablets) for the improvement of walking in adult patients with multiple sclerosis with walking disability.

20 May 2011

ViroPharma commences VP 20621 Phase 2 study for prevention of recurrent Clostridium difficile infection

ViroPharma Incorporated today announced initiation of a Phase 2 dose-ranging clinical study to evaluate the safety, tolerability, and efficacy of VP 20621 for prevention of recurrence of Clostridium difficile infection (CDI) in adults previously treated for CDI.

20 May 2011

Pfizer's axitinib Phase 3 trial in advanced renal cell carcinoma meets primary endpoints

Pfizer Inc. today announced data from the pivotal Phase 3 AXIS 1032 trial, showing that in patients with previously treated advanced renal cell carcinoma, axitinib significantly extended progression-free survival at the 47th Annual American Society of Clinical Oncology meeting in Chicago from June 3-7, 2011.

19 May 2011

Positive results from Astellas Pharma's mirabegron phase III trial in overactive bladder

Astellas Pharma US, Inc., U.S. subsidiary of Astellas Pharma Inc., today announced the results of a pivotal phase III clinical trial for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder (OAB), which show mirabegron significantly improves key OAB symptoms – urinary incontinence and frequency of micturition compared with placebo.

18 May 2011

Australian TGA approves Biogen Idec's FAMPYRA to improve walking ability in patients with MS

The Australian Therapeutic Goods Administration (TGA) has granted approval for FAMPYRA, (fampridine) 10 mg Modified Release (MR) tablet, for the symptomatic improvement of walking ability in adult patients with multiple sclerosis (MS) who have shown improvement after eight weeks of treatment.

16 May 2011

The Lancet publishes two pirfenidone Phase 3 trial results in idiopathic pulmonary fibrosis

InterMune, Inc. today announced the publication of results from two Phase 3 trials demonstrating that treatment with pirfenidone, a novel antifibrotic and anti-inflammatory drug, was associated with favorable effects on lung function, 6-minute walk test distance and progression-free survival (PFS) in patients with mild to moderate idiopathic pulmonary fibrosis (IPF).

16 May 2011

AGA's cutting-edge research on GI disorders to be presented at DDW 2011

Clinicians, researchers and scientists from around the world will gather for Digestive Disease Week- 2011, the largest and most prestigious gastroenterology meeting, from May 7-10, 2011, at McCormick Place, Chicago, IL.

7 May 2011

Acorda reports $0.7 million GAAP net loss for first quarter 2011

Acorda Therapeutics, Inc. today announced its financial results for the first quarter ended March 31, 2011.

5 May 2011

Positive results from Shire's Vyvanse clinical trial in schizophrenia

Shire plc, the global specialty biopharmaceutical company, today announced positive results from a signal-finding study of Vyvanse(R) Capsules assessing its effect in a prospective examination of adults with negative symptom predominant schizophrenia.

28 Apr 2011

Nausea and vomiting are most feared of all chemotherapy-related side effects

PediatRx, Inc. today commented on studies which reveal that chemotherapy-induced nausea and vomiting is one of the most feared of all chemotherapy-related side effects. The fear of nausea and subsequent vomiting is many times so significant that patients can develop a condition known as 'anticipatory' nausea, where the patient becomes nauseous primarily as a result of the fear of becoming nauseous.

25 Apr 2011