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.

EMA CHMP adopts positive opinion for Pfizer’s axitinib to treat advanced renal cell carcinoma

Pfizer announced today that the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the marketing authorization of axitinib in the European Union (EU), for the treatment of adult patients with advanced renal cell carcinoma (RCC), a type of advanced kidney cancer, after failure of prior treatment with sunitinib or a cytokine.

25 May 2012

Pfizer fails to meet primary endpoint in TORISEL Phase 3 study for advanced RCC

Pfizer Inc announced that the Phase 3 INTORSECT (B1771003) study, evaluating TORISEL(temsirolimus) in patients with advanced renal cell carcinoma (RCC) whose disease had progressed on or after SUTENT (sunitinib malate) therapy, did not meet the primary endpoint of prolonging progression free survival (PFS) when compared to sorafenib.

16 May 2012

New ACR guidelines recommend use of topical NSAIDs for older patients with knee OA

The American College of Rheumatology (ACR) Subcommittee on Osteoarthritis Guidelines has approved and issued several updates to clinical practice guidelines for the treatment of osteoarthritis (OA).

31 Mar 2012

Boniva generics receive FDA approval for treatment, prevention of osteoporosis

The U.S. Food and Drug Administration today approved the first generic versions of Boniva (ibandronate) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.

27 Mar 2012

FDA denies AstraZeneca Citizen Petitions on SEROQUEL labeling

AstraZeneca today announced that on March 7, 2012, the Food and Drug Administration denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labeling that omits certain hyperglycemia warning language that the FDA required AstraZeneca to include in the labeling for SEROQUEL (quetiapine fumarate) tablets and SEROQUEL XR (quetiapine fumarate) extended-release tablets.

12 Mar 2012

BioLineRx BL-7010 may reduce gluten toxicity in patients with celiac disease

BioLineRx, a biopharmaceutical development company, announced the publication of pre-clinical results demonstrating that BL-7010, an orally available treatment for celiac disease, reduces gluten toxicity (the negative effect of gluten on the patient's body).

22 Feb 2012

Acorda's fourth quarter GAAP net income increases to $12.7 million

Acorda Therapeutics, Inc. today announced its financial results for the fourth quarter and full year ended December 31, 2011.

16 Feb 2012

Shire, Janssen enter development and marketing agreement for Resolor

Shire plc, the global specialty biopharmaceutical company, announced today that it has acquired the rights to develop and market Resolor (prucalopride) in the United States (US) in an agreement with Janssen Pharmaceutica N.V.

11 Jan 2012

Shire acquires rights to develop and market Resolor in the U.S.

10 Jan 2012

FDA approves changes to REMS for Nplate and Promacta

The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration.

7 Dec 2011

Novartis to showcase 160 presentations on breast cancer, hematological disease drugs at SABCS and ASH

Novartis Pharmaceuticals Corporation will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

3 Dec 2011

Acorda third quarter GAAP net income increases to $18.9 million

Acorda Therapeutics, Inc. today announced its financial results for the third quarter ended September 30, 2011.

4 Nov 2011

Takeda receives FDA approval for VELCADE sNDA to treat MM

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE (bortezomib) for Injection, which updates the label to include additional long-term overall survival (OS) data from the VISTA trial.

2 Nov 2011

Observer bias increases likelihood of GERD diagnosis

Patients who complain of upper gastrointestinal (GI) symptoms often face a diagnosis of either gastroesophageal reflux disease (GERD) or functional dyspepsia. Because the two conditions often overlap, it can be difficult to distinguish between them and diagnose them properly. Yet ambulatory care facilities and hospitals have reported a dramatic increase in the number of GERD-related visits/discharges in recent years.

31 Oct 2011

FDA approves NDA for Edgemont's Fluoxetine 60 mg tablet

Edgemont Pharmaceuticals, LLC, a neuroscience focused company, today announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Fluoxetine Tablets 60 mg.

12 Oct 2011

Bristol-Myers to present abstracts on research in liver disease at The Liver Meeting 2011

Bristol-Myers Squibb Company announced today that 22 abstracts on the Company's research in liver disease have been accepted for presentation at The Liver Meeting 2011, the 62nd annual meeting of the American Association for the Study of Liver Diseases, in San Francisco, November 4 - 8.

1 Oct 2011

New data from Pfizer's investigational oncology compounds to be presented at EMCC 2011

Pfizer Oncology announced today that data evaluating crizotinib in anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC), as well as data from Pfizer's renal cell carcinoma (RCC) portfolio on axitinib, an investigational compound, and SUTENT(sunitinib malate) will be presented at the 2011 European Multidisciplinary Cancer Congress in Stockholm, Sweden, September 23 - 27, 2011.

14 Sep 2011

Majority of 9/11 World Trade Center attack survivors report increased incidence of GERS

Increased incidence of gastroesophageal reflux symptoms (GERS) reported by a large population of 9/11 World Trade Center attack survivors, most of whom had not reported any GERD-related symptoms prior to 9/11, worsened the health-related quality life for many rescue and recovery workers, lower-Manhattan residents and local workers who were exposed to the dust cloud and other contaminants in the aftermath of 9/11, according to a study published online today online today in The American Journal of Gastroenterology.

7 Sep 2011

New meta-analysis reaffirms safety profile of aspirin for pain relief, fever

A new meta-analysis published this week in Drugs in R&D, reaffirms the safety profile of aspirin for short-term treatment of mild to moderate pain, and aches and fever due to colds when used as directed.

2 Sep 2011

Health Canada approves Bayer's STAXYN for treatment of erectile dysfunction

Today, Bayer Inc. announced the Health Canada approval of STAXYN, the first orally disintegrating tablet for the treatment of erectile dysfunction (ED) that lasts up to eight hours.

29 Aug 2011