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.

Janssen receives positive opinion from EMA CHMP for ZYTIGA to treat mCRPC

Janssen-Cilag International NV (Janssen) announced today that the Committee for Medical Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending approval of the oral, once-daily medication ZYTIGA for use in combination with prednisone or prednisolone in the treatment of metastatic castration-resistant prostate cancer (mCRPC), in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated.

19 Nov 2012

Positive results from Santarus and Pharming’s RUCONEST Phase III trial on HAE

Santarus, Inc. and Pharming Group NV today announced that their pivotal Phase III clinical study to evaluate the safety and efficacy of the investigational drug RUCONEST (recombinant human C1 esterase inhibitor) 50 U/kg for the treatment of acute attacks of angioedema in patients with Hereditary Angioedema (HAE) met the primary endpoint of time to beginning of symptom relief.

7 Nov 2012

Positive results from POZEN's PA32540 Phase 3 trials presented at AHA Scientific Sessions 2012

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, presented positive results from two pivotal Phase 3 clinical trials of the investigational product, PA32540, at The American Heart Association (AHA) Scientific Sessions 2012, as Poster #12057: Treatment Continuation and Cardiovascular Safety of Antiplatelet Therapy with PA32540, A Tablet with Enteric-Coated Aspirin and Immediate-Release Omeprazole: Results of Two 6-Month, Phase 3 Studies.

6 Nov 2012

Pradaxa use does not appear to increase serious bleeding

The U.S. Food and Drug Administration (FDA) today announced the results of a Mini-Sentinel assessment that indicates bleeding rates associated with new use of Pradaxa (dabigatran etexilate mesylate) capsules do not appear to be higher than bleeding rates associated with new use of warfarin, which is consistent with observations from the pivotal RE-LY trial.

4 Nov 2012

Bayer announces data from riociguat Phase III trial on CTEPH

Bayer HealthCare today announced data from the Phase III CHEST-1 trial evaluating its investigational drug riociguat in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent pulmonary hypertension (PH) after surgery.

24 Oct 2012

Bayer announces data from riociguat Phase III pulmonary arterial hypertension trial

Bayer HealthCare today announced data from the Phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

22 Oct 2012

FDA approves Acton’s AEROSPAN sNDA to treat asthma

Acton Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved the sNDA (Supplemental New Drug Application) for AEROSPAN (flunisolide HFA, 80 mcg) Inhalation Aerosol, a hydrofluoroalkane (HFA) orally inhaled corticosteroid indicated for the maintenance treatment of asthma as a prophylactic therapy in adult and pediatric patients 6 years of age and older.

21 Sep 2012

Data from BioLineRx’s BL-7010 pre-clinical studies on celiac disease

BioLineRx, a biopharmaceutical development company, announced today that BL-7010, an orally available treatment for celiac disease, was found to be safe and well tolerated in pre-clinical studies conducted to date.

10 Sep 2012

Janssen receives FDA Priority Review for ZYTIGA sNDA to treat mCRPC

Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental New Drug Application (sNDA) for ZYTIGA (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

30 Aug 2012

Mexican-Americans with ancestral links have higher insulin resistance levels

Mexican-Americans with an ancestral link to Amerindian tribes were found to have higher insulin resistance levels, which is an indication of several chronic conditions such as type 2 diabetes, according to research by The University of Texas Health Science Center at Houston (UTHealth).

26 Aug 2012

Positive results from Acorda post-marketing commitment study of dalfampridine-ER for MS

Acorda Therapeutics, Inc. today announced top line results from a post-marketing commitment study evaluating a 5mg dose of dalfampridine-ER to improve walking in people with multiple sclerosis. The study failed to confirm efficacy of the 5mg dose.

13 Aug 2012

Acorda commences AMPYRA clinical study for post-stoke deficits

Acorda Therapeutics, Inc. today announced that the first patient has been enrolled in a proof-of-concept study exploring the use of AMPYRA(dalfampridine) Extended Release Tablets, 10 mg in treating patients who have post-stroke deficits.

13 Jun 2012

Statisticians devise new predictive algorithm for future medical conditions

Analyzing medical records from thousands of patients, statisticians have devised a statistical model for predicting what other medical problems a patient might encounter.

5 Jun 2012

Results from Janssen's ZYTIGA plus prednisone Phase 3 study on mCRPC

Results observed from pre-specified interim analyses of the randomized, placebo-controlled Phase 3 study, COU-AA-302, demonstrated that patients with metastatic castration-resistant prostate cancer (mCRPC) treated with abiraterone acetate (ZYTIGA) plus prednisone showed a statistically significant improvement in radiographic progression-free survival (rPFS) and all secondary endpoints compared to patients treated with placebo plus prednisone.

4 Jun 2012

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