Diarrhea News and Research

Latest Diarrhea News and Research

J&JPRD submits NUCYNTA ER sNDA to FDA for DPN associated neuropathic pain

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration for NUCYNTA ER (tapentadol) extended-release tablets, an oral analgesic, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults.

31 Oct 2011

Avanir seeks EMA marketing authorization for NUEDEXTA to treat pseudobulbar affect

Avanir Pharmaceuticals, Inc. announced today that it has submitted an application to the European Medicines Agency seeking marketing authorization for NUEDEXTA (dextromethorphan HBr and quinidine sulfate) for the treatment of pseudobulbar affect.

31 Oct 2011

EC approves Lilly's ALIMTA as continuation maintenance therapy for NSCLC

Eli Lilly and Company announced today that the European Commission has granted approval for the use of ALIMTA (pemetrexed for injection) as a single agent for continuation maintenance therapy in patients with a particular type of lung cancer, called advanced nonsquamous non-small cell lung cancer

29 Oct 2011

American College of Gastroenterology to hold special briefing for journalists

The American College of Gastroenterology will hold a special briefing for journalists at its 76th Annual Scientific meeting in Washington, DC highlighting new clinical science that explores the role of the "gut microbiota" - the bacterial composition of the GI tract - and the efficacy of probiotics in treating various GI conditions, including antibiotic-associated diarrhea, abdominal discomfort and bloating.

28 Oct 2011

Over-the-counter 'thyroid support' supplements could be dangerous

People who use over-the-counter "thyroid support" supplements may be putting their health at risk, according to a study being presented at the annual meeting of the American Thyroid Association. The supplements contain varying amounts of two different kinds of thyroid hormones apparently derived in large part from chopped up animal thyroid glands, says the study's senior investigator, Victor Bernet, M.D., an endocrinologist at Mayo Clinic in Florida.

28 Oct 2011

EC approves Pfizer's pneumococcal conjugate vaccine, Prevenar 13

Pfizer Inc. announced today that the European Commission has approved the Company's pneumococcal conjugate vaccine, Prevenar 13 (pneumococcal polysaccharide conjugate vaccine, for active immunization for the prevention of vaccine-type invasive disease caused by Streptococcus pneumoniae in adults aged 50 years and older.

27 Oct 2011

Gilead, Bristol-Myers Squibb to develop and commercialize fixed-dose combination for HIV

Bristol-Myers Squibb Company and Gilead Sciences, Inc. today announced a licensing agreement for Bristol-Myers Squibb to develop and commercialize a fixed-dose combination containing Bristol-Myers Squibb's protease inhibitor REYATAZ (atazanavir sulfate) and Gilead's cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines to potentially allow for one pill once daily dosing.

27 Oct 2011

Vertex initiates INCIVEK combination Phase 3b study for hepatitis C

Vertex Pharmaceuticals Incorporated today announced the initiation of a Phase 3b study called CONCISE that will evaluate the potential for treatment with INCIVEK (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the 'CC' variation near the IL28B gene.

24 Oct 2011

FDA's ODAC to review Affymax peginesatide NDA for treatment of CKD-associated anemia

Affymax, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the New Drug Application (NDA) for peginesatide proposed for the treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis on December 7, 2011 during the afternoon session.

24 Oct 2011

Ferring reports on FDA approval of labeling supplement for EUFLEXXA to treat knee osteoarthritis

On Oct. 11, 2011, the FDA approved a labeling supplement for EUFLEXXA (1% sodium hyaluronate) that provides 26-week efficacy data from the FLEXX trial, as well as, 52-week safety data to demonstrate the safety of repeated injection cycles.

22 Oct 2011

Janssen announces FDA label update approval for PREZISTA HIV tablets

Janssen Therapeutics, Division of Janssen Products, LP, announced today that the U.S. Food and Drug Administration (FDA) has approved a label update for PREZISTA (darunavir) tablets to include 192-week data from the ARTEMIS study.

22 Oct 2011

Intestinal ecosystem more dynamic than previously thought

The intestinal ecosystem is even more dynamic than previously thought, according to two studies by UT Southwestern Medical Center researchers published in the latest issue of Science.

20 Oct 2011

ABI provides clinical update on company activities

Amarillo Biosciences, Inc. (ABI) today provided an update on company activities.

15 Oct 2011

Frozen ground tuna recalled by Osamu Corporation

Osamu Corporation of Gardena, CA is recalling up to 1,800 cases, lot# 7013, of frozen ground tuna because the FDA found decomposition in several samples of the product and also found elevated histamine levels in samples taken from one retail location.

14 Oct 2011

Cholera epidemic in Africa: Largest yet

The United Nations Children's Fund (UNICEF) has announced in a statement that the cholera epidemic in West and Central Africa is one of the worst the area has ever seen. So far this year more than 85,000 cases have been reported in the region, including 2,466 deaths.

12 Oct 2011

Walgreens Flu Impact Report

The typical flu season always coincides with the busiest travel period of the year, and last season that spelled trouble for more than 3 million U.S. vacationers whose trips were interrupted by flu-related illness, the Walgreens Flu Impact Report suggests.

12 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

Vertex announces availability of INCIVEK to treat hepatitis C in Canada

Vertex Pharmaceuticals Incorporated announced today that INCIVEK (telaprevir) tablets are now available in Canada for people with genotype 1 chronic hepatitis C with compensated liver disease, including cirrhosis.

11 Oct 2011

WHO facing shortage of funds as it works to scale up humanitarian response to Pakistan flooding

WHO representative Guido Sabatinelli has assured Pakistan health officials that the organization "will be scaling up its humanitarian response in all the flood-affected areas of Sindh to resolve health issues faced by the displaced people," News International reports.

11 Oct 2011

Teriflunomide drug reduces relapse rate of people with MS

A new oral drug has been shown in a large international clinical trial to significantly reduce the relapse rate of people with multiple sclerosis and to slow the progression of the disease.

7 Oct 2011