Diarrhea News and Research

Latest Diarrhea News and Research

New drug approved for COPD by the FDA

The U.S. FDA has approved a new treatment for people with worsening symptoms of severe chronic obstructive pulmonary disease (COPD). COPD affects smokers and the elderly and leads to severe difficulty in breathing, chronic cough and excessive mucus production. An exacerbation can last up to several weeks and result in a decline in lung function and increased risk of death, and it may be associated with severe anxiety, the FDA says.

1 Mar 2011

FDA approves Forest Labs' Daliresp to treat COPD

Forest Laboratories, Inc. announced today that Daliresp was approved by the U.S. Food and Drug Administration as a treatment to reduce the risk of chronic obstructive pulmonary disease exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

1 Mar 2011

Intercell reports EUR 255.2m net loss for full year 2010

Today Intercell AG announced its financial results for Q4 and the preliminary results for the full financial year 2010 and presented an update on the Company's development programs.

1 Mar 2011

Cummings School granted U.S. Patent for antibody-based treatment against Hemolytic Uremic Syndrome

Researchers at the Cummings School of Veterinary Medicine have received U.S. patent approval for an antibody-based treatment for Hemolytic Uremic Syndrome (HUS), a potentially fatal outcome of E. coli poisoning and the leading cause of kidney failure in children.

1 Mar 2011

Tenofovir gel may help reduce risk of HIV from anal sex

A gel developed to protect against HIV during vaginal sex produced a strong antiviral effect when used in the rectum, according to an early-phase study presented today at the 18th Conference on Retroviruses and Opportunistic Infections (CROI). The results, based on rectal tissue biopsies sampled from HIV-negative men and women who used the product daily for one week, provide the first-ever evidence that tenofovir gel could help reduce the risk of HIV from anal sex, even though the vaginal gel formulation may not be optimal for rectal use.

28 Feb 2011

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Regeneron Pharmaceuticals, Inc. announced that in a second Phase 3 study (PRE-SURGE 2) in gout patients initiating allopurinol therapy, ARCALYST (rilonacept) met the primary and all secondary study endpoints. The primary endpoint was the number of gout flares per patient over the 16-week treatment period.

28 Feb 2011

Seattle Genetics submits brentuximab vedotin BLA to FDA for treatment of ALCL, Hodgkin lymphoma

Seattle Genetics, Inc. announced today that it has submitted a Biologics License Application to the U.S. Food and Drug Administration for the use of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma and relapsed or refractory systemic anaplastic large cell lymphoma.

28 Feb 2011

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Specialty biopharmaceutical company Santarus, Inc.and biotech company Pharming Group NV today announced the receipt of a "refusal to file" letter from the U.S. Food and Drug Administration for the RHUCIN Biologics License Application submitted by Pharming.

28 Feb 2011

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that encouraging preliminary results of a Phase 2 trial of ganetespib as a single agent in non-small cell lung cancer were presented at the International Association for the Study of Lung Cancer 11th Annual Targeted Therapies for the Treatment of Lung Cancer Meeting.

27 Feb 2011

Takeda receives FDA approval for EDARBI to treat hypertension in adults

Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food and Drug Administration approved EDARBI for the treatment of hypertension, or high blood pressure, in adults.

27 Feb 2011

AMAG fourth quarter total revenues increase to $17.2 million

AMAG Pharmaceuticals, Inc. a biopharmaceutical company focused on the development and commercialization of a therapeutic iron compound to treat iron deficiency anemia, today reported unaudited consolidated financial results for the fourth quarter and year ended December 31, 2010.

25 Feb 2011

Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection

Chimerix, Inc., a pharmaceutical company developing orally-available antiviral therapeutics, today announced the publication of the first reported case in which adenovirus infection was successfully eradicated following treatment with its broad-spectrum antiviral drug, CMX001.

25 Feb 2011

Nearly 60,000 newly acquired infections per year in Germany's intensive care units

Infections are among the most frequent complications of a stay in hospital and raise the complication and mortality rates. Calculations based on data from the Hospital Infection Surveillance System (Krankenhaus-Infektions-Surveillance-System, KISS) showed an incidence of almost 60 000 newly acquired infections per year in intensive care units in Germany.

25 Feb 2011

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Salix Pharmaceuticals, Ltd. today announced that based on a telephone conversation with the U.S. Food and Drug Administration held last evening, the Company anticipates receiving a Complete Response Letter on or before the March 7, 2011 PDUFA goal date for the supplemental New Drug Application for XIFAXAN 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome and IBS-related bloating.

25 Feb 2011

Genentech granted FDA hearing on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, today announced the U.S. Food and Drug Administration (FDA) has granted a hearing to allow the company the opportunity to present its views on why Avastin® (bevacizumab) should remain FDA-approved for metastatic breast cancer (mBC). The FDA has scheduled the hearing for June 28 to 29, 2011.

25 Feb 2011

Researchers identify probiotic bacterial strain that may treat ulcers caused by H. pylori

Researchers from Spain have identified a strain of probiotic bacteria that may be useful in treating ulcers caused by Helicobacter pylori. They report their findings in the February 2011 issue of the journal Applied and Environmental Microbiology.

25 Feb 2011

Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment

Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. today announced the companies have begun enrolling patients in a Phase 3 randomized, double-blind, placebo-controlled trial evaluating Nexavar tablets in combination with the oral chemotherapeutic agent, capecitabine, versus placebo plus capecitabine for the treatment of patients with advanced breast cancer.

24 Feb 2011

FDA allows marketing of Ridascreen Norovirus 3rd Generation EIA assay in the US

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

24 Feb 2011

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Tranzyme Pharma and Norgine B.V., have initiated dosing of ulimorelin in the first of two, Phase 3 pivotal studies - ULISES. Ulimorelin is Tranzyme's intravenous promotility agent in development for the management of postoperative ileus in hospital and acute care settings.

23 Feb 2011

Forest Labs enters definitive merger agreement to acquire Clinical Data

Forest Laboratories, Inc. and Clinical Data, Inc. today announced that they have entered into a definitive merger agreement pursuant to which Forest will acquire Clinical Data, a specialty pharmaceutical company focused on the development of first-in-class and best-in-category therapeutics, for $30.00 per share in cash plus contingent consideration of up to $6.00 per share that may be paid upon achievement of certain commercial milestones related to Viibryd.

22 Feb 2011

Diarrhea News and Research

Latest Diarrhea News and Research

New drug approved for COPD by the FDA

FDA approves Forest Labs' Daliresp to treat COPD

Intercell reports EUR 255.2m net loss for full year 2010

Cummings School granted U.S. Patent for antibody-based treatment against Hemolytic Uremic Syndrome

Tenofovir gel may help reduce risk of HIV from anal sex

Regeneron's ARCALYST meets primary, secondary endpoints in second Phase 3 gout flare study

Seattle Genetics submits brentuximab vedotin BLA to FDA for treatment of ALCL, Hodgkin lymphoma

Pharming, Santarus receive FDA refusal to file letter for RHUCIN BLA

Encouraging preliminary results from Synta's ganetespib Phase 2 trial against non-small cell lung cancer

Takeda receives FDA approval for EDARBI to treat hypertension in adults

AMAG fourth quarter total revenues increase to $17.2 million

Journal of Clinical Virology publishes positive outcome from CMX001 treatment against AdV infection

Nearly 60,000 newly acquired infections per year in Germany's intensive care units

Salix anticipates receipt of FDA's CRL for XIFAXAN 550 mg sNDA

Genentech granted FDA hearing on Avastin for metastatic breast cancer

Researchers identify probiotic bacterial strain that may treat ulcers caused by H. pylori

Onyx, Bayer initiate patient enrollment in Nexavar Phase 3 trial for breast cancer treatment

FDA allows marketing of Ridascreen Norovirus 3rd Generation EIA assay in the US

Norgine, Tranzyme commence dosing in ulimorelin Phase 3 study for restoring GI function after surgery

Forest Labs enters definitive merger agreement to acquire Clinical Data

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Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

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Diarrhea News and Research

Latest Diarrhea News and Research

Small solutions for big problems in drug discovery and delivery

Professor Nancy Ip: Pioneering New Paths in Neurodegenerative Therapy

Utilizing process Raman in optimizing cultivated meat production

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