Diarrhea News and Research

Latest Diarrhea News and Research

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Optimer Pharmaceuticals, Inc. today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011.

21 Sep 2010

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Data from the GRACE study will be published in the September 21st issue of the Annals of Internal Medicine. GRACE is the largest-ever study of treatment experienced adult women with HIV-1 to examine gender differences in response to HIV therapy. Sponsored by Tibotec Therapeutics Clinical Affairs, a division of Centocor Ortho Biotech Services, LLC, the GRACE study enrolled 67 percent women, demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies.

21 Sep 2010

Global child mortality declines by one-third since 1990, U.N. report says

The number of children who die before age 5 has declined by one-third since 1990, Reuters reports.

18 Sep 2010

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

Genentech, Inc., a member of the Roche Group, today announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment.

18 Sep 2010

LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

LigoCyte Pharmaceuticals, Inc., a private, clinical-stage biopharmaceuticals company focused on the development of innovative vaccine products, announced today that it has initiated the first clinical trial for its bivalent intramuscular (IM) norovirus vaccine candidate, marking the fourth human clinical trial in the Company's norovirus virus-like particle (VLP) vaccine program.

17 Sep 2010

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

ViroPharma Incorporated today announced the presentation of data from its Phase 1 study of VP20621 (non-toxigenic Clostridium difficile), a novel treatment approach for preventing recurrent Clostridium difficile infections, a common and dangerous gastrointestinal infection typically occurring in older adults after use of antibiotic medications.

16 Sep 2010

BioCryst reports results from forodesine studies for CTCL and CLL

BioCryst Pharmaceuticals, Inc. announced preliminary top-line results from its multinational, open-label, single-arm trial evaluating 200 mg once-daily oral forodesine in the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL), as well as interim results from the Company's exploratory Phase 2 study to investigate the efficacy and safety of 200 mg twice-daily oral forodesine as monotherapy for chronic lymphocytic leukemia (CLL).

15 Sep 2010

AMRI selects compound for advanced preclinical testing in treatment of IBS

AMRI today announced the selection of a compound from its proprietary research program for the treatment of irritable bowel syndrome (IBS) for advanced preclinical testing, with the goal of submitting an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) in 2011.

15 Sep 2010

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Optimer Pharmaceuticals, Inc. announced the presentation of new data from its North American and European fidaxomicin Phase 3 clinical trials in patients with Clostridium difficile infection (CDI) at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Boston.

15 Sep 2010

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Gilead Sciences, Inc. today announced Phase II clinical trial results showing that its investigational fixed-dose, single-tablet "Quad" regimen of elvitegravir, cobicistat and Truvada (emtricitabine and tenofovir disoproxil fumarate) for the treatment of HIV infection maintained a high rate of virologic suppression through 48 weeks, exhibiting antiretroviral activity comparable to that of Atripla(efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg).

14 Sep 2010

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Progenics Pharmaceuticals, Inc. today presented preclinical findings for its humanized monoclonal antibodies against the disease-causing toxins produced by the bacterium Clostridium difficile.

14 Sep 2010

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today announced positive top-line results from the first of two Phase 3 clinical trials assessing the efficacy and safety of the investigational drug, linaclotide, in patients with irritable bowel syndrome with constipation (IBS-C).

14 Sep 2010

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today announced that it was expanding its Phase 2 clinical trial of STA-9090 in patients with Stage IIIB and Stage IV non-small cell lung cancer (NSCLC) from up to 69 patients to up to 146 patients based on encouraging activity observed in the first stage of the two stage clinical trial.

13 Sep 2010

Santarus expands development pipeline, adds two novel biologic drug candidates

Santarus, Inc., a specialty biopharmaceutical company, has expanded its development pipeline with the addition of two novel biologic drug candidates focused on specialty markets.

13 Sep 2010

Seaside reports positive data from STX209 Phase 2 study in ASD

Seaside Therapeutics, Inc. announced today positive data from an open-label Phase 2 study of STX209 conducted in patients with autism spectrum disorders (ASD). The primary endpoint of the study, an improvement on the Irritability subscale of the Aberrant Behavior Checklist (ABC-I), achieved statistical significance (p<0.001).

9 Sep 2010

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Santarus, Inc., S2 Therapeutics, Inc. and VeroScience LLC today announced that they have entered into a distribution and license agreement granting Santarus exclusive rights to manufacture and commercialize CYCLOSET (bromocriptine mesylate) tablets in the U.S.

9 Sep 2010

Flood victims in Pakistan helped by Australian health team

Hundreds of Pakistani flood victims have been treated at an Australian health centre set up in the country last week. This center at the Punjab city of Kot Addu is manned by a team of doctors, nurses and paramedics from the Northern Territory, Western Australia, Victoria and Queensland.

8 Sep 2010

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Medicis today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 7,790,705 related to the use of SOLODYN® (minocycline HCI, USP) Extended Release Tablets. The new patent, entitled "Minocycline Oral Dosage Forms for the Treatment of Acne," relates to the use of dosage forms of SOLODYN which provide approximately 1 mg/kg dosing based on the body weight of the person, and expires in 2027.

8 Sep 2010

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Celgene Corporation today announced it has received a Paragraph IV Certification Letter advising that Natco Pharma Limited of Hyderabad, India, submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. The application requests authorization to manufacture and market generic versions of REVLIMID (lenalidomide) 5, 10, 15 and 25 mg capsules in the United States.

3 Sep 2010

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

Gilead Sciences, Inc. today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for marketing approval for the fixed-dose combination of Truvada® (emtricitabine and tenofovir disoproxil (as fumarate)) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine (as hydrochloride)) for the treatment of HIV-1 infection in adults.

3 Sep 2010

Diarrhea News and Research

Latest Diarrhea News and Research

Optimer submits fidaxomicin rolling NDA for treatment of Clostridium difficile infection

Annals of Internal Medicine publishes GRACE study data on HIV therapy

Global child mortality declines by one-third since 1990, U.N. report says

FDA decides to review information on Avastin for advanced HER2-negative breast cancer

LigoCyte to enroll 98 subjects in first clinical trial for bivalent IM norovirus vaccine

ViroPharma presents Phase 1 study data of VP20621 at ICAAC 2010

BioCryst reports results from forodesine studies for CTCL and CLL

AMRI selects compound for advanced preclinical testing in treatment of IBS

Optimer Pharmaceuticals to present fidaxomicin Phase 3 clinical trial data at ICAAC Conference

Gilead Sciences announces Quad regimen Phase II clinical trial results for HIV infection treatment

Progenics Pharmaceuticals presents findings of humanized monoclonal antibodies against C. difficile bacterium

Ironwood, Forest Laboratories announce positive results for linaclotide Phase 3 clinical trials in IBS-C patients

Synta expands STA-9090 Phase 2 clinical trial in NSCLC

Santarus expands development pipeline, adds two novel biologic drug candidates

Seaside reports positive data from STX209 Phase 2 study in ASD

Santarus, VeroScience enter agreement to commercialize CYCLOSET drug for type 2 diabetes

Flood victims in Pakistan helped by Australian health team

USPTO awards Medicis new patent for SOLODYN Extended Release Tablets

Celgene receives Paragraph IV Certification Letter on submission of ANDA for REVLIMID

Gilead Sciences seeks MAA in Europe for fixed-dose combination of Truvada and TMC278 for HIV-1 infection

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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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