Diarrhea News and Research

Latest Diarrhea News and Research

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Centocor Ortho Biotech Inc. announced today that it has filed a supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) requesting the approval of REMICADE® (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.

29 Dec 2010

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

Specialty biopharmaceutical company Santarus, Inc. and biotech company Pharming Group NV today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) to obtain marketing approval for RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).

29 Dec 2010

FDA warns against consumption of Tiny Greens brand Alfalfa Sprouts or Spicy Sprouts

The FDA is advising consumers not to eat Alfalfa Sprouts and Spicy Sprouts (which contain alfalfa sprouts mixed with radish and clover sprouts) from Tiny Greens Organic Farm of Urbana, Ill. The sprouts were distributed in 4 oz. and 5 lb. containers to various customers, including farmers' markets, restaurants and groceries, in Illinois, Indiana, Iowa, Missouri and possibly other Midwestern states.

28 Dec 2010

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Vicus Therapeutics, LLC, today announced the initiation of a Phase 2 trial evaluating VT-122, a novel investigational combination of etodolac and propranolol, and Nexavar® (sorafenib) tablets, as a potential new treatment option for patients with advanced liver cancer (hepatocellular carcinoma), systemic inflammation and cachexia.

28 Dec 2010

Placebos work

According to a new study people who knowingly take a dummy pill or placebo may benefit from it. These pills are usually made from sugar or other inert non-harmful materials. Usually when used in clinical trials patients are unaware whether they are taking the tested drug or a placebo to ensure the medical benefits of a potential new drug are assessed rigorously. However this new study published in the science journal PLoS ONE, found placebos may work even when patients are aware that they are taking them.

27 Dec 2010

American Regent initiates voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%

American Regent is conducting a nationwide voluntary recall to the consumer and user level of ALL unexpired lots of the following products: Sodium Bicarbonate Injection, USP, 7.5%, 44.6 mEq/50 mL, Single Dose Vial

24 Dec 2010

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

FDA approves Novartis' Amturnide for treatment of high blood pressure

Today Novartis announced that the US Food and Drug Administration (FDA) approved Amturnide (aliskiren, amlodipine and hydrochlorothiazide) tablets for the treatment of high blood pressure. Amturnide combines the only approved direct renin inhibitor worldwide, Tekturna (aliskiren), with the widely used calcium channel blocker amlodipine and the diuretic hydrochlorothiazide (HCTZ).

23 Dec 2010

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Takeda Pharmaceutical Company Limited ("Takeda") today announced that Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. ("TPNA"), have completed settlements with all defendants in patent litigation brought against the companies in response to their Abbreviated New Drug Applications ("ANDAs") for generic ACTOS® (pioglitazone HCl), ACTOplus met® (pioglitazone HCl and metformin HCl), and duetact® (pioglitazone HCl and glimepiride).

22 Dec 2010

Exciting progress made in MS research during 2010

Exciting advances were made in 2010 in virtually every field of MS research. Progress toward finding new therapies for MS is illustrated by the availability of the first oral disease-modifying therapy for MS. Progress was also made toward finding ways to restore function and improving quality of life and specific MS symptoms through exercise, meditation, rehabilitation and medications, including the first therapy specifically approved to treat a symptom of MS (Ampyra).

20 Dec 2010

FDA warns against consumption of Sally Jackson cheese due to risk of E. coli O157:H7

The FDA, in cooperation with other state and local public health agencies, is warning consumers not to eat any Sally Jackson cheeses. The products were processed under conditions that create a significant risk of contamination of the unpasteurized raw milk and finished cheese, and Sally Jackson cheeses have been identified as one possible source of eight cases of E. coli O157 infections in an ongoing investigation.

20 Dec 2010

Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

Genentech, a member of the Roche Group, confirmed that following the reviews of Avastin® (bevacizumab) in metastatic breast cancer by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), the following regulatory announcements were made by the individual health authorities:

17 Dec 2010

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

BELLUS Health Inc. and Celtic Therapeutics announced today that a global confirmatory phase III clinical study was initiated on December 14, 2010 for KIACTA™ (eprodisate). KIACTA™ is a drug candidate being developed for the treatment of AA amyloidosis, a life-threatening orphan disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The study is designed to confirm the safety and efficacy of KIACTA™ in preventing renal function decline in patients with AA amyloidosis.

16 Dec 2010

New study says celiac disease patients should go on gluten-free diet

Findings from a new study of 141 adults add to an ongoing medical debate over which patients with symptoms of celiac disease should go on a gluten-free diet. Published in ACS' Journal of Proteome Research, the study concludes that people currently diagnosed as "potential" celiac disease patients and not advised to follow a gluten-free diet may not be "potential" patients at all. Rather, the scientists found that these patients have the same distinctive metabolic fingerprint as patients with full-blown disease who do benefit from gluten-free diets.

16 Dec 2010

African sleeping sickness parasite's previously unrecognized extreme social behavior discovered

Long considered a freewheeling loner, the Trypanosoma brucei parasite responsible for African sleeping sickness has revealed a totally unexpected social side, opening a potential chink in the behavioral armor of this and other supposedly solitary human parasites, according to research presented at the American Society for Cell Biology's 50th Annual Meeting in Philadelphia.

15 Dec 2010

Nektar reports positive results from NKTR-102 Phase 2 study in metastatic breast cancer at CTRC-AACR SABCS

Nektar Therapeutics today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in patients with metastatic breast cancer during the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). NKTR-102, a novel investigational topoisomerase I inhibitor-polymer conjugate, is Nektar's lead oncology candidate and is being evaluated in multiple cancer indications.

14 Dec 2010

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Intercell AG announced today preliminary clinical results on its investigational Travelers' Diarrhea (TD) Vaccine Patch program and the decision not to pursue further the development of this vaccine candidate. The decision was made following the receipt of results of its randomized and placebo-controlled Phase III study (ELT301) with 2036 travelers from Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT209) with 723 travelers from Europe to India.

13 Dec 2010

Origin of Haiti cholera epidemic traced to South Asia

The strain of cholera currently sweeping through post-earthquake Haiti originated in South Asia, conclude scientists who did a rapid genetic analysis of bacteria collected from Haitian patients. The finding supports the notion that the cholera bacteria fueling the outbreak arrived on the island via recent visitors.

13 Dec 2010

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Boehringer Ingelheim Pharmaceuticals, Inc. announced that new data from a subgroup analysis of the phase IIb/III LUX-Lung 1 trial show that afatinib (BIBW 2992) reached a four-fold extension (4.4 months vs. 1.0 month for placebo) in progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients most likely to have an epidermal growth factor receptor (EGFR) mutation. The updated LUX-Lung 1 data will be presented at the Chicago Multidisciplinary Symposium in Thoracic Oncology.

13 Dec 2010

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been previously treated with an aromatase inhibitor (AI) delays disease progression compared to tamoxifen alone. These results were presented today at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas.

10 Dec 2010

Diarrhea News and Research

Latest Diarrhea News and Research

Centocor Ortho Biotech files REMICADE sBLA for ulcerative colitis in pediatric patients

Santarus, Pharming submit RHUCIN BLA to FDA for treatment of HAE attacks

FDA warns against consumption of Tiny Greens brand Alfalfa Sprouts or Spicy Sprouts

Vicus initiates VT-122 Phase 2 trial in advanced liver cancer, systemic inflammation and cachexia

Placebos work

American Regent initiates voluntary recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

FDA approves Novartis' Amturnide for treatment of high blood pressure

Takeda completes settlements in patent litigation over generic ACTOS, ACTOplus met, and duetact ANDAs

Exciting progress made in MS research during 2010

FDA warns against consumption of Sally Jackson cheese due to risk of E. coli O157:H7

Genentech confirms EMA, FDA updates on Avastin for metastatic breast cancer

BELLUS Health, Celtic Therapeutics initiate KIACTA global confirmatory phase III clinical study for AA amyloidosis

New study says celiac disease patients should go on gluten-free diet

African sleeping sickness parasite's previously unrecognized extreme social behavior discovered

Nektar reports positive results from NKTR-102 Phase 2 study in metastatic breast cancer at CTRC-AACR SABCS

Intercell to stop further development of Travelers' Diarrhea Vaccine Patch

Origin of Haiti cholera epidemic traced to South Asia

Boehringer Ingelheim reports positive results from afatinib phase IIb/III LUX-Lung 1 trial in advanced NSCLC

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

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

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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