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Lupin grants Salix exclusive worldwide rights to rifaximin

Salix Pharmaceuticals, Ltd. today announced that as of March 31, 2011 Lupin Ltd. granted Salix exclusive worldwide rights (except for India) to exploit Lupin technology and technology jointly developed by Lupin and Salix for all rifaximin products for human use. This agreement expands the collaboration that Salix and Lupin entered into as of September 30, 2009.

6 Apr 2011

Corticosteroids may decrease occurrence of hospital-acquired pneumonia in ICU patients

Patients admitted to a hospital with major trauma and treated with the steroid hydrocortisone were less likely to be diagnosed with hospital-acquired pneumonia than patients who received placebo, according to a study in the March 23/30 issue of JAMA.

23 Mar 2011

Meda launches Medivir's cold sore treatment Xerese in the U.S.

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announces that the Company's commercialization partner, Meda AB, has launched Medivir's unique cold sore treatment Xerese in the United States.

1 Mar 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

Studies show XIFAXAN 550 mg tablets demonstrate significant relief of global IBS symptoms

Salix Pharmaceuticals, Ltd. today announced the New England Journal of Medicine has published results from TARGET 1 and TARGET 2, the Company's two pivotal Phase 3 efficacy and safety studies of XIFAXAN (rifaximin) 550 mg tablets for the treatment of Irritable Bowel Syndrome without constipation, or Non-C IBS.

6 Jan 2011

Salix to discuss XIFAXAN therapy for hepatic encephalopathy at AASLD 2010 Annual Meeting

Salix Pharmaceuticals, Inc. today announced that the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2010) will be an important venue for ongoing discussion of hepatic encephalopathy, or HE.

1 Nov 2010

Salix presents two Phase 3 pivotal clinical trials data for non-C IBS at ACG Meeting

Salix Pharmaceuticals, Ltd. today announced the presentation of two analyses of data from its Phase 3 pivotal clinical trials, TARGET 1 and 2, demonstrating a 14-day course of XIFAXAN 550 mg (rifaximin) taken three times daily achieved adequate relief of symptoms of non-constipation irritable bowel syndrome (non-C IBS) in a significantly greater proportion of patients compared with placebo.

19 Oct 2010

Medivir appoints Daewoong as South Korean distributor for Xerclear

Medivir AB today announced it has appointed Daewoong Pharmaceutical Co. Ltd. as its exclusive distributor for Xerclear™ in South Korea. Under the terms of the agreement, Daewoong will be responsible for obtaining the regulatory approvals, and for marketing, sales and distribution of Medivir's cold sore product in the territory. In consideration of the rights granted to Daewoong, Medivir will receive upfront and milestone payments and royalties on sales according to a profit sharing scheme.

24 Aug 2010

FDA accepts Salix's XIFAXAN550 sNDA for Priority Review

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Company's efficacy supplement to the New Drug Application (NDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

9 Aug 2010

Hi-Tech Pharmacal fourth-quarter net sales increase 6% to $40.5 million

Hi-Tech Pharmacal Co., Inc. today reported results for the fourth quarter and year ended April 30, 2010.

13 Jul 2010

GSK, Medivir sign exclusive agreement for commercialization of Xerclear

GlaxoSmithKline and Medivir today announced an exclusive agreement for the commercialization of cold sore treatment, Xerclear (acyclovir and hydrocortisone) for non-prescription use (OTC) in key global markets. Xerclear is the first and only topical herpes labialis (cold sores) treatment clinically proven to help prevent cold sore lesions appearing.

23 Jun 2010

Salix submits efficacy supplement for XIFAXAN NDA for Non-C IBS and IBS-related bloating

Salix Pharmaceuticals, Ltd. today announced that the Company has submitted an efficacy supplement to NDA 21-361 for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non-constipation irritable bowel syndrome (Non-C IBS) and IBS-related bloating.

8 Jun 2010

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010

Meda AB's net sales for first-quarter 2010 decrease 14% to SEK 2,943M

After a strong Q4 in 2009, net sales decreased 14% in Q1 to SEK 2,943 million (3,437). Mainly currency effects but also increased competition for Astelin and Optivar reduced sales by more than SEK 400 million, compared with the same period last year.

5 May 2010

Salix Pharmaceuticals receives FDA complete response letter for GIAZO Tablets NDA

Salix Pharmaceuticals, Ltd. today announced the Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for GIAZO™ (balsalazide disodium) Tablets 1.1 g. for the treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older.

29 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

DDW2010 Investor Event to provide update on TARGET 1 and TARGET 2 Phase 3 trials

Salix Pharmaceuticals, Ltd. today announced that the Company will host a DDW2010 Investor Event on Monday, May 3 2010 from 9:00 p.m. to 10:00 p.m. Central Time (10:00 p.m. to 11:00 p.m. ET).

22 Apr 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.