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Last updated on April 17, 2014 at 15:58 EDT

Latest Macrolides Stories

2014-04-16 16:26:34

LONDON, April 16, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:PharmaPoint: Atopic Dermatitis - US Drug Forecast and Market Analysis to 2022http://www.reportbuyer.com/pharma_healthcare/diseases/pharmapoint_atopic_dermatitis_us_drug_forecast_market_analysis_2022.htmlPharmaPoint: Atopic Dermatitis - US Drug Forecast and Market Analysis to 2022SummaryAlthough the past decade has seen the atopic dermatitis market remain relatively unchanged and a saturated,...

2014-03-28 12:21:53

DUBLIN, Mar. 28, 2014 /PRNewswire/ -- Research and Markets ( http://www.researchandmarkets.com/research/lwpmln/investigation ) has announced the addition of the "Investigation Report on China Tacrolimus Market, 2009-2018" report to their offering. (Logo: http://photos.prnewswire.com/prnh/20130307/600769) Tacrolimus, also named as ""FK506"" and ""FR-900506"", was developed by Fujisawa Pharmaceutical Co., Ltd. (later became Astellas Pharma by merging with Yamanouchi Pharmaceutical Co.,...

2014-03-15 08:21:40

In the news release, U.S. FDA Accepts Veloxis' New Drug Application for Envarsus® for the Prevention of Organ Rejection in Kidney Transplant Patients, issued 13-Mar-2014 by Veloxis Pharmaceuticals, we are advised that the first bullet should read "FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 30, 2014" rather than "October 3, 2014" as originally issued inadvertently. The complete, corrected release follows: U.S. FDA Accepts Veloxis' New Drug...

2014-03-13 16:27:19

HORSHOLM, Denmark, March 13, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced the U.S. FDA accepted for standard review the company's New Drug Application (NDA) for Envarsus(®) for the prevention of organ rejection in adult kidney transplant patients. Envarsus(®) is Veloxis' once-daily tacrolimus based on the company's proprietary MELTDOSE technology. Key points: -- FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA)...

2014-03-06 12:26:42

HORSHOLM, Denmark, March 6, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) today announced that John Weinberg, M.D., currently chief commercial officer of Veloxis, has been promoted to chief operating officer. -- Dr. Weinberg, who is currently responsible for the commercial launch of Envarsus® in the U.S., if approved by the Food and Drug Administration (FDA), will expand his role at the company to include additional operational responsibilities....

2014-02-26 04:21:30

Company Initiates Joint U.S. and Japanese Registration Trial HONG KONG, Feb. 26, 2014 /PRNewswire/ -- OrbusNeich today announced that patient enrollment has been initiated in Japan in the pivotal clinical trial of the COMBO Dual Therapy Stent(TM) (COMBO Stent) employing a single Japan-U.S. protocol conducted as a Global Clinical Trial "proof-of-concept" under the framework of the joint Japan-U.S. Harmonization-By-Doing [HBD] initiative. The first patient was enrolled at Shonan...

2014-01-08 12:30:01

HORSHOLM, Denmark, Jan. 8, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus(®). The subject patent covers a method of administering Envarsus(®), Veloxis' once-daily formulation of tacrolimus employing the company's proprietary MeltDose(®)...

2014-01-04 23:01:12

Scientists in Japan and Austria say the kinase inhibitor temsirolimus stops mesothelioma growth in two different ways. Raleigh, NC (PRWEB) January 04, 2014 A new study published in the journal Oncology Reports and detailed by Surviving Mesothelioma suggests that temsirolimus, a kinase inhibitor used to treat advanced renal cell carcinoma (RCC), may offer a promising new way to treat malignant pleural mesothelioma. The group studied temsirolimus by itself and in combination with the...

2013-12-30 04:20:18

HORSHOLM, Denmark, Dec. 30, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus(®) (formerly LCP-Tacro(TM)) for the prevention of organ rejection in kidney transplant recipients. The submission is based on the entire data set from the company's clinical development program that comprised 25 studies and...

2013-12-24 08:23:55

HORSHOLM, Denmark, Dec. 24, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO), today announced that Envarsus(® )was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases. Envarsus(®) is Veloxis' once-daily formulation of tacrolimus...