http://www.biospace.comBioSpace RSS GeneratorSun, 26 May 2013 02:32:47 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.biospace.com/news_story.aspx?StoryID=296280&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><b>BREO&#0153; ELLIPTA&#0153; Gains U.S. Approval for the Treatment of COPD</b><br><br><div id"releaseBody"><p>LONDON and SOUTH SAN FRANCISCO, CA--(Marketwired - May 10, 2013) - GlaxoSmithKline...Mon, 13 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=296170&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br><b>Novartis Drug Ilaris&#0174; Approved by FDA to Treat Active Systemic Juvenile Idiopathic Arthritis, a Serious Form of Childhood Arthritis</b><br><br>EAST HANOVER, N.J.</span>, <span class"xn-chron"...Mon, 13 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=296459&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>LONDON, UK, 13 May, 2013 Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, announces that the United States Food and Drug Administration (FDA) has approved the New Drug Application...Mon, 13 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294501&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>JERSEY CITY, N.J.</span>, <span class"xn-chron">April 26, 2013</span> /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced that the Therapeutic Goods Administration, the Australian...Fri, 26 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293903&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&source"news-signup"">free GenePool newsletter</a> today!<br><br><br><br>DUBLIN, Ireland, April 22, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved MINASTRINTM 24 FE (norethindrone...Tue, 23 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294093&full=1Staying up-to-date has never been simpler. Sign up for the <a href"http://www.biospace.com/enewsletter.aspx?typeseo-article&sourcenews-signup">free GenePool newsletter</a> today!<br><br>Lyon, France - April 22, 2013 - Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the European Commission approved Sanofi Pasteurs 6-in-1 pediatric vaccine...Tue, 23 Apr 2013 12:00:00 AM GMThttp://timesofindia.indiatimes.com/business/india-business/US-nod-to-Sun-for-Merck-drug-sale-raises-eyebrows/articleshow/19571824.cmsDomestic generic major Sun Pharma's "tentative'' approval to launch generic diabetes drug Januvia in the US market has raised eyebrows, providing a twist to the patent challenge being fought between the innovator Merck and Glenmark in the country. Sun Pharma, which is a co-partner of Merck's subsidiary for marketing Januvia in the country, received approval to launch generic Januvia (sitagliptin) in...Tue, 16 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20130415006165&newsLang=enPARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Paris:BIO), today announced the receipt of marketing authorization from the U.S. Food and Drug Administration (FDA) for Sitavig in the treatment of recurring Herpes labialis, marking the successful conclusion to the assessment procedure carried out by the American authorities. After Loramyc , registered in 26 countries including the...Tue, 16 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293140&full=1DUBLIN, Ireland, April 12, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved a 200 mg strength of DORYX(R) (doxycycline hyclate) Delayed-Release Tablets. DORYX Delayed-Release Tablets are a tetracycline-class oral antibiotic. The Company anticipates that it will commercially launch DORYX Delayed-Release 200 mg...Fri, 12 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=292752&full=1ROSEMONT, Pa.</span>, <span class"xn-chron">April 8, 2013</span> /PRNewswire/ -- Duchesnay <span class"xn-location">USA</span> today announced that the Food and Drug Administration (FDA) has granted approval for Diclegis<b></b> (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP) in women who do...Tue, 09 Apr 2013 12:00:00 AM GMTCAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today Argentinas National Administration of Drugs, Food and Medical Technology (ANMAT) has approved once-daily, oral AUBAGIO 14 mg as a new treatment indicated for patients with relapsing forms of multiple sclerosis (MS).</p><p>Studied in one of the largest clinical trial programs of any MS...Mon, 08 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291890&full=1JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved Quartette (levonorgestrel/ethinyl estradiol and ethinyl estradiol) tablets for the prevention of pregnancy. Quartette represents the next generation of extended regimen oral contraceptives to be approved by the FDA, and was designed to minimize breakthrough...Tue, 02 Apr 2013 12:00:00 AM GMThttp://www.zacks.com/stock/news/95780/astellas-acofide-approved-in-japanAstellas Pharma, Inc. and Zeria Pharmaceutical Co., Ltd. recently announced that it received approval from Japans Ministry of Health, Labour and Welfare (MHLW) for Acofide for the treatment of functional dyspepsia (FD). The regulatory application was based on a multicenter, randomized, double-blind, parallel-group and placebo-controlled phase III clinical study. The results showed statistically significant...Fri, 29 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291524&full=1WAYNE, N.J.</span> and <span class"xn-location">SOUTH SAN FRANCISCO, Calif.</span>, <span class"xn-chron">March 25, 2013</span> /PRNewswire/ -- Bayer HealthCare and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced today that the Ministry of Health, Labor and Welfare (MHLW) in <span class"xn-location">Japan</span> has approved Stivarga (regorafenib) tablets for the treatment of patients...Tue, 26 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291391&full=1EAST HANOVER, N.J.</span>, <span class"xn-chron">March 22, 2013</span> /PRNewswire/ -- Novartis announced today that the US Food and Drug Administration (FDA) has approved TOBI Podhaler (tobramycin inhalation powder) 28 mg per capsule for the management of cystic fibrosis (CF) patients with <i>Pseudomonas aeruginosa</i> (<i>Pa</i>) bacteria in the lungs. <i>Pa</i> is the leading cause...Mon, 25 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291404&full=1COPENHAGEN, Denmark, March 25, 2013 (GLOBE NEWSWIRE) -- Genmab A/S (GEN.CO) and GlaxoSmithKline (GSK) announced today the approval of Arzerra (ofatumumab) by the Japanese Ministry of Health, Labor and Welfare (MHLW) for use in patients with relapsed / refractory CD20-positive chronic lymphocytic leukemia (CLL). The approval triggers a milestone payment of DKK 20 million from GSK to Genmab.</p><p...Mon, 25 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291413&full=1NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (PFE) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved XELJANZ (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis (RA) who have had an inadequate response to existing therapies. XELJANZ may be used in patients in whom clinical symptoms due to the disease remain even after appropriate treatment...Mon, 25 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290882&full=1NEW YORK and CARMIEL, Israel, March 18, 2013 (GLOBE NEWSWIRE) -- Pfizer Inc. (PFE) and Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (PLX.TA) announced today that the Brazilian National Health Surveillance Agency (ANVISA, Agencia Nacional de Vigilancia Sanitaria) has granted regulatory approval to UPLYSO(TM) (alfataliglicerase) for the long-term enzyme replacement therapy for adults with a confirmed...Tue, 19 Mar 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/03/18/us-novartis-jetrea-idUSBRE92H05220130318Novartis said its Alcon unit got a green light from the European Commission for Jetrea, a drug that treats an eye condition that can lead to blindness. Jetrea is the first eye drug to treat vitreomacular traction (VMT) associated with macular hole that can cause progressive sight-threatening symptoms and irreversible vision loss, Novartis said in a statement on Monday. Novartis has acquired the rights...Mon, 18 Mar 2013 12:00:00 AM GMThttp://www.rttnews.com/2070254/eu-approves-roche-s-perjeta-to-treat-metastatic-breast-cancer.aspx?type=qf&utm_source=google&utm_campaign=sitemapRoche announced that it has received approval from European regulators for its perjeta drug to help treat breast cancer. The approval comes from the European Medicines Agency and covers patients with previously untreated HER2-positive metastatic breast cancer. The drug is approved in combination with two other treatments - Herceptin and docetaxel - in adult patients who have not received previous anti...Wed, 06 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289115&full=1TOKYO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announced the U.S. Food and Drug Administration (FDA) has approved ABILIFY MAINTENA (aripiprazole) for extended- release injectable suspension, an intramuscular (IM) depot formulation indicated for the treatment of schizophrenia.</p><p>ABILIFY MAINTENA is the first dopamine D...Fri, 01 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289122&full=1Basel, March 1, 2013 - Novartis announced today that the European Commission (EC) has approved llaris (canakinumab, ACZ885) in the treatment of patients with acute gouty arthritis who suffer frequent attacks, and whose symptoms cannot or should not be managed with current treatment options. Ilaris is the first biologic approved in the EU for symptomatic pain relief in a gouty arthritis indication...Fri, 01 Mar 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/02/28/lundbeck-drug-idUSL6N0BS7BV20130228Danish drugmaker Lundbeck has received European Union approval for Selincro, its innovative drug to fight alcohol dependency, a small boost in its fight against falling sales and heavy investment in new products. The EU decision, which follows a positive recommendation from the European Medicines Agency in December, will allow Lundbeck to launch the drug on the market in mid-2013, the company said...Thu, 28 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289083&full=1NOTTINGHAM, UK February 27, 2013 Novozymes Biopharma, part of Novozymes A/S, a world leader in bioinnovation, has announced that one of its leading customers has achieved approval of a medical device in Japan using Recombumin Alpha - formerly Albucult, a recombinant human albumin (rAlbumin) product. Recombumin Alpha is used by MAQUET in a version of the companys proprietary BIOLINE Coating...Thu, 28 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288808&full=1FLORHAM PARK, N.J.</span>, <span class"xn-chron">Feb. 26, 2013</span> /PRNewswire/ -- Shionogi Inc., <span class"xn-location">the United States</span> (U.S.)-based company of Shionogi &amp; Co., Ltd., today announced that the U.S. Food and Drug Administration (FDA) has approved Osphena<span></span> (ospemifene) tablets for the treatment of moderate to severe dyspareunia (painful intercourse), a symptom...Wed, 27 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288392&full=1SOUTH SAN FRANCISCO, Calif. February 22, 2013 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy...Tue, 26 Feb 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130225by Richard Daverman, PhD</p><p>February 25, 2013 -- Pfizer has been granted China approval for Xalkori (crizotinib), an innovative treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive. The ALK-positive variation, which comprises between 3% and 5% of all NSCLC tumors, must be proved by a biomarker test. Pfizer...Tue, 26 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288350&full=1MUMBAI, India and BALTIMORE, February 22, 2013 /PRNewswire/ -- Approval to add to growing SUPRAX Franchise</p><p>Pharma major, Lupin Ltd., announced today that its subsidiary, Lupin Pharmaceuticals Inc. (collectively, Lupin) has received approval for SUPRAX (Cefixime) for Oral Suspension, 500 mg/5mL from the United States Food and Drugs Administration (FDA). Lupin expects to commence shipping...Fri, 22 Feb 2013 12:00:00 AM GMThttp://www.rttnews.com/2056950/aurobindo-gets-fda-nod-for-generic-equivalents-of-actos-and-actoplus-met-tablets.aspx?type=in&utm_source=google&utm_campaign=sitemapAurobindo Pharma today said it has received US health regulator's approval to market anti-diabetes drug Pioglitazone Tablets in the American market. The drug firm has received approval from US Food and Drug Administration (USFDA) to manufacture and market Pioglitazone Tablets and its earlier tentatively approved combination of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets, Aurobindo...Fri, 15 Feb 2013 12:00:00 AM GMThttp://www.moneycontrol.com/news/business/torrent-pharma-gainsusfda-nod-for-genericsactos_825331.htmlTorrent Pharmaceuticals gained more than one percent intraday on Friday as the company received approval from US FDA for generics of Actos and Actoplus Met. Takeda Global's Actos and Actoplus are anti-diabetes drugs. At 15:08 hours IST, shares rose 0.71 percent to Rs 700 on Bombay Stock Exchange.Fri, 15 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=287662&full=1JERUSALEM--(BUSINESS WIRE)-- Teva Pharmaceutical Industries Ltd. (TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for the generic version of Shires Adderall XR Capsules, 5mg, 10mg, 15mg, 20mg, 25mg and 30 mg capsules for the treatment of attention deficit hyperactivity disorder. Adderall XR had annual sales, including...Fri, 15 Feb 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130212by Richard Daverman, PhD</p><p>February 13, 2013 -- Celgene Corporation was granted approval for Revlimid (lenalidomide) by the SFDA for Revlimid (lenalidomide) to treat multiple myeloma. The approval, which is the first for Celgene in China, includes an Import Drug License. Revlimid is indicated for use in combination with dexamethasone in patients with relapsed or refractory multiple myeloma...Wed, 13 Feb 2013 12:00:00 AM GMThttp://www.sfgate.com/business/article/Sun-Pharma-rises-on-OK-of-generic-Doxil-4254227.php#ixzz2K91DFWhhHealth regulators have approved a generic version of the cancer drug Doxil in a move that could ease a months-long shortage that has threatened the lives of thousands of patients. The Food and Drug Administration said on Monday it approved a version of Doxil, known generically as doxorubicin HCI liposome injection, that is made by Sun Pharma Global FZE, a subsidiary of India's Sun Pharmaceutical Industries...Thu, 07 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286663&full=1DUBLIN, Ireland, Feb. 5, 2013 (GLOBE NEWSWIRE) -- Warner Chilcott plc (WCRX) today announced that the United States Food and Drug Administration (FDA) has approved its new 400 mg mesalamine product indicated for the treatment of ulcerative colitis. The product will be marketed as DELZICOL(TM) (mesalamine) 400 mg delayed-release capsules. The Company anticipates that it will commercially launch DELZICOL...Wed, 06 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286672&full=1PARIS</span> and <span class"xn-location">TARRYTOWN, N.Y.</span>, <span class"xn-chron">Feb. 5, 2013</span> /PRNewswire/ -- Sanofi (EURONEXT: <b>SAN</b> and NYSE: <b>SNY</b>) and Regeneron Pharmaceuticals, Inc. (NASDAQ: <b>REGN</b>) today announced that the European Commission (EC) has granted marketing authorization in the European Union for ZALTRAP 25mg/ml concentrate for solution for infusion...Tue, 05 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286527&full=1Paris, France - February 4, 2013 - Sanofi (EURONEXT : SAN and NYSE : SNY) announced today that the European Commission has granted Marketing Authorisation in Europe for Lyxumia (lixisenatide). Lyxumia, the first once-daily prandial GLP-1 receptor agonist, is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal...Mon, 04 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285774&full=1DEERFIELD, Ill.</span> and <span class"xn-location">OSAKA, Japan</span>, <span class"xn-chron">Jan. 25, 2013</span> /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Pharmaceuticals <span class"xn-location">U.S.A.</span>, Inc. today announced that <span class"xn-location">the United States</span> (U.S.) Food and Drug Administration (FDA) has...Tue, 29 Jan 2013 12:00:00 AM GMTJan. 23, 2013 -- The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).</p><p>NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions...Thu, 24 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285575&full=1GTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: MEDA AB (publ)(STO:MEDAA) Dymista has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial allergic rhinitis. National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches...Thu, 24 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285428&full=1MUMBAI and BALTIMORE, January 22, 2013 /PRNewswire/ -- Pharma major, Lupin Ltd., announced today that its subsidiary Lupin Pharmaceuticals Inc. (collectively Lupin) has received final approval for its Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg / 0.02 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Watson Laboratories, Inc.'s Lutera 28 Tablets...Wed, 23 Jan 2013 12:00:00 AM GMThttp://www.rttnews.com/2040779/novartis-meningococcal-group-b-vaccine-bexsero-gets-eu-approval-update.aspx?type=bnNovartis clinched European approval for the first vaccine against meningitis B, and will seek to sell the drug as soon as possible. "Novartis is working with health authorities to provide access to Bexsero as soon as possible," the Swiss drugmaker said in a statement on Tuesday. There is currently no approved vaccine offering broad protection against "MenB," this particular type of meningitis. Novartis...Tue, 22 Jan 2013 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/eu_nod_for_novo_nordisks_tresiba_and_ryzodeg_459776The European Commission has issued clearance to market Novo Nordisk's diabetes therapies, Tresiba and Ryzodeg, across 27 European Union (EU) states. Novo Nordisk anticipates launching Tresiba, brand name of insulin degludec, in the UK and Denmark during the first six months of 2013 and in other states all through 2013 and 2014. The company will offer Tresiba in two concentrations with 80 and 160 units...Tue, 22 Jan 2013 12:00:00 AM GMTLEUVEN, Belgium, January 18, 2013 -- /PRNewswire/ -- Positive opinion clears the way for the potential EMA approval of JETREA as the first pharmacological option for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter less than or equal to 400 microns</p><p>ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused...Mon, 21 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284911&full=1CORK, Ireland, January 16, 2013 /PRNewswire/ -- Janssen R&D Ireland announced today that the European Commission (EC) has approved a new PREZISTA (darunavir) 800mg tablet allowing people living with HIV to take one darunavir tablet once a day. Darunavir is indicated in combination with other antiretrovirals for the treatment of human immunodeficiency virus (HIV-1) infection in treatment-experienced...Wed, 16 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130111005475&newsLang=enBEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV (Janssen) announced today that the European Commission (EC) has approved an extension to the license of the oral, once-daily medication ZYTIGA (abiraterone acetate). The approved broader indication for ZYTIGA now includes its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate...Fri, 11 Jan 2013 12:00:00 AM GMThttp://www.zenopa.com/news/801512902/roches-tamiflu-receives-positive-us-regulatory-opinionThe FDA recently expanded the approved use of oseltamivir phosphate to treat children older than 2 weeks who have exhibited symptoms of flu for no longer than 2 days. Oseltamivir (Tamiflu, Roche) has not been approved for prevention of flu infection in this population, however, and the safety and efficacy to treat flu infection has not been established in children younger than 2 weeks old. Oseltamivir...Thu, 27 Dec 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/12/25/us-ucb-japan-idUSBRE8BO02I20121225Belgian pharmaceutical company UCB has secured two regulatory clearances in Japan, further cementing its worldwide shift to a new generation of drugs. The company said in a statement on Tuesday that the Japanese Ministry of Health, Labour and Welfare had approved UCB's Neupro patch to treat Parkinson's disease and moderate-to-severe Restleg Legs Syndrome in adults. Otsuka Pharmaceutical has the exclusive...Thu, 27 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283143&full=1TRENTON, N.J. -- Regulators in Japan have approved sales of an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., thats a potential blockbuster in a new category of medicines to prevent strokes and heart attacks. But thats only if it can win U.S. approval, as two rival drugs have done.</p><p>Pfizer and Bristol-Myers said Wednesday that Japan approved use...Thu, 27 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283123&full=1<div id"releaseBody"><p>BAGSVAERD DENMARK--(Marketwire - December 25, 2012) - Company announcement No 84 / 2012:<a href"http://hugin.info/2013/R/1667087/541141.pdf">http://hugin.info/2013/R/1667087/541141.pdf</a><p>This announcement is distributed by Thomson Reuters on behalf ofThomson Reuters clients. The owner of this announcement warrants that:<p>(i) the releases contained herein...Thu, 27 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283007&full=1BOCA RATON, Fla.</span>, Dec. 20, 2012 /PRNewswire/ -- Biotest AG<b></b>announced<b></b>today that Biotest Pharmaceuticals Corporation received approval for BIVIGAM for the treatment of patients with Primary Humoral Immunodeficiency (PI) from the U.S. Food and Drug Administration (FDA). BIVIGAM is the first polyspecific intravenous immune globulin manufactured in the U.S. by Biotest Pharmaceuticals...Wed, 26 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121220006104&newsLang=enPARIS--(BUSINESS WIRE)--Regulatory News: BioAlliance Pharma SA (Euronext Paris - BIO) (Paris:BIO), an innovative Company dedicated to the development of orphan oncology products and to supportive care products, announces the approval of Sitavig (acyclovir LauriadTM) for the treatment of recurrent labial herpes in 8 European countries*. The decentralized procedure, with Sweden as Reference Member State...Fri, 21 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282421&full=1LONDON</span>, <span class"xn-chron">Dec. 14, 2012</span> /PRNewswire/ -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved raxibacumab for the treatment of adult and pediatric patients with inhalational anthrax due to <i>Bacillus anthracis </i>in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax...Tue, 18 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282471&full=1LONDON</span>, <span class"xn-chron">Dec. 17, 2012</span> /PRNewswire/ -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved FLUARIX QUADRIVALENT (Influenza Virus Vaccine) for the immunisation of children (three years and older) and adults to help prevent disease caused by seasonal influenza (flu) virus subtypes A and type B contained...Mon, 17 Dec 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/12/14/us-roche-perjeta-idUSBRE8BD0KA20121214European health regulators recommended Roche's breast cancer drug Perjeta for approval on Friday, cementing the company's hopes that the drug will become the standard of care for an aggressive, incurable form of cancer. Roche is hoping that combining Perjeta with its older drug Herceptin will become the standard treatment for women with a form of cancer known as HER2-positive, which makes up about...Fri, 14 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281575&full=1CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today announced it has received European Commission approval of a product label expansion for the use of Thyrogen (thyrotropin alfa) with a wider irradiation dose range for postoperative thyroid remnant ablation. Thyrogen is used before radioiodine treatment to avoid temporarily discontinuing thyroid replacement...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281514&full=1<div id"releaseBody"><p>SUNYANI, GHANA--(Marketwire - December 06, 2012) - <table class"releaseLink"><tr><td class"releaseLink"><b>Highlighted Links</b></td></tr><tr><td><p>&nbsp;</p><a href"http://www2.marketwire.com/mw/mmframe?prid962509&attachid2174087">MacReport Media Publishing</a></td></tr><tr><td><p>&nbsp;</p><a href"http://www2.marketwire.com/mw/mmframe?prid962509&attachid21740...Thu, 06 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281405&full=1December 05, 2012 -- The European Commission has approved a revised formulation of Xaluprine (mercaptopurine oral suspension) which no longer contains the preservative propyl parabens. </p><p>The new formulation of the drug used to treat acute lymphoblastic leukaemia - is also free from artificial colours, artificial flavouring and sugar and so is particularly child-friendly.</p><p>Xaluprine...Wed, 05 Dec 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/11/29/us-astrazeneca-china-idUSBRE8AS0FT20121129AstraZeneca has won approval for its new heart drug Brilinta in China, an increasingly important market for the British pharmaceuticals group. China's State Food and Drug Administration has issued an drug import license for the product, meaning it will now be available for treating patients with acute coronary syndrome in the country, the company said on Thursday. Brilinta has proved better than the...Fri, 30 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280781&full=1<div id"releaseBody"><p>SUNYANI, GHANA--(Marketwire - November 28, 2012) - <table class"releaseLink"><tr><td class"releaseLink"><b>Highlighted Links</b></td></tr><tr><td><p>&nbsp;</p><a href"http://www2.marketwire.com/mw/mmframe?prid959072&attachid2165131">Emerging World Pharma Inc.</a></td></tr><tr><td><p>&nbsp;</p><a href"http://www2.marketwire.com/mw/mmframe?prid959072&attachid21651...Wed, 28 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280760&full=1BARCELONA, Spain and CAMBRIDGE, Massachusetts, November 28, 2012 /PRNewswire/ -- Constella (linaclotide) is the first and only medicine approved by the European Commission for the symptomatic treatment of moderate to severe IBS-C in adults, that improves abdominal pain/discomfort, bloating and constipation</p><p> First launches in Europe are expected in the first half of 2013</p><p> IBS...Wed, 28 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280594&full=1TARRYTOWN, N.Y.</span>, <span class"xn-chron">Nov. 27, 2012</span> /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). According to the European Medicines Agency (EMA) approved Summary...Tue, 27 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280381&full=1Basel, November 20, 2012 - Novartis announced today that the US Food and Drug Administration (FDA) approved the use of Flucelvax (Influenza Virus Vaccine), the first cell-culture-derived vaccine, for individuals 18 years of age and older[3].</p><p>Flucelvax utilizes full-scale cell-culture manufacturing technology, an alternative production method to traditional egg-based production[1]. Cell...Mon, 26 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280459&full=1CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Genzyme, a Sanofi company, (EURONEXT: SAN and NYSE: SNY) announced today that the Australian Therapeutic Goods Administration (TGA) has approved AUBAGIO (teriflunomide) 14 mg as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). The TGA approval will enable health professionals to prescribe AUBAGIO 14 mg in Australia...Mon, 26 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280466&full=1HATFIELD, England, November 22, 2012 /PRNewswire/ -- The All Wales Strategic Medical Group (AWSMG) has approved Zebinix (eslicarbazepine acetate) for the treatment of partial seizures in highly refractory patients who remain uncontrolled with, or are intolerant to, other anti-epileptic medicine combinations. Eslicarbazepine acetate is licenced in Europe as an adjunctive therapy for adults with partial...Mon, 26 Nov 2012 12:00:00 AM GMThttp://www.rttnews.com/2009830/bristol-myers-squibb-and-pfizer-obtain-eu-approval-for-eliquis.aspx?type=qf&utm_source=google&utm_campaign=sitemapEuropean health regulators on Tuesday approved an eagerly anticipated blood thinner developed by Bristol-Myers Squibb Co and Pfizer Inc for preventing strokes and blood clots in patients with an irregular heartbeat known as atrial fibrillation, the companies said. The drug Eliquis, also known as apixaban, is widely considered one of the most important new products for the two U.S. drugmakers, with...Fri, 23 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280133&full=1LONDON</span>, <span class"xn-chron">Nov. 19, 2012</span> /PRNewswire/ -- GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the U.S. Food and Drug Administration (FDA) has approved PROMACTA for the treatment of thrombocytopenia (low blood platelet counts) in patients with chronic hepatitis C to allow them to initiate and maintain interferon-based therapy. PROMACTA is the first supportive care...Fri, 23 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=279824&full=1PARIS & LONDON--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) today announced that the European Commission has approved Forxiga (dapagliflozin) tablets for the treatment of type 2 diabetes in the European Union (EU). Forxiga is a selective and reversible inhibitor of sodium-glucose cotransporter 2 (SGLT2) that works independently of insulin to help remove excess...Fri, 16 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=279605&full=1<div class"xn-content"><p><span class"xn-location">BASEL, Switzerland</span>, <span class"xn-chron">Nov. 13, 2012</span> /PRNewswire/ -- Syngenta today announced that it has received European Union (EU) approval for isopyrazam, the first active ingredient from its strong pipeline of next generation fungicides. Approval represents a major step forward in the control of a wide spectrum of damaging...Tue, 13 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/11/02/us-genetherapy-europe-idUSBRE8A10K520121102European officials have approved the Western world's first gene therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty genes.<br><br>The formal clearance from the European Commission paves the way for a launch next summer of the treatment for an ultra rare genetic disease that will cost around 1.2 million euros ($1.6 million) per patient...Fri, 02 Nov 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20121101_1November 1, 2012 -- Sihuan Pharmaceutical reported that its new gastrointestinal generic drug, Roxatidine Acetate Hydrochloride for Injection, received SFDA approval. As a first-to-market generic, it will enjoy four years of exclusivity in China. The drug, which was approved in both oral and injectible forms, is a treatment for ulcers and GI bleeding. More details....Fri, 02 Nov 2012 12:00:00 AM GMThttp://www.rttnews.com/1991852/teva-receives-fda-approval-for-synribo-for-injection-quick-facts.aspx<a href"http://www.biospace.com/company_profile.aspx?CompanyId97304&typepartner&sourceNewsStoryProfile"><b>Teva Pharmaceuticals</b></a> | <a href"http://www.biospace.com/jobs/search-results/CustomerId163403?typepartner&sourceNewsStoryJobs"><b>Jobs at Teva Pharmaceuticals</b></a><br><br>The U.S. Food and Drug Administration on Friday said it has approved a new leukemia treatment from Teva...Tue, 30 Oct 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121026005648&newsLang=enINGELHEIM, Germany--(BUSINESS WIRE)--For Non-U.S. and Non-U.K. Media: Boehringer Ingelheim and Eli Lilly and Company today announced that the European Commission has approved an expanded therapeutic indication for the DPP-4 inhibitor Trajenta (linagliptin) to include use in combination with insulin in adults with Type 2 Diabetes.Fri, 26 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277344&full=1Basel, October 25, 2012 Novartis announced today that Certican (everolimus) has been approved by European Health Authorities for the prophylaxis of organ rejection in adult patients receiving a liver transplant. In the European Union (EU), Certican, a mammalian target of rapamycin (mTOR) inhibitor, is also approved for the prophylaxis of organ rejection in adult patients at low-moderate immunologic...Thu, 25 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276840&full=1Halle (Germany), 22 October 2012 - Scil Proteins Production GmbH, a private biotech company specializing in the research, development and production of recombinant proteins, announced today that the European Medicines Agency (EMA) has approved Scil Proteins Halle facilities for manufacturing of Reteplase, marketed by Actavis as Rapilysin.</p><p>Scil Proteins originally signed an agreement with...Mon, 22 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276819&full=1 <div class"xn-content"><p><span class"xn-location">EXTON, Pa.</span>, <span class"xn-chron">Oct. 22, 2012</span> /PRNewswire/ -- ViroPharma Incorporated (NASDAQ: VPHM) today announced that Health Canada has granted a Notice of Compliance (NOC) and approved a New Drug Submission (NDS) for Cinryze<span></span> (C1 inhibitor [human]). Approval of Cinryze was granted for routine prevention of angioedema...Mon, 22 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276449&full=1LEUVEN, Belgium, October 18, 2012 /PRNewswire/ --</p><p>JETREA is the first pharmacological agent approved for the treatment of symptomatic VMA</p><p>Conference call scheduled today at 15.00 CET (9.00 ET).</p><p>ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced today that...Thu, 18 Oct 2012 12:00:00 AM GMThttp://www.rttnews.com/1979443/european-commission-gives-green-light-to-bayer-healthcare-s-flexyess.aspx?type=qf&utm_source=google&utm_campaign=sitemapBayer AG (BYR.L: Quote,BAYRY.PK: Quote,BAYZF.PK: Quote) said the European Commission has issued its go ahead for the approval of the company's subgroup Bayer HealthCare's new low-dose combined oral contraceptive Flexyess. Based on the European Commission's positive decision, the Health Authorities of the EU Member States will grant national approvals in the coming weeks. Flexyess will be the first...Wed, 10 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274930&full=1<div class"xn-content"><p><span class"xn-location">BRISBANE, Calif.</span>, <span class"xn-chron">Oct. 2, 2012</span> /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced that Health Canada has approved Esbriet (pirfenidone) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adult patients. IPF is a progressive and uniformly fatal disease that affects approximately...Wed, 03 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274560&full=1BEERSE, Belgium--(BUSINESS WIRE)--Janssen-Cilag International NV (Janssen) announced today that the European Commission has approved the marketing authorisation for DACOGEN (decitabine) for the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organisation (WHO) classification, who are not candidates...Mon, 01 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274555&full=1TOKYO, October 1, 2012 /PRNewswire/ --</p><p> Approval triggers $10m milestone payment to Sosei</p><p> Seebri Breezhaler 44 mcg delivered dose approved for maintenance treatment of COPD will be available to patients and physicians in some EU markets by year-end</p><p> In GLOW trials, Seebri Breezhaler improved lung function, reduced shortness of breath, reduced exacerbations...Mon, 01 Oct 2012 12:00:00 AM GMT