http://www.biospace.comBioSpace RSS GeneratorTue, 18 Jun 2013 18:52:37 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.bloomberg.com/news/2013-06-17/novo-drops-as-new-lilly-drug-threatens-victoza-copenhagen-mover.htmlStaying 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>Novo Nordisk A/S (NOVOB) fell the most among benchmark stocks in Copenhagen trading after Bank of America Merrill Lynch said the diabetes drug companys Victoza medicine faces a real threat from an Eli Lilly...Mon, 17 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=300237&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>DEERFIELD, Ill.</span> and <span class"xn-location">OSAKA, Japan</span>, <span class"xn-chron">June 17, 2013</span> /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary...Mon, 17 Jun 2013 12:00:00 AM GMThttp://www.washingtonpost.com/national/health-science/obama-administration-drops-fight-to-keep-age-restrictions-on-plan-b-sales/2013/06/10/a296406e-d22a-11e2-a73e-826d299ff459_story.htmlStaying 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>The Obama administration will scrap age restrictions on the sale of emergency contraception pills, making the morning-after pill available to women and girls without a prescription.<br><br>Help employers...Tue, 11 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=299554&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><div id"releaseBody"><p>LEUVEN, BELGIUM--(Marketwired - June 07, 2013) - TiGenix (NYSE Euronext: TIG), the European leader in cell therapy, today provided an update on the commercial prospects of ChondroCelect...Mon, 10 Jun 2013 12:00:00 AM GMThttp://www.philly.com/philly/business/20130604_FDA_weighs_lifting_restrictions_on_Glaxo_s_Avandia.htmlStaying 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>A former blockbuster diabetes pill that was subjected to major safety restrictions in 2010 may be less risky than once thought, according to the latest analysis of the much-debated GlaxoSmithKline drug Avandia...Thu, 06 Jun 2013 12:00:00 AM GMThttp://www.pharmalive.com/sacre-bleu-european-agency-rebuffs-french-regulator-over-bayer-acne-pillStaying 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>Now what will French authorities do? After months of debate, the European agency that coordinates regulation of medicines on the continent has decided that the controversial Diane 35 acne pill sold by Bayer...Thu, 30 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130523005608&newsLang=enStaying 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>The Swedish Dental and Pharmaceutical Benefits Agency, TLV has decided to fully reimburse Dymista. Dymista is a prescription drug for the treatment of seasonal and perennial allergic rhinitis and studies have...Thu, 23 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=297241&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>PRLog (Press Release) - May 19, 2013 - NEW YORK -- Immune Response BioPharma, Inc. Sets Pricing of REMUNE Vaccine in Thailand in the range of Between $75-100 Per Dose for Emergency Approval of HIV/AIDS Vaccine...Mon, 20 May 2013 12:00:00 AM GMThttp://www.washingtonpost.com/business/merck-glaxo-health-groups-bringing-cervical-cancer-vaccines-to-girls-in-poorest-countries/2013/05/09/aa1ef328-b89c-11e2-b568-6917f6ac6d9d_story.htmlStaying 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>Merck & Co. (MRK) and GlaxoSmithKline Plc (GSK) will cut the prices of their cervical cancer vaccines for some countries in the first large-scale effort to get the shots to girls in the worlds poorest regions...Thu, 09 May 2013 12:00:00 AM GMThttp://www.pharmalive.com/non-profit-to-bayer-withdraw-false-vitamin-claims-or-elseStaying 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>Threatening another showdown over product claims, a non-profit group has put Bayer on notice that a lawsuit will be filed charging the drugmaker with making unsubstantiated and illegal claims about the ability...Thu, 09 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=295935&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>9th May 2013, Billerica, MA and London, UK EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, and Plasticell of London, UK, today announced the availability of OsteoMAX-XF, the...Thu, 09 May 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/05/06/544692/0/en/Biotie-Selincro-launched-in-the-United-Kingdom.htmlStaying 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>Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has launchedSelincro in the United Kingdom. According to the terms of the license agreementbetween Biotie and Lundbeck for Selincro, Biotie...Mon, 06 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=295485&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<div id"releaseBody"><p>TURKU, FINLAND--(Marketwired - May 06, 2013) - Biotie today announced that its partner H.Lundbeck A/S (Lundbeck) has launched Selincro in the United Kingdom. According to the...Mon, 06 May 2013 12:00:00 AM GMThttp://www.pharmalive.com/novartis-probes-japanese-scandal-over-diovan-researchStaying 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>The scandal over clinical trials generated by Japanese researchers for the Diovan blood pressure drug sold by Novartis has now widened. The drugmaker has now acknowledged publicly for the first time that...Fri, 03 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294989&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>Brentwood, May 1 2013: Martindale Pharma, a leader in the manufacture and supply of specialty pharmaceuticals, is pleased to announce the UK launch of Tapclob 5mg/5ml and Tapclob 10mg/5ml Oral Suspension...Wed, 01 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=294877&full=1April 30, 2013, Billerica, MA and London, UK - EMD Millipore, the Life Science division of Merck KGaA of Darmstadt, Germany, and Plasticell of London, UK, today announced the availability of OsteoMAX-XF, the first fully defined, xeno-free human mesenchymal stem cell differentiation medium for the differentiation of mesenchymal stem cells into osteocytes. Mineralization can be detected in less than...Tue, 30 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=293991&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><div id"releaseBody"><p>TURKU, FINLAND--(Marketwired - April 22, 2013) - BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE 22 April 2013 at 9:00 a.m.<p><b>Biotie: Selincro launched in first European...Mon, 22 Apr 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130418_1by Richard Daverman, PhD</p><p>April 18, 2013 -- Cipla Ltd., an Indian generic drug company, has begun marketing a biosimilar version of the rheumatoid arthritis treatment Enbrel, which it sources from Shanghai CP Guojian Pharmaceutical Co. CPGJ has been selling the drug in China since 2006, where it has been given to more than 50,000 patients. Cipla described its relationship with CPGJ as a ...Fri, 19 Apr 2013 12:00:00 AM GMThttp://www.outsourcing-pharma.com/Contract-Manufacturing/GSK-s-Contract-Manufacturing-Delays-Cause-Shortage-of-Restless-Leg-Treatment?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyrightThe FDA announced a shortage of Horizant (gabapentin enacarbil; GlaxoSmithKline) 600mg extended-release tablets. Horizant is a prodrug of gabapentin that is indicated for postherpetic neuralgia and for moderate-to-severe primary restless legs syndrome in adults. GlaxoSmithKline is currently experiencing a backorder situation. XenoPort will assume manufacturing and commercialization of Horizant from...Thu, 18 Apr 2013 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/ema_recommends_heart_risk_restriction_for_serviers_protelos_471361EMA advisors have called for a restriction on the use of Servier's osteoporosis drug Protelos/Osseor (strontium ranelate) after linking it to serious potential side effects. The move comes after their analysis of clinical trial data showed an increased risk of heart problems, including heart attack. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) said the key data came from studies involving...Mon, 15 Apr 2013 12:00:00 AM GMThttp://www.thehindubusinessline.com/companies/dr-reddys-labs-withdraws-muscle-relaxant-drug-from-us-market/article4606133.eceDr Reddys Laboratories has initiated recall of its tizanidine tablets, used as a muscle relaxant, from the US market due to labelling issues. According to a notification issued by United States Food and Drug Administration (FDA), the recall has been initiated voluntarily by the drug maker and the same was intimated to the drug regulator through a letter on March 19. Tizanidine is a drug that is used...Thu, 11 Apr 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=292946&full=1Porton Down, UK; 10 April 2013: GW Pharmaceuticals, the biopharmaceutical company focused on discovering, developing and commercialising novel therapeutics from its proprietary cannabinoid product platform, announced that Sativex, its treatment for spasticity in Multiple Sclerosis, has today been rescheduled in the UK from Schedule 1 under the Misuse of Drugs Act to Schedule 4, Part 1. The move follows...Wed, 10 Apr 2013 12:00:00 AM GMThttp://www.pharmalive.com/novartis-retracted-papers-and-big-selling-drugA simmering controversy over published research for the Diovan blood pressure drug sold by Novartis and researchers at a Japanese university is heating up. Several papers have already been retracted amid heightened scrutiny over a relationship between the drugmaker and the Kyoto Prefectural University of Medicine, The Mainichi reports. Three papers submitted by university researchers found Diovan...Tue, 02 Apr 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130329005093&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Dr. Reddys Laboratories (NYSE: RDY) announced today that it has launched Zenatane (Isotretinoin Capsules USP) in 20 mg and 40 mg, a therapeutically equivalent generic version of Accutane (Isotretinoin Capsules USP) in the US market on March 28, 2013 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddys ANDA for Zenatane...Fri, 29 Mar 2013 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/nice_pfizers_lung_cancer_drug_xalkori_too_expensive_for_nhs_469241Patients in England and Wales with lung cancer should not have access to Pfizer's Xalkori through the NHS at the drug's current price, according to new draft guidance from cost-effectiveness body the National Institute for Health and Clinical Excellence (NICE). NICE said that despite being a clinically effective treatment, Xalkori (crizotinib) was not a cost-effective use of NHS resources for use in...Thu, 28 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291831&full=1<div id"releaseBody"><p>LEIDEN, THE NETHERLANDS--(Marketwire - March 28, 2013) - Leiden, the Netherlands, March28th, 2013. Biotech company Pharming Group NV("Pharming") (EURONEXT BRUSSELS: PHARM) announced today that it hasreceivedapproval from the European Medicines Agency (EMA) for Sanofi Chimie tomanufacture drug substance for Pharming's product Ruconest&#174; at theirAramon...Thu, 28 Mar 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130326005819&newsLang=enINGELHEIM, Germany--(BUSINESS WIRE)--A new perspective from the U.S. Food and Drug Administration (FDA) published in the New England Journal of Medicine1 states that the agency has not changed its recommendations regarding Pradaxa (dabigatran etexilate), following the November 2012 Mini-Sentinel evaluations.2 The FDA stated that bleeding rates associated with new use of Pradaxa do not appear to be...Tue, 26 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291423&full=1Just weeks after questions were raised about a GlaxoSmithKline flu vaccine and its links to narcolepsy, the FDA has issued a complete response letter for a newer vaccine that contains the same supercharged adjuvant, which is an agent that can stimulate the immune system and increase the response to a vaccine. The new vaccine is called Q-Pan H5N1 and was approved unanimously last November by an FDA...Mon, 25 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291506&full=1March 25, 2013 -- Effective immediately, or as existing contracts permit, BASF is raising its prices for N,N-Dimethylformamide (DMF) in Europe by 30 per ton or by the equivalent amount in local currency. </p><p>DMF is a versatile organic solvent that is miscible with water and many other solvents. DMF is used in various industrial applications, for example in the production...Mon, 25 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291014&full=1Porton Down, UK, 19 March 2013: GW Pharmaceuticals plc (AIM: GWP, GW), the specialty pharmaceutical company focused on cannabinoid science, today provides an update on pricing negotiations in Germany for Sativex being conducted by GWs licensing partner, Almirall S.A. (Almirall).</p><p>In June 2012 the German Federal Joint Committee (G-BA), the national reimbursement authority, determined...Wed, 20 Mar 2013 12:00:00 AM GMThttp://www.foxbusiness.com/news/2013/03/08/sanofi-us-probes-disclosures-to-fda-about-patient-response-to-plavix/The U.S. Justice Department is investigating disclosures to the Food and Drug Administration about the variability in patient responses to the blood-thinning drug Plavix, according to Sanofi (SNY), one of the drug's co-marketers. Sanofi became aware of the investigation in June 2012, but disclosed it for the first time in an annual report filed Thursday with the U.S. Securities and Exchange Commission...Mon, 11 Mar 2013 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/novartis,_roche_under_scrutiny_in_italy_on_avastinlucentis_collusion_claims_464596Antitrust authorities in Italy have opened an investigation into claims Novartis and Roche colluded to restrict the availability of a lower-cost treatment for age-related macular degeneration, a leading cause of blindness. The Italian competition authority (AGCM) acted after two private healthcare facilities complained that Roche was blocking use of its Avastin (bevacizumab) product for ophthalmic...Fri, 22 Feb 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130220006935&newsLang=enTOKYO--(BUSINESS WIRE)--R-Tech Ueno (JASDAQ:4573): Sucampo Pharmaceuticals, Inc. (hereinafter referred to as "Sucampo") announced that RESCULA Eye Drops had been launched in the U.S. market. (See Sucampo's press release dated February 19, 2013.) RESCULA Eye Drops may be used as a first-line agent or concomitantly with other topical ophthalmic drug products with ocular hypotensive effect for treatment...Thu, 21 Feb 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/02/13/novartis-britain-jakavi-idUSL5N0BCB7320130213A new drug from Novartis for myelofibrosis, a rare blood cancer, is not worth using on the state health service, Britain's healthcare cost watchdog said on Wednesday. The National Institute for Health and Clinical Excellence (NICE) said it had issued new draft guidance not recommending Jakavi because it could not be considered a cost-effective use of resources. The drug costs 3,600 pounds ($5,600...Wed, 13 Feb 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130206006567&newsLang=enBRAINTREE, Mass. & PARIS--(BUSINESS WIRE)--Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven pharmaceutical group and Braintree Laboratories, Inc., a US-based company specializing in the development, manufacturing and marketing of specialty pharmaceuticals announced today that Eziclen / Izinova (BLI-800)1 successfully completed its European decentralized registration procedure...Thu, 07 Feb 2013 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/nice_turns_down_diabetes_and_ovarian_cancer_drugs_for_nhs_use_462089Roche Holding AG (ROG)s anti-tumor drug Avastin failed for the second time in two months to win the backing of the U.K.s health-cost regulator as a treatment for ovarian cancer in a draft decision issued today. The National Institute for Health and Clinical Excellence recommended against the drug as an initial treatment for women with ovarian cancer that has spread beyond the ovarian lining and then...Fri, 01 Feb 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130201Shanghai, PR China February 1st, 2013 Luqa Pharmaceuticals today announces that Strataderm Gel is now available throughout China. Strataderm is an innovative silicone gel recently approved by the State Food and Drug Administration (SFDA).</p><p>Strataderm is a rapidly drying, non-sticky, transparent, silicone gel formulation for the treatment of scars, both old and new. Strataderm has been...Fri, 01 Feb 2013 12:00:00 AM GMThttp://www.pharmalot.com/2013/01/eu-charges-jj-and-novartis-with-pay-to-delay/In the latest bid by regulators to squash so-called pay-to-delay deals, the European Commission has filed a complaint against Johnson & Johnson and Novartis and its Sandoz generic subsidiary for allegedly conspiring to delay the generic introduction of a version of the fentanyl pain patch in the Netherlands. The move had been expected after European antitrust regulators opened a probe into the...Thu, 31 Jan 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/01/22/us-narcolepsy-vaccine-pandemrix-idUSBRE90L07H20130122Emelie Olsson is plagued by hallucinations and nightmares. When she wakes up, she's often paralyzed, unable to breathe properly or call for help. During the day she can barely stay awake, and often misses school or having fun with friends. She is only 14, but at times she has wondered if her life is worth living. Emelie is one of around 800 children in Sweden and elsewhere in Europe who developed narcolepsy...Mon, 28 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130123006323&newsLang=enWEYBRIDGE, England--(BUSINESS WIRE)--Alexion Pharma UK, a subsidiary of Alexion Pharmaceuticals, Inc., has been informed by the National Specialised Commissioning Team (NSCT) that the Ministers of Health have decided to not follow a positive recommendation by the Advisory Group for National Specialised Services (AGNSS) when assessing Soliris (eculizumab) as a treatment for patients with atypical haemolytic...Thu, 24 Jan 2013 12:00:00 AM GMThttp://www.bloomberg.com/news/2013-01-23/pfizer-s-eliquis-wins-nice-nod-for-irregular-heartbeat-patients.htmlPfizer Inc. (PFE) and Bristol-Myers Squibb Co. (BMY)s Eliquis won the backing of the U.K.s health-cost regulator for people with an irregular heartbeat, putting the drug in line to be the third new treatment recommended for such patients in the past year. The National Institute for Health and Clinical Excellence issued draft guidance recommending the blood thinner to prevent strokes in patients with...Wed, 23 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130116006239&newsLang=enTOKYO & PARIS--(BUSINESS WIRE)--Regulatory News: Teijin Pharma Limited, the core company of the Teijin Groups healthcare business, and Ipsen (Euronext: IPN; ADR: IPSEY) (Paris:IPN), today announced the launch of Somatuline 60/90/120 mg for subcutaneous injection in Japan for the treatment of acromegaly and pituitary gigantism (when response to surgical therapies is not satisfactory or surgical therapies...Thu, 17 Jan 2013 12:00:00 AM GMThttp://www.indianexpress.com/news/govt-moves-to-make-three-key-cancer-drugs-cheaper/1058247/In a move that will benefit thousands of cancer patients but is likely to upset pharma MNCs, the Department of Pharmaceuticals has started the process of issuing compulsory licences for three commonly used anti-cancer drugs, Trastuzumab (or Herceptin, used for breast cancer), Ixabepilone (used for chemotherapy) and Dasatinib (used to treat leukaemia). Compulsory licensing (CL) by the government allows...Mon, 14 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284312&full=1Last summer, GlaxoSmithKline agreed to plead guilty and pay $3 billion to resolve criminal and civil charges in connection with off-label promotion of several drugs, failing to report safety data and reporting false prices. One infraction, in particular, concerned a controversial study that was conducted for the Paxil antidepressant. Specifically, the feds noted the drugmaker participated in preparing...Thu, 10 Jan 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20121210005021&newsLang=enNEW YORK & BARCELONA, Spain--(BUSINESS WIRE)--Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM:MC) announced today that Tudorza Pressair (aclidinium bromide inhalation powder) 400mcg is now available in pharmacies throughout the United States. Tudorza is a long-acting anticholinergic recently approved by the U.S. Food and Drug Administration (FDA) for the long-term, maintenance treatment...Tue, 11 Dec 2012 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/pfizer_set_for_negative_nice_decision_on_inlyta_453429Pfizer Inc. (PFE)s Inlyta failed to win the backing of the U.K.s health cost regulator in draft guidance on the treatment of advanced kidney cancer, even after the company offered the National Health Service a discount. The preliminary decision applies to the use of the drug in patients who werent helped by the New York-based companys Sutent or treatments known as cytokines, the National Institute...Fri, 07 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121205005857&newsLang=enNEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) welcomes todays announcement from the GAVI Alliance that Pfizers pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), is now included in the expanded pediatric immunization program in Tanzania. Pneumococcal disease is one of the leading causes of vaccine-preventable deaths worldwide in...Wed, 05 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281400&full=1Kleinostheim, 05.12.2012 - curasan AG, listed on the General Standard (ISIN: DE 000 549 453 8), has introduced its new bone regeneration material CERASORB Ortho Paste to the German and European markets at the beginning of December.</p><p>CERASORB Ortho Paste is comprised of fine granules of the proven, fully resorbable, synthetic material CERASORB M Ortho suspended in a hyaluronic acid hydrogel...Wed, 05 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20121126005263&newsLang=enBETHESDA, Md.--(BUSINESS WIRE)--Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) (SPI) and Abbott (NYSE: ABT) today announced the availability of AMITIZA (lubiprostone) in Japan, a prescription medicine for the treatment of chronic constipation not caused by organic diseases. AMITIZA was approved by the Ministry of Health, Labor and Welfare (MHLW) in Japan in June. Millions of patients in Japan have...Mon, 26 Nov 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20121118005082&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Dr. Reddys Laboratories (NYSE:RDY) announced today that it has launched Sildenafil Tablets (20 mg), a bioequivalent generic version of REVATIO (Sildenafil) Tablets in the US market on November 16, 2012, following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddys ANDA for Sildenafil Tablets. The REVATIO brand had U.S. sales of approximately...Mon, 19 Nov 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/11/14/us-bayer-drugs-idUSBRE8AD0HV20121114German pharmaceutical and chemical company Bayer AG (BAYN.XE) said Wednesday it sees peak annual sales potential of 5.5 billion euros ($7 billion) for its five new drugs Xarelto, Stivarga, Alpharadin, Aflibercept and Riociguat. Bayer now includes the new drug Riociguat, which helps to treat pulmonary hypertension, in its sales forecast. The company said late last year that it sees peak sales potential...Wed, 14 Nov 2012 12:00:00 AM GMThttp://www.wisconsinrapidstribune.com/usatoday/article/1699521?odyssey=mod%7Cnewswell%7Ctext%7CFRONTPAGE%7CsA leading researcher has suggested that European governments should sue the drug firm Roche and that doctors and others boycott the companys products until it publishes missing data on Tamiflu. Peter Gtzsche, leader of the Nordic Cochrane Centre in Copenhagen, was responding to an open letter to Roche from BMJ Editor-in-chief, Dr Fiona Godlee. The letter is part of the BMJs open data campaign, aimed...Wed, 14 Nov 2012 12:00:00 AM GMThttp://www.nytimes.com/2012/11/09/business/sanofi-halves-price-of-drug-after-sloan-kettering-balks-at-paying-it.html?_r=0In an unusual move, a big drug company said it would effectively cut in half the price of a new cancer drug after a leading cancer center said it would not use the drug because it was too expensive. The move announced Thursday by Sanofi for the colon cancer drug Zaltrap could be a sign that the marketplace is becoming resistant to the unfettered increase in the prices of cancer drugs over the past...Fri, 09 Nov 2012 12:00:00 AM GMThttp://www.webmd.boots.com/asthma/news/20121109/asthma-treatment-no-longer-value-for-moneyBritain's health cost-effectiveness watchdog NICE plans to recommend against the use of Novartis's severe asthma drug Xolair, or omalizumab, after earlier endorsing it for adults only. The National Institute for Health and Clinical Excellence (NICE), which decides if medicines should be given on the state health service, said on Friday it had changed its mind in the light of evolving clinical evidence...Fri, 09 Nov 2012 12:00:00 AM GMThttp://zeenews.india.com/news/health/health-news/cipla-slashes-cancer-drug-prices-by-up-to-64_19558.htmlDrugmaker Cipla (CIPL.NS) cut prices of three cancer drugs between 50 percent and 64 percent with immediate effect, after it announced similar price cuts for three drugs early this year. Lung cancer drug Erlocip would cost 9,900 rupees for 30 tablets instead of 27,000 rupees earlier, while breast cancer treatment Docetax would be priced 1,650 rupees instead of 3,300 rupees, Cipla said in a statement...Thu, 08 Nov 2012 12:00:00 AM GMThttp://www.pharmalot.com/2012/11/astrazeneca-ptsd-and-a-buried-seroquel-study/File this under hidden clinical trial disorder. For a decade, the US military regularly prescribed its service members atypical antipsychotics, which are approved to treat schizophrenia and bipolar disorder, for various off-label uses, notably insomnia and post-traumatic stress disorder. And the antipsychotic that was most widely prescribed has been the Seroquel pill, which is sold by AstraZeneca...Thu, 08 Nov 2012 12:00:00 AM GMThttp://www.healthnewsreview.org/2012/10/bmj-pushes-roche-for-raw-data-on-tamiflu-trials/BMJ journal editor Fiona Godlee this week published an open letter to Roche, makers of the flu drug Tamiflu. Background provided by BMJ: Roche promised in 2009 to release full reports from clinical trials of oseltamivir in response to an investigation by the BMJ and the Cochrane Collaboration. In this open letter to John Bell, regius professor of medicine at Oxford University and a Roche board member...Wed, 31 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=277297&full=1Barcelona - 25th October 2012 - Phagenesis today launches the world's first approved treatment for acute dysphagia following stroke. </p><p>The Phagenyx system delivers calibrated electrical stimulus to the throat (oropharynx) for 10 minutes a day for three consecutive days to patients who suffer from dysphagia the inability to swallow safely - a debilitating condition that affects about half...Thu, 25 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276744&full=1<div id"releaseBody"><p>SOPHIA ANTIPOLIS CEDEX, FRANCE--(Marketwire - October 22, 2012) - <p> * Innovative device for differential diagnosis of acute conjunctivitis is Nicox's first commercial launch<p> * New visual identity unveiled to present Nicox as a specialty ophthalmic group<p>Nicox S.A. (PARIS: COX) today announces its United States (US)launch of AdenoPlus&#848...Mon, 22 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=276157&full=1BRACKNELL, UK--(BUSINESS WIRE)--</p><p>Indication</p><p>Acute Ischaemic Stroke</p><p>Product</p><p>Actilyse (alteplase, rt-PA)</p><p>NICE has issued final guidance on the use of alteplase (Actilyse) for the treatment of acute ischaemic stroke[1], which recommends initiation of treatment within 4.5 hours of onset of ischaemic stroke symptoms. This will give more patients access to...Tue, 16 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=275971&full=1PHILADELPHIA</span>, Oct.12, 2012 /PRNewswire/ -- Tarsa Therapeutics today announced an agreement in principle with Therapicon Slr to provide consulting assistance to the Italian firm in its challenge to the recent recommendation by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) to limit the use of calcitonin-containing medicines. Therapicon...Fri, 12 Oct 2012 12:00:00 AM GMThttp://www.thepharmaletter.com/file/116987/uks-nice-draft-guidance-backs-nhs-use-of-lucentis-in-dme.htmlDiabetic macular oedema (DMO) can now be treated with ranibizumab (Lucentis, Novartis) after the treatment was recommended by NICE. The watchdog originally published guidance in November last year but after the manufacturer produced evidence of the drug effectively treating patients with DMO, NICE agreed to look at it again. NICE now says ranibizumab should be considered as a potential treatment for...Fri, 05 Oct 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120927005528&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Dr. Reddys Laboratories (NYSE: RDY) announced today that it has launched Montelukast Sodium Oral Granules, a bioequivalent generic version of Singulair (montelukast sodium) oral granules in the US market on September, 26, 2012, following the approval by the United States Food & Drug Administration (USFDA) of Dr.Reddys ANDA for Montelukast Sodium Oral Granules.Thu, 27 Sep 2012 12:00:00 AM GMThttp://ycharts.com/analysis/story/delays_for_indias_ranbaxy_good_news_for_novartis_and_its_57_billion_drug_diovanRanbaxy LaboratoriesBSE 1.07 % has missed out on the "first -day launch" of its generic version of Novartis' blockbuster hypertension drug Diovan in the US, as it is yet to get the US food and Drug Administration's (FDA's) approval for the generic version of the drug, valsartan. India's largest drugmaker Ranbaxy has the exclusive rights to market the generic for 180 days, as it was the first company...Wed, 26 Sep 2012 12:00:00 AM GMThttp://www.bloomberg.com/news/2012-09-23/roche-5-7-billion-tumor-drug-sales-hinge-on-rival-tests.htmlAfter surgery, radiotherapy, chemotherapy, 80 visits to oncologists and more than 300 hours in clinics, Stephanie Butland decided she had had enough cancer treatment for one lifetime. The British author quit Roche Holding AG (ROG)s cancer drug Herceptin after half the time its normally prescribed. I was ready to say, Im done with cancer now and am back to my life, Butland said. I think its not...Mon, 24 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120921005162&newsLang=enUPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Orexo (STO:ORX): The Swedish specialty pharmaceutical company Orexo presents today its view on the future market for treatment of opioid dependence in the US. Opioid dependence is a clinical condition, which increasingly is being recognized as having a major societal impact and financial cost. Recent estimates indicate that in the US the cost to society...Fri, 21 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20120920005543&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Dr. Reddys Laboratories (NYSE: RDY) announced today that is has launched Amoxicillin Tablets, Capsules, and Oral Suspension, a bioequivalent generic version of Amoxil (Amoxicillin) Tablets, Capsules, and Oral Suspension in the US Market on September 17, 2012. Amoxicillin Tablets (500 mg and 875 mg), Capsules (250 mg and 500 mg), and Oral Suspension (125 mg/5 ml...Thu, 20 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273276&full=1<div id"releaseBody"><p>FOSTER CITY, CA--(Marketwire - September 18, 2012) - SciClone Pharmaceuticals, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerSCLN">SCLN</a>) today announced that consistent with the China government's review of pharmaceutical prices once a product has been included into the Reimbursement Drug List ("RDL"), the retail list price, or hospital pharmacy...Tue, 18 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=272912&full=1<div id"releaseBody"><p>SAN FRANCISCO, CA and TOKYO--(Marketwire - September 13, 2012) - Medivation, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerMDVN">MDVN</a>) and Astellas Pharma Inc. (TSE: 4503) today announced the availability of XTANDI&#174; (enzalutamide) capsules for patients with metastatic castration-resistant prostate cancer who have previously received docetaxel...Thu, 13 Sep 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120911005925&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Dr. Reddys Laboratories (NYSE: RDY) announced today that is has launched Metoprolol Succinate ER (Extended-Release) Tablets (25 mg, 50 mg, 100 mg & 200 mg), a bioequivalent generic version of Toprol-XL (Metoprolol Succinate) Tablets in the US market on September 10, 2012. Metoprolol ER (Extended-Release) Tablets (25 mg, 50 mg, 100 mg, & 200 mg) was approved by the...Tue, 11 Sep 2012 12:00:00 AM GMThttp://www.thisismoney.co.uk/money/markets/article-2200220/NICE-reconsider-Glaxo-drug-Benlysta-following-drugmakers-appeal.html?ito=feeds-newsxmlBritain's healthcare cost watchdog NICE said on Friday it was reconsidering a decision to recommend against use of GlaxoSmithKline's lupus drug Benlysta on the state health service, following an appeal by the drugmaker. The National Institute for Health and Clinical Excellence (NICE) will refer the issue back to a committee of experts, after an appeals panel at the agency upheld two points raised by...Mon, 10 Sep 2012 12:00:00 AM GMThttp://www.securingpharma.com/pharmaceuticals/brazil-seizes-fake-schering-plough-products/s40/a1357/Brazil's National Health Surveillance Agency (ANVISA) has said its enforcement officers seized and destroyed three lots of counterfeit Schering-Plough products found circulating in the country. The counterfeits included two lots of Schering-Plough's Deca-Durabolin (nandrolone decanoate) - numbered 14642 and 14126 - as well as one lot of hormone-based therapy Durateston (testosterone esters) sold by...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.ft.com/intl/cms/s/0/7b7a4eea-f5cf-11e1-a6bb-00144feabdc0.htmlTeva, the worlds largest generic drugs group, is redoubling its focus on the quality of its medicines as it steps up efforts to defend its own blockbuster patented multiple sclerosis medicine from competition by stressing its extensive safety record and distinctive characteristics. In one of his first interviews since taking over as chief executive of the Israeli-based company in May, Jeremy Levin...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=271833&full=1<div class"xn-content"><p><span class"xn-location">PARSIPPANY</span>, N. J. and MUMBAI, <span class"xn-location">India</span>, <span class"xn-chron">Sept. 4, 2012</span> /PRNewswire/ -- Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food &amp; Drug Administration (US FDA) for marketing 100 mg, 150 mg and 200 mg 12-Hr extended release tablets...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.reuters.com/article/2012/08/23/india-glenmark-napo-idUSL4E8JN0SR20120823An international arbitrator ruled that India's Glenmark Pharmaceuticals has the right to sell its HIV-associated diarrhoea drug Crofelemer in 140 countries. Glenmark developed Crofelemer with U.S.-based partners Napo Pharmaceuticals and Salix Pharmaceuticals Ltd. The Indian company sought arbitration in the United States last December after Napo terminated a three-party agreement under which Glenmark...Thu, 23 Aug 2012 12:00:00 AM GMThttp://www.pmlive.com/pharma_news/roches_avastin_strikes_out_again_with_nice_419286NICE has now issued final guidance saying it does not recommend Avastin (bevacizumab), in combination with Roches Xeloda, for the firstline treatment of metastatic breast cancer in people for whom treatment with other chemotherapy options including taxanes or anthracyclines, is not considered appropriate. The watchdog says its recommendation has remained constant throughout the process of guidance...Thu, 23 Aug 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20120817005651&newsLang=enJERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today the launch of an authorized generic of ACTOplus met (pioglitazone/metformin tablets)15 mg/500 mg, 15 mg/850 mg. ACTOplus met is marketed by Takeda Pharmaceuticals U.S.A., Inc. and used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes. ACTOplus met had annual...Mon, 20 Aug 2012 12:00:00 AM GMThttp://www.thepharmaletter.com/file/115792/uks-nice-continues-to-back-amgens-xgeva-for-most-cancer-patients-with-bone-metastases.htmlNICE is continuing to recommend Amgens Xgeva for certain groups of cancer patients whose disease has spread to their bones. In final draft guidance the watchdog recommends Xgeva (denosumab) as a treatment for people with bone metastases from most solid cancer tumours. Specifically, it recommends the drug in patients with bone metastases from breast cancer and people with bone metastases from solid...Fri, 17 Aug 2012 12:00:00 AM GMThttp://online.wsj.com/article/BT-CO-20120814-712506.html?mod=WSJ_qtoverview_wsjlatestJapan's Eisai Co. (ESALY, 4523.TO) will target a "huge unmet medical need" with its plan to begin selling the new diet drug Belviq in the U.S. in early 2013, the company's leader said Tuesday. Chief Executive Haruo Naito said Eisai will market the drug by aiming to enhance disease awareness, collaborate with patient groups and seek insurance coverage of Belviq. Obesity is "obviously a huge unmet medical...Wed, 15 Aug 2012 12:00:00 AM GMThttp://www.zenopa.com/news/801427319/Roche_requested_by_NICE_to_provide_further_Zelboraf_dataRoche has been requested to provide additional clinical data on its skin cancer therapy Zelboraf to support a potential recommendation of the drug by the National Institute for Health and Clinical Excellence (NICE). The UK regulator has asked the company to make further information available that demonstrates the benefits of Zelboraf for the treatment of unresectable locally advanced or metastatic...Mon, 13 Aug 2012 12:00:00 AM GMT