http://www.biospace.comBioSpace RSS GeneratorWed, 19 Jun 2013 12:52:12 GMT20http://rss.biospace.com/images/BSPLogo.gifhttp://www.BioSpace.com/news.aspx?SectionId=1Copyright (C) 2011http://www.biospace.com/news_story.aspx?StoryID=300467&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>June 2013 -- SCM Pharmas new 6m ($10m) contract manufacturing facility has been given the go ahead for commercial production following a successful inspection from the Medicines and Healthcare products Regulatory...Wed, 19 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=300213&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>17 June 2013 -- At its meeting held on 13 June 2013, the European Medicines Agencys (EMA) Management Board adopted the revised EMA Code of Conduct, which aims to ensure that the Agency maintains the highest...Mon, 17 Jun 2013 12:00:00 AM GMThttp://www.globenewswire.com/news-release/2013/06/11/553184/0/en/Sobi-gets-FDA-approval-to-manufacture-substance-for-Kineret-with-partner-Boehringer-Ingelheim.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>Swedish Orphan Biovitrum AB (publ) (Sobi) today announced receipt of approvalfrom the Food and Drug Administration (FDA) for the manufacture of drugsubstance for Kineret (anakinra) at Boehringer Ingelheim...Tue, 11 Jun 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/06/03/us-eu-lundbeck-drugmakers-idUSBRE9520EI20130603Staying 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 European regulator will fine Denmark's Lundbeck and eight other makers of generic drugs for limiting the supply of cheaper medicines, two people with knowledge of the matter said, its first sanction against...Tue, 04 Jun 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=298623&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>PressRelease by ICRC-Weyer GmbH -- The Berlin-based clinical contract research organization (CRO), ICRC-Weyer GmbH, has announced it will boost its drug-safety related Pharmacovigilance Services for Investigator...Fri, 31 May 2013 12:00:00 AM GMThttp://www.thehindu.com/opinion/editorial/drugs-ranbaxy-and-lies/article4760215.eceStaying 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>After the US and Indian authorities, the medicines manufactured by Ranbaxy Laboratories are now under the scanner of hospitals, too. Mumbai's leading Jaslok Hospital has already put up a notice advising its...Wed, 29 May 2013 12:00:00 AM GMThttp://www.pharmalive.com/what-patient-harm-fda-slams-shionogi-for-not-preparing-studiesStaying 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>File this under what chutzpah! Last September, the FDA informed Shionogi that two clinical trials would be required after a serious risk of an irregular heartbeat was associated with its Rybix painkiller...Tue, 28 May 2013 12:00:00 AM GMThttp://www.pharmalive.com/a-boehringer-shake-up-and-an-fda-warning-letter-over-production-gaffesStaying 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>After a string of grave and embarrassing manufacturing problems, Boehringer Ingelheim is overhauling some of its management. Late last week, Boehringer Ingelheim quietly posted on its web site that Wolfram Carius...Thu, 23 May 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130522005889&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>GURGAON, India--(BUSINESS WIRE)--Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) (Ranbaxy) today highlighted some of the major specific actions the Company has been taking in recent years to address...Wed, 22 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=297679&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>Basel, Switzerland, 22 May 2013 As human infections with a new avian influenza A (H7N9) virus continue to be reported in China, Lonza is making information available about infection control. </p><p>Influenza...Wed, 22 May 2013 12:00:00 AM GMThttp://www.indianexpress.com/news/johnson---johnsons-license-revoked-on-baby-powder-concerns/1111411/Staying 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>Health officials have revoked Johnson & Johnson's license to make cosmetics at a plant outside Mumbai after they discovered the company had used an unauthorized process for sterilizing its baby powder...Mon, 06 May 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=295176&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>2 May 2013 -- Fifty life science companies discussed how the recently-introduced Patent Box can benefit their businesses and drive future jobs and growth in the UK at the BioIndustry Association's (BIA...Thu, 02 May 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130411by Richard Daverman, PhD</p><p>April 11, 2013 -- In President Obamas new 2014 budget request, the FDA asked for $4.7 million to carry out inspections of China pharmas that export products to the US during the fiscal year 2014. The request includes funding for nine full-time equivalent employees. In previous years, the agency did not break out separate line items for China drug safety inspections...Fri, 12 Apr 2013 12:00:00 AM GMThttp://www.thehindubusinessline.com/markets/stock-markets/aurobindo-shares-spurt-as-usfda-lifts-import-alert/article4557481.eceAurobindo Pharma today said the US health regulator has lifted the import alert on its Hyderabad-based antibiotics facility, thereby allowing the company to export 9 products from this plant to the US market. US Food and Drug Administration (USFDA) has lifted the import alert for non-sterile products manufactured at Unit-VI cephalosporin facility based in Hyderabad, thereby, paving the way for resumption...Thu, 28 Mar 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20130328005515&newsLang=enRAVENSBURG, Germany--(BUSINESS WIRE)--Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices. The facility...Thu, 28 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291713&full=1Ravensburg, Germany, March 27, 2013 / B3C newswire / Vetter, a leading contract development and manufacturing organization (CDMO), announced today that its new center for visual inspection and logistics passed its first GMP inspection by the U.S. Food and Drug Administration (FDA). The inspection was conducted March 11 through 14 to ensure the facility is in compliance with good manufacturing practices...Wed, 27 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291519&full=126 March 2013: Recipharms solid dose facility located in Fontaine, France, has been approved for supply of manufactured products to the Japans pharmaceuticals market following a recent inspection by the PMDA, the Japanese drug agency. </p><p>The product dossier was presented by an existing contract manufacturing customer, also securing regulatory approval for its supply to Japan. </p><p>The...Tue, 26 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=291290&full=1BELLSHILL, SCOTLAND, 21 March 2013: Link Technologies Ltd, an ISO 9001:2008 certified specialist oligonucleotide reagent manufacturer, has launched a range of high quality cyanine dye products to support the continued increase in demand for fluorescent labelling in biological imaging and molecular diagnostics. As well as introducing a new range of 3-CPG solid supports modified with Cyanine 540 and...Wed, 20 Mar 2013 12:00:00 AM GMThttp://www.reuters.com/article/2013/03/13/usa-india-trade-idUSL1N0C57F620130313U.S. industry groups on Wednesday called for the United States to increase pressure on India to reform high-tech, agricultural and pharmaceutical policies they said block U.S. exports and damage patent rights. "India has essentially created a protectionist regime that harms U.S. job creators" in favor of the country's generic drug manufacturers, Roy Waldron, chief intellectual property counsel for...Thu, 14 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=290575&full=1SingaporeThe Regulatory Affairs Professionals Society (RAPS) is partnering with five Singapore government agencies to develop and implement a new medical device regulatory affairs (MDRA) training program by the end of 2013. In addition to covering the regulatory systems of the US, Europe and Asia Pacific markets, the training program will be the worlds first to offer instruction focused on the medical...Thu, 14 Mar 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130312_1by Richard Daverman, PhD</p><p>March 12, 2013 -- China has given the State Food and Drug Administration responsibility for monitoring the safety of the nations food supply. However, the Ministry of Health will continue to formulate food safety policies, which the SFDA will administer. The SFDA will remain an agency of the Ministry of Health, even though reports surfaced last week that the SFDA...Wed, 13 Mar 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130304by Richard Daverman, PhD</p><p>March 4, 2013 -- In the next few days, China may give the SFDA power to regulate the nations food supply. Presently, the SFDA has power over drugs, medical devices, cosmetics and health foods. China has suffered through several confidence-shattering food safety scandals in recent years, ranging from gutter oil to tainted milk. The reorganization will put responsibility...Tue, 05 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=289539&full=1Tuesday, March 5th, 2013: Oxfordshire, England: GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international...Tue, 05 Mar 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130304005677&newsLang=enUPPSALA, Sweden--(BUSINESS WIRE)--Regulatory News: Biotage (STO:BIOTA) acquired MIP Technologies in 2010 to gain access to world class development capabilities of custom designed molecular imprinted and other novel polymers. Following the acquisition Biotage has invested in the industrialization of MIP Technologies business operations. MIP Technologies is in the process of developing a range of Industrial...Mon, 04 Mar 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=288099&full=1February 20, 2013 -- Following from successful MHRA audits in 2011, Almacs Sciences Business Unit has completed a successful inspection of its analytical facilities at its Craigavon Headquarters, Northern Ireland from the US Food and Drug Administration (FDA). The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements.</p><p>The inspection...Wed, 20 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=287570&full=1<div id"releaseBody"><p>REHOVOT, ISRAEL--(Marketwire - February 12, 2013) - <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?prid984724&attachid2226540">Evogene</a></td></tr></table> Evogene Ltd. (TASE: EVGN), a leading developer of improved plant traits for the food, feed and biofuel industries...Wed, 13 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286812&full=1February 06, 2013 -- Almac today announces the successful inspection of its new US Commercial Packaging operations located in Audubon, PA by the Food and Drug Administration (FDA). The inspection took place on the 9th and 10th January 2013 from which the regulatory body concluded that the Pennsylvania based site is fully compliant with Good Manufacturing Practices, with no 483 issued.</p><p>Commenting...Wed, 06 Feb 2013 12:00:00 AM GMThttp://www.pharmalot.com/2013/02/glaxo-clashes-with-phrma-over-data-disclosure/Just how heated can the controversy over disclosing clinical trial get? One day after the US pharmaceutical industry trade group bashed the cry to release patient-level data, GlaxoSmithKline has come out in support of the notion. The support by the drugmaker comes four months after the drugmaker declared a new openness in the wake of a huge scandal over data disclosure that contributed to a $3 billion...Tue, 05 Feb 2013 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20130203005066&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--GVK Biosciences (GVK BIO) today announced that it is extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (US FDA). The GOBIOM database, which has the latest and recently updated information on all the biomarkers reported in various clinical and preclinical studies, will be beneficial...Mon, 04 Feb 2013 12:00:00 AM GMThttp://www.modernhealthcare.com/article/20130131/INFO/301319992/judge-restricts-generic-drug-company-from-making-distributing-drugsBoehringer Ingelheim GmbH, the worlds largest family-owned drugmaker, agreed to stop production at an Ohio plant until it fixes manufacturing practices that led to about 40 product recalls in a decade. U.S. District Judge Lesley Wells in Cleveland today approved a consent decree against Boehringers Ben Venue Laboratories plant in Bedford, Ohio, and three company officers after quality assurance rules...Fri, 01 Feb 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=286348&full=1January 31, 2013 -- A study funded by the European Commission has just concluded that the formula used by the UKs healthcare cost containment watchdog, the National Institute for Health and Clinical Excellence (NICE), doesnt work and in so doing has sparked off a debate on the subject of determining patient access to new therapies. </p><p>The study, conducted by the European Consortium on...Thu, 31 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285990&full=1<div id"releaseBody"><p>LEUVEN, BELGIUM and MADRID, SPAIN--(Marketwire - January 29, 2013) - <b> </b>TiGenix (EURONEXT BRUSSELS: TIG), a leader in the field of cell therapy, announced today that further to the cGMP inspection by the Spanish health authorities it has successfully renewed its manufacturing authorization for stem cell products at its manufacturing facility in Madrid, Spain.<p...Tue, 29 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=285758&full=1Goettingen, Germany | Yauco, Puerto Rico, January 25, 2013 / B3C newswire / Sartorius Stedim Biotech, a leading international equipment provider for the pharmaceutical industry, has now been awarded the highest certification for ecological and sustainable building by the U.S. Green Building Council (USGBC) for its new facility in Yauco, Puerto Rico. According to the LEED certification system, an...Fri, 25 Jan 2013 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20130118_1by Richard Daverman, PhD</p><p>January 18, 2013 -- Chinas SFDA is considering far-reaching changes to its drug approval process. The proposals would replace the present system, which considers requests on a first-come, first-serve basis, with a system that prioritizes need. Innovative drug candidates, especially those that address unmet diseases, would be processed under new fast-track procedures...Fri, 18 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284727&full=1Sydney, Australia 14 January 2013 -- Genea Stem Cells Pty Ltd (GSC), a supplier and developer of disease-specific human stem cells, today announced that 25 of its disease specific embryonic pluripotent stem cell lines have been placed on the USA National Institutes of Health (NIH) human stem cell registry. These embryonic stem cell lines are now all available commercially for use in medical research...Mon, 14 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=284383&full=1January 09, 2013 -- Following further successful GMP inspections by FDA and MHRA, Melbourn Scientific has been awarded a Manufacturer's/Importers Authorisation (MIA) and is to be named as the EU testing and release site for an aseptically prepared medicinal product on a clients pending Marketing Authorisation Application. </p><p>Melbourn already has an MIA/IMP (Manufacturer's / Importers Authorisation...Wed, 09 Jan 2013 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=283424&full=1Jan 2013 AITbiotech, a leading molecular Diagnostic (MDx) and Genomic Services provider in Singapore announced today, that it has secured CE-IVD Mark Certification for its abTES Flu 4-Plex and abTES MTB real-time PCR assays. </p><p>The CE clearance of abTES Flu and MTB qPCR Kits marked a significant milestone for AITbiotech in the year of 2012 after obtaining the ISO 13485:...Wed, 02 Jan 2013 12:00:00 AM GMThttp://www.pharmalot.com/2012/12/ema-documents-are-secret-no-longer/Two years after the European Medicines Agency adopted a new policy that is designed to provide greater access to clinical trial data, a pair of researchers put the regulator to the test and found more than 1.6 million pages of documents have been released, according to a research letter published in the Archives of Internal Medicine. As a result, the researchers wrote the EMA policy toward access to...Fri, 21 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282547&full=117 December 2012, Uppsala, Sweden: Gyros AB, a leader in utilization of microfluidic technologies to miniaturize and automate immunoassays, announced today its quality management system has received ISO 9001:2008 certification. The certification offers further reassurance to customers using the Gyros nanoliter-scale immunoassay platform that the products and services they receive are of a consistently...Thu, 13 Dec 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/index.jsp?ndmViewId=news_view&newsId=20121211005877&newsLang=enRAVENSBURG, Germany--(BUSINESS WIRE)--Vetter has announced that it has now been approved as a Known Consignor by the German Federal Aviation Office. The agency officially granted the pharmaceutical service provider the certificate of approval following an audit at Vetters Holbeinstrasse and Ravensburg Vetter West facilities. The approval means that customers will continue to have their air cargo...Tue, 11 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282016&full=1Bascharage, Luxembourg, December 11, 2012 / B3C newswire / - Cellon SA announced today that their entire range of PharmaTainer bottles and carboys are now certified clean, meeting USP 788 Particulate Matter in Injections, and the equivalent EP and JP quality standards.</p><p>Pharmatainer products are currently manufactured in PC and PET in sizes from 125ml to 20 litres. Cellon opened its state...Tue, 11 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=282020&full=1Ravensburg, Germany, December 11, 2012 / B3C newswire / Vetter has announced that it has now been approved as a Known Consignor by the German Federal Aviation Office. The agency officially granted the pharmaceutical service provider the certificate of approval following an audit at Vetters Holbeinstrasse and Ravensburg Vetter West facilities. The approval means that customers will continue to...Tue, 11 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281159&full=1Konstanz, Germany, December 3, 2012 / B3C newswire / Being the first in Europe, the Next Generation Sequencing Laboratories of the Constance Genome and Diagnostics Centre has been accredited according to ISO 17025 from the national accreditation body for the Federal Republic of Germany (DAkks). The independent governmental institution has acknowledged the high quality standard of the sequencing service...Mon, 03 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=281170&full=1PRINCETON, N.J., December 3, 2012 Covance Inc. (NYSE: CVD) today announced that its early development facility located in Shanghai, China, has received a Good Laboratory Practice (GLP) Certificate from the State Food and Drug Administration (SFDA) of the Peoples Republic of China. The Covance facility in Shanghai provides nonclinical safety assessment, bioanalytical, in vivo pharmacology, and DMPK...Mon, 03 Dec 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=280347&full=119 November 2012: Spinnovation, Nijmegen, The Netherlands: The increasingly popular cell culture analysis and optimization method, Spedia-NMR from Spinnovation Biologics, has now been validated internally in accordance to industry guidelines for analytical procedures issued by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use...Tue, 20 Nov 2012 12:00:00 AM GMThttp://business-standard.com/india/news/ranbaxy-to-get-guidance-soon-for-remedial-stepsdewas-unit/195553/onDrug maker Ranbaxy Laboratories is expecting the consultant assessment of its Dewas manufacturing facility, which is under scanner of the US Food and Drugs Administration (US FDA) since 2008, to be over by December. The move is significant because the assessment report will provide a definite guidance to the company towards the corrective measures to meet the regulators requirements. In May, Ranbaxy...Mon, 12 Nov 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=279093&full=1Rockville, MD, USA and Beijing, ChinaThe Regulatory Affairs Professionals Society (RAPS) and Chinas State Food and Drug Administration Institute of Executive Development (SFDAIED) have signed a memorandum of understanding, creating a cooperative framework to further international education and training for regulatory professionals in China and the US. RAPS is the largest global organization of and...Thu, 08 Nov 2012 12:00:00 AM GMThttp://www.pharmalot.com/2012/10/fda-warns-stem-cell-company-over-violations/Last April, the FDA inspected Celltex Therapeutics, which has ties to a controversial stem cell company in South Korea called RNL BIO, after a University of Minnesota bioethics professor wrote the agency to over concerns about patient safety, quality of scientific research supporting the proposed business model and whether both conform to federal and state laws and regulations. At the time, the agency...Wed, 17 Oct 2012 12:00:00 AM GMTOctober 2012, AITbiotech, a leading MDx and Genomic Services provider in Singapore announced today, that it has secured ISO 13485:2003 Certification. </p><p>The 13485:2003 certification are for Design, Development and Manufacturing of IVD Medical Devices for Detection of Infectious Diseases; and Manufacturing of Oligonucleotides and Sequencing Services. With the certification AITbiotech...Mon, 15 Oct 2012 12:00:00 AM GMThttp://www.pharmalot.com/2012/10/sec-probes-pfizer-domestic-overseas-reporting/The US Securities and Exchange Commission is trying to solve an accounting riddle how is that Pfizer was able to record big overseas profits but losses in the US when 40 perfcent of its sales are generated in foreign countries? Over the past few months, the agency and Pfizer have engaged in correspondence over the issue, which ultimately may determine whether Pfizer has a bigger tax bill to pay...Tue, 09 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=275348&full=1<div id"releaseBody"><p>BUDAPEST, HUNGARY--(Marketwire - October 08, 2012) - Genetic Immunity (OTCBB: <a href"http://www.marketwire.com/mw/stock.jsp?TickerPWRV">PWRV</a>) is pleased to announce the GMP approval of its manufacturing facility. The development of the GMP manufacturing process and the facility was financed from a $4 million grant received from the Hungarian Office for Innovation...Mon, 08 Oct 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20121004by Richard Daverman, PhD</p><p>October 4, 2012 -- China National Biotech Group (CNBG) vaccine for Japanese encephalitis is about to be the first vaccine from China approved for use by the World Health Organization (WHO). Once the vaccine is awarded prequalification status, NGOs such as the Global Alliance for Vaccines and Immunization (GAVI) can purchase it for distribution in less-developed...Fri, 05 Oct 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274234&full=1September 26, 2012 -- Almac is pleased to announce the successful inspection of its Clinical Services operations located in Craigavon by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The inspection, which occurred from 17th to 20th September 2012, was a routine inspection conducted by a MHRA inspector from the regulatory body who concluded that the site continues to be compliant...Wed, 26 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=274095&full=1Oxford, UK, 25 September 2012 Summit (AIM: SUMM), a UK drug discovery company, is pleased to announce that it has received approval from the UK regulatory body, the Medicines and Healthcare products Regulatory Agency (MHRA), to commence a Phase I clinical trial for SMT 19969, an oral small molecule antibiotic that is selective for the treatment of C. difficile infections (CDI). Preclinical data...Tue, 25 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=273088&full=1September 17th 2012: Site set to expand its sterile product service offering.</p><p>Recipharm Monts, located near Tours (France), specialist in the manufacture of sterile products in glass containers, today announced it has secured authorisation from the French health authorities (ANSM) to fill biotech products. Consequently, Recipharm is able to expand and diversify its combined offering.<...Mon, 17 Sep 2012 12:00:00 AM GMThttp://articles.economictimes.indiatimes.com/2012-09-03/news/33563357_1_indian-drug-drug-companies-low-cost-drugsMost Indian drug companies that were penalised for violating US drug manufacturing norms in the last few years but have subsequently taken corrective actions are being allowed to resume sales by the US drug regulator. In the last two months, the US Food and Drug Administration (FDA) lifted the ban on drugs made at the facilities of Sun Pharma, Dr Reddy's Laboratories and Claris Lifesciences while revoking...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=271881&full=1Biocitech, September 4, 2012 OCT Sante, which is specialized in the transportation of biological and pharmaceutical products, announces that its Thermo Box system, comprising innovative thermal packaging models designed by the company for the transport of category B biological materials, has received the official certification of the French National Metrology and Testing Laboratory (LNE - Laboratoire...Tue, 04 Sep 2012 12:00:00 AM GMThttp://www.japancorp.net/portal/biospace/index.asp?id=25592Tokyo/Osaka, Aug 31, 2012 (JCN Newswire) - Takeda Pharmaceutical Company Limited (Headquarters: Osaka, President: Yasuchika Hasegawa), AstraZeneca K.K. (Headquarters: Osaka, President: Paul Hudson), Mitsubishi Tanabe Pharma Corporation (Headquarters: Osaka; President: Michihiro Tsuchiya), and Eisai Co., Ltd. (Headquarters: Tokyo; President and CEO: Haruo Naito) announced today that they have submitted...Fri, 31 Aug 2012 12:00:00 AM GMThttp://www.thehindubusinessline.com/companies/article3831813.eceIndian generic drug maker Sun Pharmaceutical Industries Ltd. (524715.BY) said Tuesday the U.S. drug regulator has allowed resumption of operations at unit Caraco Pharmaceutical Laboratories Ltd.'s manufacturing facility and packaging sites in Detriot and Wixom, Michigan. Caraco had to halt operations at Detriot and Wixom after the U.S. Food and Drug Administration found some drug-manufacturing defects...Tue, 28 Aug 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20120830BEIJING, CHINA, August 27, 2012 - MicroConstants China Inc., a Contract Research Organization (CRO) conducting preclinical PK studies and providing full-service early stage clinical trial management in China, has received a renewed Endorsement of Compliance with the OECD Principles of Good Laboratory Practice (GLP) at its newly established facility in Beijing. The Endorsement was initially awarded...Tue, 28 Aug 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20120821_1by Richard Daverman, PhD</p><p>August 21, 2012 -- Biostar Pharma said its China operating subsidiary has received an Army New Drug Certificate for Zushima Analgesic Spray, a topical pain relief drug. Zushima spray was developed in cooperation with Lanzhou Military Institute of Drugs and Instruments specifically for the needs of China's military. The spray relieves pain and topical swelling, joint...Wed, 22 Aug 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.ab520ce17e34ab71ff00d635c0908a0c/index.jsp?ndmViewId=news_view&newsId=20120820006446&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--Inogent Laboratories (Inogent), a GVK BIO associate company announced today that its GMP compliant facilities in Hyderabad were audited and approved by the Japanese regulator, Pharmaceuticals and Medical Devices Agency (PMDA). PMDA conducts scientific reviews of marketing authorization application of pharmaceuticals and medical devices and monitoring of their post...Tue, 21 Aug 2012 12:00:00 AM GMThttp://www.menafn.com/menafn/dfab9d91-7fa8-4817-ae16-c67bb397d958/SEC-opens-Teva-bribery-probe?src=mainIsrael's Teva Pharmaceutical Industries , the world's biggest generic-drug maker, is being investigated by the U.S. securities regulator over the company's compliance with a U.S. law that prohibits bribery of foreign officials. In a filing with the U.S. Securities and Exchange Commission last week, Teva said it had received a subpoena dated July 9 to produce documents in connection with its business...Mon, 06 Aug 2012 12:00:00 AM GMThttp://www.businesswire.com/portal/site/biospace/template.PAGE/menuitem.b30484b92e958b11adda3242e6908a0c/index.jsp?ndmViewId=news_view&newsId=20120730005406&newsLang=enHYDERABAD, India--(BUSINESS WIRE)--GVK Biosciences, Asias leading Contract Research Organization, today announced that its Ahmedabad Clinical Pharmacology Unit successfully cleared the US FDA Audit with zero 483s/observations from the agency. USFDA visited and audited a First-to-File study for one of GVK BIOs customers.Mon, 30 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=268292&full=1Hyderabad, INDIA : AXIS Clinicals Limited, Indias Premier Clinical Research Organization (CRO), announces today that it has successfully completed its 9th US FDA Audit for Patient Population Clinical Bioequivalence study.</p><p>AXIS Clinicals successful audits confirmed that the company's quality system was found to meet the requirements established by the US, Europe and other international regulatory...Mon, 30 Jul 2012 12:00:00 AM GMThttp://www.bloomberg.com/news/2012-07-25/lundbeck-gets-eu-antitrust-complaint-on-citalopram-deals.htmlBrussels, 25 July 2012 -- The European Commission has informed the Danish pharmaceutical company Lundbeck of its objections regarding agreements concluded with four generic competitors concerning citalopram, a blockbuster antidepressant. The Commission is of the preliminary view that the agreements aimed at preventing the market entry of cheaper generic medicines, in violation of EU antitrust rules...Wed, 25 Jul 2012 12:00:00 AM GMThttp://www.foxbusiness.com/news/2012/07/24/fda-warns-sanofi-vaccine-unit-on-manufacturing-violations-at-two-facilities407024/The FDA posted a July 12 warning letter to its website Tuesday involving two Sanofi Pasteur SA vaccine-manufacturing plants. The letter stemmed from plant inspections in Canada and in France that were conducted in March and April of this year. The FDA cited problems with mold at a plant in Toronto, Ontario, and cited a plant in Marcy-l'Etoile, France, because it didn't properly investigate failures...Wed, 25 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=267034&full=117 July 2012 -- The BioIndustry Association welcomes the legislative proposal for a Regulation on clinical trials presented by the European Commission today. </p><p>A simplified and efficient regulatory framework for clinical trials is vital to improve Europe's attractiveness as a global location for clinical research and development of new medicines. This will benefit all stakeholders in the European...Tue, 17 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=267048&full=117 July 2012 -- The BIA welcomes today's publication by the Medicines and Healthcare products Regulatory Agency (MHRA) of its consultation on proposals to launch an Early Access to Medicines Scheme in the UK.</p><p>The proposed Early Access to Medicines Scheme was announced by the Prime Minister David Cameron as a key commitment within the Strategy for UK Life Sciences launched in December 20...Tue, 17 Jul 2012 12:00:00 AM GMThttp://articles.timesofindia.indiatimes.com/2012-07-13/hyderabad/32662613_1_closure-notices-aurobindo-pharma-pharma-industryA recent study conducted by the appellate authority of Andhra Pradesh Pollution Control Board (APPCB) was what eventually helped it nail the 12 erring pharmaceutical units that were issued closure notices on Thursday. Interestingly, the study in question had been allegedly initiated in connivance with the pharma companies themselves to prevent them getting blacklisted, said an APPCB source. However...Mon, 16 Jul 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20120710by Richard Daverman, PhD</p><p>July 9, 2012 -- The SFDA has issued new regulations governing the purity and safety of excipients, the pharmacologically inactive substances that drugmakers add to stabilize or deliver a drugs active ingredients. The new rules, which go into effect on October 1, place responsibility for the safety of the excipient on the drug company that uses it. The regulations...Tue, 10 Jul 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=265243&full=127 June 2012 -- The Association of the British Pharmaceutical Industry (ABPI), the BioIndustry Association (BIA) and the Clinical Contract Research Association (CCRA) have today jointly published guidance on insurance and compensation for Phase I clinical trials. The guidance, which has been developed in consultation with the Department of Health and the National Research Ethics Service (NRES) within...Wed, 27 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=263698&full=1BELLSHILL, SCOTLAND, 13 June 12: Link Technologies Ltd, an ISO 9001:2008 certified specialist oligonucleotide reagent manufacturer, has launched two new modified phosphoramidite ranges to complement its existing extensive portfolio of products to support oligonucleotide synthesis. For triplex, antisense and gene targeting studies, the new RNA-type phosphoramidites provide nuclease resistance and stability...Wed, 13 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=263263&full=1June 08, 2012 -- The European Medicines Agencys (EMA) Management Board adopted a new breach of trust procedure to deal with cases of incorrect or incomplete declarations of interests of Board members. The adoption of the latest procedure completes the Agencys framework on dealing with potential conflicts of interests of its scientific experts, committee members, Management Board members and staff...Fri, 08 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=263243&full=1<div id"releaseBody"><p>LEUVEN, BELGIUM--(Marketwire - June 08, 2012) - TiGenix (EURONEXT BRUSSELS: TIG)<p><pre> Regulated information June 8, 2012</pre><p><b>TiGenix obtains national reimbursement in the Netherlands for breakthrough cartilage therapy ChondroCelect...Fri, 08 Jun 2012 12:00:00 AM GMThttp://www.biospace.com/news_story.aspx?StoryID=261982&full=1<div id"releaseBody"><p>SAN FRANCISCO, CA and TOKYO--(Marketwire - May 30, 2012) - Medivation, Inc. (NASDAQ: <a href"http://www.marketwire.com/mw/stock.jsp?TickerMDVN">MDVN</a>) and Astellas Pharma Inc. (Tokyo: 4503) announced that the U.S. Food and Drug Administration (FDA) agreed that Medivation and Astellas may proceed with an Expanded Access Program (EAP) for the investigational therapy...Wed, 30 May 2012 12:00:00 AM GMThttp://www.chinabiotoday.com/articles/20120524by Richard Daverman, PhD</p><p>May 23, 2012 -- The stock price of Shanghai Pharmaceuticals suffered large losses after media reports alleged the company had committed accounting fraud. The reports, carried by the 21st Century Business Herald, said Shanghai Pharma was under investigation for fraudulent accounting of two M&A transactions. Shanghai Pharma denied that it was under investigation by...Thu, 24 May 2012 12:00:00 AM GMThttp://allafrica.com/stories/201205181005.htmlThe Quality Chemical Industries home in Luzira is a glassy modern piece of architecture with an exterior that would pass for a grand hotel instead of a pharmaceutical plant. But behind this faade is the adherence to a high degree of quality control that is extremely important in the pharmaceutical manufacturing industry. This strict compliance to a set of good management practices in pharmaceutical...Wed, 23 May 2012 12:00:00 AM GMThttp://www.deccanchronicle.com/channels/cities/hyderabad/medical-body-demands-ban-33-drugs-india-059The All India Drugs Control Officers Confederation (AIDCOC) has demanded that the Union health ministry suspend the approval granted to 33 drugs for sale in India with immediate effect, as the approval was given without conducting the required clinical trials. The federation claimed that the Central Drugs Standard Control Organisation (CDSCO) had granted permission for the marketing of 33 drugs without...Mon, 21 May 2012 12:00:00 AM GMThttp://www.pharmatimes.com/Article/12-05-14/We_re_not_trying_to_get_rid_of_PHARMAC_say_NZ_drugmakers.aspx"Contrary to popular misconception," the pharmaceutical industry in New Zealand has no intention of using the Trans Pacific Partnership (TPP) process to get rid of the nations drugs-buying agency PHARMAC, an industry leader has stated. However, "New Zealanders could have access to better and newer medicines if the system was streamlined and the broader questions relating to health policy and relative...Mon, 14 May 2012 12:00:00 AM GMT