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DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition" report to their offering. The report examines 91 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2016 along with 1 therapeutic drug approved by the FDA Center for Biologics Evaluation and Research (CBER) under the BLA process. PharmSource's data-rich Trend Report, CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2017 Edition, has ascertained that 2016 was not a halcyon year for new drug approvals with only 25 NMEs being approved since 2010. Global bio/pharma companies received 22 approvals in 2016 (24% of all NDAs), 10% below their 2011-2015 average. Small commercial companies were responsible for 21 approvals (23% of the total), some 5% above their five-year average. There was a clear difference between outsourcing propensity of NME and Non-NME drugs. Only 13% of NMEs sponsored by global bio/pharma companies were outsourced compared with an average of 28% from 2011-2015. However, the largest companies increased their outsourcing of Non-NME drugs from an average of 32% in 2011-2015 to 57% in 2016. In 2016, the FDA approved 92 NDAs and BLAs including new molecular entities (NMEs), therapeutic drugs approved through CBER and new formulations of older drugs. This figure represents a 25% decrease from 2015 (122) and is also 5% less than the 2011-2015 average of 97. Furthermore, 48% of NMEs were outsourced compared to 64% of Non-NME NDA products. 28 dose CMOs garnered approvals in 2016 although two companies, Vetter and Patheon, won 7 out of the 12 NMEs that were outsourced. No other company secured more than a single NME approval for contract manufacturing, although Catalent and DPT were responsible for 7 Non-NME NDA drugs. The CMO landscape is dominated by the quartet of Patheon, Baxter, Vetter and Catalent, which collectively accounted for over 30% of all NDA approvals between 2007-2016. Parenteral NME outsourcing is dominated by the first three of these, which are responsible for manufacturing 47% of all drugs, with the remainder split between 28 other companies. In depth, this report provides the following: - Provides the detailed analysis of drugs examined by the European Medicines Agency (EMA). The centralized procedure is mandatory for all New Active Substances, as well as Biosimilar drugs and certain generics depending on their therapeutic category. - Analyzes propensity to outsource by dosage form, sponsor type, nature of API and special handling requirements. In addition, it includes information on product approvals, which have utilized formulation technologies such as amorphous solid dispersion (ASD), hot melt extrusion (HME) and jet milling. - Helps for CMO executives and strategic decision-makers who seriously follow the global CMO industry, including dose and API manufacturers. For more information about this report visit http://www.researchandmarkets.com/research/9b6jb9/pharmsource_cmo


US federal staff being forced to watch Fox News instead of CNN, leaked email suggests An email has been sent to staff at the Food and Drug Administration (FDA) announcing that all their agency’s televisions will show Fox News, apparently by order of the Trump administration. Journalist Paul Thacker tweeted a screengrab of the message, but an FDA spokesperson denied there had been any such order. It reads: “Please excuse me for sending this out to your entire group via your listserv, but I was alerted by a member in your group and I wanted to let everyone know that the reason for the change from CNN to Fox. “The reason for the change is that a decision from the current administration administrative officials has requested that all monitors, under our control, on the White Oak Campus, display Fox News. “Sorry for the inconvenience, but I am unable to change any of the monitors to any other news source at this time." The email was sent to workers at the Centre for Biologics Evaluation and Research (CBER), the branch that regulates medical products. For more news videos visit Yahoo View, available now on iOS and Android. An FDA spokesperson denied people had been ordered to watch Fox News, telling ThinkProgress: "There was no directive or memorandum from the Administration that went out to employees about broadcast news channels displaying on monitors in common areas throughout the FDA’s White Oak campus." However an anonymous CBER employee told BuzzFeed News that “a lot of staff were very upset about the change”. Another FDA staff member went further, expressing fear that having a “’right wing’ news source playing in our halls…will drive away some people on the left who are already suspicious about the FDA being a shill for big pharma”. Donald Trump has made no secret of his dislike for CNN, referring to the news organisation as “fake news” on several occasions, and to the media as "the enemy of the people". The administration even went so far as to block the news outlet, along with BBC, LA Times and New York Times from a media briefing earlier this year. On one occasion, the US president wrote a scathing tweet about the media: "The Fake News media is officially out of control. They will do or say anything in order to get attention - never been a time like this!" However, his words about Fox News have been positive, and he recently congratulated the network for its "unbelievable ratings hike". The Independent has contacted the FDA for comment.


News Article | April 21, 2017
Site: www.prnewswire.com

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com


News Article | April 21, 2017
Site: www.prnewswire.co.uk

The Global Translational Regenerative Medicine market is expected to grow significantly over the forecast period. The Global Translational Regenerative Medicine market was valued at $5.8bn in 2016. Visiongain forecasts this market to increase to $14.5bn in 2021. The market is estimated to grow at a CAGR of 19.9% in the first half of the forecast period and 17.7% from 2016 to 2027. How this report will benefit you Read on to discover how you can exploit the future business opportunities emerging in this sector. In this brand new report you find 316-page report you will receive 107 tables and 66 figures - all unavailable elsewhere. The 316-page report provides clear detailed insight into the Global Translational Regenerative Medicine market. Discover the key drivers and challenges affecting the market. By ordering and reading our brand new report today you stay better informed and ready to act. • Forecasts from 2017-2027 of the leading products in the Global Translational Regenerative Medicine market: - Osteocel Plus - Trinity ELITE - TEMCELL /Prochymal - Apligraf - Dermagraft - Epifix - ReCell - Neovasculgen - Glybera (alipogene tiparvovec) - IMLYGIC (talimogene laherparepvec) • SWOT and Porter's Five Force analysis of the translational regenerative medicine market Visiongain's study is intended for anyone requiring commercial analyses for the Translational Regenerative Medicine Market and leading companies. You find data, trends and predictions. To request a report overview of this report please email Sara Peerun at sara.peerun@visiongain.com or call Tel: +44-(0)-20-7336-6100 List of Organisations Mentioned in the Report Arthritis Research UK Associazione Infermieristica per lo Studio delle Lesioni Cutanee (AISLeC) [China] Australian Regenerative Medicine Institute Australian Sports Anti-Doping Authority (ASADA) Biomedical Advanced Research and Development Authority (BARDA) British Heart Foundation [UK] California Institute of Regenerative Medicine (CIRM) Cambridge Stem Cell Biology Institute [UK] Case Western Reserve University Catalan Institution for Research and Advanced Studies Center for Biologics Evaluation and Research (CBER) [US] CHA General Hospital [Korea] Cryocenter Saint Petersburg Drugs Controller General of India (DCGI) European Group for Blood and Marrow Transplantation (EBMT) European Medicines Agency Food and Drugs Agency (FDA) [US] Haute Autorité de santé [France] Heriot-Watt University Human Fertilisation and Embryology Authority (HFEA) Institute of Biomedical Research and Innovation Hospital [Japan] International Society for Stem Cell Research (ISSCR) Karolinska Institute [Sweden] Massachusetts General Hospital (MGH) Mayo Clinic [US] Medical Research Council [UK] MiMedx Ministry of Food and Drug Safety, MFDS) [Korea] Ministry of Health, Labour and Welfare (MHLW) [Japan] Ministry of Science and Technology [China] Moorfields Eye Hospital National Tissue Engineering Center (NTEC) [China] New York Blood Center Riken Center for Developmental Biology RUSH University Medical Center [US] Russian Ministry of Healthcare and Social Development Scottish Centre for Regenerative Medicine St. Jude's Children Research Hospital State Food and Drug Administration (SFDA) [China] SUNY Upstate Medical University The Genetico Center [Russia] The StemGen Organisation Therapeutics Goods Administration (TGA) [Australia] UH San Diego Sanford Stem Cell Clinical Center UK Medicines and Healthcare Products Regulatory Agency (MHRA) Universitat Autònoma de Barcelona [Spain] University College London University of Edinburgh MRC Centre for Regenerative Medicine [UK] University of Massachusetts (UMass) Memorial Hospital University of Modena Centre for Regenerative Medicine [Italy] University of Wisconsin US National Institute of Health Wake Forest Institute Wellcome Trust World Health Organization To see a report overview please email Sara Peerun on sara.peerun@visiongain.com

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