https://www.epmmagazine.com/topics/ema/index.rss en-gb © 2020 Rapid Life Sciences Ltd, a Rapid News Group Company. All Rights Reserved. Tue, 20 Oct 2020 09:15:00 -0000 Monia Nica Monia Nica, senior regulatory affairs manager at Arriello, examines the relaxed measures regulatory agencies have set out due to Covid-19. https://www.epmmagazine.com/opinion/special-measures-a-roundup-of-pandemic-related-relaxations-t/ https://www.epmmagazine.com/opinion/special-measures-a-roundup-of-pandemic-related-relaxations-t/ Tue, 20 Oct 2020 09:15:00 -0000 Masks Maurits Lugard, Dr. Dorothee Schramm, and Anna-Shari Melin from law firm Sidley & Austin explain how pharmaceutical companies with products on the EU market can address product shortages and supply chain issues in the current Covid-19 crisis. https://www.epmmagazine.com/opinion/how-to-address-product-shortages-during-covid-19/ https://www.epmmagazine.com/opinion/how-to-address-product-shortages-during-covid-19/ Thu, 14 May 2020 09:20:00 -0000 Shortages A new liquid formulation to treat sickle cell disease is now available in the UK and Ireland after being approved by the European Medicines Agency (EMA). https://www.epmmagazine.com/news/new-liquid-formulation-available-for-sickle-cell-disease/ https://www.epmmagazine.com/news/new-liquid-formulation-available-for-sickle-cell-disease/ Tue, 31 Mar 2020 10:23:58 -0000 Sickle cell disease Maurits Lugard Anna-Shari Melin Maurits Lugard, partner at Sidley Austin’s Life Sciences practice, and Anna-Shari Melin, associate at Sidley Austin write about the measures being put into place to prevent and manage medicinal product shortages in the EU. https://www.epmmagazine.com/opinion/preventing-and-managing-medicinal-product-shortages-in-the-e/ https://www.epmmagazine.com/opinion/preventing-and-managing-medicinal-product-shortages-in-the-e/ Fri, 28 Feb 2020 11:15:00 -0000 Medicine Manufacturers of heartburn medications in both the US and Europe are being told by regulatory agencies to test for potential cancer-causing impurities. https://www.epmmagazine.com/news/fda-and-ema-tell-heart-medicine-makers-to-test-for-cancer-ca/ https://www.epmmagazine.com/news/fda-and-ema-tell-heart-medicine-makers-to-test-for-cancer-ca/ Fri, 06 Dec 2019 11:40:00 -0000 Heart Medicines Maurits JF Lugard The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA) guide marketing authorisation holders (MAH) on how to address medicinal product shortages. https://www.epmmagazine.com/news/how-to-manage-medicinal-product-shortages/ https://www.epmmagazine.com/news/how-to-manage-medicinal-product-shortages/ Tue, 22 Oct 2019 10:05:00 -0000 Medicines A major campaign has been launched in Brussels to help attract UK-based pharma and life science business to the Belgian capital following Brexit. https://www.epmmagazine.com/news/brussels-launches-campaign-to-attract-pharma-companies-post-/ https://www.epmmagazine.com/news/brussels-launches-campaign-to-attract-pharma-companies-post-/ Wed, 13 Mar 2019 09:51:24 -0000 Brussels The government is being asked to provide clarity on whether it can guarantee access to medicines and medical products in the event of a ‘no deal’ Brexit. https://www.epmmagazine.com/news/house-of-lords-calls-on-hancock-to-clarify-brexit-medicines-/ https://www.epmmagazine.com/news/house-of-lords-calls-on-hancock-to-clarify-brexit-medicines-/ Fri, 25 Jan 2019 14:49:23 -0000 medicines Kallik With the end result of Brexit fast approaching, labelling supplier Kallik looks at the implications Brexit could place on labelling and compliance in the pharmaceutical sector. https://www.epmmagazine.com/opinion/brexit-deal-or-no-deal-for-labelling/ https://www.epmmagazine.com/opinion/brexit-deal-or-no-deal-for-labelling/ Fri, 14 Dec 2018 09:00:00 -0000 Brexit Innovative cancer drugs are taking longer to get to patients due to delays in clinical trials and regulatory red tape, new data shows. https://www.epmmagazine.com/news/innovative-cancer-drugs-not-reaching-patients-fast-enough-da/ https://www.epmmagazine.com/news/innovative-cancer-drugs-not-reaching-patients-fast-enough-da/ Tue, 04 Dec 2018 11:35:00 -0000 Cancer drugs In preparations for Brexit, the EMA has redistributed the UK’s product portfolio to other EU members and is not allocating any centralised marketing authorisation applications to the MHRA. We take a closer look… https://www.epmmagazine.com/opinion/ema-redistributes-evaluation-work-from-uk/ https://www.epmmagazine.com/opinion/ema-redistributes-evaluation-work-from-uk/ Thu, 06 Sep 2018 14:36:38 -0000 Brexit An ongoing review of valsartan medicines by the European Medicines Agency (EMA), has led to the detection of low level of nitrosodiumethylamine (NDMA) in medicines produced by another company, Zhejiang Tianyu. https://www.epmmagazine.com/news/ongoing-review-of-valsartan-medicines/ https://www.epmmagazine.com/news/ongoing-review-of-valsartan-medicines/ Tue, 14 Aug 2018 11:37:18 -0000 Pills As Brexit edges nearer, the European Medicines Agency has revealed further temporary scale backs and suspension of activities as a result of higher than expected staff losses resulting from its move from London to Amsterdam. https://www.epmmagazine.com/news/ema-temporarily-scales-back-and-suspends-activities/ https://www.epmmagazine.com/news/ema-temporarily-scales-back-and-suspends-activities/ Fri, 03 Aug 2018 09:51:58 -0000 European relocation A gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-Thalassemia (TDT) is granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). https://www.epmmagazine.com/news/gene-therapy-from-bluebird-bio-gets-accelerated-assessment/ https://www.epmmagazine.com/news/gene-therapy-from-bluebird-bio-gets-accelerated-assessment/ Tue, 31 Jul 2018 11:41:05 -0000 accelerate The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Janssen’s Darzalex (daratumumab) as a frontline treatment. https://www.epmmagazine.com/news/chmp-recommends-daratumumab-as-a-frontline-treatment/ https://www.epmmagazine.com/news/chmp-recommends-daratumumab-as-a-frontline-treatment/ Mon, 30 Jul 2018 11:45:54 -0000 Approval Last week, the UK government saw heated debates and closely contested votes on the post-Brexit strategy, including a favourable outcome for the future relationship of the UK and the European Medicines Agency (EMA) https://www.epmmagazine.com/news/post-brexit-strategy-vote-pharma-industry-opinions/ https://www.epmmagazine.com/news/post-brexit-strategy-vote-pharma-industry-opinions/ Mon, 23 Jul 2018 11:53:57 -0000 Brexit health Akcea Therapeutics and Ionis Pharmaceuticals have announced that Tegsedi (inotersen) has received European marketing authorisation approval for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hATTR https://www.epmmagazine.com/news/tegsedi-receives-european-marketing-authorisation-approval/ https://www.epmmagazine.com/news/tegsedi-receives-european-marketing-authorisation-approval/ Tue, 17 Jul 2018 11:32:19 -0000 approval Data and analytics company, GlobalData, has revealed that recent survey findings from the European Medicines Agency (EMA) into Brexit preparedness of the pharma industry support its own conclusions on the matter. https://www.epmmagazine.com/analysis/gaps-in-brexit-preparedness-revealed-by-ema-survey/ https://www.epmmagazine.com/analysis/gaps-in-brexit-preparedness-revealed-by-ema-survey/ Thu, 12 Jul 2018 11:05:55 -0000 Brexit rethink Some medicines containing valsartan used for the treatment of high blood pressure and heart conditions are being recalled across Europe to be reviewed by the European Medicines Agency (EMA) to determine the extent of ingredient impurity. https://www.epmmagazine.com/news/some-valsartan-medicines-recalled-amid-impurity-concerns/ https://www.epmmagazine.com/news/some-valsartan-medicines-recalled-amid-impurity-concerns/ Mon, 09 Jul 2018 12:59:01 -0000 Product recall Now we have just passed the six-month marker (1 July) until the European Medicines Agency (EMA) moves from its current location in London to Amsterdam, as a result of Brexit, we gauge industry response to this change… https://www.epmmagazine.com/opinion/less-than-six-months-until-ema-relocates-what-does-industry-think/ https://www.epmmagazine.com/opinion/less-than-six-months-until-ema-relocates-what-does-industry-think/ Mon, 02 Jul 2018 11:56:13 -0000 Brexit opinion Cablivi (caplacizumab) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of a rare blood-clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP) https://www.epmmagazine.com/news/chmp-gives-positive-opinion-for-treatment-of-rare-blood-clot/ https://www.epmmagazine.com/news/chmp-gives-positive-opinion-for-treatment-of-rare-blood-clot/ Mon, 02 Jul 2018 11:35:54 -0000 Approval ‘Doing nothing is not an option’ is the overriding message from pharmaceutical experts who attended the recent Pharmaceutical Industry Network Group (PING) seminar, held in conjunction with Ethical Medicines Industry Group (EMIG). https://www.epmmagazine.com/news/ping-event-review-brexit-implications/ https://www.epmmagazine.com/news/ping-event-review-brexit-implications/ Mon, 18 Jun 2018 11:42:40 -0000 Brexit Pooja Phogat Pooja Phogat, regulation and compliance expert at Kinapse, advises on the best approaches to balancing the risk of patient re-identification with the need for greater data utility. https://www.epmmagazine.com/opinion/achieving-the-desired-end-goal/ https://www.epmmagazine.com/opinion/achieving-the-desired-end-goal/ Fri, 25 May 2018 10:00:00 -0000 end goal The ability of animal studies to predict human safety has been evaluated by global information analytics business, Elsevier, through big data analysis of adverse events reported to the US FDA and EMA https://www.epmmagazine.com/analysis/big-data-analysis-on-concordance-of-animal-human-studies/ https://www.epmmagazine.com/analysis/big-data-analysis-on-concordance-of-animal-human-studies/ Tue, 15 May 2018 12:43:15 -0000 Data analysis Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics. https://www.epmmagazine.com/news/the-top-five-tweets-from-packaging-to-serialisation/ https://www.epmmagazine.com/news/the-top-five-tweets-from-packaging-to-serialisation/ Fri, 11 May 2018 14:10:44 -0000 Top five The European Medicines Agency (EMA) has approved AstraZeneca and Merck’s Lynparza (olaparib) tablets as maintenance therapy for the treatment of platinum-sensitive relapsed ovarian cancer, regardless of BRCA status. https://www.epmmagazine.com/news/ema-approves-lynparza-tablets/ https://www.epmmagazine.com/news/ema-approves-lynparza-tablets/ Tue, 08 May 2018 13:03:29 -0000 Ovarian cancer Independent consulting group, NDA, has announced its findings from its fifth annual comparison of drug approvals in Europe and the US in preparation for this year’s DIA Europe in Basel, Switzerland. https://www.epmmagazine.com/analysis/nda-group-releases-findings-from-comparative-analysis/ https://www.epmmagazine.com/analysis/nda-group-releases-findings-from-comparative-analysis/ Fri, 13 Apr 2018 10:16:21 -0000 US versus EU TrakCel, software developer for gene therapy supply chain tracking and orchestration, has announced it will be organisation that is responsible for tracking and documentation of cell and gene therapy products for the Northern Alliance https://www.epmmagazine.com/news/trakcel-to-provide-services-to-northern-alliance/ https://www.epmmagazine.com/news/trakcel-to-provide-services-to-northern-alliance/ Thu, 12 Apr 2018 12:26:56 -0000 Serialisation Felicity Thomas With recent plans announced by the UK’s prime minister to remain part of the EMA, which would be favourable for many in the pharma industry, I will look at these developments as well as how they will impact industry and the reactions from leaders https://www.epmmagazine.com/opinion/race-against-time-looking-at-the-latest-brexit-developments/ https://www.epmmagazine.com/opinion/race-against-time-looking-at-the-latest-brexit-developments/ Mon, 09 Apr 2018 13:12:19 -0000 stopwatch The marketing authorisation application (MAA) for cemiplimab as a potential treatment for advanced cutaneous squamous cell carcinoma (CSCC) has been accepted for review by the European Medicines Agency (EMA). https://www.epmmagazine.com/news/ema-accepts-maa-for-cemiplimab/ https://www.epmmagazine.com/news/ema-accepts-maa-for-cemiplimab/ Wed, 04 Apr 2018 11:42:21 -0000 Review