Regulatory round-up
Welcome to our round-up of the latest news and key announcements across UK and global regulation issues affecting the cell and gene therapy industry.
Regulatory round up
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release: Cell and gene therapy clinical trials and preclinical programmesRegulatory news - June 2016Progress being made in UK regenerative therapies industry says expert reportRegulatory news - May 2016Cell Therapy Manufacturing sign new agreementNew company created to develop novel technology to treat diabetesNew report shows that capacity and capability in cell and gene therapy manufacturing continues to increase in the UKCell and Gene Therapy Catapult, UCLB and Imperial Innovations announce positive interim review in ongoing AML WT1 T cell clinical trialCell and Gene Therapy Catapult and Asymptote sign licence agreement for thawing system for cell-based therapiesFrameworks for promising therapies with less mature evidence base to secure adoptionCell and Gene Therapy Catapult appoints three new Non-Executive Directors to the BoardCell Therapy Catapult is now the Cell and Gene Therapy CatapultHorizon 2020 awards €6.8m to TETRA consortium for pivotal replacement trachea trialCell Therapy Catapult details key milestones and achievements in 2015 Annual ReviewCell Therapy Catapult signs Memorandum of Understanding with Kanagawa Prefecture, JapanBIA publishes briefing paper on ATMPs and regenerative medicineEMA releases new guidance on methods to be used in the design and conduct of post-authorisation efficacy studiesUS Guidance for Industry updateEMA implements new system for better reporting of suspected adverse reactions to medicines via EudraVigilanceEMA continues its efforts to facilitate early patient access to innovative medicines through initiation of PRIME schemeEMA issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)EMA launches new patient registry initiative for collection of clinical dataCAT publishes Monthly Report for September 2015US Guidance for Industry and FDA publications updateFDA issues Guidance for Industry on submissions for HLA testing kitsFDA issues final guidance on the design and analysis of shedding studiesHTA provides statement on regulation of blood as a starting material for ATMPsHTA announces workshops on updated codes of practiceEMA releases addendum to ICH E6 guideline on good clinical practiceUK Cell Therapy GMP Manufacturing Capacity and Capability IncreasesCollaboration to Improve Viral Vector Industrialisation ProcessCell Therapy Catapult Awards Major Contract to Cellular Therapeutics Limited to Accelerate WT1 Clinical ProgrammeCAT publishes Monthly Report for July 2015EMA publishes new draft guidance on fast track routes to marketing authorisationEMA announces workshop on facilitating the development of advanced therapies in September 2015Early dialogue to support development of medicines for childrenFDA issue draft guidance on developing drugs for Duchenne Muscular DystrophyFDA issues final guidance on early phase clinical trials for gene and cell therapiesEMA adopts Reflection Paper on Classification of ATMPsCell Therapy Catapult and Asymptote Collaborate to Revolutionise Delivery of Cell TherapiesTxCell and Trizell amend collaboration agreement to accelerate Ovasave developmentCell Medica Collaborates with Cell Therapy Catapult to Help Bring Its New Treatment to NHSNewcastle Hosts Major Interactive Science Exhibit Exploring the Wonder of Stem CellsComplementary vision and technologies shared in Cell Therapy Catapult visit to the University of LeedsAthersys and Cell Therapy Catapult announce grant to support Clinical Development of Stem Cell Therapy for Severe Acute Respiratory ConditionCell Therapy Catapult CEO appointed to Board of UK BioIndustry AssociationBioMedical Catalyst grant of £2m for University of Edinburgh liver disease therapyRecognition in today’s Hauser review of progress made by Catapult centresCell Therapy Catapult working with Tokyo Electron on Smart Cell Processing TechnologiesPublication of Cell Therapy Catapult’s First ReviewCBRE appointed as search agent for Cell Therapy Manufacturing Centre siteBusiness Secretary Vince Cable opens Cell Therapy Catapult’s state-of-the-art facilitiesUCL, Imperial & Cell Therapy Catapult collaborate to advance leukaemia cell therapyCell Therapy Catapult supports Smith & Nephew on innovative wound care productUK GMP manufacturing survey shows strong network of early-stage facilitiesTeam led by UCL & GOSH to develop infant oesophageal replacement product First joint project for Cell Therapy Catapult & UK Stem Cell Foundation.Cell Therapy Catapult to work with Athersys on projects to advance European development of MultiStem® therapyCT Catapult to discuss bioengineered organs & T cell therapies at ISCT 2014Wellcome Trust awards BloodPharma team £5m for red blood cell transfusion projectWealth of preclinical services and clinical biomarker expertise in UK CROsCell Therapy Catapult and University of Leeds to collaborate on acellular scaffoldsCell Therapy Catapult and Newcastle limbal stem cell transplant collaborationLifeSciences UK report highlights positive impact of Cell Therapy CatapultLaunch of White Paper series with ‘T Cell Therapies: An Overview’Cell Therapy Catapult to support 2013 CHRISTMAS LECTURESUK is the one-stop shop for regenerative medicine – BIA booklet launched at Cell Therapy CatapultCell Therapy Catapult & Roslin Cells to create clinical grade stem cells to accelerate research into new treatmentsTSB releases Catapult Programme Progress Update 2012-2013Cell Therapy Catapult now eligible as partner in Biomedical Catalyst projectsCell Therapy Catapult’s innovative new facilities on track for Q1 2014 openingResponse to Regenerative Medicine report from House of Lords Science and Technology CommitteeCell Therapy and Regenerative Medicine Centres in Canada and UK Collaborating to Accelerate Commercialization of New Medicines for PatientsCell Therapy Catapult Recruits Prof Johan Hyllner as Chief Scientific OfficerCell Therapy Catapult and the UK Stem Cell Foundation Agree to CollaborateReNeuron and Cell Therapy Catapult in landmark collaboration on new cell manufacturing technologiesUK clinical trials database first major output for Cell Therapy CatapultThe Cell Therapy Catapult Announces Three Hires to its Management TeamDr John Brown appointed Chairman of Cell Therapy Catapult
