References
- Thermo Fisher Scientific to acquire Brammer Bio, a leader in viral vector manufacturing. http://thermofisher.mediaroom.com/2019–03-24-Thermo-Fisher-Scientific-to-Acquire-Brammer-Bio-a-Leader-in-Viral-Vector-Manufacturing?printable
- Catalent to acquire gene therapy leader Paragon Bioservices, Inc. for $1.2 billion. www.catalent.com/index.php/news-events/news/Catalent-to-acquire-gene-therapy-leader-Paragon-Bioservices-Inc.-for-1.2-billion
- GeneDesign joins Ajinomoto Bio-Pharma Services and opens oligonucleotide API development center. https://ajibio-pharma.com/news-post/genedesign-joins-ajinomoto-bio-pharma-services-and-opens-oligonucleotide-api-development-center/
- Novartis adds clinical and preclinical anti-inflammatory programs to portfolio with acquisition of IFM Tre. www.novartis.com/news/media-releases/novartis-adds-clinical-and-preclinical-anti-inflammatory-programs-portfolio-acquisition-ifm-tre
- Puma Biotechnology and Pierre Fabre enter into exclusive license agreement to develop and commercialize NERLYNX® (neratinib) in Europe. www.pumabiotechnology.com/pr20190401.html
- PB272 (neratinib). www.pumabiotechnology.com/pb272_neratinib.html
- Kiadis to acquire CytoSen Therapeutics, Inc. https://cytosen.com/news/kiadis-to-acquire-cytosen-therapeutics-inc/
- Fulcrum Therapeutics acquires global rights to losmapimod, a potential disease-modifying therapy for facioscapulohumeral muscular dystrophy. https://static1.squarespace.com/static/57643b13bebafb4570880021/t/5cbe34a40852293126249224/1555969189392/Fulcrum_GSK_Apr.23.19.pdf
- Salix enters into license agreement with the University of California to develop and commercialize novel compound for the treatment of non-alcoholic fatty liver disease and nonalcoholic steatohepatitis. https://ir.bauschhealth.com/tools/viewpdf.aspx?page = {97CBA619-16F6-4101-AB81-459BC25E5F6D}
- Salix enters into exclusive license agreement with Mitsubishi Tanabe Pharma to develop and commercialize late stage investigational S1P modulator for the treatment of inflammatory bowel disease. www.bauschhealth.com/news-room/news-releases/news-details/201904250700pr_news_uspr_____ny30449
- Calixar signs exclusive licensing agreement with Regeneron on undisclosed therapeutic target. https://calixar.com/wp-content/uploads/2019/04/2019-04-29_purepressrelease_CalixarToSignLicenseAgreementWithRegeneron.pdf
- Calixar core business. https://calixar.com/technology-approach/technology/
- Celgene stockholders approve proposed acquisition by Bristol-Myers Squibb. https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Stockholders-Approve-Proposed-Acquisition-by-Bristol-Myers-Squibb/default.aspx
- Bristol-Myers Squibb shareholders approve Celgene Acquisition. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-shareholders-approve-celgene-acquisition
- Alnylam and Sanofi conclude research and option phase of 2014 RNAi therapeutics collaboration. http://investors.alnylam.com/news-releases/news-release-details/alnylam-and-sanofi-conclude-research-and-option-phase-2014-rnai
- Alnylam and Regeneron announce broad collaboration to discover, develop and commercialize RNAi therapeutics focused on ocular and central nervous system (CNS) diseases. http://investors.alnylam.com/news-releases/news-release-details/alnylam-and-regeneron-announce-broad-collaboration-discover
- Regeneron and Alnylam Pharmaceuticals announce collaboration to discover new treatments for nonalcoholic steatohepatitis (NASH). http://investors.alnylam.com/news-releases/news-release-details/regeneron-and-alnylam-pharmaceuticals-announce-collaboration
- Gilead Sciences and Novo Nordisk announce intent to initiate a clinical collaboration in NASH. www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-sciences-and-novo-nordisk-announce-intent-to-initiate-a-clinical-collaboration-in-nash
- Gilead and insitro announce strategic collaboration to discover and develop novel therapies for nonalcoholic steatohepatitis. www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-and-insitro-announce-strategic-collaboration-to-discover-and-develop-novel-therapies-for-nonalcoholic-steatohepatitis
- Fibrocell announces collaboration with Castle Creek Pharmaceuticals to develop and commercialize FCX-007 gene therapy. http://ir.fibrocell.com/phoenix.zhtml?c=253777&p=irol-newsArticle&ID=2394454
- Lilly and Avidity Biosciences announce licensing and Research Collaboration. http://lilly.mediaroom.com/2019-04-22-Lilly-and-Avidity-Biosciences-Announce-Licensing-and-Research-Collaboration
- Avidity Biosciences, About Us. http://www.aviditybiosciences.com/about-us/
- AveXis expands world-leading gene therapy manufacturing capacity with purchase of advanced biologics therapy manufacturing campus in Longmont, Colorado. www.novartis.com/news/media-releases/avexis-expands-world-leading-gene-therapy-manufacturing-capacity-purchase-advanced-biologics-therapy-manufacturing-campus-longmont-colorado
- Kite announces plans for new state-of-the-art facility to expand cell therapy production capabilities. www.businesswire.com/news/home/20190424005257/en/Kite-Announces-Plans-New-State-of-the-Art-Facility-Expand
- Nimble Therapeutics spins out from Roche to commercialize novel drug discovery technology with financing from Telegraph Hill Partners. www.nimbletherapeutics.com/news/nimble-therapeutics-spins-out-from-roche-to-commercialize-novel-drug-discovery-technology-with-financing-from-telegraph-hill-partners
- Ophthotech Transitions to a gene therapy focused company developing treatments for orphan inherited retinal diseases and changes name to IVERIC bio. https://investors.ivericbio.com/news-releases/news-release-details/ophthotech-transitions-gene-therapy-focused-company-developing
- Focused on developing treatments to address age-related and retinal diseases: Zimura (avincaptad pegol). https://ivericbio.com/therapeutics/#zimura
- Autolus Therapeutics receives FDA orphan drug designation for AUTO3 for treatment of acute lymphoblastic leukemia. https://autolus.gcs-web.com/news-releases/news-release-details/autolus-therapeutics-receives-fda-orphan-drug-designation-auto3
- Celgene Corporation and Acceleron Pharma announce submission of luspatercept biologics license application to US FDA. https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Corporation-and-Acceleron-Pharma-Announce-Submission-of-Luspatercept-Biologics-License-Application-to-US-FDA/default.aspx
- Celgene Corporation and Acceleron Pharma announce submission of luspatercept Marketing authorization application to the European Medicines Agency (EMA) for MDS and beta-thalassemia. https://ir.celgene.com/press-releases/press-release-details/2019/Celgene-Corporation-and-Acceleron-Pharma-Announce-Submission-of-Luspatercept-Marketing-Authorization-Application-to-the-European-Medicines-Agency-EMA-for-MDS-and-Beta-Thalassemia/default.aspx
- Gilead submits supplemental new drug application to US Food and Drug Administration for once-daily Descovy® for HIV pre-exposure prophylaxis. www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-submits-supplemental-new-drug-application-to-us-food-and-drug-administration-for-oncedaily-descovy-for-hiv-preexposure-prophylaxis
- Descovy vs Truvada. www.aids-drugs-online.com/health-conditions-from-hiv-aids/general/descovy-vs-truvada.html
- ViiV Healthcare submits new drug application to US FDA for the first monthly, injectable, two-drug regimen of cabotegravir and rilpivirine for treatment of HIV. www.gsk.com/en-gb/media/press-releases/viiv-healthcare-submits-new-drug-application-to-us-fda-for-the-first-monthly-injectable-two-drug-regimen-of-cabotegravir-and-rilpivirine-for-treatment-of-hiv/
- Janssen announces submission of new drug application to US FDA for the first monthly, injectable, two-drug regimen of rilpivirine and cabotegravir for treatment of HIV. www.janssen.com/janssen-announces-submission-new-drug-application-us-fda-first-monthly-injectable-two-drug-regimen
- US FDA approves ViiV Healthcare's Dovato (dolutegravir/lamivudine), the first, once-daily, single-tablet, two-drug regimen for treatment-naïve HIV-1 adults. www.gsk.com/en-gb/media/press-releases/us-fda-approves-viiv-healthcare-s-dovato-dolutegravirlamivudine-the-first-once-daily-single-tablet-two-drug-regimen-for-treatment-naïve-hiv-1-adults/
- ViiV Healthcare announces CHMP Positive Opinion for Dovato® (dolutegravir/lamivudine) as a once-daily, single-pill, two-drug regimen for the treatment of HIV infection. www.gsk.com/en-gb/media/press-releases/viiv-healthcare-announces-chmp-positive-opinion-for-dovato-dolutegravirlamivudine-as-a-once-daily-single-pill-two-drug-regimen-for-the-treatment-of-hiv-infection/
- Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of Type 2 diabetes. www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2242550.html
- Timmins P . Industry Update: the latest developments in the field of therapeutic delivery, 1 – 28 February 2018. Ther. Deliv.9(11), 493–504 (2018).
- Novartis announces FDA filing acceptance and priority review of brolucizumab (RTH258) for patients with wet AMD. www.novartis.com/news/media-releases/novartis-announces-fda-filing-acceptance-and-priority-review-brolucizumab-rth258-patients-wet-amd
- FDA approves Merck's Keytruda® (pembrolizumab) in combination with Inlyta® (axitinib) as first-line treatment for patients with advanced renal cell carcinoma. www.mrknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytruda-pembrolizumab-combination-inlyt
- BALVERSA™ (erdafitinib) receives US FDA approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma with certain FGFR genetic alterations. www.janssen.com/balversa-erdafitinib-receives-us-fda-approval-treatment-patients-locally-advanced-or-metastatic
- AveXis data reinforce effectiveness of Zolgensma® in treating spinal muscular atrophy (SMA) Type 1. www.novartis.com/news/media-releases/avexis-data-reinforce-effectiveness-zolgensma-treating-spinal-muscular-atrophy-sma-type-1
- Marinomed Biotech AG announces top line results of the Phase III study for Budesolv. www.marinomed.com/en/news/marinomed-biotech-ag-announces-top-line-results-of-the-phase-iii-study-for-budesolv
- ReNeuron Group Plc (“ReNeuron” or the “Company”) clinical update and conference presentation. http://4965zs3ha2l125fk78zkozo3.wpengine.netdna-cdn.com/wp-content/uploads/RENE-RP-clinical-update-26-April-2019-UK-RNS-FINAL.pdf
- Gilead presents new data in nonalcoholic steatohepatitis (NASH) at the International Liver Congress™ 2019. www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-presents-new-data-in-nonalcoholic-steatohepatitis-nash-at-the-international-liver-congress-2019
- Gilead announces topline data from Phase III STELLAR-3 Study of selonsertib in bridging fibrosis (F3) due to nonalcoholic steatohepatitis (NASH). www.gilead.com/news-and-press/press-room/press-releases/2019/4/gilead-announces-topline-data-from-phase-3-stellar3-study-of-selonsertib-in-bridging-fibrosis-f3-due-to-nonalcoholic-steatohepatitis-nash
- New data from Phase III teprotumumab trial (OPTIC) shows dramatic reduction in proptosis, or eye bulging, the main cause of morbidity in active thyroid eye disease (TED). https://ir.horizontherapeutics.com/node/16006/pdf
- Horizon Pharma plc announces Phase III confirmatory trial evaluating teprotumumab (OPTIC) for the treatment of active thyroid eye disease (TED) met primary and all secondary endpoints. http://ir.horizon-pharma.com/news-releases/news-release-details/horizon-pharma-plc-announces-phase-3-confirmatory-trial
- Poxel and Sumitomo Dainippon Pharma announce positive top-line results for imeglimin Phase III trial (TIMES 1) in Japan for the treatment of Type 2 Diabetes. www.poxelpharma.com/en_us/news-media/press-releases/detail/117/poxel-and-sumitomo-dainippon-pharma-announce-positive
- Clovis Oncology announces interim results from Rubraca® (rucaparib) Phase II study in advanced pancreatic cancer and nonclinical data in multiple solid tumor types for Rucaparib and lucitanib presented at AACR 2019. https://ir.clovisoncology.com/investors-and-news/news-releases/press-release-details/2019/Clovis-Oncology-Announces-Interim-Results-from-Rubraca-rucaparib-Phase-2-Study-in-Advanced-Pancreatic-Cancer-and-Nonclinical-Data-in-Multiple-Solid-Tumor-Types-for-Rucaparib-and-Lucitanib-Presented-at-AACR-2019/default.aspx
- Merck provides update on Phase III KEYNOTE-062 trial evaluating KEYTRUDA® (pembrolizumab) as monotherapy and in combination with chemotherapy for first-line treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma. www.mrknewsroom.com/news-release/oncology/merck-provides-update-phase-3-keynote-062-trial-evaluating-keytruda-pembrolizu
- Bristol-Myers Squibb reports first quarter financial results. https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibb-reports-first-quarter-financial-results-1