To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. To read this article in full you will need to make a payment. Dont include personal or financial information like your National Insurance number or credit card details.
Project documents | Risankizumab for previously treated - NICE Participants randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion. The need to continue treatment should be reviewed at least every 12 months. Gastroenterology. The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. Gastroenterology.
Risankizumab as induction therapy for Crohn's disease: results from the Endoscopic remission: SES-CD 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable, Enhanced clinical response: 60% decrease in average daily SF and/or 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission, Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore 1 at Baseline. Dont worry we wont send you spam or share your email address with anyone. Lancet. Risankizumab administered by subcutaneous (SC) injection. For details on when studies are available for sharing, please refer to the link below.
Phase 3 Maintenance Results Show Patients with Crohn's Disease - AbbVie For information about access in Northern Ireland, contact Chief Pharmaceutical Officer and secondary.care@health-ni.gov.uk. Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study. 2022 Nov;163(5):1470-1471. doi: 10.1053/j.gastro.2022.07.082. MD reports being a consultant for AbbVie, Arena, BMS, Boehringer Ingelheim, Celgene, Eli Lilly, Gilead, Janssen, Merck, Pfizer, Prometheus Labs, Takeda, and UCB; and received research grants from Janssen, AbbVie, and Prometheus Labs. Provisional Schedule Project Team Project lead Thomas Feist Email enquiries If you have any queries please email TATeam1@nice.org.uk Timeline Study data published in the Journal of Crohn's and Colitis support the long-term safety and efficacy of risankizumab for the treatment of Crohn disease. Feagan BG, Sandborn WJ, D'Haens G, Pans J, Kaser A, Ferrante M, Louis E, Franchimont D, Dewit O, Seidler U, Kim KJ, Neurath MF, Schreiber S, Scholl P, Pamulapati C, Lalovic B, Visvanathan S, Padula SJ, Herichova I, Soaita A, Hall DB, Bcher WO. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. z o.o., Sp.k. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. In ADVANCE 58% had prior biologic exposure, whereas in MOTIVATE 47% had intolerance to or . Risankizumab was well tolerated with no new safety signals noted. The other ingredients are succinic acid, disodium succinate. Endoscopic healing is now a critical treatment target for patients with Crohn's disease. Risankizumab is an interesting agent because it's similar to medicines that we currently have available, in that it is an inhibitor, a monoclonal antibody for interleukin-23, IL-23. Online ahead of print. Please enable it to take advantage of the complete set of features! This site needs JavaScript to work properly. According to AbbVie, a significantly greater proportion of . The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Risankizumab is in development for the treatment of several indications, including psoriasis, psoriatic arthritis, severe persistent asthma, and Crohn's disease. In a study of patients who achieved clinical response with short-term risankizumab, long-term response was maintained over a median follow-up period of 33 months. Prior exposure to p19 inhibitors (e.g., risankizumab). EVL reports being a consultant for AbbVie, Amgen, Arena Pharmaceuticals, Boehringer Ingelheim, BMS, Calibr, Celgene, Genentech, Gilead, Gossamer Bio, Iterative Scopes, Janssen, Lilly, Morphic, Ono Pharmaceutical, Pfizer, Protagonist, Scipher Medicine, Sun Pharma, Surrozen, Takeda, and UCB; research support from Alimentiv (Robarts Clinical Trials); and research grants from AbbVie, Amgen, BMS, Genentech, Gilead, Gossamer Bio, Janssen, Pfizer, Celgene (Receptos), Takeda, Theravance, and UCB. Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA).
Risankizumab as maintenance therapy for moderately to severely active Overview | Risankizumab for treating moderate to severe plaque - NICE Project Team Project lead Emily Richards Email enquiries If you have any queries please email scopingta@nice.org.uk Timeline The most common side effects of SKYRIZI in people treated for Crohn's disease include: Upper respiratory infections Injection site reactions Fever Headache Stomach (abdominal) pain Back pain Joint pain Low red blood cells (anemia) These are not all the possible side effects of SKYRIZI. 124]) were also reached with risankizumab 180 mg versus withdrawal (subcutaneous placebo; CDAI clinical remission reached in 87 [55%] of 157 patients, adjusted difference 15% [95% CI 5-24]; endoscopic response 74 [47%] of 157, adjusted difference 26% [17-35]). Accessibility Epub 2022 Aug 9. Well send you a link to a feedback form. Higher CDAI scores indicate more severe disease. The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Risankizumab (SKYRIZI) Demonstrates Significant Improvements - AbbVie EN, AS, KK, YP, VP, SB, WRD, BH, JK, XL, AR, and KW are full-time employees of AbbVie, and might hold AbbVie stock or stock options. Khanna R, Preiss JC, MacDonald JK, Timmer A. Cochrane Database Syst Rev. Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.
AbbVie Submits Application for Risankizumab - AbbVie News Center Newer biologics such as secukinumab, ixekizumab, brodalumab and risankizumab were more favourable compared to older biologics (adalimumab, etanercept, and ustekinumab) in reaching 90% or 100% skin clearance, as measured with the Psoriasis Area Severity Index. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Privacy PolicyTerms and ConditionsAccessibility, Department of Gastroenterology, Kitasato Institute Hospital, Kitasato University, Tokyo 108-8642, Japan. Guidance development process How we develop NICE technology appraisal guidance Your responsibility CDAI clinical remission of Crohn's disease is defined as CDAI < 150. 2018 Oct;3(10):671-680. doi: 10.1016/S2468-1253(18)30233-4. After seven impressive wins of the Formula 1 World Championship, Lewis Hamilton was defeated in Abu Dhabi in December, 2021, by Max Verstappen, a young talented Dutch driver. MacDonald JK, Nguyen TM, Khanna R, Timmer A. Cochrane Database Syst Rev.
Risankizumab Eases Moderate to Severe Crohn's Disease Population pharmacokinetics of the interleukin-23 inhibitor risankizumab in subjects with psoriasis and Crohn's disease: analyses of phase I and II trials. New results from a pair of phase 3 induction studies have found that risankizumab (Skyrizi, AbbVie) at both 600 mg and 1200 mg doses demonstrated significant improvements in both primary endpointsclinical remission and endoscopic responsein patients with Crohn's disease. To help us improve GOV.UK, wed like to know more about your visit today. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally. By targeting IL-23, SKYRIZI can help reduce the excess . WJS reports research grants from Abbvie, Abivax, Arena Pharmaceuticals, Boehringer Ingelheim, Celgene, Genentech, Gilead Sciences, GSK, Janssen, Lilly, Pfizer, Prometheus Biosciences, Seres Therapeutics, Shire, Takeda, and Theravance Biopharma; consulting fees from Abbvie, Abivax, Admirx, Alfasigma, Alimentiv (Robarts Clinical Trials), Alivio Therapeutics, Allakos, Allergan, Amgen, Applied Molecular Transport, Arena Pharmaceuticals, Avexegen Therapeutics, Salix (subsidiary of Bausch Health), Beigene, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Boston Pharmaceuticals, BMS, Celgene, Celltrion, Cellularity, Conatus, Cosmo Pharmaceuticals, Escalier Biosciences, Ferring, Forbion, Equillium, Genentech (Roche), Gilead Sciences, Glenmark Pharmaceuticals, Gossamer Bio, Immunic Therapeutics (formerly Vital Therapies), Incyte, Index Pharmaceuticals, Intact Therapeutics, Janssen, Kyowa Kirin Pharmaceutical Research, Kyverna Therapeutics, Landos Biopharma, Lilly, Miraca Life Sciences, Nivalis Therapeutics, Novartis, Nutrition Science Partners, Oppilan Pharma (acquired by Ventyx Biosciences), Otsuka, Pandion Therapeutics, Paul Hastings, Pfizer, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonists Therapeutics, Provention Bio, Reistone Biopharma, Ritter Pharmaceuticals, Seres Therapeutics, Shanghai Pharma Biotherapeutics, Shire, Shoreline Biosciences, Sienna Biopharmaceuticals, Sigmoid Biotechnologies, Sterna Biologicals, Sublimity Therapeutics, Surrozen, Takeda, Theravance Biopharma, Thetis Pharmaceuticals, Tigenix, Tillotts Pharma, UCB Pharma, Vendata Biosciences, Ventyx Biosciences, Vimalan Biosciences, Vivelix Pharmaceuticals, Vivreon Biosciences, and Zealand Pharma; stock or stock options from Allakos, BeiGene, Gossamer Bio, Oppilan Pharma (acquired by Ventyx Biosciences), Prometheus Biosciences, Prometheus Laboratories, Progenity, Shoreline Biosciences, Ventyx Biosciences, Vimalan Biosciences, and Vivreon Biosciences; and employment at Shoreline Biosciences. Accessibility eams scientific opinion issued to abbvie ltd for risankizumab in the treatment of moderately to severely active crohn's disease in adult patients who did not respond or where. For the full EAMS indication please see section 4.1 of the Treatment protocol: Information for healthcare professionals.
Side Effects | SKYRIZI (risankizumab-rzaa) for Crohn's Disease SKYRIZI Cost | SKYRIZI (risankizumab-rzaa) for Crohn's Disease 360 mg/2.4 mL subcutaneous injection via OBI. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
A Study of the Efficacy and Safety of Risankizumab in Participants With For more information on the process, or to submit a request, visit the following link. D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Pans J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. JP reports being a consultant or speaker for AbbVie, Arena, Boehringer Ingelheim, Celgene, Celltrion, Ferring, Genentech, GSK, Janssen, Nestle, Origo, Pandion, Pfizer, Progenity, Alimentiv, Roche, Shire, Takeda, Theravance, and Wasserman; and research grants from AbbVie and Pfizer. 2 CD is a type of inflammatory bowel disease which can affect any part of the digestive system. 1,2 In the first, Geert D'Haens and colleagues share the findings of the ADVANCE and MOTIVATE phase 3 trials comparing the efficacy and safety of risankizumab with placebo in the induction period. 2022 Oct;175(10):JC114. Adverse event rates were similar among groups, and the most frequently reported adverse events in all treatment groups were worsening Crohn's disease, arthralgia, and headache. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Risankizumab - Information for NHS Medical Director - GOV.UK Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). JAAD Int. Suggested remit: To appraise the clinical and cost effectiveness of risankizumab within its marketing authorisation for treating previously treated moderately to severely active Crohn's disease. by Zaina Hamza, Staff Writer .
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. Published 14 April 2022. Disclaimer, National Library of Medicine ZR declares no competing interests. SS reports consultant or speaker fees from AbbVie, Allergosan, Amgen, Arena, BMS, Celltrion, Falk Pharma, Ferring, Galapagos, Gilead, Genentech (Roche), GSK, IMAB, Janssen, Lilly, MSD, Pfizer, Shire, Takeda, and Viatris. phase 3 FORTIFY maintenance trial. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment [OWI]). [2010] 1.2.18 For the purposes of this guidance, severe active Crohn's disease is defined as very poor general health and one or more symptoms such as weight loss, fever, severe abdominal pain and usually frequent (3 to 4 or more) diarrhoeal stools daily. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
Long-Term Safety and Efficacy of Risankizumab Treatment in - PubMed Funding: AbbVie. Risankizumab (Skyrizi ), a humanised IgG monoclonal antibody that targets the p19 subunit of IL-23, was developed by AbbVie in collaboration with Boehringer Ingelheim for the treatment of immunological and inflammatory disorders. We use cookies to help provide and enhance our service and tailor content and ads. TH reports speaker or consultant fees from Mitsubishi Tanabe Pharma Corporation, EA Pharma, AbbVie, JIMRO, Zeria Pharmaceutical, Kyorin Pharmaceutical, Takeda, Pfizer Japan, Mochida Pharmaceutical, Celgene, Janssen, and Nichi-Iko Pharmaceutical; and reports research grants from Alfresa Pharma, EA pharma, Mitsubishi Tanabe Pharma Corporation, AbbVie, JIMRO, Zeria Pharmaceutical, Daiichi-Sankyo, Kyorin Pharmaceutical, Nippon Kayaku, Takeda, Pfizer, and Mochida Pharmaceutical. Risankizumab is an IL-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. Copyright 2022 Elsevier Ltd. All rights reserved. Bookshelf About Crohn's Disease News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports.
Risankizumab in the treatment of moderately to severely active Crohn's 12,13 Because the signs and symptoms of Crohn's disease are . DOI: 10.1016/S0140-6736 (22)00467-6 Abstract Background: Risankizumab, an interleukin (IL)-23 p19 inhibitor, was evaluated for safety and efficacy as induction therapy in patients with moderately to severely active Crohn's disease. Risankizumab is in development as a treatment option for moderate to severe Crohn's disease (CD). The most common side effects of SKYRIZI in people treated for Crohn's disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection. Source Reference: Hibi T "Risankizumab for Crohn's disease" Lancet 2022; DOI: 10.1016/S0140-6736(22)00628-6. share to facebook opens in a new tab or window share to twitter opens in a new tab or . You have reached the maximum number of saved studies (100). Risankizumab in patients with moderate to severe Crohn's disease: an open-label extension study. CD causes inflammation and ulceration, which affects food digestion, nutrient absorption, and waste elimination. Sapporo-Kosei General Hospital /ID# 160158, Sapporo Medical University Hospital /ID# 163028, Nishinomiya Munic Central Hospital /ID# 210104, Hyogo College of Medicine College Hospital /Id# 160164, National Hospital Organization Mito Medical Center /ID# 160154, Higashi Ibaraki-gun, Ibaraki, Japan, 311-3193, Sagamihara-shi, Kanagawa, Japan, 252-0375, Yokohama City University Medical Center /ID# 163906, Yokohama Municipal Citizen's Hospital /ID# 204126, Yokkaichi Hazu Medical Center /ID# 163741, Duplicate_Tohoku Rosai Hospital /ID# 163189, Osaka City University Hospital /ID# 160146, Shiga University of Medical Science Hospital /ID# 164022, Hamamatsu University Hospital /ID# 205689, Tokyo Medical And Dental University, Medical Hospital /ID# 160157, Duplicate_Tokai University Hachioji Hospital /ID# 160160, The Jikei University Hospital /ID# 163190, Duplicate_Kitasato University Kitasato Institute Hospital /ID# 160144, Tokyo Women's Medical University Hospital /ID# 205973, Wakayama Medical University Hospital /ID# 200183, Yamanashi Prefectural Central Hospital /ID# 160156, Hanyang University Guri Hospital /ID# 158673, Guri, Gyeonggido, Korea, Republic of, 11923, Duplicate_CHA bundang medical center CHA University /ID# 158672, Seongnam-si, Gyeonggido, Korea, Republic of, 13496, Duplicate_The Catholic University of Korea, ST. Vincent's Hospital /ID# 158681, Suwon, Gyeonggido, Korea, Republic of, 16247, Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03181, Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722, Pusan National University Hospital /ID# 158677, Yeungnam University Medical Center /ID# 158680, The Catholic University of Korea, Daejeon St.Mary's Hospital /ID# 213552, Pauls Stradins Clinical University Hospital /ID# 159614, Digestive Disease Center Gastro /ID# 163105, Riga East Clinical University Hospital /ID# 159613, Duplicate_Hospital of lithuanian university of Health Science Kauno Klinikos /ID# 162582, Duplicate_Vilnius University Hospital /ID# 162507, Division Pantai Barat Utara, Sabah, Malaysia, 88200, Universiti Kebangsaan Malaysia (UKM) Medical Centre /ID# 163654, Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V. /ID# 167648, Unidad de Atencion Medica e Investigacion en Salud /ID# 163624, Health Pharma Professional Research S.A de C.V /ID# 161734, Elisabeth Tweesteden Ziekenhuis /ID# 163631, Christchurch, Canterbury, New Zealand, 8011, Newtown Wellington, Wellington, New Zealand, 6021, Vestre viken - Baerum Sykehus /ID# 157886, Helse More og Romsdal HF, Alesund sjukehus /ID# 212811, Torun, Kujawsko-pomorskie, Poland, 87-100, Uniwersytecki Szpital Kliniczny nr 1 im. Queries to NHS England regarding the scheme can be submitted to england.eams@nhs.net. Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) > 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline). Prof. O.O. The risk of side effects was similar between the newer and older biologics. This open-label extension investigated the long-term safety, pharmacokinetics, immunogenicity and efficacy of risankizumab in responders to risankizumab in the parent phase 2 study. Risankizumab administered by intravenous infusion. 2017 Apr 29;389(10080):1699-1709. doi: 10.1016/S0140-6736(17)30570-6. This site needs JavaScript to work properly. Adults with Crohn's disease will receive their starter doses with SKYRIZI through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider.
Gastroenterol Rep (Oxf). The mean disease duration in these studies was 8.8 8.3 years and 11.7 8.9 years, respectively.
Risankizumab: a game changer in Crohn's disease? - The Lancet 2022 Sep 19;10(9):2325. doi: 10.3390/biomedicines10092325. Suggested remit: To appraise the clinical and cost effectiveness of risankizumab within its marketing authorisation for treating previously treated moderately to severely active Crohn's disease. DTR reports speaker or consultant fees from AbbVie, Abgenomics, Allergan, Arena Pharmaceuticals, Bellatrix Pharmaceuticals, Boehringer Ingelheim, BMS, CDx Diagnostics, Syneos, Check-Cap, Dizal Pharmaceuticals, Genentech (Roche), Gilead Sciences, Ichnos Sciences (formerly Glenmark Pharmaceuticals), InDex Pharmaceuticals, Iterative Scopes, Janssen, Lilly, Materia Prima, Narrow River Management, Pfizer, Prometheus Laboratories, Reistone, Takeda, and Techlab; and research grants from Takeda. You can change your cookie settings at any time. 11-13 It is a progressive disease, meaning it gets worse over time. Choosing to participate in a study is an important personal decision. LP-B reports personal fees from Galapagos, AbbVie, Janssen, Genentech, Ferring, Tillots, Celltrion, Takeda, Pfizer, Index Pharmaceuticals, Sandoz, Celgene, Biogen, Samsung Bioepis, Inotrem, Allergan, MSD, Roche, Arena, Gilead, Amgen, BMS, Vifor, Norgine, Mylan, Lilly, Fresenius Kabi, OSE Immunotherapeutics, Enthera, Theravance, Pandion Therapeutics, Gossamer Bio, Viatris, and Thermo Fisher Scientific; grants from AbbVie, MSD, Takeda, and Fresenius Kabi; and holds stock options in Clinical Trials Mobile Application. Pyrohov /ID# 216265, Kyiv Municipal Clinical Hospital #18 /ID# 162521, Royal Devon and Exeter NHS Trust Hospital /ID# 157517, London, London, City Of, United Kingdom, E1 2ES, Guy's and St Thomas' NHS Foundation Trust /ID# 157519, London, London, City Of, United Kingdom, SE1 9RT, Ashford and St Peter's Hospitals NHS Foundation Trust /ID# 207937, Chertsey, Surrey, United Kingdom, KT16 0PZ, Cambridge University Hospitals NHS Foundation Trust /ID# 158031, Calderdale and Huddersfield NHS Foundation Trust /ID# 209569, Hull University Teaching Hospitals NHS Trust /ID# 158757, Leeds Teaching Hospitals NHS Trust /ID# 157523, Duplicate_King's College Hospital NHS Foundation Trusts /ID# 158756, The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 163709, Newcastle Upon Tyne, United Kingdom, NE7 7DN, Oxford University Hospitals NHS Foundation Trust /ID# 158033, Duplicate_Northern Care Alliance NHS Group /ID# 207764. AP remission is defined as average daily AP score <= 1 and not worse than baseline. Declaration of interests GDH reports being a consultant or speaker for AbbVie, ActoGeniX, AIM, Allergan, Amgen, Arena, Boehringer Ingelheim, Celgene (formerly Receptos), Celltrion, Cosmo Technologies, Elan, Eli Lilly, enGene, Dr Falk Pharma, Ferring, Galapagos, Genentech, Gilead Sciences, Giuliani, Given Imaging, GlaxoSmithKline (GSK), Gossamer Bio, Janssen Biologics, Merck, Sharp & Dohme (MSD), Neovacs, Norgine, Novo Nordisk, Otsuka, PDL BioPharma, Prometheus Laboratories, Progenity, Pfizer, Alimentiv (formerly Robarts Clinical Trials), Salix, Seres and Nestle, Schering-Plough, SetPoint, Shire, Takeda, Tillotts, Tramedico, UCB, Versant, and Vifor; and reports research grants from AbbVie, Dr Falk Pharma, Given Imaging, Janssen, MSD, and PhotoPill.
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