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https://endpts.com/biomarins-roctavian-once-forecast-to-sell-50m-to-150m-this-year-only-pulls-in-a-fraction-of-that/

ENDPTS
23 Feb 2024

https://www.prnewswire.com/news-releases/biomarin-to-present-roctavian-valoctocogene-roxaparvovec-rvox-data-highlighting-long-term-durability-at-2024-european-association-for-haemophilia-and-allied-disorders-eahad-congress-302053882.html

PR NEWSWIRE
06 Feb 2024

https://www.prnewswire.com/news-releases/biomarin-announces-first-person-treated-commercially-with-roctavian-valoctocogene-roxaparvovec-rvox-for-severe-hemophilia-a-in-europe-301914118.html

PR NEWSWIRE
30 Aug 2023

https://www.prnewswire.com/news-releases/orsini-selected-by-biomarin-to-dispense-roctavian-the-first-gene-therapy-for-the-treatment-of-severe-hemophilia-a-301873984.html

PR NEWSWIRE
11 Jul 2023

https://www.prnewswire.com/news-releases/biocaresd-builds-depth-as-limited-specialty-distributor-by-adding-roctavian-rystiggo-vyvgart-hytrulo-to-portfolio-301873517.html

PR NEWSWIRE
11 Jul 2023

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-biomarins-gene-therapy-hemophilia-2023-06-29/

REUTERS
30 Jun 2023

https://www.statnews.com/2023/06/29/biomarin-wins-approval-for-gene-therapy-to-treat-hemophilia-a/

Adam Feuerstein STAT NEWS
29 Jun 2023

https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-biomarins-roctavian-valoctocogene-roxaparvovec-rvox-the-first-and-only-gene-therapy-for-adults-with-severe-hemophilia-a-301867403.html

PR NEWSWIRE
29 Jun 2023

https://investors.biomarin.com/2023-06-22-BioMarin-to-Present-ROCTAVIAN-TM-valoctocogene-roxaparvovec-Data-from-Longest-and-Largest-Hemophilia-Gene-Therapy-Clinical-Trial-Program-at-the-International-Society-on-Thrombosis-and-Haemostasis-ISTH-2023-Congress

PRESS RELEASE
22 Jun 2023

https://pharmaphorum.com/news/biomarin-gets-first-access-deal-in-eu-for-gene-therapy-roctavian/

PHARMAPHORUM
12 Jan 2023

https://www.prnewswire.com/news-releases/biomarin-announces-advancements-in-fda-review-of-roctavian-valoctocogene-roxaparvovec-for-adults-with-severe-hemophilia-a-301685915.html

PRNEWSWIRE
24 Nov 2022

https://www.ema.europa.eu/en/documents/overview/roctavian-epar-medicine-overview_en.pdf

EMA
09 Nov 2022

https://investors.biomarin.com/2022-11-07-BioMarin-Announces-Incremental-Progress-on-Biologics-License-Application-BLA-Review-for-Valoctocogene-Roxaparvovec-AAV-Gene-Therapy-for-Adults-with-Severe-Hemophilia-A-Program

PRESS RELEASE
07 Nov 2022

https://icer.org/news-insights/press-releases/icer-publishes-evidence-report-on-gene-therapies-for-hemophilia-a-and-b/

ICER
03 Nov 2022

https://www.prnewswire.com/news-releases/fda-accepts-biomarins-biologics-license-application-bla-for-valoctocogene-roxaparvovec-aav-gene-therapy-for-adults-with-severe-hemophilia-a-301647823.html

PRNEWSWIRE
12 Oct 2022

https://investors.biomarin.com/2022-09-15-BioMarins-Gene-Therapy-for-Adults-with-Severe-Hemophilia-A,-ROCTAVIAN-TM-valoctocogene-roxaparvovec-,-Assessed-to-Provide-Substantial-Cost-Savings-Per-Patient-in-a-Preliminary-Independent-Report

PRESS RELEASE
15 Sep 2022

https://www.pharmacompass.com/pdf/news/biomarins-roctavian-valoctocogene-roxaparvovec-receives-approval-in-europe-93016.pdf

EMA
06 Sep 2022

https://investors.biomarin.com/2022-08-24-First-Gene-Therapy-for-Adults-with-Severe-Hemophilia-A,-BioMarins-ROCTAVIAN-TM-valoctocogene-roxaparvovec-,-Approved-by-European-Commission-EC

PRESS RELEASE
25 Aug 2022

https://www.fiercepharma.com/pharma/biomarins-hemophilia-gene-therapy-roctavian-wins-conditional-eu-backing-fda-plan-delayed

Angus Liu FIERCEPHARMA
25 Jun 2022

https://www.biopharmadive.com/news/biomarin-fda-resubmission-delay-hemophilia-gene-therapy/624606/

N. Pagliarulo BIOPHARMADIVE
01 Jun 2022

https://www.prnewswire.com/news-releases/biomarin-to-present-findings-from-ongoing-studies-of-valoctocogene-roxaparvovec-investigational-gene-therapy-at-the-world-federation-of-hemophilia-2022-world-congress-may-8-11-2022-including-five-platform-presentations-301540667.html

PRNEWSWIRE
05 May 2022

https://www.prnewswire.com/news-releases/biomarin-announces-oral-presentation-of-2-year-analysis-of-largest-phase-3-gene-therapy-study-in-adults-with-severe-hemophilia-a-at-15th-annual-congress-of-european-association-for-haemophilia-and-allied-disorders-eahad-2-4-febr-301475471.html

PRNEWSWIRE
04 Feb 2022

https://www.fiercebiotech.com/biotech/biomarin-s-hemophilia-b-gene-therapy-hits-goal-phase-3-teeing-up-fda-filing-despite

N.P. Taylor FIERCEBIOTECH
11 Jan 2022

https://www.prnewswire.com/news-releases/biomarin-announces-stable-and-durable-annualized-bleed-control-in-the-largest-phase-3-gene-therapy-study-in-adults-with-severe-hemophilia-a-134-participant-study-met-all-primary-and-secondary-efficacy-endpoints-at-two-year-analys-301456772.html

PRNEWSWIRE
09 Jan 2022

https://investors.biomarin.com/2021-03-08-BioMarin-Announces-FDA-Regenerative-Medicine-Advanced-Therapy-RMAT-Designation-Granted-to-Valoctocogene-Roxaparvovec-Investigational-Gene-Therapy-for-Hemophilia-A

PRESS RELEASE
08 Mar 2021

https://icer-review.org/announcements/hemophilia_a_2020_evidence_report/

ICER
16 Oct 2020

https://endpts.com/in-another-shocker-fda-rejects-biomarins-hemophilia-a-gene-therapy-demanding-more-data-on-durability/

John Carroll ENDPOINTSNEWS
19 Aug 2020

https://hemophilianewstoday.com/2020/07/20/isth2020-biomarins-gene-therapy-hemophilia-drives-sustained-fviii-production-liver-biopsy-study-shows/

HEMOPHILIANEWSTODAY
20 Jul 2020

https://hemophilianewstoday.com/2020/06/24/biomarin-gene-therapy-results-huge-drop-in-bleeding-rates-factor-viii-usage-updated-data/

Marta Figueiredo HEMOPHILIANNEWSTODAY
24 Jun 2020

https://www.prnewswire.com/news-releases/biomarin-provides-additional-data-from-recent-4-year-update-of-ongoing-phase-12-study-of-valoctocogene-roxaparvovec-gene-therapy-for-severe-hemophilia-a-in-late-breaking-oral-presentation-at-world-federation-of-hemophilia-virtual-301078398.html

PR NEWSWIRE
17 Jun 2020

https://www.prnewswire.com/news-releases/biomarin-provides-highlights-of-4-years-of-clinical-data-from-ongoing-phase-12-study-of-valoctocogene-roxaparvovec-gene-therapy-for-severe-hemophilia-a-301068247.html

PRNEWSWIRE
30 May 2020

https://www.europeanpharmaceuticalreview.com/news/114882/ten-drugs-in-pre-registration-likely-to-be-blockbusters-by-2025-finds-report/

EUROPEAN PHARMACEUTICALS
11 Mar 2020

https://www.prnewswire.com/news-releases/biomarins-biologics-license-application-for-valoctocogene-roxaparvovec-accepted-for-priority-review-by-fda-with-review-action-date-of-august-21-2020-301008771.html

PR NEWSWIRE
20 Feb 2020

https://www.prnewswire.com/news-releases/biomarin-submits-biologics-license-application-to-us-food-and-drug-administration-for-valoctocogene-roxaparvovec-to-treat-hemophilia-a-300978804.html

PR NEWSWIRE
21 Dec 2019

https://www.prnewswire.com/news-releases/european-medicines-agency-validates-biomarins-marketing-authorization-application-for-valoctocogene-roxaparvovec-to-treat-severe-hemophilia-a-300978777.html

PR NEWSWIRE
21 Dec 2019

http://www.pharmabiz.com/NewsDetails.aspx?aid=119551&sid=2

PHARMABIZ
22 Nov 2019

https://www.biospace.com/article/releases/biomarin-submits-marketing-authorization-application-to-european-medicines-agency-for-valoctocogene-roxaparvovec-to-treat-severe-hemophilia-a/?s=89

BIO SPACE
21 Nov 2019

https://www.fiercebiotech.com/biotech/new-data-boost-pfizer-sangamo-hemophilia-a-gene-therapy?utm_source=internal&utm_medium=rss

Nick Paul FIERCE BIOTECH
08 Jul 2019

http://www.pmlive.com/pharma_news/biomarin_eyes_haemophilia_therapy_filing,_but_data_scares_investors_1289314

Phil Taylor PMLIVE
30 May 2019

https://www.prnewswire.com/news-releases/biomarin-announces-that-phase-3-cohort-of-valoctocogene-roxaparvovec-gene-therapy-study-in-severe-hemophilia-a-met-pre-specified-criteria-for-regulatory-submissions-in-the-us-and-europe-300857197.html

PR NEWSWIRE
28 May 2019
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