BioMarin Pharmaceutical Inc.
793 articles with BioMarin Pharmaceutical Inc.
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BioMarin Pharmaceutical announced the FDA no longer plans to hold an advisory committee meeting to review its BLA for Roctavian an AAV gene therapy for adults with severe hemophilia A.
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BioMarin Announces Advancements in FDA Review of ROCTAVIAN™ (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A
11/23/2022
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced advancements in the U.S. Food and Drug Administration (FDA) review of the Biologics License Application (BLA) of ROCTAVIAN™ (valoctocogene roxaparvovec AAV gene therapy) for adults with severe hemophilia A.
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A request for additional data may cause a 3-month delay for potential approval of BioMarin Pharmaceutical’s hemophilia A gene therapy.
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The past few weeks have seen changes that will impact the biopharma industry surrounding salaries and pay. To learn about job opportunities at some of the industry's top companies, see inside.
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BioMarin Announces Incremental Progress on Biologics License Application (BLA) Review for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A Program
11/7/2022
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today a progress update on its Biologics License Application (BLA) for valoctocogene roxaparvovec AAV gene therapy for adults with severe Hemophilia A that is currently under review by the U.S. Food and Drug Administration (FDA).
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BioMarin to Participate in Two Upcoming November 2022 Investor Conferences
11/3/2022
BioMarin Pharmaceutical Inc. announced that management will present at two upcoming investor conferences.
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During its third-quarter earnings report, BioMarin noted that the FDA planned to hold an advisory committee meeting to discuss the company's gene therapy for hemophilia A.
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BioMarin Announces Third Quarter 2022 Year-over-Year Total Revenue Growth of 24% (31% Excluding KUVAN®)
10/26/2022
BioMarin Pharmaceutical Inc. announced financial results for the third quarter ended September 30, 2022.
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Bay Area Biotech Companies Hiring Now
10/19/2022
The Biotech Bay region is home to 3,418 life sciences companies and 96,574 employees making an average of $148,285. Here's a look at a few of the bay area biotech companies hiring now. -
FDA Accepts BioMarin's Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Adults with Severe Hemophilia A
10/12/2022
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) announced today that the U.S. Food and Drug Administration (FDA) accepted the Company's resubmission of the Biologics License Application (BLA) for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.
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BioMarin Simplifies Organizational Structure to Increase Efficiency
10/7/2022
BioMarin Pharmaceutical Inc. announced its decision to redesign the organization to better focus investments that advance its R&D pipeline, maximize recent commercial launch success, prepare for a potential launch of ROCTAVIAN™ in the U.S., and drive core infrastructure optimization.
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BioMarin Pharmaceuticals announced Friday it was shedding around 4% of its global workforce, or around 120 jobs, in an effort to improve its operational efficiency.
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BioMarin to Host Third Quarter 2022 Financial Results Conference Call and Webcast on Wednesday, October 26, at 4:30pm ET
10/4/2022
BioMarin Pharmaceutical Inc. announced that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Wednesday, October 26th, at 4:30 p.m. ET to discuss third quarter 2022 financial results and provide a general business update.
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Two years after receiving a Complete Response Letter for its hemophilia gene therapy, BioMarin is heading back to the FDA with stronger and more robust data for potential approval.
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BioMarin Resubmits Biologics License Application (BLA) for Valoctocogene Roxaparvovec AAV Gene Therapy for Severe Hemophilia A to the FDA
9/29/2022
BioMarin Pharmaceutical Inc. announced that the Company resubmitted a Biologics License Application to the U.S. Food and Drug Administration for its investigational AAV gene therapy, valoctocogene roxaparvovec, for adults with severe hemophilia A.
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BioMarin's Gene Therapy for Adults with Severe Hemophilia A, ROCTAVIAN™ (valoctocogene roxaparvovec), Assessed to Provide Substantial Cost Savings Per Patient in a Preliminary Independent Report
9/15/2022
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced hat the Institute for Clinical and Economic Review (ICER) released a Draft Evidence Report updating the previous Hemophilia A assessment of the comparative clinical effectiveness and value of ROCTAVIAN ™ (valoctocogene roxaparvovec).
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The Institute for Clinical and Economic Review (ICER) concluded that even at a hefty lifetime cost of $2.5 million, gene therapies for hemophilia A and B are worth it.
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BioMarin’s Roctavian was granted conditional authorization in the European Union, making it the first gene therapy approved for severe hemophilia A. Now, the company is shooting for U.S. approval.
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First Gene Therapy for Adults with Severe Hemophilia A, BioMarin's ROCTAVIAN™ (valoctocogene roxaparvovec), Approved by European Commission (EC)
8/24/2022
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the European Commission (EC) has granted conditional marketing authorization (CMA) to ROCTAVIAN™ (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A (congenital Factor VIII deficiency) in adult patients without a history of Factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).
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BioMarin Announces Record Revenues in Second Quarter 2022; Increases Full-year 2022 Top and Bottom-line Guidance
8/3/2022
BioMarin Pharmaceutical Inc. announced financial results for the second quarter ended June 30, 2022.