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GSK and Vir Biotechnology Announce the Start of the EMA Rolling Review of VIR-7831 .
Vir Biotechnology, Inc.May 7, 2021 GMT
– Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19 –
– Review will support a formal Marketing Authorization Application –
– GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19 –
LONDON and SAN FRANCISCO, May 07, 2021 (GLOBE NEWSWIRE) GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and o
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Eiger BioPharmaceuticals Reports First Quarter 2021 Financial Results and Provides Business Update
- Phase 3 HDV D-LIVR (Lonafarnib) 75% Enrolled; Full Enrollment Planned in 2021
- Phase 3 HDV LIMT-2 (Lambda) to Initiate in 2021
- Phase 3 COVID-19 TOGETHER Platform Study to Include Lambda Arm
- $3.6M U.S. Zokinvy® Net Sales in Q1 2021
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PALO ALTO, Calif., May 6, 2021 /PRNewswire/ Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported its first quarter 2021 financial results and provided a business update. The Phase 3 D-LIVR study is now 75% enrolled, and by year-end we expect to complete enrollment of this landmark global study advancing Lonafarnib, the only oral agent in development for HDV, setting the stage for Week 48 end of treatment data in 2022, sa
Neurocrine Biosciences Reports First Quarter 2021 Financial Results
INGREZZA® (valbenazine) First Quarter 2021 Net Product Sales of $230 Million with Approximately 43,300 TRx
Initiated Pediatric Phase III Registrational Program of Crinecerfont for the Treatment of Classic Congenital Adrenal Hyperplasia
Initiated Phase II Study of NBI-827104 in Essential Tremor
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SAN DIEGO, May 5, 2021 /PRNewswire/ Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced its financial results for the first quarter ended March 31, 2021 and provided revised full-year 2021 financial expense guidance. Our first quarter results reflect a lower than normal refill rate per patient due to the typical seasonal payor dynamics for INGREZZA that were exacerbated by COVID. Importantly, we did not see an increase in discontinuations and exited the quarter with more patients on INGREZZA versus the prior quarter. New patient starts did pick up late
Total product and royalty revenues of $605 million in Q1 2021 (+6% vs Q1 2020) Jakafi® (ruxolitinib) revenues of $466 million in Q1 2021 (+1% vs Q1 2020); reaffirming full year guidance of $2.125-$2.20 billionPemazyre® (pemigatinib) now also approved in Europe and Japan, becoming the first internally discovered pro.