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Bionical Emas launches Managed Access Program for JZP 458 - a recombinant Crisantaspase produced in Pseudomonas fluorescens


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WILLINGTON, England, April 8, 2021 /PRNewswire/ Bionical Emas, a global specialist Clinical Research Organization (CRO) has today announced the launch of a Managed Access Program for Jazz Pharmaceuticals medicinal product JZP-458 for the treatment of patients with Acute Lymphoblastic Leukaemia (ALL) and Lymphoblastic Lymphoma (LBL) following hypersensitivity to E. Coli-derived asparaginases. The Managed Access Program provides a mechanism through which unsolicited physician requests, to fulfil the special need of a patient can be supported.

JZP-458 provides a further therapy option for paediatric and adult patients with ALL or LBL who have not tolerated certain asparaginase treatments and currently have limited treatment options, and we re pleased to support this program, said ....

Tom Watson , Kostenloser Wertpapierhandel , Bionical Emas , John Efthimiou , Prnewswire Bionical Emas , Clinical Research Organization , Jazz Pharmaceuticals , Clinical Development , Access Program , Access Program For Jazz , Managed Access Program , Jazz Pharmaceutical , Acute Lymphoblastic Leukaemia , Lymphoblastic Lymphoma , Chief Medical Officer , Early Access Programs , Clinical Trial , Fast Track , Managed Access , Executive Vice President , Early Access , டோம் வாட்சன் , மருத்துவ ஆராய்ச்சி ஆர்கநைஸேஶந் , ஜாஸ் மருந்துகள் , மருத்துவ வளர்ச்சி , நுழைவு ப்ரோக்ர்யாம் ,

Bionical Emas launches Managed Access Program for JZP 458 - a recombinant Crisantaspase produced in Pseudomonas fluoresc


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WILLINGTON, England, April 8, 2021 /PRNewswire/ Bionical Emas, a global specialist Clinical Research Organization (CRO) has today announced the launch of a Managed Access Program for Jazz Pharmaceuticals medicinal product JZP-458 for the treatment of patients with Acute Lymphoblastic Leukaemia (ALL) and Lymphoblastic Lymphoma (LBL) following hypersensitivity to E. Coli-derived asparaginases. The Managed Access Program provides a mechanism through which unsolicited physician requests, to fulfil the special need of a patient can be supported.
JZP 458 provides a further therapy option for paediatric and adult patients with ALL or LBL who have not tolerated certain asparaginase treatments and currently have limited treatment options, and we re pleased to ....

Tom Watson , Bionical Emas , John Efthimiou , Prnewswire Bionical Emas , Clinical Research Organization , Jazz Pharmaceuticals , Clinical Development , Access Program , Access Program For Jazz , Managed Access Program , Jazz Pharmaceutical , Acute Lymphoblastic Leukaemia , Lymphoblastic Lymphoma , Chief Medical Officer , Early Access Programs , Clinical Trial , Fast Track , Managed Access , Executive Vice President , Early Access , டோம் வாட்சன் , மருத்துவ ஆராய்ச்சி ஆர்கநைஸேஶந் , ஜாஸ் மருந்துகள் , மருத்துவ வளர்ச்சி , நுழைவு ப்ரோக்ர்யாம் , நுழைவு ப்ரோக்ர்யாம் க்கு ஜாஸ் ,

Eiger BioPharmaceuticals : Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update


Global Phase 3 D-LIVR study enrollment completion planned in 2021
Peginterferon Lambda for HDV
Global Phase 3 LIMT-2 study initiation planned in 2021
Zokinvy™ (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies
U.S. commercial launch in January 2021
EMA decision expected in 2H21
Lambda for COVID-19
Lancet Respiratory Medicine (Feld et al, 2021)
Considering strategic options to advance program
Avexitide for Post-Bariatric Hypoglycemia (PBH)
Positive Phase 2 PREVENT study published in
JCEM (Craig et al, 2021)
Corporate
Pro-forma cash, cash equivalents and investments of $176.2M, including $128.8M as of December 31, 2020 plus $47.4M from net PRV sale proceeds received in January 2021, expected to fund planned operations through Q4 2023
Fourth Quarter and Full Year 2020 Financial Results ....

Progeroid Laminopathies , David Cory , Drug Administration , Program Product Updates , Company Annual Report On Form , Prnewswire Eiger Biopharmaceuticals Inc , European Medicines Agency , Eiger Biopharmaceuticals Inc , Access Program , Hepatitis Delta Virus , Processing Deficient Progeroid , Lancet Respiratory Medicine , Post Bariatric Hypoglycemia , Full Year , Priority Review Voucher , Hutchinson Gilford Progeria Syndrome , Marketing Authorization Application , Managed Access Program , Quarterly Report , Annual Report , Consolidated Statements , Operations Financial , Eiger Biopharmaceuticals , Inc Stock Exchange , Press Release , Of Eigr ,

Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update


Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
- Phase 3 HDV D-LIVR (Lonafarnib) to Complete Enrollment in 2021
- Phase 3 HDV LIMT-2 (Lambda) to Initiate in 2021
- Strong Cash Position with $176 Million Pro-Forma Cash to Begin 2021
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PALO ALTO, Calif., March 9, 2021 /PRNewswire/ Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical stage company focused on the development and commercialization of foundational therapies for Hepatitis Delta Virus (HDV) infection, today reported financial results for fourth quarter and full year 2020 and provided a business update.
In 2021, we plan to achieve important, value creating milestones in both of our HDV clinical programs, said David Cory, President and CEO of Eiger.  We will complete enrollment of the Phase 3 D-LIVR study of Lonafarnib, the first and only ....

Progeroid Laminopathies , David Cory , Drug Administration , Program Product Updates , Company Annual Report On Form , Prnewswire Eiger Biopharmaceuticals Inc , European Medicines Agency , Eiger Biopharmaceuticals Inc , Access Program , Hepatitis Delta Virus , Processing Deficient Progeroid , Lancet Respiratory Medicine , Post Bariatric Hypoglycemia , Full Year , Priority Review Voucher , Hutchinson Gilford Progeria Syndrome , Marketing Authorization Application , Managed Access Program , Quarterly Report , Annual Report , Consolidated Statements , Operations Financial , Eiger Biopharmaceuticals , டேவிட் கோரி , ப்ரோக்ர்யாம் ப்ராடக்ட் புதுப்பிப்புகள் , நிறுவனம் ஆண்டு அறிக்கை ஆன் வடிவம் ,

Leduc family hoping for gene therapy treatment


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When Alex Johnston and Ryan Fengstad heard the government of Alberta would be funding the gene therapy drug Zolgensma, they felt a weight lift off their shoulders.
“We’ve gotten a lot of tough news and this past year, with Zolgensma specifically, it just felt like there have been a lot of closed doors in our faces, and it really felt like Reign was getting left behind. With this new announcement we were so excited, we were overjoyed, we were crying watching the announcement with [Alberta Health Minister] Tyler Shandro,” Johnston said.
We apologize, but this video has failed to load. ....

Access Program In Alberta , Access Program , Managed Access , Special Access Program , Managed Access Program , நுழைவு ப்ரோக்ர்யாம் இல் ஆல்பர்ட்டா , நுழைவு ப்ரோக்ர்யாம் , நிர்வகிக்கப்பட்டது நுழைவு , சிறப்பு நுழைவு ப்ரோக்ர்யாம் , நிர்வகிக்கப்பட்டது நுழைவு ப்ரோக்ர்யாம் ,