Download pdf - US FDA grants orphan drug status to pralatrexate

Transcript
Page 1: US FDA grants orphan drug status to pralatrexate

Inpharma 1667 - 6 Dec 2008

■ US FDA grants orphan drug status to pralatrexate.The agent is being developed by Allos Therapeuticsand is indicated for the treatment of patients withdiffuse large B-cell lymphoma.Allos Therapeutics Inc. U.S. FDA Grants Pralatrexate Orphan DrugDesignation for the Treatment of Patients with Diffuse Large B-CellLymphoma. Media Release : 25 Nov 2008. Available from: URL: http://www.allos.com 809095780

1

Inpharma 6 Dec 2008 No. 16671173-8324/10/1667-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Recommended

Innovating in Orphan Diseases in Orphan...Orphan drugs policies have been successful as they incentivise the development of new therapies 7 The FDA has approved more than 640 ORPHAN
Innovating in Orphan Diseases in Orphan...Orphan drugs policies have been successful as they incentivise the development of new therapies 7 The FDA has approved more than 640 ORPHAN Documents
Development of Orphan Drugs – Regulatory Viewpoints from ...Orphan drugs • “In all, more than one-third of new drugs approved by the FDA last year were orphans.” • “In
Development of Orphan Drugs – Regulatory Viewpoints from ...Orphan drugs • “In all, more than one-third of new drugs approved by the FDA last year were orphans.” • “In Documents
Orphan analysis
Orphan analysis Art & Photos
The Orphan
The Orphan Self Improvement
EvaluatePharma Orphan Drug Report 2015 · The Orphan Drug Report also reveals that worldwide orphan drug sales will reach $178bn by 2020. The proportion of orphan drugs in relation
EvaluatePharma Orphan Drug Report 2015 · The Orphan Drug Report also reveals that worldwide orphan drug sales will reach $178bn by 2020. The proportion of orphan drugs in relation Documents
An agency of the European Union Presented by: Jordi Llinares Head of orphan medicines Orphan drug designation in the European Union (EU) FDA/EMA Orphan
An agency of the European Union Presented by: Jordi Llinares Head of orphan medicines Orphan drug designation in the European Union (EU) FDA/EMA Orphan Documents
Restoring the Foundations Orphan Heart Orphan Lifestyle Chester and Betsy Kylstra
Restoring the Foundations Orphan Heart Orphan Lifestyle Chester and Betsy Kylstra Documents
Australian public assessment for Pralatrexate  · Web viewPDX-3501 (Protocol synopsis submitted) – a randomised, comparative, open-label, study of pralatrexate vs. treatment of
Australian public assessment for Pralatrexate  · Web viewPDX-3501 (Protocol synopsis submitted) – a randomised, comparative, open-label, study of pralatrexate vs. treatment of Documents
On the Horizon: Emerging Systemic Therapies for T-Cell ... Pro.pdf · Relapsed/Refractory PTCL FDA-Approved agents Agent Dose/schedule N ORR (%) CR (%) DOR, Mos Pralatrexate 30 mg/m2
On the Horizon: Emerging Systemic Therapies for T-Cell ... Pro.pdf · Relapsed/Refractory PTCL FDA-Approved agents Agent Dose/schedule N ORR (%) CR (%) DOR, Mos Pralatrexate 30 mg/m2 Documents
FDA Marks Orphan Drug Act Milestone: 30 Year Recognition January 2013
FDA Marks Orphan Drug Act Milestone: 30 Year Recognition January 2013 Documents
Presentations - Orphan designation - Key concepts and ... · Orphan designation Key concepts and ... 6.0% 3.0% Marketing authorisations Protocol assistance ... Orphan designation
Presentations - Orphan designation - Key concepts and ... · Orphan designation Key concepts and ... 6.0% 3.0% Marketing authorisations Protocol assistance ... Orphan designation Documents
Improving Health Outcomes in HIV Immunologic Non ... FDA Conf Call Minutes Final.pdfImproving Health Outcomes in HIV Immunologic Non-Responders (INRs) Orphan Drug Designation Possibilities
Improving Health Outcomes in HIV Immunologic Non ... FDA Conf Call Minutes Final.pdfImproving Health Outcomes in HIV Immunologic Non-Responders (INRs) Orphan Drug Designation Possibilities Documents
Orphan Horns
Orphan Horns Documents
FDA orphan designation - ema.europa.eu · •If the sponsor who originally obtained orphan exclusive approval of the drug for only one indication within a designated disease subsequently
FDA orphan designation - ema.europa.eu · •If the sponsor who originally obtained orphan exclusive approval of the drug for only one indication within a designated disease subsequently Documents
NORD Study of FDA Approval of Orphan Drugs
NORD Study of FDA Approval of Orphan Drugs Documents
Orphan Sunday
Orphan Sunday Documents
November 2018 ORPHAN DRUGS · orphan drug processes. In this report, GAO examines, among other things, (1) the actions FDA has taken to address the growing demand for orphan designations;
November 2018 ORPHAN DRUGS · orphan drug processes. In this report, GAO examines, among other things, (1) the actions FDA has taken to address the growing demand for orphan designations; Documents
Orphan designation withdrawal assessment report - Vitrakvi · Orphan designation withdrawal assessment report . Vitrakvi (larotrectinib) Sponsor: Bayer AG ... Orphan designation withdrawal
Orphan designation withdrawal assessment report - Vitrakvi · Orphan designation withdrawal assessment report . Vitrakvi (larotrectinib) Sponsor: Bayer AG ... Orphan designation withdrawal Documents