Navigation Links
Emerging Pharma Catalysts: H2 2012
Date:9/20/2012

NEW YORK, Sept. 20, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

 

Emerging Pharma Catalysts: H2 2012

http://www.reportlinker.com/p0968564/Emerging-Pharma-Catalysts-H2-2012.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Pathology

 

An analysis of upcoming catalysts that will affect selected companies in the Emerging Pharma peer set and Datamonitor's prediction of the outcome of these binary events. These catalysts include both PDUFA dates and expected Phase III trial results for key pipeline drugs.Focuses on the background and factors affecting the outcome of selected FDA drug approval decisions and Phase III trial results for covered companies Includes coverage of Amylin, ArQule, BioMarin, Elan, Exelixis, Ironwood, Medivation, NPS, Onyx, Regeneron, Rigel, Salix, Santarus, United Therapeutics Many important regulatory and clinical catalysts will occur in the second half of 2012 that will have a sizable impact both directly on the companies in Datamonitor's Emerging Pharma peer set and also indirectly on the wider market.Identify important catalysts that will have a large impact on the prospects for these Emerging Pharma companies and their products Assess the background and clinical data surrounding each of the listed products Analyze the factors affecting each catalyst and obtain Datamonitor's opinion on the outcome

 

 

 

ABOUT THIS REPORT•PharmaVitae Explorer database

 

EXECUTIVE SUMMARY•Catalysts

 

PDUFA DATES•Regeneron - Zaltrap: PDUFA – August 4

- Eylea: PDUFA – September 21

 

•Salix - Crofelemer: PDUFA – September 5

 

•Ironwood - Linaclotide: PDUFA – September 8

- Linaclotide clinical trials

 

•NPS Pharmaceuticals - Gattex PDUFA – September 28

- Gattex should win approval based on positive Phase III data and CHMP positive opinion

 

•Amylin - Metreleptin: PDUFA – October 3

- Ultra-rare nature of lipodystrophy lowers bar for approval

 

•Santarus - Uceris: PDUFA – October 16

- Uceris clinical trials

 

•United Therapeutics - Oral treprostinil: PDUFA – October 26

 

•Medivation - Enzalutamide: PDUFA – November 21

 

•Onyx - Regorafenib: PDUFA – November 23

- Positive data make approval likely, but uptake may be low

 

•Exelixis - Cabozantinib: PDUFA – November 29

- Cabozantinib looks likely to be approved based on strong Phase III data

 

 

PHASE III TRIAL RESULTS•ArQule: tivantinib – non-small cell lung cancer - Tivantinib: Phase III results – H2 2012

- Interim analysis of MARQUEE trial expected in H2 2012

 

•BioMarin: Firdapse – Lambert-Eaton myasthenic syndrome - Firdapse Phase III results – H2 2012

- Phase III LMS-002 trial

 

•BioMarin: GALNS – mucopolysaccharidosis IVA - GALNS Phase III results – H2 2012

- Phase II trials

- Phase III trial

 

•Elan: bapineuzumab – Alzheimer's disease - Bapineuzumab Phase III results – H2 2012

- Phase II trials

- Phase III trials

 

•Rigel: fostamatinib – rheumatoid arthritis - Fostamatinib Phase III results – H2 2012

- Phase III program: OSKIRA and head-to-head clinical trials

 

 

APPENDIX•References - Datamonitor Reports

 

•Exchange rates

 

 

TABLES

•Table: Emerging Pharma catalysts, H2 2012

•Table: Recently launched Emerging Pharma products

•Table: Regeneron catalysts, H2 2012

•Table: Zaltrap colorectal cancer clinical trials

•Table: Summary of results from the Phase III VELOUR trial

•Table: Overview of pivotal Phase III data for Eylea and Lucentis in macular edema secondary to CRVO

•Table: Salix catalysts, H2 2012

•Table: Salix Phase III trials in diarrhea indication

•Table: Ironwood catalysts, H2 2012

•Table: Ironwood Pharmaceuticals' Phase III clinical trial program, including four pivotal trials and two safety studies

•Table: NPS Pharmaceuticals catalysts, H2 2012

•Table: NPS Phase III trials for small bowel syndrome

•Table: Amylin catalysts, H2 2012

•Table: Santarus catalysts, H2 2012

•Table: Overview of pivotal Phase III data for Uceris in ulcerative colitis

•Table: United Therapeutics catalysts, H2 2012

•Table: Medivation catalysts, H2 2012

•Table: Pivotal Phase III PREVAIL and AFFIRM trials for enzalutamide in prostate cancer

•Table: Onyx catalysts, H2 2012

•Table: Summary of efficacy results from the Phase III CORRECT trial

•Table: Exelixis catalysts, H2 2012

•Table: Phase II results for GALNS in MPS IVA

•Table: Phase II trial summary for bapineuzumab in Alzheimer's disease

•Table: Phase III trial summary for bapineuzumab in Alzheimer's disease

•Table: Summary of ongoing Phase III trials for FosD in rheumatoid arthritis

•Table: Exchange rates, 2012

 

 

FIGURES

•Figure: PharmaVitae Explorer

 

 

 

Companies Mentioned

Arrow Electronics, Inc., Bunzl plc, Dendreon Corporation, Hutchison 3G UK Limited, Incyte Corporation, Janssen Pharmaceuticals, Inc., Merck KGaA, Schindler Holding Ltd., Seattle Genetics, Inc., Telenor ASA, United Therapeutics Corporation, Zain Group

 

 

 

To order this report:

Pathology Industry: Emerging Pharma Catalysts: H2 2012

 

Nicolas Bombourg
Reportlinker
Email: nicolasbombourg@reportlinker.com
US: (805)652-2626
Intl: +1 805-652-2626

 

 


'/>"/>
SOURCE Reportlinker
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. MD+DI, MPMN, Qmed and CMDM Announce Emerging Trends in Medical Device
2. Post-Recession, the Global Market for Surgical Equipment Picks Up Speed, Particularly In China and Emerging Economies
3. Emerging Trends in Medical Device Outsourcing and Contract Manufacturing
4. LTCLINK-Tank Competition Announced To Introduce Your Emerging Product to the Aging Care Continuum
5. This Week: UBM Canon Presents an Online Event and Conference Dedicated to Emerging Trends in Medical Device Outsourcing/Contract Manufacturing
6. Global Market for Medical Imaging Equipment to Reach $25.3 Billion as Retiring Boomers and Emerging Markets Demand Better Healthcare
7. Increasing Incidence of Cardiovascular Diseases to Drive The Cardiovascular Devices Market in Emerging Countries
8. Emerging Markets for Enzyme Inhibitors Surge, To Grow More Than 50% by 2016
9. Diabetes Care Devices in Emerging Countries (China, India, Brazil) to 2017 - Greater Awareness is Increasing Demand for Self-Monitoring of Blood Glucose (SMBG) in the Home Care Segment
10. Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
11. Emerging Pharmaceutical Market in Brazil - Regulatory Framework Forces MNCs to Partner with Local Players Resulting in Profit and Control Sharing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... HOUSTON , 8. Februar 2016 /PRNewswire/ ... veröffentlichte heute eine Infografik mit dem Titel ... ganzen Welt), mit der der Krankheit gegenüber ... die dazu ermutigen soll, Medikamentenresistenz bei Epilepsie ... der allgemeinen Diskussion zu machen. Mithilfe der ...
(Date:2/5/2016)... Feb. 5, 2016  ivWatch, a medical devices company, is ... Award granted by Governor Terry McAuliffe,s office. ivWatch ... February 25th at an event to be held at the ... award honors professionals and business that have made significant contributions ... Logo - http://photos.prnewswire.com/prnh/20160205/330117LOGO ...
(Date:2/5/2016)... -- Aethlon Medical, Inc. (Nasdaq: AEMD ), today announced ... presenting at Source Capital Group,s 2016 Disruptive Growth & Healthcare ... 2:15 p.m. ET on Wednesday, February 10, 2016.  Mr. Joyce ... at 3:15 p.m. ET. http://www.aethlonmedical.com .  The webcast ... conclusion of the live event. The panel discussion will not ...
Breaking Medicine Technology:
(Date:2/8/2016)... ... February 08, 2016 , ... ... 50% lower incidence rate of type 2 diabetes in the GrassrootsHealth cohort with ... time to make a change in public health,” states Carole Baggerly, Director of ...
(Date:2/8/2016)... Las Vegas, NV (PRWEB) , ... February 08, 2016 , ... ... transformation on February 9th, 10th and 11th, 2016 in honor of his birthday on ... relationships and true happiness. Mahendra Trivedi is known by over 250,000 people from ...
(Date:2/7/2016)... (PRWEB) , ... February 07, 2016 , ... Women's Excellence ... National Wear Red Day. National Wear Red Day is the first Friday each ... Heart disease and stroke cause 1 in 3 deaths among women each year – ...
(Date:2/6/2016)... ... February 06, 2016 , ... US Sports Camps is proud ... . This event brings together top non-profit leaders, ultimate organizations, and coaches from around ... Valerio Iani, Bay Area Disc Program Director of Youth and Education, describes this year ...
(Date:2/5/2016)... ... 2016 , ... Steven Tonkinson, 36, of Coconut Grove, Florida, ran the Miami ... in 2003. This year, he ran all 26.2 miles with a green 25-pound ShelterBox ... Miami Heat. , This Sunday, while many are watching the Superbowl, Steven Tonkinson will ...
Breaking Medicine News(10 mins):