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:10/12/2017)... 2017 West Pharmaceutical Services, Inc. ... injectable drug administration, today announced that it will release ... Thursday, October 26, 2017, and will follow with a ... at 9:00 a.m. Eastern Time. To participate on the ... conference ID is 94093362. ...
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
(Date:10/4/2017)... the Centers for Disease Control and Prevention (CDC), influenza vaccination should ... helping communities across Massachusetts , Connecticut ... shots through the end of the month. *Some exclusions apply ... ... is by the end of October, according to the Centers for Disease ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... ... 13, 2017 , ... Coveros, a leader in agile coaching ... contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise Agile ... of Agile methodologies in a consistent and high value manner across CMS programs. ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... now treating sleep apnea using cutting-edge Oventus O2Vent technology. As many ... sleep disorder characterized by frequent cessation in breathing. Oral appliances can offer significant ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
Breaking Medicine News(10 mins):