Navigation Links
BioPharm Insight Releases its Catalyst Monitor for April 2013
Date:3/26/2013

Norwood, MA (PRWEB) March 26, 2013

BioPharm Insight’s monthly Catalyst Monitor analyzes the most material events in the sector during the upcoming month. The Catalyst Monitor tracks significant events and announcements such as US Food and Drug Administration (FDA) approvals, Advisory Committee meetings and expected key clinical results.

Allergan’s Levadex (dihydroergotamine mesylate) is expected to receive FDA approval for the treatment of acute migraines. Its review date is 15 April. The Phase III FREEDOM-301 study impressively hit its four co-primary endpoints and had an excellent safety and tolerability profile. Additionally, Levadex’s pain relief scores are similar to what is seen from marketed triptans. A human factors study cannot be ruled out, though, considering the FDA has previously delayed applications for migraine products, notably GlaxoSmithKline and Pozen’s Treximet (sumatriptan naproxen sodium).

Despite a three month delay by the FDA for an approval decision date, Sucampo Pharmaceuticals and Takeda Pharmaceutical Company’s Amitiza (lubiprostone) is anticipated to get the green light for opioid-induced constipation. Experts noted that the Phase III open-label study results indicated the drug is safe and efficacious. Approval in two indica¬tions, chronic idiopathic constipation and irritable bowel syndrome with constipation, further underscores the drug’s solid safety profile.

On the development front, Trius Therapeutics and Bayer’s second Phase III TR-701 (tedizolid phosphate) trial is expected to have positive results. But anti-infectives experts questioned, however, the validity of Trius’ claims of greater potency and lesser toxicity as tedizolid’s benefits over Pfizer’s Zyvox (linezolid) based on current evidence.

Other catalysts in April include:

  •     Raptor Pharmaceutical’s cystinosis candidate, RP103, expected to clinch FDA nod
  •     Titan Pharmaceuticals’ opioid-dependence drug, Probuphine, will likely get FDA go-ahead, but market size is questionable
  •     XenoPort’s arbaclofen for multiple sclerosis spasticity is expected to yield Phase III efficacy

Learn how BioPharm Insight can help you find new business opportunities by starting a free trial today.

About BioPharm Insight
BioPharm Insight is the definitive guide to the global biopharma community. BioPharm Insight provides subscribers with an information edge by combining the most comprehensive real-time database of companies, drugs, contacts, M&A and licensing deals, forecasts and clinical trial data with proprietary forward-looking intelligence uncovered by an independent team of investigative journalists months or even years before it breaks in mainstream media. To learn more, visit http://www.biopharminsight.com. Follow BioPharm Insight on LinkedIn and Twitter.

About Infinata, Inc.
Infinata provides personalized technology solutions to turn information into insight. Services include a comprehensive BioPharm Solutions Suite, unique Wealth Prospecting tools and innovative Custom Data Services. Infinata is a part of Mergermarket, a Financial Times Group company and a division of Pearson plc. To learn more, visit http://www.infinata.com.

Read the full story at http://www.prweb.com/releases/2013/3/prweb10562274.htm.


'/>"/>
Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Galien Foundation Appoints Kimberly Ha of Infinata’s BioPharm Insight to US Advisory Board
2. New Opportunity: The Biomedical Innovations of Tomorrow - Research Report on PhotoMedex, Axiall Corp, Varian Medical Systems, Volcano Corporation and Navidea Biopharmaceuticals
3. Keryx Biopharmaceuticals to Present at the 25th Annual ROTH Conference
4. Leica Biosystems and Synthon Biopharmaceuticals Partner to Develop a Companion Diagnostic Program for Targeted Cancer Therapies
5. ISPE Conference to Benchmark and Advance Quality by Design in the Biopharmaceutical Industry
6. Infinata’s BioPharm Insight Gears Up for the 2013 American College of Cardiology Meeting with the Release of its Cardiovascular Diseases Report
7. Array Biopharma and Global Blood Therapeutics Announce Drug Discovery Collaboration Focused on Hematology
8. Infinata’s BioPharm Insight Releases Licensing League Tables Report for 4Q12 and YE12
9. Infinata's BioPharm Insight Journalist Awarded Fellowship by Association of Health Care Journalists
10. PDL BioPharma to Present at Two Upcoming Investor Conferences
11. Patheon Exhibits at the 2013 Biopharmaceutical Development and Production Week
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV ), a ... targeted antiviral therapies, announced today that it will present ... held February 8-9, 2016, at the Waldorf Astoria New ... Healthcare Conference, taking place in New York ... Sapirstein , Chief Executive Officer of ContraVir, will provide ...
(Date:2/4/2016)... February 4, 2016 Strasbourg, France ... Inc. --> Strasbourg, France , to ... PharmaVentures is pleased to announce that it acted as ... manufacturing unit in Strasbourg, France , to ... --> --> Transgene (Euronext: TNG), a ...
(Date:2/3/2016)...  With the growing need for better therapeutics, ... therapies such as monoclonal antibodies, recombinant protein therapeutics ... indications are in high demand. Conventionally expression systems ... production of these therapeutics. However, due to issues ... novel approaches and novel expression systems are currently ...
(Date:2/3/2016)... ... February 03, 2016 , ... ... new office dedicated to the North American healthcare market. , Aerocom Healthcare, LLC ... facilities. The company will provide new pneumatic tube systems or expand existing ...
Breaking Biology Technology:
(Date:1/20/2016)... --  MedNet Solutions , an innovative SaaS-based eClinical technology ... is pleased to announce the attainment of record-setting corporate ... of the company,s laser focus on (and growing international ... comprehensive, easy-to-use and highly affordable cloud-based technology platform. ... growth achievements in 2015 include: , Record ...
(Date:1/18/2016)... 2016  Extenua Inc., a pioneering developer of ... and access of ubiquitous on-premise and cloud storage, today ... Cyber.  ... C4ISR and Cyber initiatives in support of National ... technology solutions," said Steve Visconti , Extenua ...
(Date:1/13/2016)... , January 13, 2016 ... published a new market report titled - Biometric Sensors Market ... Forecast, 2015 - 2023. According to the report, the global biometric ... is anticipated to reach US$1,625.8 mn by 2023, expanding ... In terms of volume, the biometric sensors market is ...
Breaking Biology News(10 mins):