SYS-CON MEDIA Authors: Ava Smith, Scott Bampton, Elizabeth White, Glenn Rossman, Pat Romanski

News Feed Item

FDA Considering Allowing Developers of Critical Drugs/Treatments to Conduct Smaller, Faster Clinical Trials

The Paragon Report Provides Stock Research on ImmunoGen and Orexigen Therapeutics

NEW YORK, NY -- (Marketwire) -- 11/02/12 -- The Food and Drug Administration Commissioner Margaret Hamburg has told scientific advisers that the FDA is considering a faster pathway for obesity treatments, life-saving antibiotics and other drugs deemed to offer societal benefit. The Paragon Report examines investing opportunities in the Biotech Industry and provides equity research on ImmunoGen, Inc. (NASDAQ: IMGN) and Orexigen Therapeutics, Inc. (NASDAQ: OREX).

Access to the full company reports can be found at:
www.ParagonReport.com/IMGN
www.ParagonReport.com/OREX

Under the new pathway the FDA would allow developers of such drugs to conduct smaller, faster clinical trials, and provide a "special medical use" label which would allow doctors to administer drugs to patients with critical need. Hamburg has said that the FDA needs to take into account the needs people with deadly or debilitating diseases that may be willing to take on the risks of unproven drugs.

"A pathway that would allow products to come to market faster but would ensure they were used only in patients where there was an applicable risk-benefit situation would be good," said Pew Health Group's Allan Coukell, deputy director of medical programs. "It would be good for developers, for companies and it would be good for public health."

Paragon Report releases regular market updates on the Biotech Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.ParagonReport.com and get exclusive access to our numerous stock reports and industry newsletters.

ImmunoGen develops targeted anticancer therapeutics using expertise in cancer biology, engineered antibodies and highly potent cancer-cell killing agents. ImmunoGen's collaborative partners include Amgen, Bayer HealthCare, Biotest, Lilly, Novartis, Roche, and Sanofi. The company recently reported that marketing applications have been submitted for trastuzumab emtansine (T-DM1) in the U.S. and Europe.

Orexigen Therapeutics is a biopharmaceutical company focused on the treatment of obesity. The Company's lead product candidate is Contrave, which has completed Phase III clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The company is scheduled to release its third quarter 2012 results on November 7, 2012.

The Paragon Report has not been compensated by any of the above-mentioned publicly traded companies. Paragon Report is compensated by other third party organizations for advertising services. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at:
http://www.paragonreport.com/disclaimer

Add to Digg Bookmark with del.icio.us Add to Newsvine

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Compute virtualization has been transformational, yet security policy implementation and enforcement has lagged behind in agility and automation. There are a number of key considerations when implementing policy in private and hybrid clouds. In his session at 15th Cloud Expo, Holland Barry, VP of Technology at Catbird, will discuss the impact of this new paradigm and what organizations can do to...
Can we look to the paradigm of cloud computing from a completely different perspective? In his General Session at 15th Cloud Expo, Gundars Kulups, Sales Director at DEAC, will discuss what we can learn from our dining habits when choosing a cloud solution. Gundars Kulups is Sales Director at DEAC, full service data center operator. An IT expert, he specializes in European countries and has worke...
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and ...
SYS-CON Events announced today that SOA Software, an API management leader, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. SOA Software is a leading provider of API Management and SOA Governance products that equip business to deliver APIs and SOA together to drive their company to mee...
As cloud gives an opportunity to businesses to buy services externally - how is cloud impacting your customers? In his General Session at 15th Cloud Expo, Fabio Gori, Director of Worldwide Cloud Marketing at Cisco, will provide answers to big questions: Do you see hybrid cloud as where the world is going? What benefits does it bring? And how does Cisco connect all of these clouds? He will also te...
SYS-CON Events announced today that TMCnet has been named “Media Sponsor” of SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Technology Marketing Corporation (TMC) is the world's leading business to business and integrated marketing media company, servicing niche markets within the communications and t...
SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, E...
We live in a time when seconds – even milliseconds – can have a dramatic economic impact on your company’s future. With technology being the primary conduit for consumer interaction, the user experience is at center stage. User experience will be a deciding factor in separating the future winners from the losers. By building more speed and agility into the application delivery process, DevOps prom...
SYS-CON Events announced today that AgilePoint, the leading provider of Microsoft-centric Business Process Management software, will exhibit at SYS-CON's 2nd International @ThingsExpo which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. AgilePoint is the leading provider of Microsoft-based Business Process Management (BPM) software products, has 1,...
SYS-CON Events announced today that Parasoft will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. For 27 years, Parasoft has researched and developed software solutions that help organizations deliver defect-free software efficiently. By integrating Development Testing, API/cloud/SOA/composi...