| December 4, 2014 | ISSUE NUMBER 380 VOL 4 |
|
Special Feature
2014 Pharma and Biotech Trends in Review
Like all industries, pharma and biotech are facing industry-specific changes coupled with disruptive events in the external global environment. In this article, Peter Young highlights details from Young & Partners’ “Pharma and Biotech Strategic, M&A, and Financial Trends Report,” which covers the first three quarters of 2014 and the outlook for the future ...Read more
After several stops and starts, biosimilars are making inroads in the U.S. market. The FDA has established an approval pathway, and global biosimilar sales are expected to reach $24 billion by 2019. So what does biosimilar market entry mean? This  paper
examines three case studies of biosimilar-like drug introductions in the United States, offering insight on the specific circumstances and tactics that affected market share.
Ebola
Randomized Trials Key to Determining Effectiveness of Ebola Therapies & Vaccines
US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations. Anthony Fauci, director of the National Institute of Allergy & Infectious Diseases (NIAID), articulated the case for “gold-standard” randomized trials at a hearing before the House Energy & Commerce Health subcommittee last month. Jill Wechsler reports ...Read more
Best Practices for a Successful Global Access Program
Monday, January 12, 2015, 11:00 AM Eastern Standard Time
Click here
to Register Free.
Regulatory
Breakthrough Drug Successes Create Manufacturing Challenges
The US’s breakthrough drug initiative has accelerated the development and approval of highly effective therapies. Twelve breakthrough drugs have been approved over the past two years for several critical conditions in addition to cancer, and dozens more are in the pipeline. But the success has pressured manufacturers to address formulation, stability and quality production issues very early in development ...Read more
Applied Clinical Trials/Pharmaceutical Executive E-Book & Web Portal: Clinical Trial Data Sharing and Disclosure
This e-book features information from a recent conference of global thought-leaders in clinical data disclosure and transparency, which address current practices, potential challenges and solutions for pharmaceutical companies complying with the regulatory, ethical and legal issues around clinical trial data sharing.
Click
 here
to download the e-book. Click
here
to visit the web portal.
Global
Read the Pharm Exec Global Digest ‘Toward 2015’ Special
In this month’s issue: Europe and Transparency in 2015; Cloud Technology: a Five-Year Outlook; Brazil’s Revised Growth Forecast; Warehousing and the Future of the HCV Treatment Market; and more
...Read more
|
|
|
|
 //BioClinica (Newtown, PA) appointed John Hubbard, Ph.D., FCP, as Chief Executive Officer and a member of the Board of Directors. Dr. Hubbard, 58, will join from Pfizer, where he has served as Senior Vice President and Head of Worldwide Development Operations.//Idera Pharmaceuticals (Cambridge, MA) named Vincent J. Milano as CEO. Mr Milano previously served as Chairman, President and Chief Executive Officer of ViroPharma.//RaNA Therapeutics (Cambridge, MA) announced that its Board of Directors appointed Ronald C. Renaud, Jr., as Chief Executive Officer. Mr. Renaud most recently served as the President and Chief Executive Officer at Idenix Pharmaceuticals until its acquisition by Merck in August 2014.// |
|
|
|
|
|
 |
|
 |
 |
What role should the US government be playing in the Ebola outbreak?
|
|
|
|
