Public-Private Partnerships and Neurological Diseases

08.16.13 | By

Despite the great medical advances of the last century, there is still a lot of work to be done when it comes to developing medications and treatments to deal with neurological disorders such as Parkinson’s disease. These conditions pose vexing challenges for researchers trying to unlock the secrets that will improve the lives of millions living with the daily challenges that neurological diseases pose.

Bringing Science to Life for Patients

08.15.13 | By

As I read the Wall Street Journal’s article this week on gene breakthroughs in cancer treatment, I felt a range of emotions. First was excitement. Decades of devotion to research have taken science to new heights and it’s important that people are aware of the tremendous progress that has been made. This awareness is what saved the life of Kellie Carey featured in the story.

Sustained Innovation Generated by the Biopharmaceutical Research Sector

08.09.13 | By

In case you missed it, a blog post and article published in Health Affairs by FDA officials earlier this week highlights 25 years of steady and sustained innovation generated by the biopha

Impact of Personalized Medicine on Patients

08.06.13 | By

Last week, I highlighted a Hill briefing hosted by the Personalized Medicine Coalition and the great examples it provided of the impact of personalized medicine on patients. I was reminded why we must advocate for policies that support continued progress against disease and fulfill the promise of personalized medicine.

Prescription Drug User Fee Rate Exceeds $2 Million per Application

08.06.13 | By

Last week, the U.S. Food and Drug Administration (FDA) announced the prescription drug user fee rates for FY2014 –$2.169 million per application requiring clinical data review.  This reflects a significant increase of more than 10 percent over the FY2013 rates – and a twenty-fold increase in the user fees established in the Prescription Drug User Fee Act (PDUFA) of 1992.

Request for Comments on Docket No. FDA-2013-N-0556

July 30, 2013

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Re: Docket No. FDA-2013-N-0556 – New Approaches to Antibacterial Drug Development; Request for Comments, 78 Fed. Reg. 105, 32669 (May 31, 2013)

Dear Sir or Madam:

Encouraging FDA to Utilize Existing Regulatory Flexibility to Facilitate the Development and Approval of New Antibacterials

08.05.13 | By

As noted in past Catalyst posts, the urgent need for new antibacterials is undisputed.  A recent article in Nature states that, “Health officials are watching in horror as bacteria become resistant to powerful carbapenem antibiotics — one of the last drugs on the shelf.”

MS Can’t Take Away Hope

08.02.13 | By

We recently released our Medicines in Development for Neurological Disorders report, which includes 38 medicines for multiple sclerosis (MS). It is a condition that impacts approximately 500,000 Americans. We recently had an opportunity to speak with Jodi Dwyer, a health activist who has MS and hope for a cure.

MS Can’t Take Away Hope

Industry Support for Exempting FDA User Fees from Sequestration

Washington, DC – August 1, 2013 – Today, Sen. Mark Pryor (D-AR), chairman of the Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies, and Sens. Roy Blunt, (R-MO), Daniel Coats (R-IN), Al Franken (D-MN), and Jerry Moran (R-KS) introduced S. 1413 to exempt future Food and Drug Administration (FDA) user fees from sequestration.  A similar bill, H.R. 2725, was introduced in the U.S.

Statement on Physician Payments Sunshine Act

WASHINGTON, D.C. (July 31, 2013) – Pharmaceutical Research and Manufacturers of America (PhRMA) Senior Vice President Matthew Bennett issued the following statement today:

“PhRMA is committed to the principles of the Sunshine Act and continues to believe that careful implementation is essential to ensuring that Sunshine fulfills its objective of usable, transparent, and understandable sharing of information.


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