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Once Again, Retained Rights In Federally Funded, Patented Drugs Will Not Be Asserted To Control Price
In a June 7, 2016, letter to Rep. Lloyd Doggett (D-TX), Secretary of Health and Human Services Sylvia Burwell again reaffirmed the agency's position that the exercise of march-in rights with respect to Xtandi was not appropriate.
United States
6 Jul 2016
2
What You Need To Know About Retained Rights In Federally Funded Patented Drugs
More than 50 members of Congress, led by Rep. Lloyd Doggett (D-TX), sent a letter to Secretary of Health and Human Services Sylvia Matthews Burwell and to National Institutes of Health (NIH) Director Francis Collins on January 11, 2016, urging the agencies "to utilize your existing statutory authority to respond to the soaring cost of pharmaceuticals" to address "price gouging" by pharmaceutical manufacturers
United States
1 Apr 2016
3
Limiting Antibiotic Use In Animals How States Are Taking Charge
While the FDA has received engagement of drug manufacturers who produce medically important antibiotics for use in animals, manufacturers have until the end of 2016 to fully comply with the FDA's guidance.
United States
29 Oct 2015
4
Many Questions For, But Not Many Answers From, The FDA On Biosimilars Implementation After Last Week's Hearing
The US Senate Committee on Health, Education, Labor and Pensions on September 17, 2015 convened a hearing entitled Biosimilars Implementation: A Progress Report from the FDA. Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research of the FDA appeared as the witness for the agency.
United States
2 Oct 2015
5
Identifying The Likely Beneficiaries Of An Emerging Biosimilars Market
Financial analysts have predicted that over the next five years, biosimilars will be a $10 billion market, so it is understandable why considerable attention and investment is being made in this space.
United States
3 Aug 2015
6
Biosimilars In The US: Hurdles To Progress
This client alert is the third of a three-part series that discusses hot topics to come out of the 2015 BIO International Convention.
United States
30 Jul 2015
7
For Biosimilars In The US, Interchangeability With The Innovator Reference Product Is The Goal, But There Is Still Much Work To Be Done
This client alert is the third of a three-part series that discusses hot topics to come out of the 2015 BIO International Convention.
United States
28 Jul 2015
8
Patients' Voices Carry: Drug Development Increasingly Driven By Patients' Needs And Concerns
With the recent announcement of Sarepta's filing for approval of its drug, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD), it has become clear that the role of patient advocates and patient-centered outcomes has had a significant favorable impact both upon the FDA and the development of products for rare diseases.
United States
27 Jul 2015
9
Patients' Voices Carry: Drug Development Increasingly Driven By Patients' Needs And Concerns
This client alert is the second of a three-part series that discusses hot topics to come out of the 2015 BIO International Convention.
United States
24 Jul 2015
10
When It Comes To Personalized Medicine (Or Precision Medicine!), There Seem To Be More Questions Than Answers
There is general recognition that as medicine becomes more tailored to the individual—whether through tumor analysis, pathogen sensitivity testing, or predicted drug response—cost of care and cost per treatment will rise...
United States
16 Jul 2015
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