19:55 , Oct 13, 2017 |  BioCentury  |  Regulation

Expanding the HAE tool kit

Despite an increasingly crowded market, hereditary angioedema patients who attended FDA’s Patient-Focused Drug Development meeting said there remains room for improvement in dosing convenience and reducing attack frequency. Two subcutaneous prophylactics that have completed Phase...
01:31 , Sep 2, 2017 |  BioCentury  |  Strategy

Breach of contract

Merck & Co. Inc. Chairman and CEO Kenneth Frazier’s resignation in August from a White House advisory council was an act of principle, and a reminder that 30 years ago Merck was one of the...
22:23 , Aug 11, 2017 |  BioCentury  |  Regulation

Foundation for inclusion

Hosting a patient-focused drug development workshop was the National Kidney Foundation Inc. ’s first step in assuming the role of facilitator to collect patient perspectives that will shape R&D for kidney disease. On Aug. 4,...
07:00 , Oct 31, 2016 |  BioCentury  |  Politics, Policy & Law

Debating drug prices

  A recent debate pitting two of the Democratic Party’s leading health policy experts against pharma advocates provides a glimpse of how a Hillary Clinton administration would follow through on her promise to rein in...
07:00 , Sep 28, 2015 |  BioCentury  |  Regulation

Serving nerves

Testimony at the first of FDA's patient-focused drug development meetings last week revealed that several programs in industry's pipeline for Huntington's disease are aligned with patient and caregiver desires for drugs that could halt progression...
07:00 , Jun 1, 2015 |  BioCentury  |  Regulation

Formalizing function

FDA agreed with patients at a workshop on functional GI disorders that patient-reported outcomes measures should tease out the relationship between symptom relief and corresponding quality of life. But doing so presents a catch-22 for...
08:00 , Feb 17, 2014 |  BioCentury  |  Regulation

Sickle cell suffering

There are two key takeaways from...
07:00 , Sep 30, 2013 |  BioCentury  |  Regulation

Wake-up call

Narcolepsy patients told...
07:00 , Jul 22, 2013 |  BioCentury  |  Regulation

Lopsided in lung cancer

There are two take-home messages from...
07:00 , Apr 15, 2013 |  BC Week In Review  |  Company News

PPL, Roslin Institute other research news

PPL and Roslin scientists produced 5 transgenic sheep using their nuclear transfer procedure (see BioCentury Feb. 24). Fibroblasts cultured from Poll Dorset sheep were transfected with a gene encoding a human plasma protein or a...