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14 Total results for product and free and sample content found
Pink Sheet
By Sue Sutter 22 Aug 2018
Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
Pink Sheet
By Vibha Sharma 19 Jan 2018
The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem.
Topic Rare Disease
Datamonitor Healthcare
12 Oct 2017
Biosimilars Development in Autoimmune and Inflammatory Diseases webinar
Topic Biosimilars Rare Disease
Scrip
By Lucie Ellis 04 Oct 2017
With three products now approved in Europe and/or the US for Duchenne Muscular Dystrophy
Topic Rare Disease
Datamonitor Healthcare
25 Sep 2017
Find out about the past, present and future of regenerative medicine.
Topic Cancer Rare Disease
Pink Sheet
14 Jun 2017
Using lessons learned from the first wave of biosimilar approvals – and citing high prices in the US – some developers are starting to 'think small' with biosimilars for rare disease markets. Alexion’s Soliris is a case in point.
Topic Biosimilars Rare Disease Research
Pink Sheet
By Mark W. Sherman 04 Jun 2017
Sponsored plotline for General Hospital was careful to avoid irking US FDA; agency withdrew its guidance on disease awareness campaigns in 2015.
Topic Rare Disease
Pink Sheet
By Emily Hayes 04 May 2017
Filing supporting Brineura was supported by a tiny, single-arm study and had no advisory committee review, the latest sign of the US regulatory agency's willingness to speed orphan drugs for serious pediatric diseases.
Topic Rare Disease
Scrip
By Lucie Ellis 23 Mar 2017
Orphan drug development used to be considered a license to print money, with high price tags and a focused customer base. With the development of an increasingly tough orphan drug pricing environment in the US and Europe, biotechs are adopting new strategies. CNS drug developer Minoryx will introduce endpoints into its Phase II/III studies for rare brain disease X-ALD that should help demonstrate both efficacy and value for future pricing discussions.
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