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15 Total results for product and free and sample content found

In Vivo

From US To EU: Young Biotechs Going It Alone

By Jo Shorthouse 28 Nov 2019

Analysis

Europe’s patchwork of reimbursement agencies make it a daunting place for a small US biotech to do business. Traditionally large pharma partners or CMSOs have provided an experienced hand to hold, but as a new wave of gene therapies and orphan drugs get the EMA green light, smaller drug developers are applying innovation to commercialization and choosing to go solo.

Pink Sheet

US FDA's Regulatory Flexibility To Be Tested As Delcath Overhauls Melphalan Trial Design

By Sue Sutter 22 Aug 2018

US FDA's Regulatory Flexibility To Be Tested As Delcath Overhauls Melphalan Trial Design

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%.

Topic Clinical trials Drug approval Rare Disease FDA

Pink Sheet

Pharma Wants Clarity On Joint Evaluation Of EU Paediatric And Orphan Regulations

By Vibha Sharma 19 Jan 2018

Pharma Wants Clarity On Joint Evaluation Of EU Paediatric And Orphan Regulations

The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem.

Topic Rare Disease

Datamonitor Healthcare

Biosimilars in Inflammatory and Autoimmune Disease

12 Oct 2017

Biosimilars Development in Autoimmune and Inflammatory Diseases webinar

Topic Biosimilars Rare Disease

Scrip

Duchenne Muscular Dystrophy: The Race For The $1bn Opportunity

By Lucie Ellis 04 Oct 2017

Duchenne Muscular Dystrophy: The Race For The $1bn Opportunity

With three products now approved in Europe and/or the US for Duchenne Muscular Dystrophy

Topic Rare Disease

Datamonitor Healthcare

Future of Regenerative Medicine

25 Sep 2017

Future of Regenerative Medicine

Find out about the past, present and future of regenerative medicine. 

Topic Cancer Rare Disease

Pink Sheet

Orphan Biosimilar: Soliris Is One Target

14 Jun 2017

Orphan Biosimilar: Soliris Is One Target

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

Disease Awareness Campaigns Still Must Tread Carefully, Observer Says

By Mark W. Sherman 04 Jun 2017

Disease Awareness Campaigns Still Must Tread Carefully, Observer Says

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

BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs

By Emily Hayes 04 May 2017

BioMarin's Brineura Approval Shows FDA's Open Door For Orphan Drugs

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

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