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16 Total results for product and free and sample content found
Scrip
Phase III results support early 2020 filings for what could be the RNAi specialist’s third commercial product, but two competing drugs for primary hyperoxaluria from Dicerna and OxThera aren’t far behind.
In Vivo
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
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
The European Commission's plans to evaluate the EU pediatric and orphan drugs regulation in tandem.
Topic Rare Disease
Datamonitor Healthcare
Biosimilars Development in Autoimmune and Inflammatory Diseases webinar
Topic Biosimilars Rare Disease
Scrip
With three products now approved in Europe and/or the US for Duchenne Muscular Dystrophy
Topic Rare Disease
Datamonitor Healthcare
Find out about the past, present and future of regenerative medicine.
Topic Cancer Rare Disease
Pink Sheet
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
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
No Records Found
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