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16 Total results for product and free and sample content found

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

Alnylam Seeking Lumasiran Approvals Soon, But Has Two Rivals On Its Heels

18 Dec 2019

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: 医療用医薬品・医療機器産業の経営層向けニュース

From US To EU: Young Biotechs Going It Alone

28 Nov 2019

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: 世界の薬事規制と承認審査に関するニュース

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

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: 世界の薬事規制と承認審査に関するニュース

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

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: 医療用医薬品の市場調査レポート

Biosimilars in Inflammatory and Autoimmune Disease

12 Oct 2017

Biosimilars Development in Autoimmune and Inflammatory Diseases webinar

Topic biosimilars rare-disease

Scrip: 世界の医療用医薬品&製薬産業に関するニュース

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: 医療用医薬品の市場調査レポート

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: 世界の薬事規制と承認審査に関するニュース

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

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