Scrip: 世界の医療用医薬品＆製薬産業に関するニュース

J.P. Morgan Notebook Day 1: Pfizer, Gilead, Alnylam, Novartis, Sarepta, Deal Trends And Cell Therapy Challenges

10 Jan 2019

News and notes from the 2019 J.P. Morgan Healthcare Conference. Pfizer CEO Bourla underscores need for scientific and commercial innovation, Gilead makes M&A a priority, Novartis' new R&D chief reflects on first meeting with CEO Narasimhan, Sarepta CEO Ingram clarifies regulatory path for micro-dystrophin, J.P. Morgan outlines deal and macro biopharma trends in 2019, and cell therapy panel discusses manufacturing challenges.

Datamonitor Healthcare: 医療用医薬品の市場調査レポート

Gene Therapy: A Paradigm Shift in Medicine

30 Nov 2018

The following analysis reviews several aspects of the gene therapy market. The history of gene therapy is briefly discussed, alongside a look at the trend in the volume of candidates in development over the past 20+ years, and how the regulatory landscape in the US and EU has recently adapted to help move the field forward. A deep dive into the pipeline with  breakdowns by delivery method and therapy area is provided, as are the key companies involved and the major partnership deals that have made gene therapy a hot commodity. Manufacturing, pricing, and reimbursement issues are also addressed.

Scrip：世界の医薬品産業ニュースサービス

Competitive Strategies Critical As EMA Decides On Kymriah And Yescarta

22 Aug 2018

With Novartis’s and Kite’s CAR T-cell therapies both expected to gain recommendations for pan-EU approval this week, discounts will need to be negotiated for these new treatments to reach the markets in Europe.

Pink Sheet：世界の薬事規制と承認審査に関するニュース

CAR-T Therapy In Medicare: National Coverage Policy Could Come In 2019

18 May 2018

Medicare begins analysis process for CAR-T cancer therapies in response to a request from United Healthcare for a national coverage policy.

Datamonitor Healthcare

Gene therapy

15 May 2018

Datamonitor Healthcare

Tapping into the potential commercial success of cell and gene therapies

By Pharma Intelligence 16 Nov 2016

Financing and deal trends, and clinical expectations and reimbursement issues in the regenerative medicine

Datamonitor Healthcare

Celgene opts in on Juno’s early-phase CAR-T therapies for $1bn upfront

By Zachary McLellan 02 Jul 2015

On 29 June 2015, Celgene and Juno Therapeutics announced a global collaboration for the development and commercialization of chimeric antigen receptor T cells (CAR-T) and T-cell receptor

Trialtrove

Recent Trends In Personalized Medicine

By Fern Barkalow 10 Mar 2014

To further encourage the use of biomarkers in clinical trials, the United States FDA issued additional biomarker guidance in August 2011 designed in part to help promote and harmonize biomarker development among regulatory agencies in the United States, European Union and Japan.