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14 Total results for product and free and sample content found

Pink Sheet

Zolgensma Data Integrity Fallout

20 Nov 2019

Zolgensma Data Integrity Fallout

Novartis finds itself facing possible criminal or civil action for admitted data manipulation on its application for Zolgensma, a gene therapy used to treat children with spinal muscular atrophy (SMA) – manipulation disclosed only after FDA approval. Pink Sheet was the first to report on the drug’s loss of EU accelerated assessment, nearly 3 weeks before the pharma giant admitted to submitting falsified data to FDA. Follow the scandal and anticipate its implications on the industry with Pink Sheet’s coverage and timeline.

Topic Cell and gene therapy FDA

Datamonitor Healthcare

Webinar: Outlook for NASH Therapies and Market Dynamics

By Joseph Haas 04 Nov 2019

Non-alcoholic steatohepatitis (NASH) is poised to become an even greater epidemic and pharma companies of all sizes are competing to be the first to bring a NASH drug to market. Listen to an in-depth discussion about new and repurposed drug exploration treat NASH, as well as deal making, licensing and partnerships activity for the area.

Topic Cell and gene therapy Drug development landscape Drug approval

Scrip

Progress Being Made With Cell And Gene Therapy Market Access, But Challenges Remain

By Mandy Jackson 18 Oct 2019

Progress Being Made With Cell And Gene Therapy Market Access, But Challenges Remain

Drug developers and payers are coming together long before product approvals to work out payment options for high-cost, high-impact cell and gene therapies, but challenges like portability of commercially insured patients and Medicaid best price requirements remain.

Topic Cell and gene therapy Drug development landscape

Scrip

Payers Must Brace For Coming Wave Of Cell And Gene Therapies

By Mandy Jackson 18 Oct 2019

Payers Must Brace For Coming Wave Of Cell And Gene Therapies

One regenerative medicine for an ultra-rare disease may have a small impact, but payers will be flooded with dozens of new cell and gene therapies over the next few years. Enzyvant, Novartis and Spark share how they are positioning their complex products.

Topic Cell and gene therapy

Datamonitor Healthcare

Webinar: Manufacturing Challenges Facing Cell and Gene Therapy

By Amanda Micklus 27 Sep 2019

As more regenerative medicine products approach clinical testing and commercialization, seize this opportunity to hear detailed insights and industry best practices from preeminent sector experts. You’ll gain a deep understanding of numerous nurdles unique to bringing durable, curative therapies to patients in need.

Topic Cell and gene therapy

Scrip

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

By Jessica Merrill 11 Jun 2019

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

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.

Topic BioPharmaceutical Cell and gene therapy

Datamonitor Healthcare

Gene Therapy: A Paradigm Shift in Medicine

By Amanda Micklus 10 Apr 2019

Gene Therapy: A Paradigm Shift in Medicine

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.

Topic Cell and gene therapy

Scrip

Bayer Bosses Beg Risk-Averse Europe To Rethink

By Kevin Grogan 07 Mar 2019

Bayer Bosses Beg Risk-Averse Europe To Rethink

The German group believes it is going to be at the forefront of development in the cell and gene therapy space but is worried that Europe is failing to recognize the value that the pharma industry and its new technologies can create for society.

Topic Cell and gene therapy

Scrip

Competitive Strategies Critical As EMA Decides On Kymriah And Yescarta

By Neena ​ Brizmohun 22 Aug 2018

Competitive Strategies Critical As EMA Decides On Kymriah And Yescarta

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.

Topic Cell and gene therapy

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