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A weekly podcast highlighting the most important news developments and its impact on the orphan drug, cell and gene therapy world including research advancements, corporate events and regulatory changes.

Weekly Roundup: July 17, 2018

The U.S. FDA’s new guidance on gene therapy was recently announced by FDA Commissioner Dr. Scott Gottlieb, the P4A team discuss key implications of these guidelines along with an update on UK’s Brexit Whitepaper and new measures by the French government to improve patient access to innovative drugs.
Presenter: Joanna Fernandes
Contributors: Christina Poschen & Aparna Krishnan

Weekly Roundup: July 11, 2018

This week, the team discuss the U.S. Centres for Medicare & Medicaid Services withdrawing support for a novel payment model for Novartis’ Kymriah; Pfizer rolling back drug price rise in the U.S. and Axovant’s deal with Benitec Biopharma.
Presenter: Joanna Fernandes
Contributor: Aparna Krishnan

Weekly Roundup: July 4, 2018

This week, the P4A team discuss the CHMP approval of two CAR-T Therapies; Scotland’s new rules for ultra-orphan drugs and the reaction to the announcement of National Coverage Analysis for CAR-T drugs in the U.S.
Presenter: Max Rex
Contributors: Sophie Schmitz & Alison Kneen

Weekly Roundup: June 26, 2018

This week, the P4A team delve into the pharma industry’s proposal to the EU on the role of national HTA bodies post harmonization of clinical assessments for innovative drug technologies; the European Medicines Agency’s new portal for orphan drug designation applications and Ireland’s entry into the Beneluxa Initiative.
Presenter: Joanna Fernandes
Contributor: Aparna Krishnan

Weekly Roundup: June 19, 2018

The P4A team give a summary of the gene therapy FDA news this week and also discuss President Trump’s drug pricing plans for Medicare as well as UK cost watchdog NICE’s rejection of Crysvita.
Presenter: Max Rex
Contributors: Aparna Krishnan, Joanna Fernandes

Weekly Roundup: June 12, 2018

This week’s episode discusses the EU’s research and innovation budget; Italy’s AIFA responding to physician criticism of new guidelines and Oxford Biomedica’s $842 million deal with Axovant Sciences.
Presenter: Max Rex
Contributors: Aparna Krishnan and Joanna Fernandes

Weekly Roundup: June 5, 2018

This week, the P4A team discuss key advancements in oncology treatments – a genetic test indicating whether chemotherapy is beneficial in a particular breast cancer patient group and successful result of an immunotherapy using T cells in an advanced breast cancer patient. In addition, news involving a potential new sickle cell therapy under development.
Presenter: Max Rex
Contributors: Alison Kneen and Aparna Krishnan

Weekly Roundup: May 31, 2018

In its very first podcast of Rare Diseases Weekly RoundUp, P4A discusses the US FDA’s accelerated regulatory process for gene therapy; President’s Trump’s proposed drug pricing plan; the European Commission’s proposal to amend SPC; the NHS England budget ringfencing; Irish government’s attempt to trim the HSE and the new GDPR laws. Max Rex hosts with contributions from Aparna Krishnan, Corporate Affairs Lead and Alison Kneen, Vice President, International Operations.

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