European Union

NICE Reverses Its Decision and Now Recommends Radium-223 (Xofigo) For Men Who Have Had Chemotherapy

According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy (castrate resistant prostate cancer) that has also spread to the bones. However, they only recommend it for these men if they've already been treated with chemotherapy. The Scottish Medicines Consortium (SMC), which operates independently of NICE, hasn’t yet considered radium-223 availability on the NHS in [...]

Enzalutamide (XTANDI) Now Approved in Europe for Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT) in whom chemotherapy is not yet clinically indicated. Europe now joins the United States in allowing Xtandi to be given to men who have not yet had chemotherapy. The rationales for this amendment are derived from the pivotal [...]

Dendreon Files for Chapter 11 Voluntary Bankruptcy Reorganization – Production Continues

It was announced this morning that Dendreon (the manufactures of Provenge) has filed for voluntary Chapter 11 Bankruptcy. After having spoken with a representative at Dendreon I have learned that the company has been in negotiations with its creditors and agreed to voluntarily file for financial reorganization. The agreement that Dendreon has reached with their creditors specifies that the reorganization will either allow another company to take over Dendreon to continue the production of Provenge or to privatize the company which will also continue the production of Provenge. Dendreon plans on fully continuing their operations, both providing commercial distribution and [...]

Provenge is Approved to Market in the European Union

It was announced today by Dendreon Corp. that the European Commission (EC) has granted marketing authorization for Provenge in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows recent positive opinions from both the European Medicines Agency or EMA Committee for Advanced Therapy and the Committee for Medicinal Products for Human Use urging that PROVENGE be granted marketing authorization in the EU. This approval covers the commercialization of Provenge in all 28 countries [...]

By | September 17th, 2013|Drugs & Treatments, European Union, Provenge, vaccines|0 Comments
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