Opinion on Oncology in Europe

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Type Product title / description Pub Price
CommentWire
CommentWire

Eli Lilly: Gemzar gets Finnish approval

Regulatory officials in Finland have approved an expanded indication for Eli Lilly's [LLY] Gemzar (gemcitabine) in combination with paclitaxel for advanced breast cancer. Further EU and, most importantly, US approval should follow soon, providing Gemzar with a large range of indications and blockbuster status by the end of 2003.

Published By Datamonitor
02 Jul 2003
CommentWire
CommentWire

Merck KgaA: Erbitux applies for European approval

The controversial cancer drug Erbitux is likely to gain approval in Europe by next year, following Merck's [MRCG.F] filing of marketing authorization applications in Switzerland and the EU. This may also improve the drug's chances of receiving approval in the US, where an application has already been rejected once due to insufficient information.

Published By Datamonitor
07 Jul 2003
CommentWire
CommentWire

ImClone Systems: Erbitux fortunes rally

The submission of Erbitux for marketing authorization in the European Union and Switzerland is the latest indication of a rally in ImClone Systems' [IMCL] fortunes following a rocky eighteen months. The European results also put ImClone's US licensing partner, Bristol Myers Squibb [BMY], a in a better position to try again for FDA approval.

Published By Datamonitor
16 Jul 2003
CommentWire
CommentWire

Roche: Bondronat gains additional indication

Roche's [ROCZ.S] bisphosphonate drug Bondronat has been recommended for the prevention of bone complications in patients with breast cancer and bone metastases by the EU advisory committee. Market authorization would significantly increase the drug's patient potential, but it is unlikely to threaten the supremacy of Novartis' [NVS] Zometa.

Published By Datamonitor
28 Jul 2003
CommentWire
CommentWire

Novartis: bisphosphonate study should boost Zometa sales

A meta-analysis of bisphosphonate studies found that the drugs can lower skeletal morbidity in patients with metastatic disease. With Novartis' [NVS] Zometa recently gaining a sNDA for patients with bone metastases from advanced malignancies and this class of adjunct therapy becoming increasingly used, Zometa should be blockbuster by the end of 2003.

Published By Datamonitor
01 Sep 2003
CommentWire
CommentWire

Roche: poor results for NeoRecormon

Researchers have found that Roche's [ROCZ.S] anemia treatment NeoRecormon might worsen survival in head and neck cancer patients who undergo radiotherapy. Despite the poor findings, the study is unlikely to have any significant repercussions for NeoRecormon's rival erythropoietins, Amgen's [AMGN] Epogen and J&J's [JNJ] Procrit.

Published By Datamonitor
20 Oct 2003
CommentWire
CommentWire

Merck KGaA: good news finally for Erbitux

Swiss regulators have recommended the approval of Merck KGaA's [MRK.F] Erbitux as a second-line therapy for colorectal cancer. The drug is set to be approved within 30 days and Switzerland will be the first market to approve the drug. Given Erbitux's past difficulties, it is welcome news, not only for Merck, but also for ImClone [IMCL] and BMS [BMY].

Published By Datamonitor
17 Nov 2003
CommentWire
CommentWire

AstraZeneca: Faslodex on track for EU approval

Based on phase III clinical trial data, it looks highly likely that AstraZeneca's [AZN.L] Faslodex will receive EU-wide marketing approval in early 2004. In the long run this is likely to allow AstraZeneca to maintain its domination of the anti-estrogen market.

Published By Datamonitor
24 Nov 2003
CommentWire
CommentWire

Imclone/Merck KGaA: first approval for Erbitux

The Swiss agency for therapeutic products has approved Erbitux for the treatment of patients with colorectal cancer who no longer respond to standard chemotherapy treatment with irinotecan. This is likely to be followed by approval across Europe, where it should provide Merck KGaA [MRK.F] with annual sales of more than $260 million by 2008.

Published By Datamonitor
04 Dec 2003
CommentWire
CommentWire

Roche: improved potential for MabThera

A phase III clinical trial of Roche's [ROCZg.VX] MabThera (rituximab) in patients below 60 years of age with aggressive non-Hodgkin's lymphoma was halted early because its primary efficacy endpoint was met two years earlier than expected. These trial results are likely to consolidate MabThera's position as the best-selling innovative agent for cancer.

Published By Datamonitor
08 Dec 2003

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