Clinical Trial

FDA accepts MAA for Revlimid

12.05.2006

The EMEA has accepted a marketing authorization application for the Thalidomide analogon Revlimid® submitted by Celgene Corp. (Summit, USA) for review. The application for the treatment is based upon the safety and efficacy results of two large randomized pivotal Phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating the orphan drug plus dexamethasone in multiple myeloma patients that have received at least one prior therapy. Interim analysis showed that both studies achieved the primary endpoint of time-to-disease progression with combination therapy of lenalidomide and dexamethasone. Due to its teratogenic potential, the drug can only be obtained through a special programme (RevAssist).

Tech Review

12.03.2010

How much of you is you? In the habitat of the human body, the percentage of cells bearing your genetically distinct DNA is in the clear minority, vastly outnumbered by a host of microbes. Only around a tenth of the estimated 100...

BioPeople

12.03.2010

French immunology specialist TxCell S.A. (Valbonne) has appointed Miguel Forte as its Chief Medical Officer. Forte, who worked at UCB, Bristol-Myers Squibb and Nabi Pharmaceuticals, will be responsible for the clinical...

Clinical Trial

11.03.2010

Martinsried – German autoimmune and cancer specialist 4SC AG has started enrolment of 30 patients with incurable cancers for a Phase I study of its oral Eg5 kinesin spindle protein inhibitor 4SC-205. The dose-finding study will...

Clinical Trial

11.03.2010

Lachen – Swiss Octapharma AG has kicked-off the first of a series of pivotal Phase III studies for its new 10% high purity intravenous immunoglobulin (IVIG) in primary immune deficiency. The 5% solution of human recombinant...

Tech Review

11.03.2010

Genome engineering specialist Cellectis designs and markets meganucleases, which enable targeted modifications to DNA, with three primary aims: understanding, production and treatment. The technology platform surrounding these...

BioPeople

11.03.2010

BioPhausia (Stockholm) CEO Claes Thulin is leaving his post after 8 years in order to pursue other entrepreneurial activities. The change is supported by the company’s board, which has already begun the process of recruiting a...

Tech Review

10.03.2010

Molsheim – With a volume of US$36.687bn, according to the latest market report from Datamonitor, therapeutic monoclonal antibodies (mAbs) were once again the most important class of bio­pharmaceuticals in business terms in 2009....

Clinical Trial

10.03.2010

Basel – Amgen‘s RANKL blocker Prolia (denosumab) has achieved primary and secondary endpoints in a Phase III head-to-head comparison with Novartis’ bisphosphonate Zometa (zoledronic acid) in patients with bone metastases from...

Clinical Trial

10.03.2010

London – The European Medicines Agency (EMA) has outlined its strategy for facing current regulatory challenges. A 22-page draft for public consultation entitled “The European Medicines Agency Road Map to 2015 – the Agency’s...

Clinical Trial

10.03.2010

Basel/London – The EMA and Swissmedic have agreed to confidentially share information on post-marketing safety and efficacy issues related to H1N1 vaccines and drugs in mid-February.

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