Archives for June 25, 2007

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Preclinical services news in brief

By  Kirsty Barnes

In this week's review of recent activity within the preclinical research services arena, news has emerged involving Gendata, Achaogen, NiKem Research and Verona Pharma.

Alexion's drug first to get EU fast-track approval

By  Emilie Reymond

US biotech company Alexion has been given the green light by European regulators to market its new orphan drug Soliris (eculizumab) - the first therapy to be approved under the EU's new fast-track review process.

Three new 'biosimilars' to be launched in EU

By  Emilie Reymond

A European regulatory committee has recommended the approval of three generic versions of Johnson & Johnson's (J&J) anaemia blockbuster Eprex in what could lead to the market launch of new "biosimilars" by the end of the year.

Once daily Cialis comes up with the goods

By  Anna Lewcock

Eli Lilly's once-daily version of its erectile dysfunction treatment Cialis (tadalafil) has been granted approval by the European Commission, giving it a head-start over other ED treatments that are taken on an as-required basis.

FRAME aims for animal alternatives

By  Dr Matt Wilkinson

Research into new tools that will remove the need to use animals in medical research has received a £240,000 (€356,000) boost at the University of Nottingham.

Contract manufacturing news in brief

By  Emilie Reymond

Granules India, Dalton Pharma Services, Polymun, and CMC Biopharmaceuticals have all announced new contract manufacturing deals this week.

Bioxel submits DMF for docetaxel

By  Katrina Megget

Bioxel Pharma is the latest company to submit a Drug Master File (DMF) to the US Food and Drug Administration (FDA) for docetaxel in the lead up to the patent expiring on Sanofi-Aventis' version of the cytotoxic chemical at the end of this year.