News

Complete response letter issued for anti-epileptic

Country
United States

The US Food and Drug Administration has issued a complete response letter for ezogabine, an investigational anti-epileptic drug, saying it cannot accept the application for marketing. GSK and Valeant Pharmaceuticals are the sponsors.

Round-up of European biotech funding

Country

Antibiotic projects aimed at tackling multi-drug resistant bacteria are among the novel programmes to have received funding from government institutions and venture capitalists in Europe recently. The following article summarises this seed funding, as well as financing for later-stage biotechnology projects.

SuppreMol GmbH closes €15.5 million Series C round

Country
Germany

SuppreMol GmbH, a 2002 spin-out of the Max Planck Institute for Biochemistry in Germany, has closed a €15.5 million Series C financing round to further clinical studies of its lead product for two autoimmune diseases.

J&J to start offer for Crucell despite manufacturing problem

Country
Netherlands

Johnson & Johnson Inc said it will start its previously-announced €1.75 billion offer for Crucell NV before 10 December despite an ongoing investigation into a manufacturing problem at a plant in Korea that has affected two Crucell vaccines.

EMA to make more documents public

Country
United Kingdom

The European Medicines Agency has taken further steps to give the public access to documents relating to the regulatory decision-making process. The new policy will be implemented in a two-stages from 1 December 2010.

Consultation starts on biosimilar mAb guideline

Country
United Kingdom

The consultation period has started for a guideline from the European Medicines Agency advising drug developers on the regulatory requirements for monoclonal antibody-containing medicines that claim to be similar to marketed biologics.

GSK raises investment in UK in response to tax measures

Country
United Kingdom

GlaxoSmithKline Plc has responded speedily to a new series of tax proposals from the UK government with a commitment to invest more than £500 million in manufacturing infrastructure in the country and to raise venture capital outlays.

GSK raises stake in US respiratory developer

Country
United Kingdom

GlaxoSmithKline Plc has raised its stake to 19% from about 12% in Theravance Inc, a US biopharmaceutical company with whom it has a collaboration in respiratory medicines. The transaction is valued at $129 million.

Novartis plans 30 regulatory submissions before end 2012

Country
Switzerland

Novartis International AG expects to make 30 regulatory submissions for new drugs before the end of 2012 as part of its plans to raise investment in original pharmaceutical research. Eight of these submissions will take place in 2010.

ViiV Healthcare pays $20 million milestone for HIV drug

Country
United States

A new non-nucleoside reverse transcriptase inhibitor (NNRTI) drug candidate against HIV has entered a Phase 2b trial triggering a $20 million payment from the ViiV Healthcare Company to Idenix Pharmaceuticals Inc of the US.