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.
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, 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.
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.
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.
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.
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.
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 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.
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.