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.
The European Medicines Agency’s scientific committee has issued a positive opinion for Pumarix, a mock-up vaccine that could be used in a new influenza pandemic. It is an adjuvanted vaccine that induces a response against the H5N1 antigen.
A group of US researchers has reported that breast cancer stem cells, which are thought to be resistant to current anti-cancer therapies, are stimulated by estrogen through a pathway that mirrors normal stem-cell development.
Compared with many other antibody companies, MorphoSys AG has taken the long route to therapeutic antibody development. Founded in 1992, the Munich-based company developed a library, a service business, and risk-sharing discovery partnerships with larger companies, before it brought its first proprietary antibody into the clinic in 2008. But could the proverbial tortoise be overtaking the hares?
Zealand Pharma A/S of Denmark has made an initial public offering of its shares on the Nasdaq OMX exchange in Copenhagen, one of the very few European biotechnology companies to seek a public listing in more than a year.