The US Food and Drug Administration has ordered Genzyme Corp to pay the government $175 million as a penalty for selling drugs that were manufactured at a plant in Allston, Massachusetts which had serious quality problems.
The US National Institute of Allergy and Infectious Diseases has awarded a grant to a San Diego, California-based company to progress new technology for fighting S. aureus by disrupting a signalling process called quorum sensing.
EMA prepares for first stem-cell application
The European Medicines Agency is inviting comment on a draft regulatory document for stem-cell therapies ahead of what is expected to be the first ever marketing authorisation application in Europe for such a therapy. At a workshop on 10 May 2010, Thomas Lönngren, the agency’s executive director, said the manufacturer of a stem-cell therapy has signaled its intention to seek approval for the product’s launch on the market. The regulatory review of the product will be informed by the new document, which is open for comment until 30 June. The document describes the proposed regulatory requirements for stem-cell therapies including the quality, non-clinical and clinical aspects. It also deals with subjects such as biodistribution. According to the EMA, there are about 40 clinical trials of stem-cell therapies underway in Europe exploring the regeneration of lost or damaged tissue, and in haematological or solid-organ malignancies. The majority of these trials use mesenchymal cells derived from adipose tissue, bone marrow, stromal cells and connective tissue. A small proportion is using haematopoietic stem cells.
New EU funding for regenerative medicine
The European Commission will be inviting researchers, including companies, to apply for a new tranche of funding in July under its Seventh Framework Programme (FP7). The call will include funds for clinical trials of regenerative medicines and for the application of new tools and technologies to these medicines. According to Charles Kessler, of the Commission’s research division, the new funding will be targeted at small and medium-sized enterprises. There will be a two-step application process, geared to the needs of small companies.
Advantages of iPS cells explained
One of the still-to-be explored applications of induced pluripotent stem cells (iPS) is their use in the treatment of monogenic diseases, according to Marc Peschanski, scientific director of the French research institute, I-Stem. Speaking at a European Medicines Agency workshop on 10 May, Mr Peschanski said iPS cells, which are embryonic-like stem cells created from adult somatic cells, could be used to treat inherited diseases that are controlled by a single pair of genes. The iPS technology could be used to create a bank of cell lines with different haplotypes which would be compatible with the immune systems of patients in need of a graft. “iPS [technology] allows us to go after specific donors with specific haplotypes,” Mr Peschanski commented.
Call for longer incubation for regenerative medicines
At a time when capital is scarce, inventors of new regenerative medicine technology should incubate this technology longer rather than rush to start up companies, according to Greg Bonfiglio, managing partner of Proteus Venture Capital. Speaking at a conference in London on 12 May, Mr Bonfiglio said money is tight for all but the most ‘pristine’ technologies and business plans. Investors are less willing to take risks now than before the start of the financial crisis. This means scientists should be keeping their technologies in translation centres for longer, even through Phase 2. Examples of translation centres are the UK’s Medical Research Council, the Fraunhofer Society in Germany and the California Institute for Regenerative Medicine, he said.
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Scientists at the J. Craig Venter Institute in the US have reported the successful construction of a self-replicating, synthetic bacterial cell, technology that could have future application to pharmaceuticals.
TPP Global Development Plc, a newly formed investor in spin-outs from research institutes and universities, has received a £9.6 million investment from the Scottish Venture Fund and other investors.
Astellas Pharma of Japan is paying $4 billion in cash to acquire the US biotechnology company, OSI Pharmaceuticals Inc, giving it rights to the cancer drug, Tarceva (erlotinib). The purchase price is a sweetened $57.50 per share.
The Belgian and Swedish developers of a new cancer antibody that targets the placental growth factor (PIGF) are set to receive a €10 million from Roche following the start of a new trial of the drug in patients with colorectal and ovarian cancer.
Pharming Group NV has reached a deal with former shareholders of its wholly-owned subsidiary, DNage BV, under which the shareholders will forego €10 million of earn-out payments due to them in return for 49% of DNage and 5 million Pharming shares.
Crucell NV is accelerating the development of its pipeline amid plans to increase spending on research and development by more than one-third in 2010. Overseeing the company’s R&D strategy is the new CMO, Jerald Sadoff.
Intercell AG is investing €15 million to acquire antibody technology directed at discovering new therapies for infectious disease including hospital-acquired infections. It is buying the technology from Cytos Biotechnology Ltd.