FDA's stem cells authority
The US District Court for the District of Columbia has ruled that FDA has the authority to regulate stem-cell treatments as
drugs. The ruling paves the way for FDA to enforce oversight over the numerous stem-cell clinics that have come into existence
over the past few years.
EMA follow-up measures
The EMA is phasing out follow-up measures to marketing authorisations in place of a new classification system that will be
introduced in a stepwise manner. The EMA began reclassifying outstanding unclassified follow-up measures in August. Affected
marketing-authorisation holders will receive an outcome fax about the new classification.
In the coming years, the global industry is expecting more improved consistency among regulatory inspections; inspections
that are well-informed by global issues; and enhanced recognition and reliance upon inspections conducted by recognised health
authorities, which may reduce the total number of regulatory inspections at any one site.
The EMA has reported on the benefits of its increased interaction and cooperation with Japanese medicines regulatory authorities.
In particular, EMA says progress has been made in the are of orphan medicines and rare diseases. Paediatrics, advanced therapies,
pharmacogenomics, and nanomedicines have also benefited from the collaboration.
Read regular news updates at
UK invests in stem cells
The UK is investing €10.2 million in a centre that will be dedicated to stem-cell biology and medicine, with the aim of developing
therapeutic approaches to illnesses that have no effective treatments. A facility is being purpose-built for the institute
on the University of Cambridge's Biomedical Research Campus.
Silk protein innovation
Research from Tufts University in the US shows that silk protein can be used to stabilise and maintain the potency of vaccines
and other drugs without the need for refrigeration. Silk stabilisation preserved the efficacy of the measles, mumps and rubella
(MMR) vaccine, as well as penicillin and tetracycline, significantly better than other options.
Elan spins off discovery
Elan Corp. is spinning its discovery unit and Neotope Biosciences division, which is resposinble for the discovery of the
monoclonal antibody therapy Tysabri. The new entity will be called Neotope Biosciences and will focus on identifying and translating
targets into potential therapies for chronic degenerative and other related disease areas.
Novartis in cancer deal
Novartis is collaborating with the US's University of Pennsylvania to research, develop and commercialise targeted cancer
therapies. In particular, the two parties will focus on targeted chimeric antigen receptor (CAR) immunotherapies. As part
of the collaboration, Novartis and the university intend to jointly establish a new R&D facility.
See our latest blog posts at